Laurie Zoloth

<h2>Summary</h2> The International Society for Stem Cell Research (ISSCR) task force that developed new <i>Guidelines for the Clinical Translation of Stem Cells</i> discusses core principles that should guide the responsible transition of basic stem cell research into appropriate clinical applications.

HomeCirculationVol. 129, No. 4Risk Stratification for Sudden Cardiac Death Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBRisk Stratification for Sudden Cardiac DeathA Plan for the Future Jeffrey J. Goldberger, MD, Anirban Basu, PhD, Robin Boineau, MD, Alfred E. Buxton, MD, Michael E. Cain, MD, John M. CantyJr, MD, Peng-Sheng Chen, MD, Sumeet S. Chugh, MD, Otto Costantini, MD, Derek V. Exner, MD, Alan H. Kadish, MD, Byron Lee, MD, Donald Lloyd-Jones, MD, Arthur J. Moss, MD, Robert J. Myerburg, MD, Jeffrey E. Olgin, MD, Rod Passman, MD, William G. Stevenson, MD, Gordon F. Tomaselli, MD, Wojciech Zareba, MD, PhD, Douglas P. Zipes, MD and Laurie Zoloth, PhD Jeffrey J. GoldbergerJeffrey J. Goldberger From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Anirban BasuAnirban Basu From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Robin BoineauRobin Boineau From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Alfred E. BuxtonAlfred E. Buxton From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Michael E. CainMichael E. Cain From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , John M. CantyJrJohn M. CantyJr From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Peng-Sheng ChenPeng-Sheng Chen From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Sumeet S. ChughSumeet S. Chugh From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Otto CostantiniOtto Costantini From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Derek V. ExnerDerek V. Exner From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Alan H. KadishAlan H. Kadish From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Byron LeeByron Lee From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Donald Lloyd-JonesDonald Lloyd-Jones From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Arthur J. MossArthur J. Moss From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Robert J. MyerburgRobert J. Myerburg From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Jeffrey E. OlginJeffrey E. Olgin From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Rod PassmanRod Passman From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , William G. StevensonWilliam G. Stevenson From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Gordon F. TomaselliGordon F. Tomaselli From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Wojciech ZarebaWojciech Zareba From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.C.); Summa Health System Cardiovascular Institute, Cleveland, OH (O.C.); CON-ECT Clinical Coordinating Centre, Calgary, Alberta, Canada (D.V.E.); Department of Medicine, University of California, San Francisco (B.L., J.E.O.); Department of Medicine (A.J.M.), and Department of Medicine Cardiology (W.Z.), University of Rochester Medical Center, Rochester, NY; Department of Medicine, University of Miami Health System, Miami, FL (R.J.M.); Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (W.G.S.); and Department of Medicine, The Johns Hopkins University Baltimore, MD (G.F.T.). Search for more papers by this author , Douglas P. ZipesDouglas P. Zipes From the Department of Medicine-Cardiology (J.J.G., A.H.K., R.P.), Department of Preventive Medicine (D.L.-J., R.P.), and Weinberg College of Arts and Sciences and Medical Humanities and Bioethics (L.Z.), Northwestern University, Chicago, IL; Department of Health Services and Pharmacy, University of Washington, Seattle (A.B.); National Institutes of Health, Washington DC (R.B.); Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (A.E.B.); Department of Medicine, University at Buffalo, The State University of New York, Buffalo (M.E.C., J.M.C.); Krannert Institute of Cardiology, Indiana University, Indianapolis (P.-S.C., D.P.Z.); Cardiac Electrophysiology Research, C

Human embryonic stem (ES) cells are valuable for biomedicine, but differing cultural, political, legal, and religious perspectives are potential barriers to international collaboration in this fledgling field. Recognizing the need for scientists to act transparently, to serve the public interest, and to preserve public trust, the International Society for Stem Cell Research (ISSCR) convened a task force to formulate guidelines for human ES cell research. The ISSCR guidelines were written by scientists, ethicists, and legal experts from 14 countries (1).

Building on 40 years of progress in cancer detection and treatment, survival rates for childhood cancers have risen from 20 % to almost 80 % [1,2]. Approximately 270,000 Americans are childhood cancer survivors and, by 2010, an estimated 1 in every 250 adults will be living with a history of childhood cancer [2,3]. The early and late effects of treatment are beginning to take on greater importance for survivors, their families and providers [4]. Increasing numbers of childhood cancer survivors are beginning to face a new challenge in returning to normalcy after cancer.

The purpose of this report is to offer investigators and members of SCRO and animal research committees well-grounded ethical standards for evaluating research involving the transfer of multipotent and pluripotent human stem cells and their direct derivatives into animal systems. This report is deliberately written in general terms so that its recommendations can apply to diverse institutions and international settings. Thus, investigators and reviewers should aspire to these proposed ethical standards while exercising appropriate judgment in individual situations.

Is it time to reassess the 14-day rule for human embryo research?

A potential impediment to evidence-based policy development on medical male circumcision (MC) for HIV prevention in all countries worldwide is the uncritical acceptance by some of arguments used by opponents of this procedure. Here we evaluate recent opinion-pieces of 13 individuals opposed to MC. We find that these statements misrepresent good studies, selectively cite references, some containing fallacious information, and draw erroneous conclusions. In marked contrast, the scientific evidence shows MC to be a simple, low-risk procedure with very little or no adverse long-term effect on sexual function, sensitivity, sensation during arousal or overall satisfaction. Unscientific arguments have been recently used to drive ballot measures aimed at banning MC of minors in the USA, eliminate insurance coverage for medical MC for low-income families, and threaten large fines and incarceration for health care providers. Medical MC is a preventative health measure akin to immunisation, given its protective effect against HIV infection, genital cancers and various other conditions. Protection afforded by neonatal MC against a diversity of common medical conditions starts in infancy with urinary tract infections and extends throughout life. Besides protection in adulthood against acquiring HIV, MC also reduces morbidity and mortality from multiple other sexually transmitted infections (STIs) and genital cancers in men and their female sexual partners. It is estimated that over their lifetime one-third of uncircumcised males will suffer at least one foreskin-related medical condition. The scientific evidence indicates that medical MC is safe and effective. Its favourable risk/benefit ratio and cost/benefit support the advantages of medical MC.

Human embryonic stem cells can divide indefinitely and have the potential to develop into many types of tissue. Research on these cells is essential to one of the most intriguing medical frontiers, regenerative medicine. It also raises a host of difficult ethical issues and has sparked great public interest and controversy.This book offers a foundation for thinking about the many issues involved in human embryonic stem cell research. It considers questions about the nature of human life, the limits of intervention into human cells and tissues, and the meaning of our corporeal existence. The fact that stem cells may be derived from living embryos that are destroyed in the process or from aborted fetuses ties the discussion of stem cell research to the ongoing debates on abortion. In addition to these issues, the essays in the book touch on broader questions such as who should approve controversial research and what constitutes human dignity, respect, and justice. The book contains contributions from the Ethics Advisory Board of the Geron Coroporation; excerpts from expert testimony given before the National Bioethics Advisory Commission, which helped shape recent National Institutes of Health policy; and original analytical essays on the implications of this research.

