Report
T h e Hasti n g s C e n ter
FROM THE EDITOR
VOLUME 44, NO. 4 • july-august 2014
Rules, Regs, and What’s Right
Gregory E. Kaebnick Editor
everal items in this issue of the Hastings Center Report try to fill gaps or resolve uncertainties in the regulatory systems that govern research on human subjects. The biggest of these items is a special report, published as a supplement to the issue, that considers a long-running and vexing regulatory problem: the uncertain relationship between the two sets of federal regulations for research. The one most familiar to readers of the Report is the body of rules often called the “Common Rule,” which guide the treatment of human subjects. The other, discussed less frequently in our pages but plenty familiar to any university official who’s tasked with oversight of research conducted at the university, is the body of regulations concerning “research misconduct,” which has to do with fraud—plagiarism and fabrication of data, for example. Both sets may govern a study, and when something goes wrong in a study, provisions in each set may be triggered. Figuring out how to meet the various requirements can be bewildering. The goal of this special report is to provide guidance. The lead article inside the issue addresses a problem generated by newly emerging genomic research. Such studies are likely to generate what are known as “incidental findings”—results that have nothing to do with the aims of the study but that might be very significant to the subject. How should potential subjects be informed of that possibility? When and how should such findings be passed along to them? Since the Common Rule requires that subjects be informed about how studies will be conducted, presumably the procedures for providing incidental findings need to be explained. In the lead article, Paul Appelbaum and colleagues argue that routine approaches to informed consent will probably not work, and they develop four alternative approaches. Incidental findings are also the subject of the lead essay, by Lisa Lee, of the Presidential Commission for the Study of Bioethical Issues, and Peter Marks, of the Food and Drug Administration. The commission outlined a framework last year for how to handle the release of incidental findings in research, and in this essay, Lee and Marks offer their thoughts about how that framework can be applied to incidental findings that occur in screenings in the public health context. The second essay in the issue, by Joseph Fins of New York Cornell Medical Center, poses questions about the relationship between regulations and ethics. “Is it always enough,” Fins asks, “to abide by the rules and regulations for human subjects research? Or, in fact, might too close a focus on the rules blind both investigator and regulator to larger, overarching concerns?” Possibly, he posits, arguments could show that a study has abided by the language of the requirements even though, when one steps back from the regulatory language, a study still seems problematic. If that can happen, then perhaps a focus on the logic of regulatory requirements could lead one astray. That’s not at all to say that rules and regs are useless and following them wrongheaded, but that they are attempts to capture moral concerns and one has to be looking in both places at once. —GEKn
Laura Haupt Managing Editor
S
2 HASTIN G S C E N T E R R E P ORT
Susan Gilbert Stephen R. Latham Contributing Editors Nora Porter Art Director Nancy Berlinger Michael K. Gusmano Josephine Johnston Erik Parens Editorial Committee The Hastings Center Report (ISSN 0093-0334 print; ISSN 1552-146X online) is published bimonthly on behalf of The Hastings Center by Wiley Subscription Services, Inc., a Wiley Company, 111 River St., Hoboken, NJ 07030-5774. The Hastings Center, an independent, nonpartisan, nonprofit organization, addresses fundamental ethical issues in the areas of health, medicine, and the environment as they affect individuals, communities, and societies. For more information on the Center’s interdisciplinary research and education programs, visit its website at www.thehastingscenter.org. The Hastings Center Report is sent to individual and institutional subscribers. For ordering information, claims, and any inquiry concerning your journal subscription, please go to http:// www.wileycustomerhelp.com/ask or contact your nearest office. Americas: [email protected] or 1-800-8356770. Europe, Middle East, and Africa: [email protected]; +44 (0)-1865778315. Asia Pacific: cs-journals@wiley. com or +65-6511-8000. Periodicals postage paid at Hoboken, NJ, and additional mailing offices. postmaster: Send all address changes to the Hastings Center Report, Journal Customer Services, John Wiley and Sons, Inc., c/o The Sheridan Press, PO Box 465, Hanover, PA 17331. Contents copyright © 2014 by The Hastings Center. All rights reserved. July-August 2014
