Using mobile health (mHealth) research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that the Common Rule does or does not “apply,” the extent to which these different meanings of “apply” matter, and, when the Common Rule does apply (however that term is defined), how it applies.
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References
1.
45 C.F.R. Subpart A (2018).
2.
Id. § 46.101(a). As of October of 2019, the following 16 federal departments and agencies are official signatories to the revised Common Rule, known as the “2018 Common Rule”: Department of Homeland Security, 6 C.F.R. Pt. 46; Department of Agriculture, 7 C.F.R. Pt. 1c; Department of Energy, 10 C.F.R. Pt. 745; National Aeronautics and Space Administration, 14 C.F.R. Pt. 1230; Department of Commerce, 15 C.F.R. Pt. 27; Social Security Administration, 20 C.F.R. Pt. 431; Agency for International Development, 22 C.F.R. Pt. 225; Department of Housing and Urban Development, 24 C.F.R. Pt. 60; Department of Labor, 29 C.F.R. Pt. 21; Department of Defense, 32 C.F.R. Pt. 219; Department of Education, 34 C.F.R. Pt. 97; Department of Veterans Affairs, 38 C.F.R. Pt. 16; Environmental Protection Agency, 40 C.F.R. Pt. 26; Department of Health and Human Services, 45 C.F.R. Pt. 46; National Science Foundation, 45 C.F.R. Pt. 690; Department of Transportation, 49 C.F.R. Pt. 11. In addition, according to OHRP, two federal entities that were signatories to the pre-2018 Common Rule — Department of Justice, 28 C.F.R. Pt. 46, and Consumer Product Safety Commission, 16 C.F.R. Pt. 1028 — intend to become signatories to the revised Common Rule. Office for Human Research Protections, Federal Policy for the Protection of Human Subjects (“Common Rule”), available at <https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html> (last visited January 20, 2020). Finally, both the Central Intelligence Agency and the Office of the Director of National Intelligence follow the 2018 Common Rule, per Executive Order 12333 (1981), as amended by Executive Orders 13284 (2003), 13355 (2004), and 13470 (2008). Id.
Office of the Secretary and Food and Drug Administration, Department of Health and Human Services, “Human Subject Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”Federal Register76 (July26, 2011): 44,512-44,531, at 44,528 (hereinafter ANPRM) (“Most institutions voluntarily extend the applicability of their FWAs to all the research conducted at their institutions, even research not conducted or supported by one of the Federal departments or agencies that have adopted the Common Rule.”).
5.
Meyer, supra note 4, at 246 n.33.
6.
See, e.g., D.D.Federman, K.E.Hanns, and L.L.Rodriguez, eds., Responsible Research: A Systems Approach to Protecting Research Participants (Washington, D.C.: National Academies Press, 1993); National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants (Bethesda, MD: 2001).
7.
ANPRM, supra note 4, at 44,528 (proposal “requiring domestic institutions that receive some Federal funding from a Common Rule agency for research with human subjects to extend the Common Rule protections to all research studies conducted at their institution”).
8.
Federal Policy for the Protection of Human Subjects, Federal Register 80 (Sept. 8, 2015): 53,933, 54,034 (NPRM).
9.
Id., at 53,989-53,990.
10.
Id., at 53,991.
11.
Id., at 54,047 (“Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”).
12.
Federal Policy for the Protection of Human Subjects, Federal Register82 (January19, 2017): 7149, 7155 (Final Rule).
13.
Id., at 7156.
14.
See Public Health Service Act, 42 U.S.C. ch. 6A §201 et seq at §§289(a) (“The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit … assurances satisfactory to the Secretary that it has established … an ‘Institutional Review Board’… to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.” (emphasis added)).
15.
Final Rule, supra note 12, at 7155-7156.
16.
Id., at 7156.
17.
Id., at 7156 (acknowledging the proposal “would benefit from further deliberation”); id. (“[W]e are persuaded that the proposed extension of the Common Rule is not appropriate to include in a final rule at this time. We will continue to carefully consider the related issues.”).
18.
Id. (“We concluded that [maintaining the “check the box” option] would not further the expressed goal of increasing the application of consistent protections to clinical trials, regardless of the source of support, because the extension of the FWA would be optional. We therefore plan to implement the proposed non-regulatory change to the assurance mechanism to eliminate the voluntary extension of the FWA to non-federally funded research.”).
19.
See S.A.Tovino, “Mobile Research Applications and State Research Laws,”Journal of Law, Medicine & Ethics48, no. 1, Suppl. 1 (2020): 82-86.
20.
NPRM, supra note 8, at 54,034 (“academic institutions… generally extend protections to all human subjects research at their institution, even if they have not ‘’checked the box’ on their FWA indicating that they do so”); Final Rule, supra note 12, at 7516 (“We recognize that institutions may choose to establish an institutional policy that would require IRB review of research that is not funded by a Common Rule department or agency (and indeed, as commenters noted, almost all institutions already do this).”).
21.