Who should go first in phase-I human trials when neither risks nor benefits can be estimated? By assessing concerns raised by Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar, we highlight a tragic dimension underlying all such trials. We discuss strategies to avoid the pitfalls of ethical hubris by promoting fidelity and trust. Who should go first in phase-I human trials when neither risks nor benefits can be estimated? By assessing concerns raised by Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar, we highlight a tragic dimension underlying all such trials. We discuss strategies to avoid the pitfalls of ethical hubris by promoting fidelity and trust. There is a profound moral question at the heart of all translational research: Who should go first in human trials when the risks are not possible to estimate, the trial highly observed, and the effects of failure far-reaching? This paper aims at addressing this question by unveiling the epistemological problem at its core. To this end, we will begin by considering a set of claims put forward in Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar's ethical assessment (Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar) of the first FDA-approved clinical trial that applies cells derived from human embryonic stem cells to patients (also discussed in the response from Geron authors, Wirth et al., 2011Wirth E. Lebkowski J.S. Lebacqz K. Cell Stem Cell. 2011; 8 (this issue): 476-478Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar). Second, we draw attention to some of the unresolvable ethical and epistemological challenges underlying any type of translational research involving human beings (Kimmelman and London, 2011Kimmelman J. London A.J. PLoS Med. 2011; 8: e1001010Crossref PubMed Scopus (82) Google Scholar, Perkel, 2011Perkel, J.M. (2011). First human trials of embryonic stem cell-based therapies head to the clinic. In StemBook, The Science Collaboration Framework, http://www.stembook.org/node/707.Google Scholar). This tragic dimension of all phase-I human trials is impossible to unroot and is reflected in the running title of our discussion (Solbakk, 2010Solbakk J.H. The tragic nature of biomedical ethics/La naturaleza trágica de la ética biomédica.Revista Redbioética/UNESCO. 2010; 1: 51-59Google Scholar). The critical focus of Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar's discussion is not the use of human embryonic stem cells per se, but the enrollment in a phase-I study of a group of patients deemed, in their eyes, as particularly vulnerable. Indeed, the arguments raised by Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar are used to support their objection to the trial's enrollment of patients diagnosed with subacute complete spinal cord injury (SCI); notably, the same patient population predicted to be among the eventual recipients of the putative therapy under investigation. Given that the authors do not question the justifiability of conducting phase-I trials with patients as participants, we presume that they acquiesce with the epistemological and ethical preconditions on which translational research involving human beings is based:•that the questions posed cannot be answered by restricting the search to in vitro and in vivo experiments using animals or even nonhuman primates, or cells thereof, or to in vitro studies employing human embryonic stem cells, and•that the protocol is essentially designed in a way to maximize “its yield of knowledge,” while at the same time minimizing the risks and uncertainties to which enrolled participants will be exposed (Kimmelman et al., 2006Kimmelman J. Baylis F. Glass K.C. Hastings Cent. Rep. 2006; 36: 23-26Crossref PubMed Scopus (17) Google Scholar). It is important to keep in mind that in translational research, uncertainty is not restricted to risk; i.e, to quantifiable forms of uncertainty: Nonquantifiable forms of uncertainty, as well as genuine ignorance, have to be taken into consideration as well. Consequently, it is important to distinguish between:•risk; i.e., uncertainty conceived of “as quantitative probabilities in a known sample space,”•strict uncertainty; i.e., uncertainty where the sample space is known, but probabilities of events cannot be quantified, and•ignorance; i.e., uncertainty where the sample space is not fully known (Rørtveit and Strand, 2001Rørtveit G. Strand R. Tidsskr. Nor. Laegeforen. 2001; 121: 1382-1386PubMed Google Scholar). The authors' main concern seems to be that the particular group of patients Geron has enrolled is exposed to the additional risk of losing the potential benefit of spontaneous recovery (Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar). However, as Wirth et al., 2011Wirth E. Lebkowski J.S. Lebacqz K. Cell Stem Cell. 2011; 8 (this issue): 476-478Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar discuss in their Forum article in this issue, in order to be eligible for the trial, which is designed to assess the safety and tolerability of GRNOPC1, prospective patients are assessed on multiple occasions according to the ASIA (American Spinal Injury Association) Impairment Scale (AIS). Specifically, the authors state that the “Geron clinical protocol includes several preinjection International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exams to ensure, to the extent feasible, that all participants are neurologically complete at the time of GRNOPC1 injection” (Wirth et al., 2011Wirth E. Lebkowski J.S. Lebacqz K. Cell Stem Cell. 2011; 8 (this issue): 476-478Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar). Furthermore, AIS patients with injuries assessed at grade A have only the smallest chance of recovery, and that is the reason the Geron study targets this group. “The ASIA Impairment Scale follows the Frankel scale, but differs from the older scale in several important respects. First, instead of no function below the injury level, ASIA A is defined as a person with no motor or sensory function preserved in the sacral segments S4-S5. This definition is clear and unambiguous.” (http://www.asia-spinalinjury.org, accessed on April 19, 2011). Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar also question the appropriateness of selecting this group as trial participants due to the relatively short time that has passed since the patients in question have suffered their cataclysm: “Seven to 14 days postinjury, which is the recruitment period for the Geron trial, is a time during which the patients who will have suffered an acute traumatic event will be experiencing stress, anxiety, fear, and depression in degrees proportionate to the severity of injury” (Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar). For this reason, the authors draw the conclusion that this group of patients is particularly susceptible to the trap of therapeutic misconception. In addition, they make the claim that these patients will, almost by definition, not understand the invitation to enroll in a way that is in compliance with proper informed consent requirements and with the principle of nonexploitation. The points raised by Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar are interesting and potentially relevant claims, but they suffer from insufficient substantiation. First, the contention that the enrollment of this group of patients might jeopardize the possibility of spontaneous functional improvement among a subgroup of these patients is not supported by any reference to relevant scientific studies. The only reference provided addresses challenges related to extending the basic ethical and epistemological requirement in phase III-trials—so-called “clinical equipoise”—to phase-I human trials in general, and can hardly be said to support the claim that this particular group of participants will be worse off than any other patient group (Anderson and Kimmelman, 2010Anderson J.A. Kimmelman J. Kennedy Inst. Ethics J. 2010; 20: 75-98Crossref PubMed Scopus (23) Google Scholar). Many clinical trials, because of their very nature, must be conducted with groups of patients who bear newly diagnosed illness or injury. All clinical trials in neonatal care, or emergency medicine, for example, face this same complex set of negotiations. Similarly, the authors' contention that this particular group of patients will be more susceptible to the trap of therapeutic misconception, and thereby to exploitation, than the alternative groups of patients they themselves propose comes out as rather speculative. So is the theory that targeting patients in the acute phase of their diagnosis renders adult subjects, however despairing they may be, incapable of making difficult and complex decisions about the moral choices they must confront. Certainly, such patients must already make decisions about their situation and their response from the moment they are conscious after their accident. In fact, a core admonition of bioethicists is to support maximal autonomous decision-making in patients. Moreover, it is unclear why duration of disease makes a patient less vulnerable, or less subject to inappropriate hope. Even less supportable is Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar's claim that chronic complete SCI patients represent a less-vulnerable group to target in this particular context. This group would under no circumstances benefit from such an enrollment, since the entire premise of the trial in question is based on the medical reality that the glial scar that forms across the spinal cord makes it highly unlikely that neuronal stem cells could restore function. In fact, by suggesting that chronic complete SCI patients are more suitable for testing safety, the authors indirectly acknowledge that it is, ethically speaking, more justifiable in a research context to use a group of patients merely as a means of generating scientific knowledge (here: safety) that will be of no relevance whatsoever to the trial subjects themselves, than to use an alternative group of patients for acquiring knowledge about safety, while at the same time at least not excluding the possibility that some kind of functional benefit might also take place. The FDA's approval of the Geron trial as a phase-I clinical trial was partly based on the fact that besides assessing safety, an additional endpoint was to look for evidence of change in function (see www.clinicaltrials.gov, trial identifier NCT01217008, accessed April 19, 2011). For this reason, the enrolled patients will be followed for 15 years to track both change and durability of change in function, in addition to long-term safety. Notably, in spite of their concerns about subacute SCI patients being more susceptible to the trap of therapeutic misconception and of exploitation than chronic SCI patients, Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar proceed to suggest that subacute incomplete SCI patients should be preferred over subacute complete SCI patients in efficacy tests. This position invalidates their initial argument about “subacuteness” not being in compliance with proper informed consent requirements and with the principle of nonexploitation. Furthermore, the list of potential adverse effects that the authors use to argue against the trial enrollment of acute chronic SCI patients is as relevant for any other patient group, including the three groups that they themselves suggest—chronic complete SCI patients, subacute incomplete SCI patients, and multiple sclerosis (MS) patients. Of particular concern is the suggestion that first-use trials should take place in patients with chronic, deteriorating MS—a condition for which the animal models are limited (Mathews et al., 2008Mathews D.J. Sugarman J. Bok H. Blass D.M. Coyle J.T. Duggan P. Finkel J. Greely H.T. Hillis A. Hoke A. et al.Neurology. 2008; 71: 288-293Crossref PubMed Scopus (54) Google Scholar), and for which no FDA documentation has been filed. Finally, Anderson and Kimmelman's observation that, so far, “no widely accepted standards for judgments of risk, benefit, and value in Phase I trials” have seen the day (Anderson and Kimmelman, 2010Anderson J.A. Kimmelman J. Kennedy Inst. Ethics J. 2010; 20: 75-98Crossref PubMed Scopus (23) Google Scholar), draws attention to an underlying tragic dimension of translational research from which there is no resolution in terms of compromise or mediation. That is, it can certainly be viewed as tragic that, in order to eventually translate basic research into clinical applications, patients must be enrolled into an interim study phase designed not to offer benefit, but to obtain knowledge about safety. Although this step, hopefully, in its turn, will make a clinical trial in compliance with the basic epistemological and ethical requirement of therapeutic trials (i.e., clinical equipoise) possible, it is our contention that no widely accepted standards for judgments of risk, benefit, and value in phase-1 trials in compliance with this basic requirement will become reality. This failure, we believe, relates to the fact that phase-I trials will always contain a tragic dimension from which there is no ethically neat or risk-free course. That is, bringing basic research into clinical application cannot bypass the phase-I study step, at least not in jurisdictions with rigorous policy formation and enforcement. Such is the nature of resolution in relation to the complex challenges raised by phase-I trials involving patients; when the work is done, moral doubt and epistemological ambiguity will still remain (Solbakk, 2010Solbakk J.H. The tragic nature of biomedical ethics/La naturaleza trágica de la ética biomédica.Revista Redbioética/UNESCO. 2010; 1: 51-59Google Scholar). Our contention is that there are no standards whatsoever that will be able to fully resolve these enigmas. Research on humans will inevitably have an existential moment at which it must be begun, and taking this step will always require deep courage and serious altruism on the part of those individuals who volunteer to participate, persons whom researchers cannot fully rescue from their fragility as patients in crisis, and patients for whom the choice to participate or not can represent an important moral option. Nothing that a critic can say, and no set of regulations can change this fundamental reality and instrumentality of all translational research. It is simply unavoidable that the abrupt, stark negative change to one's condition is an inherent component of the severe trauma or sudden illness that is the setting for much of this research. A set of patients for whom hope is completely impossible, knowledge is rationally organized, and all risks fully understood has simply never been found—and a quixotic search for them will only postpone the time when the full duty of research must be confronted and the actual population of persons for whom the intervention might offer respite must be tested. This requirement seems especially necessary in this case, given that a 15-year follow-up is part of the research design. Criteria for determining the most appropriate first human use for translational research will be an ongoing discussion, and in the case of stem cell research, so wrapped in competing political and religious appeals, so yearned for and so long promised, patient selection and research design must be a matter of robust discourse. We suggest that this discourse needs two caveats. First, bioethicists are “strangers at the bedside” (Rothman, 1999Rothman D. Strangers at the Bedside. Basic Books, New York1999Google Scholar) and thus should not be the people who design the science. This error marked the early debates in the field in which nonscientists suggested experimental approaches to “create morally acceptable embryos” in the lab, which were not actually possible to make scientifically (Hurlbut, 2007Hurlbut W.B. BioDrugs. 2007; 21: 79-83Crossref PubMed Scopus (8) Google Scholar). In our estimation, Bretzner et al., 2011Bretzner F. Gilbert F. Baylis F. Brownstone R. Cell Stem Cell. 2011; 8 (this issue): 468-475Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar fall prey to this same error by suggesting the use of “morally acceptable,” but not medically necessary, groups of patients for the initial safety trial of GRNOPC1 cells. Second, the language of virtues needed to confront the tragedies of translation needs to include a call for the long and patient commitment to structure support for participants in clinical trials. We suggest a principle of fidelity (Zoloth, 2010Zoloth L. Crossing the Border at Nightfall: The Schiavo Case, Faith and Ethics, Chapter 7. The Case of Terry Schiavo: Ethics, Politics and Death in the 21st Century. Oxford University Press, Oxford, UK2010Google Scholar) in which researchers make moral promises to not only remain in contact with subjects, but promise to “stand with” subjects over time and throughout changing conditions of illness. Will the research yield either short-term or durable benefit, however small? Will the research cause terrible harm, or even moderate increase in human suffering now or in the future? We cannot say, and we cannot design a way to know without asking and risking. We can, however, insist that this is a social relationship in which the investigators and the watching public have a duty to witness and respond to whatever need may arise. Furthermore, the risk of failure must not be borne by patients alone, but shared as much as possible by the investigators who also stand to gain in light of clinical success. In calling for fidelity, we expand our moral universe beyond the moment of instrumental use, and raise the issue of the enduring relationship between subjects, researchers, and society that has long been an unspoken part of the research enterprise. Consequently, we find that in the interim phase between basic research and applied therapy, we are left with a complex mixture of scientific ambition, different forms of uncertainty (risk, strict uncertainty, ignorance, and benefit), and fallibility. The challenge, therefore, is not to stop, but to describe the inherent pitfalls of translation in a way that is in compliance with the principles of transparency, accountability, and minimization of harm to implicated patients, and to stand together, shoulder to shoulder, throughout the journey in order to finally witness and enjoy the culmination of the medical potential that stem cells have promised.

Improvements in cancer treatment have changed the way in which cancer is viewed and experienced. However, these same treatments have led to numerous early and late effects, including the loss of fertility. Infertility can influence the biologic and psychologic health of both male and female survivors. Reproductive science can now offer methods to address this concern and provide promising new approaches that may eliminate or mitigate this treatment-related outcome. For current and future reproductive options to serve the needs of survivors more fully, health providers must understand the complexities of infertility as well as their role in delivering answers their patients require. This review will discuss what is known about the causes and experience of infertility among cancer survivors as well as the forms of fertility preservation available.

The prevention and relief of suffering has long been a core medical concern. But while this is a laudable goal, some question whether medicine can, or should, aim for a world without pain, sadness, anxiety, despair or uncertainty. To explore these issues, we invited experts from six of the world's major faith traditions to address the following question. Is there value in suffering? And is something lost in the prevention and/or relief of suffering? While each of the perspectives provided maintains that suffering should be alleviated and that medicine's proper role is to prevent and relieve suffering by ethical means, it is also apparent that questions regarding the meaning and value of suffering are beyond the realm of medicine. These perspectives suggest that medicine and bioethics have much to gain from respectful consideration of religious discourse surrounding suffering.

Oncofertility is one of the 9 NIH Roadmap Initiatives, federal grants intended to explore previously intractable questions, and it describes a new field that exists in the liminal space between cancer treatment and its sequelae, IVF clinics and their yearning, and basic research in cell growth, biomaterials, and reproductive science and its tempting promises. Cancer diagnoses, which were once thought universally fatal, now often entail management of a chronic disease. Yet the therapies are rigorous, must start immediately, and in many cases result in premature failure of the body's reproductive ability. In women, this loss is especially poignant; unlike the routine storage of sperm, which is done in men and boys facing similar treatment decisions, freezing oocytes in anticipation of fertility loss is not possible in most cases, and creating an embryo within days of diagnosis raises significant moral, social and medical challenges. Oncofertility is the study of how to harvest ovarian tissue in women facing cancer to preserve their gametes for future use with IVF, thus allowing the decisions about childbearing to be deferred and reproductive choices to be preserved. The research endeavor uses the capacity of the ovarian follicle to produce eggs in vitro. Developing the human follicle to ovulate successfully outside the body is scientifically difficult and ethically challenging. Infertility is linked to long-standing religious and moral traditions, and is intertwined with deeply contentious social narratives about women, families, illness and birth. Is the research morally permissible? Perhaps imperative if understood as a repair from iatrogenic harms? How are considerations of justice central to the work? How will vulnerable subjects be protected? What are the moral implications of the work for women, children and families? What are the implications for society if women could store ovarian tissue as a way of stopping the biological clock? What are the moral possibilities and challenges if eggs can be produced in large quantities from a stored ovarian tissue?

Oncofertility has emerged as a way to address potential lost or impaired fertility in cancer patients and survivors, with active biomedical research that is developing new ways to help these individua

Engineering biology is being applied toward solving or mitigating some of the greatest challenges facing society. As with many other rapidly advancing technologies, the development of these powerful tools must be considered in the context of ethical uses for personal, societal, and/or environmental advancement. Researchers have a responsibility to consider the diverse outcomes that may result from the knowledge and innovation they contribute to the field. Together, we developed a Statement of Ethics in Engineering Biology Research to guide researchers as they incorporate the consideration of long-term ethical implications of their work into every phase of the research lifecycle. Herein, we present and contextualize this Statement of Ethics and its six guiding principles. Our goal is to facilitate ongoing reflection and collaboration among technical researchers, social scientists, policy makers, and other stakeholders to support best outcomes in engineering biology innovation and development.

