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2.
RieschH.PotterC., “Citizen Science as Seen by Scientists: Methodological, Epistemological and Ethical Dimensions,”Public Understanding of Science23, no. 1 (2013): 107–120; WigginsA.CrowstonK., “From Conservation to Crowdsourcing: A Typology of Citizen Science,”Proceedings of the 44th Hawaii International Conference on System Sciences (2011): 1–10.
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5.
RiveraJ.van der MeulenR., “Gartner Says in 2015, 50 Percent of People Considering Buying a Smart Wristband Will Choose a Smartwatch Instead,”Gartner (November 18, 2014), available at <http://www.gartner.com/newsroom/id/2913318> (last visited December 2, 2015).
Sage Bionetworks, “How Can We Together Better Manage the Symptoms of Parkinson Disease?”available at <http://sagebase.org/bridgeapps/> (last visited December 2, 2015).
10.
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).
21 C.F.R. Parts 50 (protection of human subjects) and 56 (IRBs) (last visited July 12, 2015).
15.
21 C.F.R. § 51(a).
16.
See supra note 8.
17.
Id.
18.
Id. See PowellA. C.LandmanA. B.BatesD. W., “In Search of a Few Good Apps,”Journal of the American Medical Association311, no. 18 (2014): 1851–1852 (recommending a certification process for apps).
21st Century Cures Act, H.R. 6, 114th Cong., 1st Sess. (2015), at § 1124.
24.
See RozovskyF. A.AdamsR. K., Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance (San Francisco: Jossey-Bass, 2003): At 25–56 (detailing provisions of all state research laws).
25.
Cal. Health & Safety Code § 24175 (requiring informed consent before medical experimentation).
26.
Md. Code Ann., Health-Gen. § 13–2002 (applying the Common Rule to all human subjects research conducted in the state).
27.
N.Y. Pub. Health § 2442 (requiring informed consent for human subjects research); N.Y. Pub. Health § 2444 (requiring IRB review).
28.
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).
29.
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).
30.
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).
31.
See VanderWaldeA.KurzbanS., “Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What?”Journal of Law, Medicine & Ethics39, no. 3 (2011): 543–558 (reviewing history of research rules regarding payment to research subjects).
32.
HalvorsonC. M. E.RossL. F., “Incidental Findings of Therapeutic Misconception in Biobank-Based Research,”Genetics in Medicine14, no. 6 (2012): 611–615; PentzR. D., “Therapeutic Misconception, Misestimation, and Optimism in Participants Enrolled in Phase 1 Trials,”Cancer118, no. 18 (2012): 4571–4578.
33.
FullertonS. M., “The Input-Output Problem: Whose DNA Do We Study, and Why Does It Matter?” in BurkeW.EdwardsK. A.GoeringS., eds., Achieving Justice in Genomic Translation: Re-thinking the Pathway to Benefit (New York: Oxford University Press, 2011): At 40–55.
BrothersK. B.MorrisonD. R.ClaytonE. W., “Two Large-Scale Surveys on Community Attitudes Toward an Opt-Out Biobank,”American Journal of Medical Genetics155, part A (2011): 2982–2990; Corbie-SmithG., “Attitudes and Beliefs of African Americans Toward Participation in Medical Research,”Journal of General Internal Medicine14, no. 9 (1999): 537–546.
36.
See, e.g., HendersonG., “Is Informed Consent Broken?”American Journal of Medical Sciences342, no. 4 (2011): 267–272; KoenigB. A., “Have We Asked Too Much of Informed Consent?”Hastings Center Report44, no. 4 (2014): 33–34.
37.
Department of Homeland Security et al., “Federal Policy for the Protection of Human Subjects; Proposed Rules,”Fed. Reg.80 (2015): 53,933.
38.
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.
39.
See 45 C.F.R. § 46.111(a) (7); WhiteJ. G., “Physicians' Liability for Breach of Confidentiality: Beyond the Limitations of the Privacy Tort,”South Carolina Law Review49, no. 4 (1998): 1271–1276.
40.
BrothersK. B., “Practical Guidance on Informed Consent for Pediatric Participants in a Biorepository,”Mayo Clinic Proceedings89, no. 11 (2014): 1471–1480.
41.
American Academy of Pediatrics, Council on Communications and Media, “Children, Adolescents and the Media,”Pediatrics132, no. 5 (2013): 958–961.
42.
See, e.g., FabsitzR. 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 Genetics3, no. 6 (2010): 574–580; WolfS. M., “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,”Genetics in Medicine14, no. 4 (2012): 361–384.
43.
Id.
44.
See Celeste ConditM., “What Should Be the Character of the Researcher-Participant Relationship?”IRB: Ethics and Human Research37, no. 4 (2015): 1–10.
45.
JeromeF., “Science by Press Conference,”Technology Review42, no. 5 (1989): 72–73.
46.
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).