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Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

Published online by Cambridge University Press:  01 January 2021

Abstract

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

Grady, C., “Institutional Review Boards: Purpose and Challenges,” Chest 148, no. 5 (2015): 1148-1155.CrossRefGoogle Scholar
Office for Human Research Protections, International Compilation of Human Research Standards, available at <https://www.hhs.gov/ohrp/internatinal/compilation-human-research-standards/index.html> (last visited September 23, 2019).+(last+visited+September+23,+2019).>Google Scholar
Taylor, H.A., “Moving Beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research,” IRB: Ethics & Human Research 29, no. 5 (2007): 9-14; Coleman, C.H. and Bouesseau, M. C., “How Do We Know That Research Ethics Committees Are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review,” BioMedical Central Medical Ethics 9, no. 6 (2008); Millum, J. and Menikoff, J., “Streamlining Ethical Review,” Annals of Internal Medicine 153, no. 10 (2010): 655-657; Mascette, A.M. et al., “Are Central Institutional Review Boards the Solution? The National Heart, Lung, and Blood Institute Working Group’s Report on Optimizing the IRB Process,” Academic Medicine 87, no. 12 (2012): 1710-1714.Google Scholar
Emanuel, E.J., Wendler, D., and Grady, C., “What Makes Clinical Research Ethical?” Journal of the American Medical Association 283, no. 20 (2000): 2701-2711.CrossRefGoogle Scholar
Hammack-Aviran, C.M., Brelsford, K.M., and Beskow, L.M., “Ethical Considerations in the Conduct of Unregulated mHealth Research: Expert Perspectives,” Journal of Law Medicine & Ethics 48 no. 1 (supp.) (2020): 9-36.CrossRefGoogle Scholar
Namey, E.E. and Trotter, R., “Qualitative Research Methods,” in Guest, G. and Namey, E.E., eds., Public Health Research Methods (Los Angeles: SAGE, 2015): at 447.Google Scholar
MacQueen, K.M. et al., “Codebook Development for Team-based Qualitative Analysis,” Cultural Anthropology Methods 10, no. 2 (1998): 31-36.Google Scholar
Moreno, J.D., Schmidt, U., and Joffe, S., “The Nuremberg Code 70 Years Later,” Journal of the American Medical Association 318, no. 9 (2017): 795-796.CrossRefGoogle Scholar
Miller, F.G., “Homage to Henry Beecher (1904-1976),” Perspectives in Biology & Medicine 55, no. 2 (2012): 218-229.CrossRefGoogle Scholar
Cobb, W.M., “The Tuskegee Syphilis Study,” Journal of the National Medical Association 65, no. 4 (1973): 345-348.Google Scholar
Grady, supra note 1.Google Scholar
Jones, D.S., Grady, C., and Lederer, S.E., “Ethics and Clinical Research — The 50th Anniversary of Beecher’s Bomb-shell,” New England Journal of Medicine 374, no. 24 (2016): 2393-2398.CrossRefGoogle Scholar
Beecher, H.K., “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354-1360.CrossRefGoogle Scholar
Publication L. 93-384 National Research Act. Title II — Protection of Human Subjects of Biomedical and Behavioral Research, available at <https://history.nih.gov/research/downloads/PL93-348.pdf> (last visited February 14, 2020).+(last+visited+February+14,+2020).>Google Scholar
World Medical Association, Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Subjects, available at <https://www.wma.net/policies-post-wma-deciaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/> (last visited September 23, 2019).+(last+visited+September+23,+2019).>Google Scholar
Moon, M.R. and Khin-Maung-Gyi, F., “The History and Role of Institutional Review Boards,” Virtual Mentor 11, no. 4 (2009): 311-321.Google Scholar
Fanelli, D., Costas, R., and Ioannidis, J.P., “Meta-assessment of Bias in Science,” Proceedings of the National Academy of Sciences of the United States of America 114, no. 14 (2017): 3714-3719.CrossRefGoogle Scholar
Federal Policy for the Protection of Human Subjects, “Final Rule,” Federal Register 82, no. 12 (2017): 7149-7274.Google Scholar
Emanuel, supra note 4.Google Scholar
Abbott, L. and Grady, C., “A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn,” Journal of Empirical Research on Human Research Ethics 6, no. 1 (2011): 3-19.CrossRefGoogle Scholar
Silverman, H., Hull, S.C., and Sugarman, J., “Variability Among Institutional Review Boards’ Decisions within the Context of a Multicenter Trial,” Critical Care Medicine 29, no. 2 (2001): 235-241; McWilliams, R. et al., “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” Journal of the American Medical Association 290, no. 3 (2003): 360-366; Green, L.A. et al., “Impact of Institutional Review Board Practice Variation on Observational Health Services Research,” Health Services Research 41, no. 1 (2006): 214-230; Kastner, B. et al., “Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards’ Responses,” PLoS One 10, no. 8 (2015): e0135997.CrossRefGoogle Scholar
Summers, E.I and Feige, M., “Accreditation of Human Research Protection Programs,” in Gallin, J.I., Ognibene, F. P., and Johnson, L.L., eds., Principles and Practice of Clinical Research 4th ed. (Boston: Academic Press, 2018): 63-72.CrossRefGoogle Scholar
Grady, C., “Do IRBs Protect Human Research Participants?” Journal of the American Medical Association 301, no. 10 (2010): 1122-1123; see Jones, supra note 12; Abbott, supra note 20.CrossRefGoogle Scholar
De Vries, R., DeBruin, D.A., and Goodgame, A., “Ethics Review of Social, Behavioral, and Economic Research: Where Should We Go From Here?” Ethics & Behavior 14, no. 4 (2004): 351-368.CrossRefGoogle Scholar
Menikoff, J., Kaneshiro, J., and Pritchard, I, “The Common Rule, Updated,” New England Journal of Medicine 376, no. 7 (2017): 613-615.CrossRefGoogle Scholar
Emanuel, E. J. et al., “Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals,” Annals of Internal Medicine 141, no. 4 (2004): 282-291.CrossRefGoogle Scholar
Bloss, C. et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medicine Internet Research 18, no. 12 (2016): e329.CrossRefGoogle Scholar
Ienca, M. et al., “Considerations for Ethics Review of Big Data Health Research: A Scoping Review,” PLoS One 13, no. 10 (2018): e0204937.CrossRefGoogle Scholar
Shuren, J., Patel, B., and Gottlieb, S., “FDA Regulation of Mobile Medical Apps,” Journal of the American Medical Association 320, no. 4 (2018): 337-339; Cortez, N.G., Cohen, I.G., and Kesselheim, A.S., “FDA Regulation of Mobile Health Technologies,” New England Journal of Medicine 371, no. 4 (2014): 372-379.CrossRefGoogle Scholar
Vayena, E. et al., “Digital Health: Meeting the Ethical and Policy Challenges,” Swiss Medicine Weekly 148 (2018): w14591.Google Scholar
Moore, S. et al., “Consent Processes for Mobile App Mediated Research: Systematic Review,” Journal of Medical Internet Research mHealth and uHealth 5, no. 8 (2017): e126.CrossRefGoogle Scholar
Salloch, S., “The Dual Use of Research Ethics Committees: Why Professional Self-Governance Falls Short in Preserving Biosecurity,” BioMed Central Medicine & Ethics 19, no. 1 (2018): 53.CrossRefGoogle Scholar
Vayena et al., supra note 30.Google Scholar