Bioethics consultation is flourishing in the private sector. The corporate clients are aware that their work raises substantive ethical issues, and often they are concerned about how their response to these issues may affect their public image and their financial standing. Many are prepared to compensate ethics consultants at substantial rates. This is a new phenomenon for the field of bioethics. Traditionally, most requests for comment and analysis arose within the academic setting, where compensation for consultation is generally modest, if it is offered at all. But consultations are not new. Bioethicists have provided clinical consultations on individual cases and on policy development within academic medical centers, health care delivery systems, and community health care institutions. (1) They have consulted about the design and conduct of clinical trials for public and private funding agencies and have participated on institutional data and safety monitoring boards for those trials. (2) They have also participated as consultants for governmental, quasi-public, and private-foundation working groups developing guidelines for the ethical practice of medicine, biomedical research, and health policy. (3) What distinguishes this newest form of bioethics consultation are several features: * the consultation is sought by a for-profit client, not by an academic institution (although this distinction loses force as patents, profits, and biotechnology come increasingly to characterize the academy); * the issues have potential financial implications for the clients; * the consultant is offered a substantial fee and perks for the consultation; and * the consultant is not a full-time employee of the client (full time consultancy relations raise still other issues, beyond the scope of this report). Examples of the types of arrangements considered in this report include: * serving as a member of an ongoing bioethics board such as the Geron Ethics Advisory Board or the DNA Sciences Ethics Advisory Board; (4) * serving as art ad hoc advisor about a company's research programs or product development, as in the AbioCor Independent Patient Advocacy Council and Pfizer's Advisory Panel on Viagra; (5) and, * developing background analyses that identify ethical issues and possible corporate responses, as has been done for Framingham Genomic Medicine and by Dupont's Advisory Panel on Biotechnology. (6) Educational sessions, public performances, and agent-negotiated after-dinner speaking engagements fall outside this list and are not reached by this text. But as academic institutions anti not-for-profit corporations begin acting more like for-profit firms, they will fall within the guidelines suggested below. There are those who have thoughtfully and seriously challenged this new role of bioethicists. (7) In part, these commentators are concerned about the appropriateness of ethicists who should have broader interests, such as concerns about social justice, serving clients whose primary interest is profit-maximizing. This concern is heightened when it is suspected that the consultation is not a genuine request for advice, but rather just an effort to justify what is planned anyway. In part, too, the critics are concerned about the increased conflicts of interest created by the substantial fees available in the private sector. Finally, they are concerned about the effect that these new consultations may have on both the integrity of the field and its reputation for objectivity, independence, and impartiality. Some are worried about the effect that even the appearance of a conflict might have on the reputation of the field. While some might regard these concerns as inherent in the process of bioethics consultation, others see these problems as unique to this new type of consultation. …

This chapter seeks to explain our preliminary reflections on how different religious communities might use their texts and traditions to respond to and assess the ethics of oncofertility research and technologies. Specifically, this chapter will briefly explore the Catholic, Evangelical Christian, Muslim, Jewish, Hindu, and Buddhist traditions and their anticipated or potential contributions to the ethical discourse surrounding oncofertility. The chapter will sketch a few characteristic principles and describe some preliminary responses from practitioners that may guide each religion's traditional stances toward reproductive technologies and procreation. The material presented herein builds upon exploratory research by two classes of undergraduate students at Northwestern University. The author's additional research sought out additional sources and considered additional religious traditions. The students' research included interviews with local ministers, rabbis, faith communities, including campus ministers, and also student participants in various religious traditions. The clergy, intrigued by the questions raised by the research, suggested some of the preliminary sources and general directions pursued in this chapter.

Abstract Background Recent attempts in the USA and Europe to ban the circumcision of male children have been unsuccessful. Of current concern is a report by the Tasmanian Law Reform Institute (TLRI) recommending that non-therapeutic circumcision be prohibited, with parents and doctors risking criminal sanctions except where the parents have strong religious and ethnic ties to circumcision. The acceptance of this recommendation would create a precedent for legislation elsewhere in the world, thereby posing a threat to pediatric practice, parental responsibilities and freedoms, and public health. Discussion The TLRI report ignores the scientific consensus within medical literature about circumcision. It contains legal and ethical arguments that are seriously flawed. Dispassionate ethical arguments and the United Nations Convention on the Rights of the Child are consistent with parents being permitted to authorize circumcision for their male child. Uncritical acceptance of the TLRI report’s recommendations would strengthen and legitimize efforts to ban childhood male circumcision not just in Australia, but in other countries as well. The medical profession should be concerned about any attempt to criminalize a well-accepted and evidence-based medical procedure. The recommendations are illogical, pose potential dangers and seem unworkable in practice. There is no explanation of how the State could impose criminal charges against doctors and parents, nor of how such a punitive apparatus could be structured, nor how strength of ethnic or religious ties could be determined. The proposal could easily be used inappropriately, and discriminates against parents not tied to the religions specified. With time, religious exemptions could subsequently be overturned. The law, governments and the medical profession should reject the TLRI recommendations, especially since the recent affirmative infant male circumcision policy statement by the American Academy of Pediatrics attests to the significant individual and public health benefits and low risk of infant male circumcision. Summary Doctors should be allowed to perform medical procedures based on sound evidence of effectiveness and safety with guaranteed protection. Parents should be free to act in the best interests of the health of their infant son by having him circumcised should they choose.

Recently, the gene therapy field has begun to experience clinical successes in a number of different diseases using various approaches and vectors. The workshop Gene Therapy: Charting a Future Course, sponsored by the National Institutes of Health (NIH) Office of Biotechnology Activities, brought together early and mid-career researchers to discuss the key scientific challenges and opportunities, ethical and communication issues, and NIH and foundation resources available to facilitate further clinical advances.

This commentary examines the relationship between genetics and Jewish identity. It focuses especially on the use of Y-chromosome testing to map the genealogies of the Lemba in southern Africa.

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on the early stages of the research (members of the IRBs, the Geron Ethicist Advisory Board, and the National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate.

Although various aspects of clinical ethics consultation have been discussed in the literature, there has yet to be sustained systematic debate about the fundamental philosophical and methodological issues at stake in doing clinical ethics. Arguing that the field of clinical ethics is at ta critical crossroads, the author of this article outline the core issues that need to be addressed, debated, and resolved in order for the field to secure a meaningful future.

Posthumous reproduction is an issue fraught with legal, ethical, religious, and moral debate. The involvement of the hospice and palliative care community in this debate may be peripheral due to the fact that other health care professionals would be actually delivering the services. However, the hospice and palliative care community are more likely to treat patients considering posthumous reproduction as they near the end of their lives. This article provides the hospice and palliative care community with a review of the medical, ethical, and legal considerations associated with posthumous reproduction. Having knowledge of these issues, and a list of available resources, will be useful if hospice and palliative care staff find themselves facing a patient or family that is considering posthumous reproduction.

This report considers whether research involving the creation of human-animal interspecies somatic cell nuclear transfer (iSCNT) embryos raises new ethical issues, and if so, whether it requires additional or special criteria and oversight distinct from research on human-animal chimeras.

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reoect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory Board, and the National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate.

In contemporary society, translational medical research is the name of hope itself. For many, advances in modern medicine can be seen as a steady progression of science over dreadful and intractable illnesses, especially illness of children and young adults. Advances in the creation of families and protection of children have most clearly marked medicine’s success. Yet every scientific discovery and medical advance carries with it the inevitable dilemmas of choice and power. This chapter will look carefully at the effect on treatment when two trajectories of translational research converge to form a new field of inquiry—the field of oncofertility—and explore the ethical and social implications of the power that such research will create.

If you go running in Chicago in the early morning, as the first light glances and reflects on Lake Michigan, you can hear the great flocks of wild geese stirring and calling before you can see them. They have come down from the Artic where as the winter comes to the Midwest, just as the flu season begins. They crowd in the cove with the gulls and the dogs run toward them, and they scatter and fill the air. They will land at the high school in town, in the farms along the interstate, and in the City zoo, with the ducks and the pigeons. A pandemic that (hopefully) has not yet occurred dominates the newspaper headlines this winter—avian flu. Avian flu is on the front cover of most popular magazines, and news agencies like CNN frequently report on the spread of avian flu around the globe: an infected parrot found in Britain, a swan in Belgium, a flock of ducks in Turkey. There are also reports from China about a group of children with pneumonia who initially test positive for H5N1, the scientific name for the strain of influenza known as avian flu. Even before the test results are confirmed, tens of thousands of chickens in the region are killed, just in case (CDC 2005; Russert 2005). Avian flu also tops the agenda at the European Union, the United Nations, and the White House. As we were writing this article, the United States Congress added a billion dollars to the proposed flu budget, the World Health Organization met to craft a plan to stockpile vast amounts of the anti-viral drug Tamiflu (even though we don’t know if it is effective against the H5N1 strain), and the American Centers for Disease Control proposed new regulations requiring airlines and shipping companies to maintain electronic records of all passengers. Nevertheless, America lags far behind many other countries in preparing for a potential pandemic. Despite four years and billions of dollars spent on Operation Bioshield, we’re still putting our faith in a flu vaccine prepared by using 19th century technology and chicken eggs as the base medium How should bioethics think about the problem of avian flu, as the fear of its coming rises like the call of the geese in the wintering air? There are two equally powerful narratives we encounter when we reflect on the ethical dilemmas raised by the growing crisis about H5N1 and the threat that it will mutate into a pandemic viral disease that will alter human history. The first scenario involves what we call “feverish thinking”—namely, that flu fears are an absurd moral panic, the latest hyped-up fear campaign to divert us from real problems in health care, such as the malaria, tuberculosis and infant diarrhea that kills millions of people every year. In this story, the risk of the H5N1 stain of influenza mutating into a variant that would pose danger to humans is so extremely small as to be meaningless. Furthermore, the way the modern medicine is structured with our ICUs and our ventilators and our antiviral drugs and our ability to quarantine means that pandemics cannot affect the world in the same way that the 1918 pandemic did. Hence, to worry about avian flu is to be duped. In this story, the ethical issue is about how to refocus our attention on the real issues. The second scenario is what we call “fair warning.” We are now faced with the very disaster that we have been warned about for decades. As Gina Kolata warned in her 1999 book, “perhaps as we grow smug about influenza, that most quotidian of infections, a new plague is now gathering deadly force” (Kolata 1999). The emergence of a new strain of influenza, H5N1, is closely linked by virulence, genetics and epidemiology to the 1918 strain that killed 50 million worldwide, nearly 5% of the world’s population (Frist 2005). The 1918 pandemic also sickened millions more, overwhelming the American health care system, stopping most modern commerce, and even bringing an abrupt halt to World War I (Barry 2004).According to this narrative, we need to reflect immediately on what to do to prevent another pandemic and set in place a fair and just system that will distribute limited health care resources in order to save the greatest number of lives. Getting it wrong is an all-or-nothing problem—if we turn from the tasks that our second narrative suggests and the worst (or even the pretty dreadful) happens, we truly will have failed. Overreacting will have a far less catastrophic effect for, at the worst, we could end up thinking about how to create a health care system that is responsive to and serves the interests of the majority of the peoples of the world. Planning for pandemic disease might actually allow Americans to end up with things that they need, such as an effective public health system that serves poor and marginalized populations, a coherent system for delivering of a decent minimum of health care access and service to all, a systematic way of organizing and distributing medical data, a plan for the production and wide-scale distribution of vaccines, and a deeper respect for how genetic medicine and a firm grasp of evolutionary biology can be useful.

A substantial portion of the developed world’s population is increasingly dependent upon machines to make their way in the everyday world. For certain privileged groups, computers, cell phones and PDAs, all permitting the faster processing of information, are commonplace. In these populations, even exercise can be automated as persons try to achieve good physical fitness by riding stationary bikes, running on treadmills, and working out on cross-trainers that send information about performance and heart rate.

In this essay, the author considers how one particular faith community, contemporary Judaism, in all its internal diversity, has reflected on the issue of how far the project of genetic intervention ought to go when the subject of the future--embodied, willful, and vulnerable--is at stake. Knowing, naming, and acting to change is not only a narrative of faith traditions; it is a narrative of biological science as well.

In September 2007, Northwestern University's Feinberg School of Medicine received a $21.1 million dollar, 5-year grant from the National Institutes of Health to fund the Oncofertility Consortium (OFC). Over the course of the grant, those engaged with the psychological, legal, social, and ethical issues arising from oncofertility provided recommendations to the OFC. The inclusion of serious, real-time consideration of ethical issues as a funded focus of the grant and the work of scholars in law, bioethics, and economics was a key part of the process of research. Now that this grant has ended, this commentary points to some of the issues that came forward during the 5 years of this project. Because of the emerging status of oncofertility, these issues are ones that need continued discussion and clarification, prompting our call for an oversight mechanism to provide guidance for how this technology should proceed. An initial draft of this commentary arose from notes taken during a small colloquium held to discuss the oversight of oncofertility following the conclusion of the grant. This colloquium occurred in the fall of 2011. Using these notes as a starting point, the draft was then sent to other researchers who had been involved with the OFC in considering the psychological, legal, social, and ethical issues related to fertility preservation for cancer patients during the course of the grant. Finally, this commentary was further framed by the authors' review of existing published and gray literature regarding issues concerning fertility preservation for cancer patients. We provide several points to consider and then offer two suggestions for an oversight mechanism for research as it continues. We assert the need not just for guidelines for the clinical practice of oncofertility, but also for oversight of the scope of this emerging technology because of its profound implications. We recognize that many long to a have a child and form a family and that, for some, cancer interrupts this path. With the conclusion of this grant, we call for the creation of a permanent oversight mechanism to thoughtfully and earnestly consider how to guide oncofertility to allow this emerging technology to be carefully considered as it develops. The circumstances in which fertility preservation should be discussed and the patients for whom fertility preservation would be most suitable are important guideline issues for people who survive cancer and for their treatment team. Oversight of the field of oncofertility would strengthen the rights of cancer patients and help protect them from abuses as well as alert health care professionals to their correlative duties to these vulnerable patients and families.

