Citizen Science on Your Smartphone: An ELSI Research Agenda

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Sage Bionetworks, “How Can We Better Manage the Symptoms of Breast Cancer Treatment Together?” available at <http://sagebase.org/bridgeapps/> (last visited December 2, 2015).

Western IRB #2012068 (2015).

45 C.F.R. § 46.101(a).

U.S. Department of Health and Human Services, “IRBs and Assurances,” available at <www.hhs.gov/ohrp/assurances/index.html> (last visited July 12, 2015).

21 C.F.R. Parts 50 (protection of human subjects) and 56 (IRBs) (last visited July 12, 2015).

21 C.F.R. § 51(a).

See supra note 8.

Id. See Powell A. C. Landman A. B. Bates D. W. , “In Search of a Few Good Apps,” Journal of the American Medical Association 311, no. 18 (2014): 1851–1852 (recommending a certification process for apps).

Department of Health and Human Services, Food and Drug Administration, “Examples of MMAs That Are NOT Medical Devices,” available at <http://www/fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm388746.htm> (last visited August 9, 2015); Department of Health and Human Services, Food and Drug Administration, “Examples of Mobile Apps for Which the FDA Will Exercise Enforcement Discretion,” available at <www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm368744.htm> (last visited August 9, 2015).

45 C.F.R. Parts 160, 164.

45 C.F.R. § 160.103.

45 C.F.R. § 164.508(b).

21st Century Cures Act, H.R. 6, 114th Cong., 1st Sess. (2015), at § 1124.

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Cal. Health & Safety Code § 24175 (requiring informed consent before medical experimentation).

Md. Code Ann., Health-Gen. § 13–2002 (applying the Common Rule to all human subjects research conducted in the state).

N.Y. Pub. Health § 2442 (requiring informed consent for human subjects research); N.Y. Pub. Health § 2444 (requiring IRB review).

Va. Code Ann. §§ 32.1–162.16 to 32.1–162.20 (applying the Common Rule to all human subjects research conducted in the state).

See also 410 Ill. Comp. Stat. 50/3.1(a) (requiring at least an explanation of research and opportunity to object); N.J. Stat. Ann. § 26:14–4 (suggesting requirement of informed consent for human subjects research).

See World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (1964), as amended (2013), available at <http://www.wma.net/en/30publications/10policies/b3/> (last visited August 7, 2015) (requiring independent “ethical review committees” to evaluate research protocols).

See VanderWalde A. Kurzban S. , “Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What?” Journal of Law, Medicine & Ethics 39, no. 3 (2011): 543–558 (reviewing history of research rules regarding payment to research subjects).

Halvorson C. M. E. Ross L. F. , “Incidental Findings of Therapeutic Misconception in Biobank-Based Research,” Genetics in Medicine 14, no. 6 (2012): 611–615; Pentz R. D. , “Therapeutic Misconception, Misestimation, and Optimism in Participants Enrolled in Phase 1 Trials,” Cancer 118, no. 18 (2012): 4571–4578.

Fullerton S. M. , “The Input-Output Problem: Whose DNA Do We Study, and Why Does It Matter?” in Burke W. Edwards K. A. Goering S. , eds., Achieving Justice in Genomic Translation: Re-thinking the Pathway to Benefit (New York: Oxford University Press, 2011): At 40–55.

Pew Research Center, “Mobile Technology Fact Sheet,” 2015, available at <http://www.pewinternet.org/factsheets/mobile-technology-fact-sheet> (last visited December 2, 2015).

Brothers K. B. Morrison D. R. Clayton E. W. , “Two Large-Scale Surveys on Community Attitudes Toward an Opt-Out Biobank,” American Journal of Medical Genetics 155, part A (2011): 2982–2990; Corbie-Smith G. , “Attitudes and Beliefs of African Americans Toward Participation in Medical Research,” Journal of General Internal Medicine 14, no. 9 (1999): 537–546.

See, e.g., Henderson G. , “Is Informed Consent Broken?” American Journal of Medical Sciences 342, no. 4 (2011): 267–272; Koenig B. A. , “Have We Asked Too Much of Informed Consent?” Hastings Center Report 44, no. 4 (2014): 33–34.

Department of Homeland Security et al., “Federal Policy for the Protection of Human Subjects; Proposed Rules,” Fed. Reg. 80 (2015): 53,933.

See Council on Ethical and Judicial Affairs, American Medical Association, Code of Medical Ethics of the AMA, 2014–2015 ed. § 5.05 (Chicago: AMA, 2014): At 168.

See 45 C.F.R. § 46.111(a) (7); White J. G. , “Physicians' Liability for Breach of Confidentiality: Beyond the Limitations of the Privacy Tort,” South Carolina Law Review 49, no. 4 (1998): 1271–1276.

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American Academy of Pediatrics, Council on Communications and Media, “Children, Adolescents and the Media,” Pediatrics 132, no. 5 (2013): 958–961.

See, e.g., Fabsitz R. R. , “Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines from a National Heart, Lung, and Blood Institute Working Group,” Circulation and Cardiovascular Genetics 3, no. 6 (2010): 574–580; Wolf S. M. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361–384.

See Celeste Condit M. , “What Should Be the Character of the Researcher-Participant Relationship?” IRB: Ethics and Human Research 37, no. 4 (2015): 1–10.

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National Institutes of Health, “NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources,” available at <http://grants.nih.gov/grants/sharing.htm> (last visited December 2, 2015).