Revising the Common Rule: Ethics,Scientific Advancement,and Public Policy in Conflict

Department of Health and Human Services et al., “Final Rule: Federal Policy for the Protection of Human Subjects,” Federal Register 82, no. 12 (2017): 7149-7274, at 7150.

See K. L. Hudson and F. S. Collins , “Bringing the Common Rule into the 21st century,” New England Journal of Medicine 373, no. 24 (2015): 2293-2296; the Precision Medicine Initiative website, available at <https://obamawhitehouse.archives.gov/node/333101> (last visited August 23, 2017). The Precision Medicine Initiative is now implemented primarily through the NIH All of Us Research Program. See All of Us website, available at <https://allofus.nih.gov> (last visited August 23, 2017).

Department of Health and Human Services, Protection of Human Subjects, Subpart A: Basic HHS Policy for Protection of Human Research Subjects, 45 CFR 46. See Final Rule, supra note 1, at 7149.

Department of Health and Human Services, “Advance Notice of Proposed Rule Making: Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” Federal Register 76, no. 143 (2011): 44512-44531. See Final Rule, supra, note 1, at 7150.

Department of Health and Human Services et al., “Notice of Proposed Rule Making: Federal Policy for the Protection of Human Subjects,” Federal Register 80, no. 173 (2015): 53933-54061 (“NPRM”). See H. F. Lynch , I. G. Cohen , and B. E. Bierer , “Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule,” IRB: Ethics & Human Research 39, no. 1 (2017): 17-19; Final Rule, supra, note 1, at 7150.

See Hudson and Collins, supra note 2.

The case of the Havasupai Tribe cinvolved researcher collection and testing of blood samples to study diabetes (with tribal council approval), with allegations that researchers also studied and published articles about schizophrenia, in-breeding, and migration of the tribe allegedly without the tribal members' knowledge or consent. The case illustrates issues of group-based harm based in linking individual members of a group with a stigmatizing condition as well as undermining a fundamental cultural belief system of the group. See, e.g., M. A. Rothstein , “Is Deidentification Sufficient to Protect Health Privacy in Research?” American Journal of Bio-ethics 10, no. 9 (2010): 3-11, at 6; L. E. Wolf , “Advancing Research on Stored Biological Materials: Reconciling Law, Ethics, and Practice,” Minnesota Journal of Law, Science, and Technology 11, no. 1 (2010): 99-156, at 118-122; M. A. Rothstein , “Ethical Issues in Big Data Health Research,” Journal of Law, Medicine & Ethics 43, no. 2 (2015): 425-429, at 426-427 (citing Tilousi v. Arizona State Univ. Bd. of Regents, 2005 WL 6199562 (D. Ariz., March 3, 2005); K. Drabiak-Syed , “Lessons from Havasupai Tribe v. Arizona State University Board of Regents: Recognizing Group, Cultural, and Dignitary Harms as Legitimate Risks Warranting Integration into Research Practice,” Journal of Health & Biomedical Law 6, no. 2 (2010): 175-225); E. A. Hurley , “From the Director: Informed Consent in the Revised Common Rule,” available at <http://blog.primr.org/ftd-informed-consent-revised-common-rule/> (last visited August 23, 2017).

NPRM, supra note 5, at 53936; see Hudson and Collins, supra note 2.

NPRM, supra note 5, at 53936.

The federal departments and agencies that are signatories to the final rule are the Department of Homeland Security, the Department of Agriculture, the Department of Energy, the National Aeronautics and Space Administration, the Department of Commerce, the Social Security Administration, the Agency for International Development, the Department of Housing and Urban Development, the Department of Labor, the Department of Defense, the Department of Education, the Department of Veterans Affairs, the Environmental Protection Agency, the Department of Health and Human Services, the National Science Foundation, and the Department of Transportation. Although the Central Intelligence Agency has not issued the Common Rule in regulations, historically it has complied with all subparts of the HHS regulations at 45 CFR part 46, and it will continue to do so pursuant to Executive Order 12333 of December 4, 1981, as amended. The Department of Labor was not a signatory to the 1991 rule but has now adopted the final rule. The Consumer Product Safety Commission, subject to Commission vote, intends to adopt the final rule through a separate rulemaking. The Department of Justice, which has been a signatory to the 1991 rule, is not a signatory to the final rule. Final Rule, supra note 1, at 7154.

