Hostname: page-component-586b7cd67f-gb8f7 Total loading time: 0 Render date: 2024-11-25T04:14:31.720Z Has data issue: false hasContentIssue false
  • English
  • Français

Citizen Science on Your Smartphone: An ELSI Research Agenda

Currents in Contemporary Bioethics

Published online by Cambridge University Press:  01 January 2021

Mark A. Rothstein ,
John T. Wilbanks  and
Kyle B. Brothers
Get access Rights & Permissions [Opens in a new window]

Extract

Beginning in the 20th century, scientific research came to be dominated by a growing class of credentialed, professional scientists who overwhelmingly displaced the learned amateurs of an earlier time. By the end of the century, however, the exclusive realm of professional scientists conducting research was joined, to a degree, by “citizen scientists.” The term originally encompassed non-professionals assisting professional scientists by contributing observations and measurements to ongoing research enterprises. These collaborations were especially common in the environmental sciences, where citizen scientists participated in counting wildlife and measuring environmental conditions. Later, patient groups began to play a more active role in supporting clinical trials and collecting health records from affected individuals.

Type
JLME Column: Currents in Contemporary Bioethics
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 4 , Winter 2015 , pp. 897 - 903
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Lucier, P., “The Professional and the Scientist in Nineteenth-Century America,” Isis 100, no. 4 (2009): 699–732.CrossRefGoogle Scholar
Riesch, H. Potter, C., “Citizen Science as Seen by Scientists: Methodological, Epistemological and Ethical Dimensions,” Public Understanding of Science 23, no. 1 (2013): 107–120; Wiggins, A. Crowston, K., “From Conservation to Crowdsourcing: A Typology of Citizen Science,” Proceedings of the 44th Hawaii International Conference on System Sciences (2011): 1–10.CrossRefGoogle Scholar
Abelon, D., “Hacker Culture: The Key to Future Prosperity?” Tech Crunch, March 25, 2012, available at <http://techcrunch.com/2012/03/25/hacker-culture-the-key-to-future-prosperity> (last visited December 2, 2015); Waldman, A., “Hacking Science: The Intersection of Web Geeks and Science Geeks,” Scientific American (August 29, 2011), available at <http://blogs.scientificamerican.com/guest-blog/hacking-science-the-intersection-of-web-geeks-and-science-geeks> (last visited December 2, 2015).+(last+visited+December+2,+2015);+Waldman,+A.,+“Hacking+Science:+The+Intersection+of+Web+Geeks+and+Science+Geeks,”+Scientific+American+(August+29,+2011),+available+at++(last+visited+December+2,+2015).>Google Scholar
Naci, H. Ioannidis, J. P. A., “Evaluation of Wellness Determinants and Interventions by Citizen Scientists,” Journal of the American Medical Association 314, no. 2 (2015): 121–122.Google Scholar
Rivera, J. van der Meulen, R., “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).+(last+visited+December+2,+2015).>Google Scholar
U.S. Department of Health and Human Services, Examples of MMAs the FDA Regulates, <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/Mo> (last visited August 9, 2015); Xu, W. Liu, Y., “mHealthApps: A Repository and Database of Mobile Health Apps,” JMIR mHealth uHealth 3, no. 1 (2015) e28.Google Scholar
FDA, “Medical Devices, Products and Medical Procedures, Connected Health, Mobile Medical Applications,” available at <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm> (last visited August 13, 2015).+(last+visited+August+13,+2015).>Google Scholar
U.S. Department of Health and Human Services, Food and Drug Administration, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (2015), available at <http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance/Documents/UCM263366.pdf> (last visited December 2, 2015).+(last+visited+December+2,+2015).>Google Scholar
Sage Bionetworks, “How Can We Together Better Manage the Symptoms of Parkinson Disease?” available at <http://sagebase.org/bridgeapps/> (last visited December 2, 2015).+(last+visited+December+2,+2015).>Google Scholar
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).+(last+visited+December+2,+2015).>Google Scholar
Western IRB #2012068 (2015).Google Scholar
45 C.F.R. § 46.101(a).Google Scholar
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).+(last+visited+July+12,+2015).>Google Scholar
21 C.F.R. Parts 50 (protection of human subjects) and 56 (IRBs) (last visited July 12, 2015).Google Scholar
21 C.F.R. § 51(a).Google Scholar
See supra note 8.Google Scholar
Id.Google Scholar
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).Google Scholar
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).+(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++(last+visited+August+9,+2015).>Google Scholar
45 C.F.R. Parts 160, 164.Google Scholar
45 C.F.R. § 160.103.Google Scholar
45 C.F.R. § 164.508(b).Google Scholar
21st Century Cures Act, H.R. 6, 114th Cong., 1st Sess. (2015), at § 1124.Google Scholar
See Rozovsky, F. A. Adams, R. 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).Google Scholar
Cal. Health & Safety Code § 24175 (requiring informed consent before medical experimentation).Google Scholar
Md. Code Ann., Health-Gen. § 13–2002 (applying the Common Rule to all human subjects research conducted in the state).Google Scholar
N.Y. Pub. Health § 2442 (requiring informed consent for human subjects research); N.Y. Pub. Health § 2444 (requiring IRB review).Google Scholar
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).Google Scholar
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).Google Scholar
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).+(last+visited+August+7,+2015)+(requiring+independent+“ethical+review+committees”+to+evaluate+research+protocols).>Google Scholar
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).Google Scholar
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. et al. , “Therapeutic Misconception, Misestimation, and Optimism in Participants Enrolled in Phase 1 Trials,” Cancer 118, no. 18 (2012): 4571–4578.Google Scholar
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.Google Scholar
Pew Research Center, “Mobile Technology Fact Sheet,” 2015, available at <http://www.pewinternet.org/factsheets/mobile-technology-fact-sheet> (last visited December 2, 2015).+(last+visited+December+2,+2015).>Google Scholar
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. et al. , “Attitudes and Beliefs of African Americans Toward Participation in Medical Research,” Journal of General Internal Medicine 14, no. 9 (1999): 537–546.Google Scholar
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.Google Scholar
Department of Homeland Security et al., “Federal Policy for the Protection of Human Subjects; Proposed Rules,” Fed. Reg. 80 (2015): 53, 933.Google Scholar
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.Google Scholar
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.Google Scholar
Brothers, K. B. et al. , “Practical Guidance on Informed Consent for Pediatric Participants in a Biorepository,” Mayo Clinic Proceedings 89, no. 11 (2014): 1471–1480.CrossRefGoogle Scholar
American Academy of Pediatrics, Council on Communications and Media, “Children, Adolescents and the Media,” Pediatrics 132, no. 5 (2013): 958–961.CrossRefGoogle Scholar
See, e.g., Fabsitz, R. R. et al. , “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. et al. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361–384.Google Scholar
Id.Google Scholar
See Celeste Condit, M. et al. , “What Should Be the Character of the Researcher-Participant Relationship?” IRB: Ethics and Human Research 37, no. 4 (2015): 1–10.Google Scholar
Jerome, F., “Science by Press Conference,” Technology Review 42, no. 5 (1989): 72–73.Google Scholar
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).+(last+visited+December+2,+2015).>Google Scholar