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Vexed Again: Social Scientists and the Revision of the Common Rule, 2011-2018

Published online by Cambridge University Press:  01 January 2021

Zachary M. Schrag
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Abstract

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.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 2: Human Subject Protection , Summer 2019 , pp. 254 - 263
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

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.+(last+visited+March+29,+2019).+The+exchange+starts+at+minute+56+of+the+video+recording.>Google Scholar
Schrag, Z. M., 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.Google Scholar
American Anthropological Association, “Commentary on Notice of Proposed Rulemaking,” January 6, 2016, 3, available at <https://www.regulations.gov/document?D=HHSOPHS-2015-0008-0001> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Beauchamp, T. L. and Saghai, Y., “The Historical Foundations of the Research—Practice Distinction in Bioethics,” Theoretical Medicine and Bioethics 33, 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.CrossRefGoogle Scholar
Schrag, Ethical Imperialism, supra note 2, at 192.Google Scholar
Beecher, H. K., “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (June 16, 1966): 1354–1360, available at <https://doi.org/10.1056/NEJM196606162742405> (last visited March 29, 2019).CrossRefGoogle Scholar
Baumann, J., “White House Finalizes Scaled Back Research Regs,” Bloomberg Law, January 19, 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. Emanuel, E. J. and Menikoff, J., “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.Google Scholar
As John Conley notes, today's biospecimen donors are unlikely to be exposed the way Lacks and her family were. Conley, J., “Some Thoughts on the New Common Rule for Human Subjects Research — The Privacy Report,” The Privacy Report (blog), March 29, 2017, available at <https://theprivacyreport.com/2017/03/29/some-thoughts-on-the-new-common-rule-for-human-subjects-research/> (last visited March 29, 2019).Google Scholar
Carome, M., “Letter to Secretary Burwell Re: Common Rule NPRM,” November 20, 2014, available at <https://www.citizen.org/sites/default/files/2232.pdf> (last visited March 29, 2019).Google Scholar
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.Google Scholar
Emanuel and Menikoff, supra note 7.Google Scholar
Fiske, S. T., “A New Day for Human Subjects Research Participation,” APS Observer 27, no. 8 (September 30, 2014), available at <https://www.psychologicalscience.org/observer/change-is-coming> (last visited March 29, 2019).Google Scholar
Puglisi, T., “Reform within the Common Rule?” Hastings Center Report 43, no. s1 (2013): S40–S42.CrossRefGoogle Scholar
Basken, P., “Federal Overhaul of Rules for Human Research Hits Impasse,” Chronicle of Higher Education, March 7, 2013.Google Scholar
Rubin interview, supra note 7.Google Scholar
Shea, C., “New Rules for Human—Subject Research Are Delayed and Debated,” Chronicle of Higher Education, November 3, 2014.Google Scholar
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): 44515.Google Scholar
Capron, A. M., Strauss, D. H., and Hurley, E. A., “RE: Document 2015-21756, Federal Policy for the Protection of Human Subjects (80 Federal Register 53931),” January 6, 2016, available at https://www.regulations.gov/document?D=HHSOPHS-2015-0008-1053 (last visited March 29, 2019)Google Scholar
Interagency Advisory Panel on Research Ethics Government of Canada, “Interagency Advisory Panel on Research Ethics,” February 5, 2016, available at <http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Australia, National Health and Medical Research Council, “National Statement on Ethical Conduct in Human Research (2007) — Updated 2015,” available at <https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
National Research Council, Protecting Participants and Facilitating Social and Behavioral Sciences Research (Washington, DC, 2003), 8.Google Scholar
The ANPRM's footnote cited the Monash Bioethics Review on Australian regulation. I believe that was its sole citation to non-U.S. sources.Google Scholar
Presidential Commission for the Study of Bioethical Issues, “Moral Science: Protecting Participants in Human Subjects Research” (Washington, DC, 2011), 44.Google Scholar
“SACHRP Charter,” Text, HHS.gov, June 23, 2009, available at <https://www.hhs.gov/ohrp/sachrp-committee/charter/index.html> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
“Secretary's Advisory Committee on Human Research Protections (SACHRP): Membership Roster and OHRP Contacts,” November 26, 2015, available at <https://web.archive.org/web/20151126231708/ http://www.hhs.gov/ohrp/sachrp/members/committee/index.html> (last visited June 19, 2019); hhs.gov, “Attachment A: Recommendations NPRM,” Text, HHS.gov, March 9, 2016, <https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2016-january-5-recommendation-nprm-attachment-a/index.html> (last visited March 29, 2019).+(last+visited+June+19,+2019);+hhs.gov,+“Attachment+A:+Recommendations+NPRM,”+Text,+HHS.gov,+March+9,+2016,++(last+visited+March+29,+2019).>Google Scholar
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): 44513.Google Scholar
Rubin interview, supra note 7.Google Scholar
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,” December 11, 2012, available at <www.nationalacademies.org> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Rena Lederman, interview by Z. Schrag, telephone, August 10, 2018.Google Scholar
Margo Schwab to Andrea Palm, “Annotated draft reg text for Common Rule,” October 29, 2014, reproduced in Michael Carome, “Letter to Secretary Burwell Re: Common Rule NPRM,” November 20, 2014.Google Scholar
Rubin interview, supra note 7.Google Scholar
“Federal Policy for the Protection of Human Subjects,” Federal Register 82, no. 12 (January 19, 2017): 7174, available at <https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Riley, W. T. and Akbar, F., “Revision to the Common Rule: Implications for Behavioral and Social Sciences Research,” APS Observer 30, no. 5 (April 28, 2017), available at <https://www.psychologicalscience.org/observer/revisions-to-the-common-rule-implications-for-behavioral-and-social-sciences-research> (last visited March 29, 2019); S. T. Fiske and J. Rivard, “A New Era in Human-Subjects Regulation,” Nature Human Behaviour 1 (April 7, 2017), article 0091.Google Scholar