See, e.g., H. F. Lynch , I. G. Cohen , and B. E. Bierer , “Common Rule Revisions: Impact of Public Comment, and What's Next?” available at: <http://www.thehastingscenter.org/common-rule-revisions-impact-public-comment-whats-next/> (last visited August 23, 2017); J. D. Smith , A. C. Birkeland , E. B. Goldman , J. C. Brenner , T. E. Carey , K. Spector-Bagdady , A. G. Shuman , and E. B. Goldman , “Immortal Life of the Common Rule: Ethics, Consent, and the Future of Cancer Research,” Journal Of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 35, no. 17 (2017): 1879-1883; J. Baumann , “Trump Administration Seen Unlikely to Change Human Research Rule,” available at <https://www.bna.com/trump-administration-seen-n73014451606/> (last visited August 23, 2017); Hurley, Informed Consent, supra note 7.

See, e.g., Lynch, Cohen, and Bierer, supra note 11; H. F. Lynch and M. N. Meyer , “Regulating Research with Bio-specimens under the Revised Common Rule,” The Hastings Center Report 47, no. 3 (2017): 3-4; Smith, et al., supra note 11; H. F. Lynch and S. Joffee , “A Lesson from the Henrietta Lacks Story: Science Needs Your Cells,” available at <https://www.nytimes.com/2017/04/21/opinion/henrietta-lacks-why-science-needs-your-cells.html?mcubz=1> (last visited August 23, 2017); E. A. Hurley , “From the Director: Reflections on the Revised Common Rule,” available at <http://blog.primr.org/reflections-revised-common-rule/> (last visited August 23, 2017).

Final Rule, supra note 1, at 7150.

See J. Menikoff , J. Kaneshiro , and I. Pritchard , “The Common Rule, Updated,” New England Journal of Medicine 376, no. 7 (2017): 613-615.

Id., at 613.

Id., at 614.

Final Rule, supra, note 1, at 7150.

See S. M. Rivera , K. B. Brothers , R. J. Cadigan , H. L. Harrell , M. A. Rothstein , R. R. Sharp , and A. J. Goldenberg , “Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box,” American Journal of Bioethics 17, no. 7 (2017): 1-3.

See, e.g., Wolf, supra note 7, at 130-133; Lynch and Meyer, supra note 12; Hurley, supra note 7.

NPRM, supra note 5, at 53942-48.

The final rule allows waiver or alteration of consent requirements in research involving access to or use of identifiable private information or identifiable bio-specimens only if the research could not practicably be carried out without using such information or biospecimens in an identifiable format. Final Rule, supra, note 1, at 7150, 7225-7226; §__.116(f) (3)(iii).

Menikoff, Kaneshiro, and Pritchard, supra note 14, at 613.

See Final Rule, supra, note 1, at 7168.

See Lynch, Cohen, and Bierer, supra note 11; Lynch, Cohen, and Bierer, supra note 5.

Lynch, Cohen, and Bierer, supra note 5.

M. A. Rothstein , personal communication, June 28, 2017.

As categorized by the Council on Government Relations, the highest number of public comments were received from patients, the general public, researchers, universities/medical centers/IRBs, professional associations, and advocacy groups. Council on Government Relations website, “Analysis of Common Rule Comments,” available at <http://www.cogr.edu/Human-Subjects-and-Animal-Research> (last visited August 23, 2017).

See the Cancer Moonshot website, available at <https://obamawhite-house.archives.gov/cancermoonshot> (last visited August 23, 2017). Vice President Biden continues this work via the Biden Cancer Initiative. See Biden Cancer Initiative website, available at <http://bidenfoundation.org/pillars/cancer-initiative/> (last visited August 23, 2017).

See Rothstein, Deidentification, supra note 7, at 8 (discussing studies).

See Lynch, Cohen, and Bierer, supra note 11.

See Lynch, Cohen, and Bierer, Public Engagement, supra note 5, at 18.

Final Rule, supra note 1, at 7198.

Rothstein, Deidentification, supra note 7, at 3 (arguing that there is no justification for perpetuating the dichotomy in law that applies legal protections to “identifiable” information, but no protections whatsoever to “not identifiable” information).

SACHRP Recommendations website, “Recommendations on the Notice of Proposed Rulemaking entitled ‘Federal Policy for the Protection of Human Subjects,’” available at <https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2016-january-5-recommendation-nprm-attachment-a/index.html> (last visited August 23, 2017).

See, e.g., Lynch and Meyer, supra note 12, at 3.