The UN Intergovernmental Panel on Climate Change (IPCC) issued a report today that says the effects of climate change are already occurring on all continents and across the oceans. The world, in many cases, is illprepared for risks from a changing climate. The report also concludes that there are opportunities to respond to such risks, though the risks will be difficult to manage with high levels of warming.

<h2>Summary</h2> All of science takes place amidst a world shaken by uncertainty, social and political upheaval, and challenges to truthful testimony. Just at the moment in which increasing control over biology has been theorized, our social world has become increasingly contentious and its values more divisive. Using the example of gene drives for malaria control to explore the problem of deep uncertainty in biomedical research, I argue that profound uncertainty is an essential feature. Applying the language and presumptions of the discipline of philosophical ethics, I describe three types of uncertainty that raise ethical challenges in scientific research. Rather than mitigate these challenges with excessive precautions and limits on progress, I suggest that researchers can cultivate classic values of veracity, courage, humility, and fidelity in their research allowing science to proceed ethically under conditions of deep uncertainty.

In its excitement over the quandries posed by biotechnology, bioethics is in danger of neglecting basic health care needs. What is needed is an understanding of ethics that emphasizes responsibility to others rather than rights.

As biotech revolution hits full stride, one is as likely to find stories on emerging medical technologies in business section as in science section. As New York Times notes, reporting case of academic researcher Kirk Hammond, also founder of company Collateral Therapeutics, With biomedical revolution in full swing, academic scientists who lack industry ties are as rare as giant pandas in wild.[1] Conflicts of interest for clinical researchers have long been seen as an issue in bioethics. Yet bioethicists themselves negotiate with temptations as potent as those faced by research scientists. We are funded not only by universities, but by private donors directly or only once removed from very industries we assess. This article reflects on this emerging problem: conflict faced by a bioethicist who participates as a consultant in research, often in private sector and often on new biotechnology or pharmaceuticals. I will make two claims about conflicts of interest in field of bioethics. The first is that there is and should be a conflict of interest whenever we take a realistic look at any new technology. It is in nature of bioethics that contention is a part of moral reflection, that competing moral appeals call upon our loyalty. Only by a stark appraisal of deep calls to conscience that participation in bioethics consultancy ought to provide can we understand depths of potential breaches of ethics in work. The second claim is that to focus question posed by conflicts of interest on rules about finances is a diversion, a necessary but ultimately simplistic account of temptations of power and influence that are part of work of bioethicist. I hope here to raise some preliminary questions for our further exploration.[2] It is my contention that questions that should animate us are not normative or regulatory ones, but epistemic and ontological ones: How can one know what one needs to know to consult on a new technology? Who does one become by taking part in this consultancy? The Duty to Third To be observant as a consultant is to notice conflict. When bioethicists are invited to consult on biotechnology, their role is to introduce social--implications for future, history of past abuses, and present considerations of justice. Conflict is only meaningful possibility for debate. Every interaction of abstract principles occurs within a narrative context, every boardroom discussion takes place within a larger social and political frame--the marketplace, clinic, public square--and it is role of ethicist to pull narrative frame from private view within institution to larger world that surrounds institution, a world of obligation, of suffering, of injustice, and of potential. It is this ability, this role of narrative construction, that allows for reflection and assessment. It is made possible by presence of what Levinas calls the third, witness to interaction of self and constantly calling other that interrupts self.[3] Because it is presence of third that makes judgment--and hence justice--possible, it is important to see problem of conflict as a radical opportunity, not an avoidable mistake. Only in frank confrontation with an alternative view is it possible to understand total alterity of another and need to include this alternative in our deliberations. Because narrative of poor, uninsured, or marginalized might not be represented at table, ethicist is entrusted with their story. The bioethicist might also hear from a range of more particular communities--disease groups, disabilities groups, patient advocacy groups. In all of this, it is being alive to double-horned dilemma that is useful. We hold things in tension--the reasonableness of a marketplace, realpolitik of private financing, nature of social constraints of our health care funding, and aspirations of justice. …

Abstract This chapter addresses the following question: If we adopt the view that it is the brain that feels, thinks, and decides, then how do we accommodate commonsense explanations of human behavior and the notion that we are intentional rational agents capable of voluntary action? It argues that there are limits to the coexistence of folk psychology (and the notion that we are intentional rational agents) and neuroscience. It explores how neuroethics must accommodate both science and ethics and, drawing on contemporary studies of deception, lies, and others, urges an awareness of the limitations of neuroscience in determining thought and defining responsibility for actions.

Journal Article Risky Hospitality: Ordinal Ethics and the Duties of Abundance Get access Laurie Zoloth Laurie Zoloth * *Laurie Zoloth, Northwestern University, Evanston, IL 60204, USA. E-mail: lzoloth@northwestern.edu. Search for other works by this author on: Oxford Academic Google Scholar Journal of the American Academy of Religion, Volume 83, Issue 2, June 2015, Pages 373–387, https://doi.org/10.1093/jaarel/lfv014 Published: 18 May 2015

Greater transcultural and transdisciplinary engagement within Muslim contexts and deliberate inclusion of diverse Muslim voices in the development of international guidelines is required to improve understanding of the state of stem cell science, strengthen thinking about attendant ethical complexities, enhance compliance, deepen public deliberation, increase trust, and strengthen practice standards. Greater transcultural and transdisciplinary engagement within Muslim contexts and deliberate inclusion of diverse Muslim voices in the development of international guidelines is required to improve understanding of the state of stem cell science, strengthen thinking about attendant ethical complexities, enhance compliance, deepen public deliberation, increase trust, and strengthen practice standards. Global concerns such as climate change and the COVID-19 pandemic make us keenly aware that the world is deeply connected. The field of stem cell research and related therapies is no exception. The implications of developments in this field, actual and promised, concern people and countries around the globe and future generations. International dialogue exists about the future of the research, where it should be directed, and how participants in the field can best shape priorities. While not absent, relatively silent in this conversation has been the diversity of voices from Muslim contexts. In this paper we argue that facilitating the inclusion of perspectives from faith traditions, including viewpoints that emerge from texts, laws, and traditions of Muslims, may deepen understanding, improve quality of and compliance with international guidelines, widen public deliberation, increase trust, and strengthen practice standards. We advocate for global leaders in the field to find opportunities to involve the voices of Muslim scientists and scholars, political and faith leaders, and Muslim peoples themselves, in deliberations about the scientific, political, ethical, and moral issues that emerge from research and therapy related to stem cells and regenerative medicine. For ethical guidelines to be effective, they need to speak to the contexts in which they are intended to be applied. Activities in research affect populations across the spectrum of economic and educational status, geographies, and diverse religious systems. The ethical decisions we make take place in relationship to particular communities, and for many of us our sense of morality, of what is important to pursue, is influenced by religious values and norms (Davis, 1999Davis D.S. It ain’t necessarily so: clinicians, bioethics and religious studies.J. Clin. Ethics. 1999; 5: 315-319Google Scholar). The arguments for inclusion we offer in this paper apply across all faith traditions. This is because faith communities have made questions of medicine and science a part of their belief systems and thus, when their members inquire about the propriety of an action, they turn to these systems and leaders. This is certainly true for Muslims for whom faith is often described as a way of life, where the distinction between the domains of religious and worldly affairs is not recognized (Sajoo, 2010Sajoo A. Roots and branches.in: Sajoo A. A Companion to Muslim Ethics. IB Taurus, 2010: 1-30https://doi.org/10.5040/9780755611218.ch-001Crossref Google Scholar). Inclusion is critical when proposing science policy where the methods of investigation use gametes, human embryos, and stem cells, which are given special significance in these traditions as the bearers of fecundity and generativity. Our focus in this paper is on Muslim voices. Muslim societies are diverse. They exist in geographies that vary from climate and culture to history and language. They differ in economic condition, from extreme poverty to extreme wealth. They are governed by monarchies, republics, and democracies of varying kinds, served by institutions at various stages of maturity. To provide context for our analysis and recommendations, we offer a brief description of the long and storied relationship between Muslim societies and the global knowledge society. Muslim societies have a particular obligation, based on centuries-old traditions, to promote the pursuit of knowledge and explore new boundaries of learning. In the pre-modern world, Muslim scientists and thinkers were in constant communication with the existing heritages of Asia and the Mediterranean World, which preserved the development of science. The necessary catalyst was a spirit of pluralism. Learning was drawn from wherever it could be found, regardless of tradition, and academic work was undertaken by scholars from diverse backgrounds and faiths with various interests of study (Nanji, 1988Nanji A.A. Medical ethics and the islamic tradition.J. Med. Philos. 1988; 13: 257-275https://doi.org/10.1093/jmp/13.3.257Crossref PubMed Scopus (16) Google Scholar). The production of knowledge flourished in multiple centers and was spread widely. Muslim civilizations succeeded partly because of their openness and their ability to create educational institutions and networked knowledge societies. This pursuit of knowledge in the Muslim world contributed significantly to the evolution of modern science and mathematics (Masood, 2009Masood E. Science and Islam: A History. Icon Books, 2009Google Scholar). A shift then occurred in many Muslim contexts away from the new sciences and discoveries developing in the West. This was due to greater focus on traditional, inherited knowledge; the impact of colonialism and conflict, which created social and economic conditions inhospitable to investment in science and research; an ensuing lack of infrastructure and expertise; and isolation from the international research community owing to physical distance and language (Ofek, 2011Ofek H. Why the Arabic world turned away from science.New Atlantis. 2011; 30: 3-23Google Scholar; Hoodbhoy, 2007Hoodbhoy P. Science and the Islamic world—the quest for rapprochement.Phys. Today. 2007; 60: 49https://doi.org/10.1063/1.2774098Crossref Scopus (26) Google Scholar; Yusuf, 2019Yusuf S. The express tribune.https://tribune.com.pk/story/1907056/science-technology-decline-muslim-worldDate: 2019Google Scholar). This was also due to the fact that few academic institutions of note emerged to address modern scientific questions. To receive training, interested scholars had to go overseas. When they returned, they were highly invested in replicating Western models of research, failing to contextualize this to conditions in their own world (Mobareksheva, 2017Mobareksheva M. Islam and Higher Education: Concepts, Challenges and Opportunities. Routledge, 2017Google Scholar). In recent decades, many Muslim countries have been investing resources in developing high-quality research institutions. Among these are the University of Central Asia, established through partnership between Tajikistan, the Kyrgyz Republic, Kazakhstan, and the Aga Khan Development Network, focusing on the needs of high mountain populations. The King Abdullah University of Science and Technology in Saudi Arabia reflects almost every Persian Gulf country’s growing interest and investment in emerging biotechnologies. The Erciyes University in Turkey is pursuing adult stem cell research. There is also much closer collaboration between these institutions and those in the Western world and the rest of the Muslim world. The field of stem cell research and regenerative medicine is a specific area with which the Muslim world seems especially ready to engage. With a more flexible stance on the use of human embryonic stem cells, Iran is a global leader in stem cell research popularity and clinical trials. Several national and transnational bodies in Muslim countries have produced guidelines related to stem cell research and/or therapy. Prominent examples include Iran, Saudi Arabia, Turkey, Jordan, Pakistan, and the Gulf countries (Table 1).Table 1Examples of stem cell research guidelines in Muslim countriesTransnational institutions•Islamic Organization for Medical Sciences, Islamic Fiqh Academy, and International Islamic Fiqh Academy institutionalized interdisciplinary collaboration and, with the deliberative mechanism of collective ijtihad, provided direction on themes including the beginning of human life and use of surplus embryos in researchIran•Council for Development of Stem Cell Sciences and Technologies and National Institute for Medical Research Development oversaw national stem cell research policy•National Committee for Ethics in Biomedical Research developed comprehensive research ethics guidelines on stem cell regenerative medicine in animals and humansJordan•A multi-disciplinary committee including religious scholars, physicians, scientists, and Arabic language experts developed stem cell research and therapy legislation, overseen by a national committeeMalaysia•National Guidelines for Stem Cell Research and Therapy established and enforcedPakistan•National Bioethics Committee developed guidelines on stem cell researchQatar•Ministry of Public Health issued a revised edition of the national regulatory frameworkSaudi Arabia•Issued the second edition of Law of Ethics of Research on Living Creatures, including stem cell researchTurkey•Ministry of Health issued directives prohibiting all stem cell research not including adult stem cells Open table in a new tab This historic and contemporary background suggests the potential for greater engagement with Muslim perspectives globally. Inclusion of diverse Muslim contexts in international deliberation can also strengthen best-practice standards in science and policy. Consider the 14-day rule, emanating from the United States (1979) and the United Kingdom (1984). This rule states that human embryos, for whatever purpose, should not be grown in vitro for longer than 14 days post fertilization, in part because of the special status of the embryo after this stage. Muslim approaches, of which there is a diversity, consider the issue of moral status differently. The official policy in Turkey prohibits the use of human embryos for research purposes (Karakaya and Ilkilic, 2016Karakaya A. Ilkilic I. Ethical assessment of human embryonic stem cell research according to Turkish Muslim scholars: first critical analysis and some reflections.Stem Cell Rev. Rep. 2016; 12: 385-393https://doi.org/10.1007/s12015-016-9658-4Crossref PubMed Scopus (2) Google Scholar). In an alternative interpretation, some scholars of Islam understand the embryo to go through three developmental stages, after the third of which it acquires a human soul (ensoulment) and gains moral status. In this view the use of human embryos for research would be permissible up to 40 days post fertilization (Sachedina, 2009Sachedina A. Islamic Biomedical Ethics. Oxford University Press, 2009Google Scholar). Yet the 14-day rule is applied in most countries, even where human embryo research is permissible. Observation of the 14-day rule in Muslim settings is attributed to the need to meet international standards as a requirement for publication in international journals. However, the standard is not the product of reflection that emerged in Islamic contexts—it holds scientists whose values are shaped by Islam to standards that do not align with their local normative frameworks. Thus, it makes different expressions of moral reasoning irrelevant, which may slow the possibility of legitimate advances in our understanding of the complexities of the research. Despite the historical tradition of scientific inquiry, largely absent from most Muslim countries is a robust public debate on ethical issues and participation of citizens in policy-making processes (Sing, 2008Sing M. Sacred law reconsidered: the similarity of bioethical debates in islamic contexts and western societies.J. Religious Ethics. 2008; 36: 97-121https://doi.org/10.1111/j.1467-9795.2008.00338.xCrossref Scopus (11) Google Scholar). If the scope of international deliberations is broadened and the implications for these contexts are engaged, it can also improve public deliberation in these parts of the world about issues that are of deep concern to these citizens. This is necessary to better understand public concerns and expectations so that these may inform regional policies. Building a shared moral sensibility through inclusion of Muslim perspectives can enable greater commitment to and compliance with international standards and guidelines in stem cell research and therapy. This can also build trust and help protect public safety: today, for-profit rogue companies and institutions in different geographical areas are promoting unproven and potentially harmful stem cell-based therapies. These pose risks to patients and could undermine support for the development of evidence-based therapies. An engaged society is a lever for enacting and adhering to standards for regulating such activity. Greater inclusion will require action by leaders in multiple contexts. Within the Muslim world, governments and higher education institutions need to build bridges among religious scholars, biomedical scientists, social scientists, and bioethics researchers to develop an understanding of each other’s work and collaborate in the search for answers to complex ethical problems in this field. The Human Heredity and Health in Africa consortium, 2010The Human Heredity and Health in Africa consortium, 2010. https://h3africa.org/.Google Scholar is one model whereby fundamental genomic research into diseases on the African continent, led by African scientists for the African people, pursues the development of infrastructure, resources, training, and ethical guidelines to support a sustainable African research enterprise. The consortium’s approach integrates research into ethical, legal, and social implications, training and capacity building for bioinformatics, capacity for biobanking, and coordination and networking. Government forums and bodies that formulate international research guidelines can purposefully widen circles of deliberation to include the diversity of other ethical traditions, especially religious traditions. International ethical guidelines currently rest on prevailing approaches to bioethics which are largely dominated by a principle-driven approach that sees itself as universal. Nominally secular, this approach has deep, historical indebtedness to the Western Christian tradition (Ali, 2016Ali M. The “Bio” in biomedicine: evolution, assumptions, and ethical implications.in: Ghaly M. Islamic Perspectives on the Principles of Biomedical Ethics. Imperial College Press, 2016: 41-67https://doi.org/10.1142/9781786340481_0002Crossref Google Scholar). This implicit bias, together with the lack of diversity in science and in science communication (Thorpe, 2020Thorpe H.H. Time to look in the mirror.Science. 2020; 368: 1161https://doi.org/10.1126/science.abd1896Crossref PubMed Scopus (24) Google Scholar), indicate the importance of consciously expanding the participation of thought leaders. Participation should be broadened to those from traditions and contexts that are impacted but not currently involved or that do not have easy cultural access to present-day norm-forming institutions. For example, the International Society for Stem Cell Research (ISSCR) could work with Muslim scientists, ethicists, and policy and thought leaders to more systematically include voices from diverse Muslim societies in the formulation and communication of guidelines for stem cell research. In its attempt to model a method for inclusion and collaboration in stem cell research and policy making, the Aga Khan University has been undertaking an exercise to bring together leading scholars from multiple countries and faith perspectives with backgrounds in science, medicine, ethics, law, and politics to exchange views about the state of the science, ethics, and policy in multiple settings, with a focus on Muslim contexts. The scholars released “The Lisbon Statement” (Thinking Group on Regenerative Medicine, 2019Thinking Group on Regenerative Medicine, Stem Cell Research and Associated Therapies. (2019). The Lisbon statement. The Aga Khan University Centre for Regenerative Medicine and Stem Cell Research. https://www.aku.edu/crm/ethics/Pages/thinking-group.aspxGoogle Scholar) advocating that:•As research and dialogue extend to more countries and contexts, a central goal should be to build upon established, transcultural guidelines (such as those of the ISSCR). These should increasingly be inclusive of wide, pluralistic representation from multiple competency areas; dynamic and flexible to enable response to new advances and discoveries; and advisory, providing direction to different governing bodies to be incorporated in their respective jurisdictions.•To enable more inclusive dialogue and deliberation, it will be key to support the creation of multiple deliberative spaces. These forums should be accessible to a full range of participants in civil society including scientists, ethicists, lawyers, and journalists. The participation of policy makers, religious scholars, and community leaders from traditions and contexts impacted by but not currently involved in the conversation should be enabled wherever possible. We believe that more of such actions are needed to enrich our understanding of current science and ethics practice, to support research and knowledge creation, to better appreciate public concerns and expectations, to improve international cooperation and the enhancement of best practice, and, in general, to inspire and broaden participation in the global knowledge society. The Thinking Group on Ethics and Regenerative Medicine, Stem Cell Research and Associated Therapies (the Thinking Group) was funded by the Aga Khan University. We are grateful to Ehsan Masood (Nature) and Dr. Maryam Matar (UAE Genetic Diseases Association) for their participation in the Thinking Group. We thank Hossein Baharvand (Royan Institute for Stem Cell Biology and Technology, University of Science and Culture) and Kavintheran Thambiratnam (University of Malaya) for providing information about stem cell research guidelines in Iran and Malaysia, respectively. We also thank Susan Rink (Fraser Health Authority) for invaluable administrative support through the writing and submission process, and Safina Kousar (Aga Khan University) for assistance with research. All authors are members of the Aga Khan University Thinking Group on Ethics and Regenerative Medicine, Stem Cell Research and Associated Therapies. J.R. is a member of the Editorial Board for Stem Cell Reports, Steering Group for the 2021 ISSCR Stem Cell Guidelines, and Board of Directors of Notch Therapeutics. H.d.M. is a member of the National Council on Medically Assisted Reproduction, Vice-President of the Portuguese Bioethics Association, President of the Association for the Study of Biolaw, and invited Professor of Porto Medical School.