45 CFR 46.017, 204.Google Scholar
Fiske and Rivard, “A New Era in Human-Subjects Regulation,” supra note 33.Google Scholar
Beollstorff, T., comment on ANPRM, available at <https://www.regulations.gov/document?D=HHS-OPHS-2011-0005-0179> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Opsal, T. et al., “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,” Qualitative Health Research 26, no. 8 (July 1, 2016): 1137–1150.CrossRefGoogle Scholar
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.Google Scholar
§__.111(b).Google Scholar
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.Google Scholar
Department of Health and Human Services, “Public Health Service Human Research Subjects,” Federal Register 46, no. 16 (January 26, 1981): 8369.Google Scholar
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.Google Scholar
“Federal Policy for the Protection of Human Subjects,” January 19, 2017, 7153.Google Scholar
Office for Protection from Research Risks, “Exempt Research and Research That May Undergo Expedited Review,” OPRR Reports 95-02 (May 5, 1995), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm> (August 22, 2007).+(August+22,+2007).>Google Scholar
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.Google Scholar
“Federal Policy for the Protection of Human Subjects,” January 19, 2017, 7153.Google Scholar
Office for Human Research Protections, “Exempt Research Determination FAQs,” Text, HHS.gov, accessed October 31, 2018, available at <https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/exempt-research-determination/index.html> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Fiske, S. T. and Rivard, J., “A New Era in Human-Subjects Regulation,” Nature Human Behaviour 1 (April 7, 2017): 0091, available at <https://doi.org/10.1038/s41562-017-0091> (last visited March 29, 2019).CrossRefGoogle Scholar
Princeton University Research Integrity and Assurance, “Policies and Guidelines | Research Integrity and Assurance,” available at <https://ria.princeton.edu/human-research/policies-and-guidelines> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
For a pre-revision snapshot of such policies, see Loe, J. D., Winkelman, D. A., and Robertson, C. T., “An Assessment of the Human Subjects Protection Review Process for Exempt Research,” Journal of Law, Medicine & Ethics 44, no. 3 (2016): 481–491, available at <https://doi.org/10.1177/1073110516667944> (last visited March 29, 2019).CrossRefGoogle Scholar
“Federal Policy for the Protection of Human Subjects,” Federal Register 82, no. 12 (January 19, 2017): 7175, available at <https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
Peltason, J. W., “Comment on the Proposed Regulations from Higher Education and Professional Social Science Associations,” IRB: Ethics and Human Research 2, no. 2 (February 1, 1980): 10.CrossRefGoogle Scholar
Wood, A., Grady, C., and Emanuel, E. J., “The Crisis in Human Participants Research: Identifying the Problems and Proposing Solutions,” (September 2002), available at <https://bioethicsarchive.georgetown.edu/pcbe/background/emanuelpaper.html> (last visited March 29, 2019).Google Scholar
“Federal Policy for the Protection of Human Subjects,” January 19, 2017, supra note 51, 7239.Google Scholar
Opsal, T. et al., “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,” Qualitative Health Research 26, no. 8 (July 1, 2016): 1137–1150, available at <https://doi.org/10.1177/1049732315580109> (last visited March 29, 2019).CrossRefGoogle Scholar
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).+(last+visited+March+29,+2019).>Google Scholar
Emanuel, E. J., “Human Subjects Protection Reform” (August 30, 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.Google Scholar
National Research Council, Proposed Revisions to the Common Rule, supra note 56, at 49.Google Scholar
“Federal Policy for the Protection of Human Subjects,” Federal Register 80, no. 173 (September 8, 2015): 54039.Google Scholar
National Research Council, Proposed Revisions to the Common Rule, supra note 56, at 8.Google Scholar
Schrag, Z. M., “What Is This Thing Called Research?” in Human Subjects Research Regulation: Perspectives on the Future (Cambridge: MIT Press, 2014), 285–298.CrossRefGoogle Scholar
U.S. Department of Health and Human Services, When Does the Common Rule Apply? Review of the Basics Under the Revised Rule, available at <https://www.youtube.com/watch?v=Sptom2vU924&feature=youtu.be> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
“Federal Policy for the Protection of Human Subjects,” January 19, 2017, 7174.Google Scholar
“The Universal Declaration of Human Rights,” accessed March 3, 2014, available at <http://www.un.org/en/documents/udhr/> (last visited March 29, 2019); Office of the United Nations High Commissioner for Human Rights, “International Covenant on Economic, Social and Cultural Rights,” available at <https://www.ohchr.org/en/professionalinterest/pages/cescr.aspx> (last visited March 29, 2019).+(last+visited+March+29,+2019);+Office+of+the+United+Nations+High+Commissioner+for+Human+Rights,+“International+Covenant+on+Economic,+Social+and+Cultural+Rights,”+available+at++(last+visited+March+29,+2019).>Google Scholar
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,” December 5, 2014, available at <http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/> (last visited March 29, 2019).+(last+visited+March+29,+2019).>Google Scholar
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): 44513.Google Scholar
Rubin, P., “Changes to the Human Subjects System: A View from Someone Formerly on the Inside,” FABBS Blog (blog), February 16, 2018, available at <https://blog.fabbs.org/2018/02/16/changes-to-the-human-subjects-system-a-view-from-someone-formerly-on-the-inside/> (last visited March 29, 2019).Google Scholar
Rubin interview, supra note 7.Google Scholar