See also D.Hernandez and D.Seetharaman, “Facebook Offers Details on How It Handles Research,”Wall Street Journal, June14, 2016, available at <https://www.wsj.com/articles/facebook-offers-details-how-it-handles-research-1465930152> (last visited January 20, 2020) (“Microsoft and wearables maker Fitbit Inc…. contract with external IRBs for some of their research projects.”).
22.
M.De Mooy and S.Yuen, “Toward Privacy Aware Research and Development in Wearable Health: A Report from the Center for Democracy & Technology and Fitbit, Inc.,”May2016, available at <https://healthblawg.com/images/2016/06/CDTFitbit-report.pdf> (last visited January 20, 2020) (describing Fitbit’s internal research review process).
23.
See M.N.Meyer, “Ethical Considerations When Companies Study—and Fail to Study—Their Customers,” in E.Selinger, J.Polonetsky and O.Tene, eds., The Cambridge Handbook of Consumer Privacy (Cambridge University Press, 2018): 207-231, at 224-227 (discussing how the Facebook and Fitbit internal review processes compare to the Belmont Report principles and the Common Rule and factors companies should consider in establishing and operating internal research ethics review boards).
24.
Consumer Privacy Protection Act of 2015, S. 1158, 114th Cong.
Compare id., at § 5.1.3(iii) (last visited January 20, 2020) with 45 C.F.R. § 46.116.
29.
See, e.g., M.A.Rothsteinet al., “Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations,”Journal of Law, Medicine & Ethics48, no. 1, Suppl. 1 (2020): 196-226.
30.
The Common Rule merely requires that the informed consent form or process — when consent is required at all — disclose to prospective participants whether or not compensation or medical treatment for research-related injuries is available. 45 C.F.R. § 116(b)(6).
31.
Public Health Services Act, supra note 14, at § 289(b)(2) (“The Secretary shall establish a process for the prompt and appropriate response to information provided to the Director of NIH respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this chapter. The process shall include procedures for the receiving of reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such violations.”). See also 45 C.F.R. § 46.123.
Office for Human Research Protections, supra note 32; Department of Health and Human Services Office of Inspector General (OIG), “OHRP Generally Conducted Its Compliance Activities Independently, but Changes Would Strengthen Its Independence” (July2017): 1-29, at 24, available at <https://oig.hhs.gov/oei/reports/oei-01-15-00350.pdf> (last visited January 20, 2020) (reviewing OHRP compliance oversight activities from 2000 through 2015).
38.
Id.
39.
OHRP closed a total of 15 for-cause and not-for-cause evaluations in 2016, 1 evaluation in 2017, 1 evaluation in 2018, and 2 evaluations in 2019 to date. OHRP, supra note 36.
40.
OIG, supra note 37, at 8-9.
41.
In 2016, OHRP did publish in an academic journal aggregate statistics about the kinds of incident reports it received between 2008 and 2014 and the kinds of corrective actions institutions implemented as a result. See Ramnath et al., supra note 34.
42.
Id., at 7-8.
43.
OIG, supra note 37, at 14.
44.
Id., at 7.
45.
T.Delfino, “With Just One Investigation in 2013, OHRP Seems ‘Invisible’ After SUPPORT Dust-Up,”Report on Research Compliance (2014): 1-5, available at <https://www.bmj.com/sites/default/files/response_attachments/2014/07/rrc-reprint-0514.pdf> (last visited January 20, 2020) (quoting critical comments by bioethicist Art Caplan, Senator Charles Grassley, and Public Citizen’s Michael Carome).
Office for Human Research Protections (2008), supra note 48, at § B(4).
50.
Id., at § B(6).
51.
Id., at § B(11).
52.
M.N.Meyer, “Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Experimentation,”Colorado Technology Law Journal13, no. 2 (2015): 273-331, at 311-312 and n.139.
53.
See 45 C.F.R. §§ 46.107, 46.111(a)(3), 46.111(b). See also 45 C.F.R. Subparts B, C, and D (additional regulations which Common Rule departments may but need not adopt providing special protections for pregnant women, human fetuses and neonates; prisoners; and children, respectively).
Public Health Services Act, supra note 14, at §289(a) (“The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an ‘Institutional Review Board’) to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.” (emphasis added)).
56.
45 C.F.R. § 46.102(l).
57.
See also L.I.Horwitz, M.Kuznetsova, and S.A.Jones, “Creating a Learning Health System through Rapid-Cycle, Randomized Testing,”New England Journal of Medicine381, no. 12 (2019): 1175-1179 (describing several “randomized quality-improvement projects” conducted as part of a learning health system).
58.
The research/practice distinction dates back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was called upon by Congress, in the National Research Act of 1974, to distinguish between biomedical and behavioral research, on the one hand, and “the accepted and routine practice of medicine,” on the other, in order to subject the former to special regulation. Title II of the National Research Act, Pub. L. 93–348, 88 Stat. 342 (1974) at §202(a)(1)(B)(i). See also 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. The Commission produced several important reports, including the Belmont Report, which formed the basis for the Common Rule.
59.
Delfino, supra note 45, at 5 (quoting John Lantos).