Protecting the public from the risks of synthetic biology depends on the scientific community's will, capacity, and commitment to regulate itself.

Protecting the public from the risks of synthetic biology depends on the scientific community's will, capacity, and commitment to regulate itself.

Will powerful new technologies affect our perception of self-identity?

A substantial portion of the developed world's population is increasingly dependent on machines to make their way in the everyday world. For certain privileged groups, computers, cell phones, PDAs, Blackberries, and IPODs, all permitting the faster processing of information, are commonplace. In these populations, even exercise can be automated as persons try to achieve good physical fitness by riding stationary bikes, running on treadmills, and working out on cross-trainers that send information about performance and heart rate.This essay is drawn from collaborative research conducted under the auspices of the “Altering Nature: How Religious Traditions Assess the New Biotechnologies” project at Rice University from 2002 to 2004 through the financial support of The Ford Foundation (Grant #1010-1601). The paper is submitted with the permission and acknowledgement of the project coordinators and The Ford Foundation. The authors also acknowledge the research and editorial assistance of Dr. Siobhan Baggot and Ms. Sarah Gehrke.

Introduction Ethical, Legal and Social Implications (ELSI) research has been a new constant in basic genomic projects for two decades. In the last 10 years, the inclusion of research as a required component in a wide range of sponsored basic and translational research projects--from medicine to chemistry--has reassured the public that scientists who receive public funding work closely with academic bioethicists, legal scholars and social theorists to carefully explore the implications of new science. These grants have also inspired a generation of bioethics research on genetics, genomics, stem cells, climate change, synthetic biology and nanotechnology. This article, while celebrating this attention to ethics, raises the issue of whether the structure of funding such work creates inadvertent conflicts of interest and commitment. This paper asks: if the Principal Investigator (PI) of the grant controls the funding of the ethics projects, can ethicists undertake serious, objective reflection and make normative suggestions independently and fearlessly, especially in an economic climate in which reductions in ethics and humanities funding jeopardize other employment? Ethical issues in science research have concerned both scientists and the public for decades. The first formal designation of funding for study of basic research by federal agencies is most clearly linked to biological advances in the 1950s and 1960s that eventually led to the development of recombinant DNA (rDNA) technology in the early 1970s. Paul Berg of Stanford developed a method of joining fragments of monkey virus SV-40 (a tumor gene) and bacteriophage lambda. Further work, however, was halted due to concerns that this rDNA could find its way into E. coil, the most widely used bacterial species in laboratories, also commonly found in human intestine, and risk infection of lab workers. This concern was deepened by the fact that, at that time, researchers working with rDNA increasingly were biochemists not practiced in the standard safety measures used by microbiologists. Due to concern within the field itself, in 1975 a conference was organized at the Asilomar Conference Center in Pacific Grove, California to discuss the potential biohazards and regulation of rDNA. Known as the Asilomar Conference, this meeting of scientists drafted voluntary guidelines to address the concerns of rDNA technology and research (Profiles in Science). History of The history of the specific funding called ELSI began in the mid-1980s as the NIH and Department of Energy undertook the task of mapping out the human genome, under what was to become the Human Genome Project (HGP). Harking back to the Asilomar Conference, those in charge of the HGP, as well as researchers, social scientists and lawmakers, understood that exploring uncharted areas of science was likely to raise a number of complex moral issues for individuals and society (Human Genome Project). James Watson was appointed the Director of the HGP in 1988 and determined that the project would set aside funds specifically to study the issues arising under the HGP, openly explaining that the intent was to reassure a public concerned with the increasing reach and power of science. Each year, between three and five percent of the funds earmarked for HGP was dedicated to ELSI. From the beginning, the HGP's program has examined a variety of issues, ranging from privacy, to commercialization, to the use of Genetically Modified Organisms (GMOs) as food. While it was initially contemplated to address the potentially harmful consequences of the project, the HGP and programs shared the common goal of addressing larger moral issues from the outset; thus ELSI, rather than impeding HGP progress, was viewed as an important adjunct that would facilitate its success (Everson 2007, p. 124). The expansion of the program to a variety of emerging technologies provides evidence of its success. …

Well aware of Jews having once been the victims of Nazi eugenics policies, many Jews today have an ambivalent attitude toward new genetics and are understandably wary of genetic forms of identity and intervention. At the same time, the Jewish tradition is strongly committed to medical research designed to prevent or cure diseases. Jews and Genes explores this tension against the backdrop of various important developments in genetics and bioethics-new advances in stem cell research; genetic mapping, identity, testing, and intervention; and the role of religion and ethics in shaping public policy. Jews and Genes brings together leaders in their fields, from all walks of Judaism, to explore these most timely and intriguing topics-the intricacies of the genetic code and the wonders of life, along with cutting-edge science and the ethical issues it raises.

An in-depth look at genetic alteration in the natural world and the oppositions to it, seen through the case study of a gene drive for malaria. May We Make the World? is an engaging reflection on the history, nature, goal, and meaning of using a new technological idea—CRISPR-based genetic engineering—to alter the genome of the mosquito that carries malaria. This technology, called a “gene drive,” can alter the sex ratio in Anopheles gambiae mosquitoes, the key vector for falciparum, the deadliest form of malaria. P. Falciparum kills 400,000 people a year, largely the poorest children in the world among them. In her sobering examination of the issue, Laurie Zoloth considers the leading ethical arguments for and against gene drives, explores the regulatory efforts that have emerged long in advance of the science, and considers the philosophical questions raised by the struggle to eliminate malaria. The development of a gene drive for malaria will have far-reaching implications for it represents the first use of genetic engineering in the natural world and the first creation of a genetic variant intended to spread in the African wild beyond human control. Drawing on two decades of work, Zoloth brilliantly argues that we can understand the complex moral issues at stake only by carefully reflecting on the science, the nature of the local and global discourse about genetic engineering, and the long history of malaria, which—as it transformed from a worldwide disease to a tropical one—reshaped the world as we know it.