T h e Hasti n g s C e n ter
FROM THE EDITOR
VOLUME 44, NO. 4 • july-august 2014
Rules, Regs, and What’s Right
Gregory E. Kaebnick Editor
everal items in this issue of the Hastings Center Report try to fill gaps or resolve uncertainties in the regulatory systems that govern research on human subjects. The biggest of these items is a special report, published as a supplement to the issue, that considers a long-running and vexing regulatory problem: the uncertain relationship between the two sets of federal regulations for research. The one most familiar to readers of the Report is the body of rules often called the “Common Rule,” which guide the treatment of human subjects. The other, discussed less frequently in our pages but plenty familiar to any university official who’s tasked with oversight of research conducted at the university, is the body of regulations concerning “research misconduct,” which has to do with fraud—plagiarism and fabrication of data, for example. Both sets may govern a study, and when something goes wrong in a study, provisions in each set may be triggered. Figuring out how to meet the various requirements can be bewildering. The goal of this special report is to provide guidance. The lead article inside the issue addresses a problem generated by newly emerging genomic research. Such studies are likely to generate what are known as “incidental findings”—results that have nothing to do with the aims of the study but that might be very significant to the subject. How should potential subjects be informed of that possibility? When and how should such findings be passed along to them? Since the Common Rule requires that subjects be informed about how studies will be conducted, presumably the procedures for providing incidental findings need to be explained. In the lead article, Paul Appelbaum and colleagues argue that routine approaches to informed consent will probably not work, and they develop four alternative approaches. Incidental findings are also the subject of the lead essay, by Lisa Lee, of the Presidential Commission for the Study of Bioethical Issues, and Peter Marks, of the Food and Drug Administration. The commission outlined a framework last year for how to handle the release of incidental findings in research, and in this essay, Lee and Marks offer their thoughts about how that framework can be applied to incidental findings that occur in screenings in the public health context. The second essay in the issue, by Joseph Fins of New York Cornell Medical Center, poses questions about the relationship between regulations and ethics. “Is it always enough,” Fins asks, “to abide by the rules and regulations for human subjects research? Or, in fact, might too close a focus on the rules blind both investigator and regulator to larger, overarching concerns?” Possibly, he posits, arguments could show that a study has abided by the language of the requirements even though, when one steps back from the regulatory language, a study still seems problematic. If that can happen, then perhaps a focus on the logic of regulatory requirements could lead one astray. That’s not at all to say that rules and regs are useless and following them wrongheaded, but that they are attempts to capture moral concerns and one has to be looking in both places at once. —GEKn
Laura Haupt Managing Editor
S
2 HASTIN G S C E N T E R R E P ORT
Susan Gilbert Stephen R. Latham Contributing Editors Nora Porter Art Director Nancy Berlinger Michael K. Gusmano Josephine Johnston Erik Parens Editorial Committee The Hastings Center Report (ISSN 0093-0334 print; ISSN 1552-146X online) is published bimonthly on behalf of The Hastings Center by Wiley Subscription Services, Inc., a Wiley Company, 111 River St., Hoboken, NJ 07030-5774. The Hastings Center, an independent, nonpartisan, nonprofit organization, addresses fundamental ethical issues in the areas of health, medicine, and the environment as they affect individuals, communities, and societies. For more information on the Center’s interdisciplinary research and education programs, visit its website at www.thehastingscenter.org. The Hastings Center Report is sent to individual and institutional subscribers. For ordering information, claims, and any inquiry concerning your journal subscription, please go to http:// www.wileycustomerhelp.com/ask or contact your nearest office. Americas: [email protected] or 1-800-8356770. Europe, Middle East, and Africa: [email protected]; +44 (0)-1865778315. Asia Pacific: cs-journals@wiley. com or +65-6511-8000. Periodicals postage paid at Hoboken, NJ, and additional mailing offices. postmaster: Send all address changes to the Hastings Center Report, Journal Customer Services, John Wiley and Sons, Inc., c/o The Sheridan Press, PO Box 465, Hanover, PA 17331. Contents copyright © 2014 by The Hastings Center. All rights reserved. July-August 2014