See, e.g., Horwitz et al., supra note 57, at 1175.
65.
Id., at 1178.
66.
M.A.Baily, “Harming Through Protection?”New England Journal of Medicine358, no. 8 (2008): 768-769.
67.
Id. (citing M.A.Bailyet al., “The Ethics of Using QI Methods to Improve Health Care Quality and Safety,”Hastings Center Report36, no. 4 (2006): S1-S40.
68.
See Meyer, supra note 23.
69.
45 C.F.R. § 46.102(e)(1). References to the collection and analyses of biospecimens in the definition of “human subject” have been omitted for conciseness, since mHealth apps alone cannot (yet) collect and transfer to researchers for use biospeci-mens. mHealth apps can, of course, be used in conjunction with biospecimen collection and analysis, whether for clinical, research, or infotainment purposes.
70.
Id., at §46.102(e)(2).
71.
Id., at §46.102(e)(3).
72.
See, e.g., Rothstein et al., supra note 29, at 3 (“Although research with deidentified specimens or data is not considered human subjects research under the Common Rule, our focus on unregulated research does not make such a distinction.”).
73.
See M.N.Meyer, “Research Ethics Issues Raised in Collecting and Maintaining Large Scale, Sensitive Online Data” (2019): 1-23, at 4, available at <https://securelysharingdata.com/resources/meyer.pdf> (last visited January 20, 2020) (white paper).
ANPRM, supra note 4, at 44,524; NPRM, supra note 8, at 53,942.
79.
H.F.Lynch, B.E.Bierer, and I.G.Cohen, “Confronting Bio-specimen Exceptionalism in Proposed Revisions to the Common Rule,”Hastings Center Report46, no. 1 (2016): 4-5.
80.
H.F.Lynch and M.N.Meyer, “Regulating Research with Bio-specimens under the Revised Common Rule,”Hastings Center Report47, no. 3 (2017): 3-4.
81.
45 C.F.R. § 46.102(e)(4).
82.
Id., at § 46.104(d).
83.
Id., at §§ 46.104(d)(2)(iii), 46.104(d)(3)(i)(C), 46.104(d)(7), 46.104(d)(8)(iii).
The ethics community has a long history of worrying about the negative psychosocial effects of learning information about oneself — especially genomic information — with little supporting evidence to support those concerns. See generally “Special Report: Looking for the Psychosocial Impacts of Genomic Information,”Hastings Center Report49, no. S1 (2019).
91.
45 C.F.R. §46.104(d)(8)(iv).
92.
J.Bobe, M.N.Meyer, and G.Church, “Privacy and Agency Are Critical to a Flourishing Biomedical Research Enterprise: Misconceptions about the Role of CLIA,”Florida Law Review71 (forthcoming 2019).
93.
The Common Rule itself acknowledges non-research reasons for returning individual results, including complying with legal requirements to do so. Id. (noting that “[t]his provision does not prevent an investigator from abiding by any legal requirements to return individual research results”). Whether an IRB would recognize other reasons for returning individual results as non-research activities is a closer call.
94.
See M.N.Meyer, “Practical Tips for Ethical Data Sharing,”Advances in Methods and Practices in Psychological Science1, no. 1 (2018): 1-14, at 12.
95.
See Email correspondence between Brenda Belcher, Research Compliance Analyst, University of California Santa Cruz, and Misti Ault Anderson, HHS Office for Human Research Protections, April 9, 2019-July 11, 2019, available at <https://drive.google.com/file/d/1GrxMHOl2L8GIinE-hp2V9VLvMTaIpD3D/view> (last visited January 20, 2020) (cited with permission of Ms. Belcher).
96.
Meyer, supra note 4, at 244-245.
97.
See H.F.Lynchet al., on behalf of the Consortium to Advance Effective Research Ethics Oversight (AEREO), “Of Parachutes and Participant Protection: Moving Beyond Quality to Advance Effective Research Ethics Oversight,”Journal of Empirical Research on Human Research Ethics14, no. 3 (2019): 190-196.
98.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, DC: US Gov’t Printing Office, 1979): section B-2.
99.
45 C.F.R. § 46.111(a)(1).
100.
Cf. M.A. Rothstein et al., supra note 29, at 17-19 (describing and interpreting the obligation to maximize the benefits of research).
101.
Meyer, supra note 4, at 251-263.
102.
See, e.g., K.Drabiak-Syed, “Lessons from Havasupai Tribe v. Arizona State University Board of Regents: Recognizing Group, Cultura, and Dignitary Harms as Legitimate Risks Warranting Integration into Research Practice,”Journal of Health & Biomedical Law6, no. 1 (2010): 175-225.
103.
45 C.F.R. § 46.111(a)(2).
104.
See Meyer, supra note 4, at 292-298.
105.
45 C.F.R. § 46.116(f).
106.
Id., at § 46.102(j) (“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”).
See Meyer supra note 23, at 224-227 (discussing principles and process elements of the Common Rule and IRB review that unregulated entities might wish to voluntarily adopt).