Abstract This chapter is a critical review of the scholarly literature about religion and climate change. It then turns to sources in the tradition of Jewish thought to describe a larger issue: our existential state of exile itself. This chapter argues that this theme of exile is both ontological and theological. As such, because human beings do not possess the Earth, but only traverse it, we can move to a different relationship to the planet. The chapter reviews the structure of Jewish ethics, focusing on the way that discourse and argumentation operate in the logic of rabbinic ethics. The chapter introduces the centrality of the Sha’ma liturgy, which connects human moral behavior to the functioning of the seasons and the regularity of rain and sun, linking all of human productive activity to human moral choices. The chapter concludes with the prophetic voice we encounter in the text of Jeremiah, which makes this link strongly.

Abstract This is an introduction to the main themes of global warming and Jewish thought. The introduction to a book about climate change and Jewish ethics describes why the issue of climate change has an intense urgency, and why we have so far failed to find a way to respond powerfully enough to change the course of the problem. In part, this book was written to think aloud about the most pressing ethical issue of our time. The chapter argues that there are inescapable and role-specific duties: in the face of a crisis, one must act with all that one has. This book was written because nothing else, no other language, has worked to change human behavior or challenge political and economic structures. The language of Scripture, the Talmud, and philosophy of Judaism may offer a different kind of argument, and a different sort of language, for such a change. The chapter argues that the traditions, histories, and texts of Jewish thought address precisely the sort of existential crisis that we face now, and thus deepen and enrich our public discourse about what to do, how to live, and who to be in our fraught time. Finally, this book was written because of the quickening of the air, the shift in the light, that tells us that we are running out of time to make a difference.

Abstract The conclusion of this book considers what virtues and values we will need to address global warming, and how difficult the problem will be when we are living in a divided democracy. The chapter carefully considers the arguments against the author’s position made by a friend who works at a conservative organization and who disagrees with the author’s views and explains what is incorrect about this data. The chapter then, optimistically, turns to the past and describes how two different social movement—one that opposed an American war in Vietnam, and one that opposed public cigarette smoking—were able to make large change possible. The chapter considers the power of faith communities in history and returns to the contention that the Scriptural resources important to Americans are a place to recover strong argument for the social good. This chapter argues that only a public discourse and social activities can change the course of history

Abstract This chapter provides a concise review of the history of climate change science, including how the phenomena of global warming and the “greenhouse effect” were first theorized in the early years of the Industrial Revolution, including the work of a woman scientist, Eunice Foote. The scientific observations of weather and weather patterns became increasingly important during World War II, and then, the scientists emerged from war prepared to do serious and long-range forecasting. The chapter briefly describes the earth and atmosphere science that has now discerned the path from industrial production, the use of fossil fuels, to the patterns of global warming. These insights led to a greater understanding of the dynamics of carbon buildup in the Earth’s atmosphere and to the likely effects on the weather of the planet. The chapter then turns to the history of the efforts to address this problem and describes the early meetings that led to the United Nations Intergovernmental Commission on Climate (UNIPPC). The chapter describes the political efforts at the national and international level to create treaties to address the issue and the ways that they have so far failed to curtail extraction and production of fossil fuels. The chapter describes the projected outcomes of a warming planet and describes the dreadful scenarios of the future if we do not intervene.

Abstract This chapter was first presented as a speech by the author when she was president to the American Academy of Religion. It calls on the author’s field to stop what it is doing to focus attention on the crisis of climate change and for the wider world of scholars and citizens to consider why such a cessation is necessary. First written in 2014, which was a sabbatical year in the Jewish liturgical calendar, it calls for the institution of a “sabbatical year” in which attendees would not meet in a large group of 10,000, in a fancy hotel, but would teach instead in their own places and teach about climate change and think about what to do. While this call did not work to stop the conferences, ironically, by the next Jewish calendar sabbatical year, in 2020 and 2021, indeed, they did not meet, for by then, COVID-19 had swept across the globe, and they entered a two consecutive winters of virtual events. This chapter explains how a warmer world is also a sicker world, more vulnerable to infection and plague and why a sabbatical year is still important. This chapter uses the concept of the sabbatical in the Hebrew Bible to explore how cessation from ownership and production is a key element of a just society. This chapter develops a “theology of interruption” as the theory that is foundational to this call.

Abstract How can we come to understand our existence on this earth, surrounded by the stark beauty of air and light and water, while living in a place we deliberately and carelessly abuse, where resources are becoming scarce, and where the well-being and basic health of our neighbors are threatened? In Ethics for the Coming Storm, Laurie Zoloth argues that our debates about environmental issues have largely been driven by the language of economics and political power, and have become both deeply divisive and symbolic, turning our differing truth claims and moral appeals into signs of identity. This discourse has utterly failed to change the human behavior or political and economic structures necessary to face global warming serious and directly. So Zoloth turns to another language, found in the texts and traditions of Jewish thought—the language of Scripture, the Talmud, and philosophy of Judaism—which, she contends, offers a different kind of argument for such a change. In fact, Zoloth claims, the traditions, histories, and texts of Jewish thought address precisely the sort of existential crisis that we now face, and thus deepen and enrich our public discourse about what to do and who to be. This book uses a careful attention to Scriptural, rabbinic, and philosophical sources in Jewish thought to provide a novel framework through which we can reassess the choices we make that affect our climate, our environment, and our social structures.

Abstract This chapter turns to the historical example of a natural event that became a national tragedy because of human structural choices to organize a society in a specific way. This dynamic is a metaphoric way to think about our situation as we confront climate change—where human choices will set in motion destructive natural processes that will threaten the lives of our fellow citizens. It is the contention of this chapter that we can learn from the reactions to the Lisbon Earthquake of 1755, and to the ongoing reception of the story of that day, as we look for thoughtful and meaningful responses to the catastrophes of our time, a time in which the fragility and paradoxical power of the natural world challenge our faith traditions, and when we will also need to turn to our text and traditions to draw a different language for our response. It then considers how Jewish rabbinic thought thinks about earthquake and other disruption of the natural world and their relationship to human societies and their choices.

Abstract This chapter considers the problem of moral luck, individual responsibility, and the death of the unknown stranger. It first describes a narrative that is a metaphor for our situation, that of passengers on a train that runs over innocent and unknown strangers. Moving from that example to a parallel narrative in the Talmud in which an unknown stranger is killed in the unincorporated area between two cities, the met mitzvah, the chapter considers how rabbinic tradition, itself an exegesis on a verse in the Hebrew Scripture, elaborates the duties of the witnesses to this death. The chapter considers the problem of “tipping points” in the larger discourse of climate change as an example of how one’s individual choices will affect the unknown stranger. It reflects on Arendt’s issue of bystanders. We are entangled in the world in complex ways, and while the death of others seems not to be directly our fault, it is an act in which we participate, a theo-political reality. Turning to the rabbinic text offers a theological response to this issue.

Abstract This chapter will raise a somewhat different question, in a somewhat different tone. This chapter will make the argument that people who seek to stop the use of carbon will find they have powerful enemies, and while the talk of sin and sinners is quite out of fashion, it is a powerful and important part of the language of religion. This chapter talks about enemies and will explore the creation of Amalek as the archetypical enemy by first closely analyzing the biblical verses that surround the enemy narrative and then reflecting on how this story of enemies shapes modern concepts of enemies. The chapter then considers this text in light of a larger project, which is to find a moral language to understand our present crisis, one that is rooted in shared Scriptural traditions, one that will awaken us, and allow us to act. The chapter considers several questions. Amalek is a fundamental part of the existence of Israel, tied up in the liberation narrative at the heart of all Scriptural possibility. Amalek is the very face of evil but also the very face of a contrary, stochastic universe. Amalek attacks the uncertain—the doubtful in the Exodus narrative, and the weak in the Deuteronic text—and that is his signal characteristic. The chapter then considers how oil and gas extraction companies are to blame not only for the profit taking at the cost of human lives and human futures, but how they colluded to defeat movements to stop them by creating false narratives—doubt—about the problem. It reflects on the problem of sinfulness and radical evil in the thinking about climate change and the role of these companies and turns again to Arendt to consider issues of guilt and responsibility. It also discusses the duty to remember and the work of Paul Ricoeur.

Abstract This chapter uses the methods of comparative feminist thought, Jewish thought, and the logic of Scriptural reasoning, which is a method of comparative exegesis, to explore the particular challenges that face women as the climate changes. Global warming most directly impacts the economies of water use. Since women in the developing world are largely responsible for the task of bringing water, for drinking, cooking, and washing, into the home, women will bear the first effects of global warming. In this way, global warming is a feminist issue. This chapter argues that this relationship is not new, for the difficulties faced by women in obtaining water have always been a matter of scarcity and power relationships. Thus, in the Hebrew Bible, the New Testament, and the Qur’an, scenes of women at wells, negotiating for access, are central narratives. This chapter reflects on three Abrahamic accounts of women and water as a way to think about our current situation. It also reflects on the Papal Encyclical by Pope Francis to consider this issue.

Abstract This chapter reviews the Intergovernmental Panel on Climate Change report about Syria to show how drought led to desperation and war. If exile is our essential existential condition, then the answer to that problem is hospitality, the welcoming of the stranger. Hospitality is the first and the last moral gesture of our time, for we must enact it even if we fail to stop global warming. In this, the chapter turns to the work of Hannah Arendt about the need for the “space of appearing” or the public square. Then it turns to the rabbinic discussions about the way that private choices affect the public good, using the example in the Talmud about building a wall and tossing the stones you don’t need into a public space, which is prohibited. The chapter argues that the moral problem of climate change is made more acute because of the abundance, wealth, and power of the West relative to countries in the developing world. The chapter considers the story of Joseph and his brothers in both the Hebrew Bible and the Quran to reflect on how the rabbinic imagination looks at the challenges of hospitality.

The last several years have seen a sharpening of debate in the United States regarding the problem of steadily increasing medical expenditures, as well as inflation in health care costs, a scarcity of health care resources, and a lack of access for a growing number of people in the national health care system. Some observers suggest that we in fact face two crises: the crisis of scarce resources and the crisis of inadequate language in the discourse of ethics for framing a response. Laurie Zoloth offers a bold claim: to renew our chances of achieving social justice, she argues, we must turn to the Jewish tradition. That tradition envisions an ethics of conversational encounter that is deeply social and profoundly public, as well as offering resources for recovering a language of community that addresses the issues raised by the health care allocation debate. Constructing her argument around a careful analysis of selected classic and postmodern Jewish texts and a thoughtful examination of the Oregon health care reform plan, Zoloth encourages a radical rethinking of what has become familiar ground in debates on social justice.

This chapter begins the discussion with Jewish ethical and religious perspectives on reproductive health, ethics, and family planning policy. It argues that to fully reflect on Jewish perspectives on reproductive health and ethics, one must have a clear understanding of both history and text. A Jewish contribution to the debate on family planning is based on both what is written and what is performed. In reflecting on Jewish ethics, one considers the whole of human activity and the whole of community as well: women as well as men are moral agents, and the lifeworld of the family, of women, and of children, is a central concern of religion. This discourse is primarily contained in the extensive literature of debate and exegesis of the rabbinic literature, which is primarily collected in a set of volumes called the Talmud.

I begin this reflection on Jewish bioethical response to the dilemmas within oncofertility with a familiar caveat: there is no one particular authority on Jewish ethics, nor even on the legal, or halachic norms that govern Jewish community practice. Jewish bioethics has historically been an account of optimism about research, as a project of repair in a broken or unfinished world [1]. While Freedman has raised some cautionary caveats about the need for full consent and safety [2] and while others have raised some questions of justice (including this author), the main thrust of Jewish responses to both artificial reproduction and to new technology in treating cancer has been to celebrate the advances as a part of the general goal of human development, creativity, and capacity.

