In revising the Federal Policy for the Protection of Human Subjects (Common Rule) between 2009 and 2018, regulators devoted the vast bulk of their attention to debates over biomedical research. They lacked both expertise in and concern about the social sciences and humanities, yet they imposed their will on experts in those fields. The revision process was secretive, spasmodic, and unrepresentative, especially compared to rulemaking in Canada, where social scientists participate in the process, and revisions take place every few years. The result was a final rule that offers some wins for social science and the humanities, but that fails to solve the problems identified by Ezekiel Emanuel and in the 2011 advance notice of proposed rulemaking.
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References
1.
U.S. Department of Health and Human Services, NPRM Town Hall Meeting Part 3: Audience Q&A (Afternoon Session), available at <https://www.youtube.com/watch?v=YVFrtK3hu8> (last visited March 29, 2019). The exchange starts at minute 56 of the video recording.
2.
Z. M.Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 (Baltimore: Johns Hopkins University Press, 2010); Z. M. Schrag, “The Case Against Ethics Review in the Social Sciences,” Research Ethics 7, no. 4 (2011): 120–131.
T. L.Beauchamp and Y.Saghai, “The Historical Foundations of the Research—Practice Distinction in Bioethics,”Theoretical Medicine and Bioethics33, no. 1 (2012): 45–56; D. Whicher et al., “The Views of Quality Improvement Professionals and Comparative Effectiveness Researchers on Ethics, IRBs, and Oversight,” Journal of Empirical Research on Human Research Ethics (2015), doi: 1556264615571558.
5.
Schrag, Ethical Imperialism, supra note 2, at 192.
6.
H. K.Beecher, “Ethics and Clinical Research,”New England Journal of Medicine274, no. 24 (June16, 1966): 1354–1360, available at <https://doi.org/10.1056/NEJM196606162742405> (last visited March 29, 2019).
7.
J.Baumann, “White House Finalizes Scaled Back Research Regs,”Bloomberg Law, January19, 2017. Emanuel and Menikoff noted that their work was “consistent” with President Obama's Executive Order 13563, issued in January 2011, but they do not claim that the order started their work. E. J. Emanuel and J. Menikoff, “Reforming the Regulations Governing Research with Human Subjects,” New England Journal of Medicine 365, no. 12 (2011): 1145–1150; Philip Rubin, interview by Z. Schrag, telephone, October 17, 2018.
I have submitted multiple FOIA requests in an effort to learn more, but as of December 2018, I have not received any documents, nor do I expect them any time soon.
T.Puglisi, “Reform within the Common Rule?”Hastings Center Report43, no. s1 (2013): S40–S42.
14.
P.Basken, “Federal Overhaul of Rules for Human Research Hits Impasse,”Chronicle of Higher Education, March7, 2013.
15.
Rubin interview, supra note 7.
16.
C.Shea, “New Rules for Human—Subject Research Are Delayed and Debated,”Chronicle of Higher Education, November3, 2014.
17.
U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”Federal Register76 (July26, 2011): 44515.
18.
A. M.Capron, D. H.Strauss, and E. A.Hurley, “RE: Document 2015-21756, Federal Policy for the Protection of Human Subjects (80 Federal Register 53931),”January6, 2016, available athttps://www.regulations.gov/document?D=HHSOPHS-2015-0008-1053 (last visited March 29, 2019)
National Research Council, Protecting Participants and Facilitating Social and Behavioral Sciences Research (Washington, DC, 2003), 8.
22.
The ANPRM's footnote cited the Monash Bioethics Review on Australian regulation. I believe that was its sole citation to non-U.S. sources.
23.
Presidential Commission for the Study of Bioethical Issues, “Moral Science: Protecting Participants in Human Subjects Research” (Washington, DC, 2011), 44.
U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”Federal Register76 (July26, 2011): 44513.
27.
Rubin interview, supra note 7.
28.
Division of Behavioral and Social Sciences and Education Institute of Medicine, “Committee Membership Information. Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences,”December11, 2012, available at <www.nationalacademies.org> (last visited March 29, 2019).
29.
Rena Lederman, interview by Z. Schrag, telephone, August 10, 2018.
30.
Margo Schwab to Andrea Palm, “Annotated draft reg text for Common Rule,”October29, 2014, reproduced in Michael Carome, “Letter to Secretary Burwell Re: Common Rule NPRM,” November 20, 2014.
T.Opsalet al., “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,”Qualitative Health Research26, no. 8 (July1, 2016): 1137–1150.
38.
National Research Council, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (Washington, DC: National Academies Press, 2014): 6.
39.
§__.111(b).
40.
U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”44528.
41.
Department of Health and Human Services, “Public Health Service Human Research Subjects,”Federal Register46, no. 16 (January26, 1981): 8369.
42.
U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”44519.
43.
“Federal Policy for the Protection of Human Subjects,”January19, 2017, 7153.
U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”44520.
46.
“Federal Policy for the Protection of Human Subjects,”January19, 2017, 7153.
S. T.Fiske and J.Rivard, “A New Era in Human-Subjects Regulation,”Nature Human Behaviour1 (April7, 2017): 0091, available at <https://doi.org/10.1038/s41562-017-0091> (last visited March 29, 2019).
For a pre-revision snapshot of such policies, see J. D.Loe, D. A.Winkelman, and C. T.Robertson, “An Assessment of the Human Subjects Protection Review Process for Exempt Research,”Journal of Law, Medicine & Ethics44, no. 3 (2016): 481–491, available at <https://doi.org/10.1177/1073110516667944> (last visited March 29, 2019).
J. W.Peltason, “Comment on the Proposed Regulations from Higher Education and Professional Social Science Associations,”IRB: Ethics and Human Research2, no. 2 (February1, 1980): 10.
“Federal Policy for the Protection of Human Subjects,”January19, 2017, supra note 51, 7239.
55.
T.Opsalet al., “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,”Qualitative Health Research26, no. 8 (July1, 2016): 1137–1150, available at <https://doi.org/10.1177/1049732315580109> (last visited March 29, 2019).
56.
National Research Council, Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (Washington, DC: National Academies Press, 2014), 65, available at <http://www.nap.edu/catalog.php?record_id=18614> (last visited March 29, 2019).
57.
E. J.Emanuel, “Human Subjects Protection Reform” (August30, 2011), available at <https://bioethicsarchive.georgetown.edu/pcsbi/node/314.html> (last visited March 29, 2019); U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” Federal Register 76 (July 26, 2011): 44512–44531.
58.
National Research Council, Proposed Revisions to the Common Rule, supra note 56, at 49.
59.
“Federal Policy for the Protection of Human Subjects,”Federal Register80, no. 173 (September8, 2015): 54039.
60.
National Research Council, Proposed Revisions to the Common Rule, supra note 56, at 8.
61.
Z. M.Schrag, “What Is This Thing Called Research?” in Human Subjects Research Regulation: Perspectives on the Future (Cambridge: MIT Press, 2014), 285–298.
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, “Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans,”December5, 2014, available at <http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/> (last visited March 29, 2019).
66.
U.S. Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”Federal Register76 (July26, 2011): 44513.
