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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.+(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.>Google Scholar

See FWA Form to 2020 at section 4(b), available at <https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/fwa-form-2017/index.html> (last visited January 20, 2020).+(last+visited+January+20,+2020).>Google Scholar

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Meyer, supra note 4, at 246 n.33.Google Scholar

See, e.g., Federman, D.D., Hanns, K.E., and Rodriguez, L.L., 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).Google Scholar

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Id., at 53,989-53,990.Google Scholar

Id., at 53,991.Google Scholar

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.”).Google Scholar

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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)).Google Scholar

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Id., at 7156.Google Scholar

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.”).Google Scholar

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.”).Google Scholar

See Tovino, S.A., “Mobile Research Applications and State Research Laws,” Journal of Law, Medicine & Ethics 48, no. 1, Suppl. 1 (2020): 82-86.CrossRefGoogle Scholar

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).”).Google Scholar

23andMe subjects “much” of its research to review by an independent IRB, even when the research involves non-identifiable information and hence falls outside the scope of the Common Rule, even if those regulations directly applied to 23andMe. See 23andMe, “Protecting People in People Powered Research,” 23andMeBlog, July 30, 2014, available at <https://blog.23andme.com/23andme-research/protecting-people-in-people-powered-research/> (last visited October 21, 2019); 23andMe, “23andMe Improves Research Consent Process,” 23andMeBlog, June 24, 2010, available at <https://blog.23andme.com/23andme-research/23andme-improves-research-consent-process/> (last visited January 20, 2020). See also Hernandez, D. and Seetharaman, D., “Facebook Offers Details on How It Handles Research,” Wall Street Journal, June 14, 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.”).+(last+visited+October+21,+2019);+23andMe,+“23andMe+Improves+Research+Consent+Process,”+23andMeBlog,+June+24,+2010,+available+at++(last+visited+January+20,+2020).+See+also+Hernandez,+D.+and+Seetharaman,+D.,+“Facebook+Offers+Details+on+How+It+Handles+Research,”+Wall+Street+Journal,+June+14,+2016,+available+at++(last+visited+January+20,+2020)+(“Microsoft+and+wearables+maker+Fitbit+Inc….+contract+with+external+IRBs+for+some+of+their+research+projects.”).>Google Scholar

See Jackman, M. and Kanerva, L., “Evolving the IRB: Building Robust Review for Industry Research,” Washington & Lee Law Review Online 72, no. 3 (2016): 442-457, (describing Facebook’s internal research review process); Hernandez and Seetharaman, supra note 21 (noting that, of the research at Microsoft and Fitbit that are not reviewed by independent IRBs, “[t]he rest are largely reviewed internally”); De Mooy, M. and Yuen, S., “Toward Privacy Aware Research and Development in Wearable Health: A Report from the Center for Democracy & Technology and Fitbit, Inc.,” May 2016, available at <https://healthblawg.com/images/2016/06/CDTFitbit-report.pdf> (last visited January 20, 2020) (describing Fitbit’s internal research review process).Google Scholar

See Meyer, M.N., “Ethical Considerations When Companies Study—and Fail to Study—Their Customers,” in Selinger, E., Polonetsky, J. and Tene, O., 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).CrossRefGoogle Scholar

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See White House, “Administration Discussion Draft: Consumer Privacy Bill of Rights Act of 2015,” February 27, 2015, available at <https://www.democraticmedia.org/sites/default/files/field/public/2015/draft_consumer_privacy_bill_of_rights_act.pdf> (last visited January 20, 2020). The criteria resemble the Common Rule’s criteria for waiving consent. See infra Part III.+(last+visited+January+20,+2020).+The+criteria+resemble+the+Common+Rule’s+criteria+for+waiving+consent.+See+infra+Part+III.>Google Scholar

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Compare id., at § 5.1.3(iii) (last visited January 20, 2020) with 45 C.F.R. § 46.116.Google Scholar

See, e.g., Rothstein, M.A. et al., “Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations,” Journal of Law, Medicine & Ethics 48, no. 1, Suppl. 1 (2020): 196-226.CrossRefGoogle Scholar

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).Google Scholar

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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.Google Scholar

OIG, supra note 37, at 8-9.Google Scholar

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.Google Scholar

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This is what happened, for example, when researchers at Cornell and Facebook collaborated on the infamous emotional contagion experiment. See Meyer, M.N., “Everything You Need to Know about Facebook’s Controversial Emotion Experiment,” Wired, June 30, 2014, available at <http://www.wired.com/2014/06/everything_you_need_to_know_about_facebooks_manipulative_experiment> (last visited January 20, 2020); Meyer, M.N., “Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Experimentation,” Colorado Technology Law Journal 13, no. 2 (2015): 273-331, at 311-312 and n.139.Google Scholar

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).Google Scholar

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See Smith, M.D. et al., eds., Better Care at Lower Cost: The Path to Continuously Learning Health Care in America (Washington, DC: National Academies Press, 2012). It is sometimes claimed that the concept of a learning health system encompasses only observational methods such as “big data” analysis. For a contrary view, see, e.g., Faden, R.R., Beauchamp, T.L., and Kass, N.E., “Learning Health Care Systems and Justice,” Hastings Center Report 41, no. 4 (2011): 3 (“[I]t can be ethically acceptable to randomize patients without express consent in trials comparing widely used, approved interventions that pose no additional risk. With appropriate oversight, learning health care systems ought to conduct such trials on a regular basis.”). See also Horwitz, L.I., Kuznetsova, M., and Jones, S.A., “Creating a Learning Health System through Rapid-Cycle, Randomized Testing,” New England Journal of Medicine 381, no. 12 (2019): 1175-1179 (describing several “randomized quality-improvement projects” conducted as part of a learning health system).Google Scholar

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 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. The Commission produced several important reports, including the Belmont Report, which formed the basis for the Common Rule.CrossRefGoogle Scholar

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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.Google Scholar

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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.Google Scholar

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