At the Last Well on Earth:Climate Change Is a Feminist Issue Laurie Zoloth (bio) Keyword climate change, ethics, Emmanuel Levinas, water, women Finitude and Feminist Thought There will be a time, in most of the world, when the last well goes dry. And this is because so much of the world lives already on the brink of a dreadful thirst, a life only made tolerable because women travel great distances to find the wells or the rivers or the ditches, scoop up the water, and bring it home. They carry it on their backs, or their heads, or on their hips, like a child. In Africa alone, women walk forty billion hours a year to bring this water home.1 In sub-Saharan Africa, women and girls are responsible for 72 percent of all the water collected. This means that women spend a significant proportion of their lives simply carrying water. And as the climate steadily gets warmer, droughts will become more frequent and water will become more salinized, harder to find, and farther away from habitation. As it now stands, clean water is already unavailable to over 633 million people—one in ten of the people of the earth. Diseases from contaminated water kill on the aggregate more people than any form of violence, including wars and acts of terror. Forty-three percent of these people are children under age five.2 Water is a large part of the embodied life of women who bear these infants. Without abundant water, it is hard to carry a pregnancy safely to term, to give birth, nurse, or bathe children, or to [End Page 139] launder clothes and diapers—all details for which women, and women alone, are largely responsible. According to a 2002 report, "gender-related inequalities are pervasive in the developing world. Although women account for almost 80 per cent of the agricultural sector in Africa, they remain vulnerable and poor. Seventy per cent of the 1.3 billion people in the developing world living below the threshold of poverty are women."3 Consider the scenario in the eastern Mediterranean region in 2009 when the UN Intergovernmental Agency on Climate Change was gathering its findings for its next report. The project director on the study, Dr. Yousef Meslmani, was known to be a loyal government official, a scientist charged with studying his country's climate. It took him five years to write and submit his report, and his careful account described the northern portion of Syria, where unprecedented declines in the water table had left the wells all dry. Entire villages had been abandoned; fields of peppers seemed to have vanished; and the rice croplands were shifting under the yellow winds. In the 164-page document with a picture of the country's most ancient and beautiful city on the front, Meslmani explained that thousands of families had left the dying farms, which had once provided 30 percent of the entire gross domestic product, and were streaming into cities. These people needed water, sanitation, health care, schools, and jobs. The report described a region staggering under a drought that had lasted for four years, the worst drought ever recorded in the history of the country, one of the world's most fertile areas, the cradle of human civilization.4 But the president in question was not responsive and the country in question is Syria. And as a million and half internal refugees crowded outside of Aleppo and Damascus, the protests grew, as the displaced demanded water. Two years later, thousands of frustrated, landless farmers—a full quarter of the country's population—staged protests in the Arab Spring of 2011. But unlike other states of the region—Libya, Egypt, or Tunisia—President Bashar al-Assad refused to meet with the protestors and bombed their neighborhoods. And thus began the civil war. Meslmani's report was the last that Syria sent as a part of the UN's Intergovernmental Panel on Climate Change. After its publication, Meslmani joined the five million refugees who left the country. Syrians may have been the first climate refugees of the current era, but they were not the last. Consider Tengger, China, where the Gobi...

This corrects the article DOI: 10.1038/nbt.4015.

The Recombinant DNA Advisory Committee (RAC) was founded at the behest of concerned scientists based on the principle that public trust of advanced technologies must be earned through transparency and expert deliberation. For more than 40 years, the RAC has served as custodian of the National Institutes of Health (NIH) guidelines, with responsibilities in human gene therapy evolving from regulatory to advisory to the NIH and Food and Drug Administration (FDA). However, the NIH director and FDA commissioner have proposed the elimination of RAC review of human gene therapy protocols ([ 1 ][1], [ 2 ][2]). The changes proposed to the NIH guidelines are even broader: “Eliminat[e] references to the RAC, including its roles in [human gene therapy] and biosafety” ([ 3 ][3]). The NIH and FDA cited a lack of recent RAC reviews (three in 2 years) as justification for the changes ([ 1 ][1]). Yet, since the NIH accepted the Institute of Medicine's recommendations to restrict the RAC's advisory role ([ 4 ][4]), NIH itself, not the RAC, is responsible for setting the RAC's agenda ([ 5 ][5]). Removing RAC involvement from all aspects of human gene therapy and laboratory biosafety continues a worrisome trend of cutting independent experts and public discussion out of government decision-making ([ 6 ][6]). ClinicalTrials.gov has been proposed as an alternative to the RAC ([ 1 ][1]). However, this system does not extend to laboratory research, provides insufficient information about ongoing human gene therapy trials to satisfy the public's interest in transparency, and—unlike the RAC—involves no scientific oversight ([ 7 ][7]). Current regulations require only that clinical trial results be posted within 1 year of trial completion ([ 8 ][8]), and in practice, this information is rarely posted. Local institutional biosafety committees and institutional review boards, whose expertise varies widely, now assume sole responsibility for assessing the hazards and ethics of research using emerging recombinant DNA technologies and planning appropriate steps for their mitigation. At a recent meeting convened by the NIH Office of Science Policy, representatives of institutional biosafety committees voiced concern over these responsibilities and asked instead for better guidance on new emerging technologies from the NIH and the RAC ([ 9 ][9], [ 10 ][10]). We urge the NIH director to reconsider the consequences of the proposed changes and ensure that viable alternatives are in place that preserve the transparency and accountability required to maintain public trust in the regulation of recombinant DNA, laboratory biosafety, and human gene therapy ([ 11 ][11]). 1. [↵][12]1. F. S. Collins, 2. S. Gottlieb , N. Engl. J. Med. 379, 1393 (2018). [OpenUrl][13] 2. [↵][14]1. J. Brainard , Science 361, 734 (2018). [OpenUrl][15][Abstract/FREE Full Text][16] 3. [↵][17]NIH, “National Institutes of Health (NIH) Office of Science Policy (OSP) recombinant or synthetic nucleic acid research: Proposed changes to the NIH guidelines for research involving recombinant or synthetic nucleic acid molecules (NIH Guidelines)” (2018); [www.federalregister.gov/d/2018-17760/p-14][18]. 4. [↵][19]1. R. N. Lenzi, 2. B. M. Altevogt, 3. L. O. Gostin , Eds., Oversight and Review of Clinical Gene Transfer Protocols (National Academies Press, 2018). 5. [↵][20]NIH, “Final action under the NIH Guidelines for Research involving recombinant or synthetic nucleic acid molecules (NIH Guidelines)” (2016); [www.federalregister.gov/d/2016-06448][21]. 6. [↵][22]1. K. Boyle, 2. M. Kotchen , Science 361, 729 (2018). [OpenUrl][23][Abstract/FREE Full Text][24] 7. [↵][25]NIH, About the Results Database (<https://clinicaltrials.gov/ct2/about-site/results>). 8. [↵][26]NIH, “2016: Final NIH policy on the dissemination of NIH-funded clinical trial information issued” (<https://clinicaltrials.gov/ct2/about-site/history#FinalNIHPolicy>). 9. [↵][27]NIH, “NIH guidelines: Honoring the past, charting the future” (2017); <https://osp.od.nih.gov/event/nih-guidelines-honoring-the-past-charting-the-future>. 10. [↵][28]NIH, “NIH guidelines: Honoring the past, charting the future workshop (day 2)” (2017); <https://videocast.nih.gov/summary.asp?live=24766&bhcp=1>. 11. [↵][29]These views represent the authors' own opinions as members of the scientific community, not the views of the RAC. 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Here is the picture of the seeker on the spiritual path. A person walks alone, the way is difficult, the terrain dramatic. Without knowing the gender of the person depicted by the text, do we have any doubt that the seeker is male?. . . .Such texts always leave me muttering about who is watching the four-year-olds near the water, who is bouncing the babies to sleep at the edges of the gathering, who is washing the plates after dinner, who is dying the cloth for the sacred raiment. The work that must support the quest is invisible. And the oldest construct in theology and philosophy is this very invisibility. Yet for women it is this work that frames the world and the critical struggle to find moral meaning, especially in light of the starkness of the absence of this feminist perspective in traditional text.The spiritual quest is written as a quest away—a journey away from the ordinary to the sacred, away from the demands of the daily to the purity of the holy. Yet in the struggle to encounter what God wants of us, I must find meaning, holiness in this life. It cannot mean that God wants flight from what I can know as most holy—the birth and breath of my children.Judaism has been criticized with extraordinary vigor for the lack of attention to the female voice in the text, and this critique is justified. The challenge, then, is to construct an ethics of ordinariness without sentimentality about the daily moral choices that are made by women and to reflect on the theology that is partner to such an ethics. In this construct the notions of ethics and spirituality are inseparable, neither possible without the light of the other.We are drawn into the process of public discourse by the sensational acts at the outskirts of human community: the pregnancies by radical technology, the rescue of the particular child. Yet the daily acts of choice that thousands of women make, and see as choices of faith, are far more difficult. What would the shape of ethics or spirituality be if we focused on the ethics and theology of the moral gesture of raising children who are in our lives and through whom we carry the obligation to the past and the next generation?This article began as a conversation with colleagues, feminist scholars of religion and ethics, about why we couldn’t seem to get our articles in on time. It was all the interruption! The chicken pox! The field trip! And here we were, trying to write important things about The Good, each of us balancing the teaching and creation of theological reflection with the teaching and the creation of the babies and children who we mother. Usually, this second work is seen as that distraction that takes us from the rigor of the first. The parallel universe of the mundane is the messy, tangible, and embodied that surrounds all of our theory. . . .What is at stake in this argument is not the simple recognition that the work of the female role needs to be honored or seen, although this has been a key feminist insight. What is at stake, rather, is the claim that the paradigm of the faith journey as usually envisioned . . . is just not the one that describes an accurate story of women’s lives. The very notion of spirituality as otherworldliness, as taking place outside the home, understood as a leavetaking from family, as rooted in autonomous journey, is a different vision than the one we carry in our daily lives. But there is a countervailing notion: that it is the bonds of obligation, found within the family, and within the ordinary, that generate the renewal of daily meaning. . . .I do not mean to heroicize mothering uncritically: The family is complex, both liberatory and conservative. Chicken pox happens, and much, much worse. The ordinary difficult obligations, dependency, tragic loss, and tragic angers are often precisely what people want sacred refuge from. But I want to turn us back into the place of secular, mundane time, into regular and familiar moral choices. It is precisely in these smaller heroic acts that we need to construct an ethics of the larger public sphere.

The controversy about research on human embryonic stem cells both divides and defines us, raising fundamental ethical and religious questions about the nature of the self and the limits of science. This article uses Jewish sources to articulate fundamental concerns about the forbiddenness of knowledge in general and of knowledge thought of as magical creation. Alchemy, and the turning of elements into gold and into substances for longevity, and magic used for the creation of living beings was at stake in various Talmudic texts. Since contemporary discourse calls regenerative science magical, and makes claims about its restorative power, careful reflection on when magic is forbidden and when it is responsible allows a novel understanding of ethical questions in stem cell research.

This essay will address the problem of error in social theories, and how one locates, amends, and forgives error. Although there is a rich literature on the meaning of mistakes in law and in medici...

There will be a point in any ASBH (American Society of Bioethics and Humanities) meeting at which Tristram Engelhardt will rise to speak. It will be at a moment of contention, or perhaps a moment in which we, as a field, are considering our “identity” and we do not agree. The room shifts to watch, for we know that what will be said will be amicable, feisty, and smart. Tris Engelhardt, remembering that “moral diversity is the most challenging form of human diversity” (Engelhardt, 2015, 279) will not turn away from a disagreement, and in so doing, he allows us to see the intricate and difficult work of bioethics. This is one of his great duties as a teacher, it is clear: teaching the necessity of citizenship in a field by disagreement. Bioethics, as it emerges as an American conversation at the meetings that honored Engelhardt by our Lifetime Achievement award, can indeed seem to be a diverse set of narratives, or rather, a field that exists as a collection of people with complex and contradicting duties, with only some overlapping consensus, and not enough copies of Kant to go around. We are the ones, apparently, who have shown up, ready to think together about some of societies’ hardest problems, some of which, Engelhardt reminds us, are some of the oldest problems human beings face; how to proceed when the power of medicine is so large, and yet the certainty of science so vexed? Bioethics is a way of discussing the order of things, in one sense, and it is hoped that if we take the time to listen to the order of the other, we might be convinced by a good argument that we have been wrong. Surely this is what has happened so often when Engelhardt makes his arguments, and this is a lifetime achievement. It is a lifetime achievement as well to have the courage and the patience to teach. Engelhardt comes to the meetings and listens with special care to the papers of graduate students; and I know, for I was one in his presence, and still am so grateful for his stern, truthful critique. We are not clergy, there is no authoritative text, and we are fragile; we are human, and we are obligated. To what? For Engelhardt, to two projects: first, to honor and defend the humanities in a world dominated by science, powerful because it is of enormous benefit, yet not possessive of the entire horizon of possibility; and second, to have the courage to live in this time of conflict, to live, as it were, always on the Ship of Theseus, in the midst of a journey we cannot avoid, replacing, plank by plank, and perhaps, if not making a new ship, allowing the conversation to stay afloat and, most importantly, to live as teachers. Bioethics meets, actually, not in the rooms of the hotels, but in a very real sense on that boat, where one cannot walk away from an argument—one must stay and defend one’s position. The basic ideas we carried into the location of bioethics were Platonic at first: ourselves as the Guardians, and a shared notion of the Good, a moral law that would emerge, and better, could be empirically tested, counted, and fixed. But actual persons are more particular, with narratives and commitments that are not held in common, and with the capacity to quarrel and resist fixities. As teachers, we have come to question the idea of shared notions of the Good, yet, we cannot not raise them again in search of the argument in its name.