“Limited IRB review” includes such findings as broad consent was properly obtained, the research is within the scope of that consent, provisions to protect confidentiality are adequate, and the study plan does not include returning individual research results. See Final Rule, supra note 1, at 7197-7199; §__.111(a)(8).

By means of comparison, all of the other countries that allow the use of broad consent in the context of biospecimen research require consent to do research with nonidentified specimens. The practice in this country of allowing researchers to strip identifiers from identifiable specimens and use them for research without consent, notice, or oversight is not followed elsewhere. Rothstein, personal communication, supra note 26.

See Rothstein, Big Data, supra note 7, at 426-427.

See Smith et al., supra note 11, at 1880.

See id., at 1879.

Id.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Department of Health, Education, and Welfare, Office of the Secretary, “Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the Belmont Report),” available at <https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html> (last visited August 23, 2017).

Compare Rothstein, Big Data, supra note 7, at 426-427 (noting that many individuals strongly believe that they ought to be consulted and asked for permission before their specimens and data are collected, analyzed, stored, and used for research) with SACHRP, supra note 34 (stating that the NPRM's proposed biospecimen framework inappropriately diminished the relevance of justice and beneficence, and only purported to assign predominance and primacy to respect for persons).

SACHRP, supra note 34.

See B. Lo and M. Barnes , “Federal Research Regulations for the 21st Century,” New England Journal of Medicine 374, no. 13 (2016): 1205-1207, at 1207.

For a discussion of research with deidentified biospecimens and data that an individual might consider objectionable from a religious, moral, ethical, or other standpoint, see Rothstein, Deidentification, supra note 7, at 7.

SACHRP, supra note 34.

See Rothstein, Deidentification, supra note 7, at 7 (discussing ways to address group-based harms in the context of research with deidentified information or biospecimens).

See Rothstein, Big Data, supra note 7, at 426-427 (quoting the Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011): at 70, available at <https://bioethicsarchive.georgetown.edu/pcsbi/node/558.html> (last visited June 27, 2017)).

See Rothstein, Deidentification, supra note 7, at 9

Lo and Barnes, supra note 45, at 1207.

45 CFR § 46.102.

See Final Rule, supra, note 1, at 7163-7164.

See Final Rule, supra, note 1, at 7168.

Id., at 7169.

See Lo and Barnes, supra note 45, at 1207.

Final Rule, supra, note 1, at 7169.

Lo and Barnes, supra note 45, at 1206. See Rothstein, Deidentification, supra note 7, at 9 (arguing that deidentification should be considered a necessary but insufficient means of protecting health privacy).

This point was made by a commenter to the NPRM and is highlighted in the Preamble to the final rule. See Final Rule, supra, note 1, at 7167.

See CIRCULAR NO. A—130 Memorandum to: The Heads of Executive Departments and Agencies Subject: ‘‘Managing Information as a Strategic Resource,’’ July 7, 2016. See especially, Appendix II: Responsibilities for Managing Personally Identifiable Information, available at <https://a130.cio.gov/appendix1/> (last visited June 25, 2017).

Whereas final federal regulations have the force of law, guidance documents do not set new legal standards, impose legal requirements, or have the force of law, but instead help interpret or clarify an existing regulation. See, e.g., OIRA website, “Regulations and the Rulemaking Process,” available at <https://www.reginfo.gov/public/jsp/Utilities/faq.jsp#reg_rule> (last visited August 23, 2017); Office of the Federal Register, A Guide to the Rulemaking Process, available at <https://www.federalregister.gov/uploads/2013/09/The-Rulemaking-Process.pdf> (last visited August 23, 2017); FDA, “What Is the Difference between the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA Regulations, and FDA Guidance?” available at <https://www.fda.gov/aboutfda/transparency/basics/ucm194909.htm> (last visited August 23, 2017).

Final Rule, supra, note 1, at 7260; §__.102(e)(7).

Lynch and Meyer, supra note 12, at 4.

See Lo and Barnes, supra note 45, at 1206.

See, e.g., Lynch and Meyer, supra note 12, at 4; B. E. Bierer , M. Barnes , and H. F. Lynch , “Revised ‘Common Rule’ Shapes Protections for Research Participants,” Health Affairs 36, no. 5 (2017): 784-788.

See CIRCULAR, supra note 60.

Final Rule, supra, note 1, at 7202.

See id., at 7207; §__.111(a)(7)(i).

Id., at 7202.