Abstract This chapter summarizes several classic arguments about consciousness and the nature of the mind (Descartes, Russell, Parfit, Skinner, Armstrong, Nagel, Dewey, James, Searle, and Koch). It argues that a coherent view of consciousness will include a way to understand memory and rational action, and suggests areas for future research on ethics in a world in which traditional ideas about duty, covenant, ipsity, and relationality are rapidly being re-understood in biological terms. It contends that ethics depends on narrative structures that give meaning to norms. Hence, the way that minds (and brains, to be precise) structure story and rule is critical to how we know and discern. At the core of this is memory and motive, yet for the ethicist, it will be the publicity of the moral gesture, the play out in history and social space, that is the final criterion of what beings mean to one another.

The Lancet–Palestinian Health Alliance (July 3, p 7)1Horton R The Lancet—Palestinian Health Alliance in 2010.Lancet. 2010; 376: 7-8Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar provides unfortunate evidence that a political agenda inexorably debases medical science. There are many regions of the world with far more pressing public health problems than those experienced in Gaza, the West Bank, and the portions of Jerusalem occupied by Jordan between 1948 and 1967. But given this prominent effort by The Lancet, one would at least hope for reasonable science by investigators committed to objective evaluation of data. Richard Horton writes not just of improving health, but of devising “long-term solutions to the many and varied health injustices that Palestinian people face”,1Horton R The Lancet—Palestinian Health Alliance in 2010.Lancet. 2010; 376: 7-8Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar attributed explicitly to Israel. The accompanying Comment2Abeer A Yaha A Abu Qara AA et al.Making the future ours in the occupied Palestinian territory.Lancet. 2010; 376: 8-11Summary Full Text Full Text PDF PubMed Scopus (2) Google Scholar by Birzeit University students is an unsubstantiated polemic that makes a variety of misleading if not dishonest assertions. It would be promptly rejected if it dealt with any other topic as not befitting a medical evidence-based publication. Under a genuinely repressive regime, by contrast with Israel's benign administration, the paper and its authors would be unlikely to see the light of day. For the accompanying abstracts published online-only, there is no evidence of true peer review nor of genuine scientific analysis. No mention is made anywhere in print or online of the fact that life expectancy in Gaza is 73·68 years and on the West Bank 74·78 years—both higher than Egypt, for example, and in the top half of the world's nations according to the American Central Intelligence Agency.3Central Intelligence AgencyCountry comparison: life expectancy at birth. World Factbook, 2010https://www.cia.gov/library/publications/the-world-factbook/rankorder/2102rank.htmlGoogle Scholar Infant mortality on the West Bank and Gaza is likewise well within the middle of the range for the world's nations.4Central Intelligence AgencyCountry comparison: infant mortality rate. World Factbook, 2010https://www.cia.gov/library/publications/the-world-factbook/rankorder/2091rank.htmlGoogle Scholar The West Bank, still under at least partial Israeli control and benefiting from the availability of Israeli medical care, surpasses China, Turkey, Libya, and Mexico in that regard. It is hard to explain on any rational grounds why The Lancet has chosen to make a unique and selective focus on these disputed territories. A broader Lancet-inspired scientific health alliance for the area, including research coming from the many Israeli medical institutions where Jewish, Muslim, and Christian physicians work side by side and publish research together, might be a useful contribution to both medicine and peace. Unfortunately, publication of papers that are thinly disguised polemics posing as thoughtful scientific treatises takes the world further from not closer to the Editor's stated goal. We declare that we have no conflicts of interest.

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Abstract This chapter argues that asking about life’s origins uncovers intriguing questions about chance, meaning and order, and allows a rather startling discourse about the nature of knowledge in a world with physical realities and enduring cultural narratives. It addresses some of the many ethical issues engaged in synthetic biology and its emerging community of basic research scientists. It describes how the design of an artificial, self-organizing, evolving cellular environment may cross the border between things that are nonliving and things that are living. This chapter suggests that the main goal of ethics is a stance of deeply informed and thorough attention, rather than calls for moratoria or cessation of activities.

In the move to critique managed care, the essential principles that first made it a reasonable alternative to fee-for-service medicine can easily be lost. Careful reflection on the history of early grassroots movements that created managed care, and on selected textual narratives of the founders of the managed care organizations at their inception, offers us insight into which of the critical premises and goals of that effort might be reclaimed as we analyze the current managed care environment.

New devices are emerging that utilize the convergent technologies of several different fields of science and engineering to create tissue that can mimic the structure and function of the natural world. Examples include the creation of skin grafts, corneas, bone, cartilage, and, in some pilot studies, bladders. Such advances herald a remarkable ability to heal, a long-awaited solution to several intractable problems, and a serious alternative to cadaveric or living-donor whole organ transplants. However, no medical advance of this magnitude takes place without raising ethical concerns. This chapter poses the questions: What are the distinctive ethical challenges to the field of tissue engineering? Does tissue engineering raise new ethical issues, or are the concerns changed by the convergence of other technologies that have been understood to be individually ethically freighted? How do ethical questions about the manipulation of human stem cell, the use of CRISPR or other methods of gene editing, and the challenges of organ transplantation appear when tissue engineering emerges as a possibility?

(2001). Justice as Cardiovascular Therapy. The American Journal of Bioethics: Vol. 1, No. 2, pp. 24-25.

Debates about embryo and human embryonic stem (ES) cell research reveal deeply divided judgments about the status of early forms of human life and are often occasions for polemics rather than respectful dialogue. It is a merit of these two books that they engage their subjects thoughtfully and earnestly, even though they take very different approaches. Green describes his work as a philosophical memoir (p. xv) of his experiences as a member of the 1994 NIH Human Embryo Research Panel. His reflections on that tenure, as well as chapters about human cloning and ES cells, provide a highly engaging critique of what he deems an inappropriate politicization of such debates, especially by conservative religious groups (thus the vortex of his title). The Holland-Lebacqz-Zoloth edited volume, with its twenty chapters from nineteen contributors, provides a broader overview, with four sections devoted, respectively, to the state of current ES cell research, ethical issues, religious perspectives, and policy concerns. These books are especially interesting for the issues of policy ethics that they engage. First is the central, apparently unresolvable issue of the moral status of the human embryo, which raises questions about which perspectives should govern appropriate pluralistic policy. Second, how are we to assess claims about possible scientific breakthroughs, and how should we weigh them against other less quantifiable values and perspectives? Finally, what are the implications of so-called reason and deliberative democracy for embryo and ES cell debates? More generally, how should we craft genuinely respectful public policy on controversial matters that involve collective funding? Too often, emphases on individual liberty and social utility tend to dismiss other concerns as merely symbolic, parochial, or epistemologically privileged. Yet all forms of public discourse, including appeals to individual rights and preference satisfaction, are deeply symbolic in their own right as particular (and often quite minimalistic) depictions of human flourishing. These questions may be less intriguing to many observers than musings about tomorrow's scientific miracles. Yet issues of policy ethics are of fundamental importance because the framework for public dialogue and policy choice we establish now may well set the tone and substance of public debates about reproductive and regenerative medicine for the foreseeable future. Consider how an appropriate pluralism might address the core question in dispute--the moral status of embryonic human life. Green and several contributors to the stem cell volume (Elliot Dorff, Laurie Zoloth, Margaret Farley, Erik Parens, Gilbert Meilaender, and Ted Peters) explore this issue in detail. In comparing and contrasting their perspectives, two questions arise. What interpretive paradigms best frame their differing views and, more pointedly, what, if anything, does for human embryos entail? For a significant minority, including traditional Roman Catholics and others, respect for embryos follows from seeing them as early and quite vulnerable forms of human life and therefore as human subjects worthy of protection. It is not entirely clear what that perspective suggests for the fate of spare embryos, but one can surmise either of two recommendations: that such embryos should be adopted by other infertile couples or, in ways analogous to the ethics of end of life care, that such subjects be allowed to die (that is, that life-suspending treatment be discontinued) but not killed for non-therapeutic reasons. For others who see embryos as very early forms of human pre-personal or even pre-individuated life, the language of respect is more difficult to interpret. It clearly cannot mean that embryos are deemed human subjects. Instead, it may suggest parallels with the paradigm of tissue donation, wherein donor consent is a central requirement. …

This chapter discusses the social stigma associated with genetic research and bioethical issues. Genetic research, in its determination to seek the fundamental answers to human biology, has dominated scientific debate since the discovery of nuclear DNA. Thus, human embryonic stem cell research—that fully uses the insights and essential framework of genomics but seeks to understand far more about how cells signal, repress, and express the proteins that shape them—emerged as a part of the larger series of intellectual and social debates about molecular biology, human genetics, and medicine. The debate about the meaning, telos, and nature of the work thus takes place on several levels of discourse simultaneously, signifying and symbolizing a great deal more than the mechanics of method, as do all great debates in science. Claiming to deconstruct and define such questions have been problems, firmly understood to be in the domain of ethics and religion, for the science of essential biology remained frustratingly speculative. The revolution on molecular biology accelerated the process as new frontiers were continually explored. However, current ethical and moral debates on human stem cells mark both a new centrality of ethical reflection and a collective sense of caution about how to cross these new frontiers. In several critical ways, research on human embryonic stem cells recapitulates old arguments about one's faith in science, progress, and technology. In some ways, research raises fears about forbidden and new knowledge; in other ways, it potentiates fears about violations of “mother nature,” an argument engaged by both fundamentalists and environmentalists.

New devices are emerging that utilize the convergent technologies of several different fields of science and engineering to create tissue that can mimic the structure and function of the natural world. Examples include the creation of skin grafts, corneas, bone, cartilage, and, in some pilot studies, bladders. Such advances herald a remarkable ability to heal, a long-awaited solution to several intractable problems, and a serious alternative to cadaveric or living-donor whole organ transplants. This chapter poses the questions: What are the ethical challenges to the field of tissue engineering? Does tissue engineering raise new ethical issues, or is it a description of one of the modalities enabled by the convergence of other technologies that have been understood to be individually ethically freighted?

Abstract This chapter addresses how the textual tradition of Jewish thought regards the problem of human suffering in theological and moral terms. It highlights core differences in the tradition that have come to define and delineate one of the most salient issues in American bioethics: the way that human suffering and its tragic or redemptive nature is at stake in debates as varied as stem cell research, end-of-life care, and reproductive policy. The chapter looks at the historical view of suffering, from the classical to early and postmodern thinkers, and then sketches some outlines for how the view of suffering in Jewish thought is developed and debated, finally showing how one rabbinic text structures a response of reversibility between healer and patient. The chapter concludes with some ideas about how an appreciation of the different voice that Judaism brings to ethics may largely be because of its different evaluation of suffering.

As popular discourse considers the issue of suicide in American culture, we see a range of responses, from the new Hallmark card (“I know that the Creator has already welcomed your loved one home”) to the formal consideration of the issue by legislatures and courts. Except in Oregon, the embrace of assisted suicide has not been entirely robust, but as ethicist Carl Elliott has noted: “while many physicians seem uncomfortable with the idea… academic moral philosophers have been prominent in those who… seem sympathetic to the idea of physician-assisted death” (Elliott, 1996). Hence, I will consider how to solve the many perplexing problems raised by the issue and in so doing reflect on the modest question: Why not philosopher-assisted suicide? In particular, why have only a few considered the obvious advantages of underemployed moral philosophers and bioethicists as the best suited to the job of dispatching the patient who wants not only to die, but to die with the assistance of a well-regarded (even priestly) professional presence? Oregon, the only state to have legalized physician-assisted suicide may want to employ them. In outlining this suggestion, I do not tangentially consider the secondary benefit of finding a solution to the tightening job market for academically trained moral philosophers with a specialization in medical ethics.

Jewish ethics provides resources not only for exotic cases, but also for the practical necessities of everyday business practice, such as sustaining non-profit health care. Non-profit health care presents tough choices for justice because it is motivated by community compassion but must meet the pressures of the marketplace. Feminist ethics offers an "ethics of care" to guide our actions in such conflicts. This article argues that an ethics derived from both ferrlinism and Jewish sources calls for a different approach, one which is rooted in the history of business practice, in the history of women's leadership in this health care, and in the Jewish legal teaching (halacha) that seeks a balance between competing moral appeals in the marketplace.

Abstract Human stem cell research, because of its potential for both transformative sources of knowledge and for translation into widespread practical applications, has been a subject of ethical, religious, and policy debates since the first cells were characterized. The technology touches on some of humanities most urgent concerns and some of our most fundamental narratives. Stem cell research is characterized by a swiftly moving knowledge base, with first human embryonic (hES), then induced pluripotent cells (iPS) being seen as the best new hope in the search for cures to diseases. Each new advance in science brings new ethical and moral quandaries to the debate. This presentation will outline the history of ethical questions surrounding stem cell research, describe the variety of responses to such concerns, and define some of the international policy that has emerged to create ethical frameworks for ongoing research on stem cells. We will consider what questions, if any , can be understood as settled within a general consensus, and what questions may be raised by the future directions of stem cell research.