Simon, C.M., et al., “Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models,” Genetics in Medicine 13, no. 9 (2011): 821–31; Clayton, E.W., “The Unbearable Requirement of Informed Consent,” American Journal of Bio-ethics 19, no. 5 (May 2019): 19–20.CrossRefGoogle Scholar

Beskow, L.M. and Weinfurt, K. P., “Exploring Understanding of ‘Understanding’: The Paradigm Case of Biobank Consent Comprehension,” American Journal of Bioethics 19, no. 5 (2019): 6–18; Gillies, K. A. et al., “Patient Reported Measures of Informed Consent for Clinical Trials: A Systematic Review,” PLoS One 13, no. 6 (2018): e0199775; Montalvo, W. and Larson, E., “Participant Comprehension of Research for Which They Volunteer: A Systematic Review,” Journal of Nursing Scholarship 46, no. 6 (2014): 423–431.CrossRefGoogle Scholar

Bromley, E. et al., “From ‘Informed’ to ‘Engaged’ Consent: Risks and Obligations in Consent for Participation in a Health Data Repository,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 172–182.CrossRefGoogle Scholar

Aldinger, C.E. et al., “Returning Aggregate Results of Clinical Trials: Empirical Data of Patient Preferences,” Journal of Clinical and Translational Science 2, no. 6 (2018): 356–362.CrossRefGoogle Scholar

Grady, C., “Enduring and Emerging Challenges of Informed Consent,” New England Journal of Medicine 372, no. 9 (2015): 855–862.CrossRefGoogle Scholar

Henry, L.M. et al., “Just Compensation: A No-Fault Proposal for Research-Related Injuries,” Journal of Law and the Biosciences 2, no. 3 (2015): 6456–68.Google Scholar

“NIH Data Sharing Policies,” 2019, available at <https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_policies.html> (last visited February 11, 2020).+(last+visited+February+11,+2020).>Google Scholar

Clayton, E.W. et al., “A Systematic Literature Review of Individuals' Perspectives on Privacy and Genetic Information in the United States,” PLoS One 13, no. 10 (2018): e0204417.CrossRefGoogle Scholar

Grady, C. et al. “Broad Consent for Research with Biological Samples: Workshop Conclusions,” American Journal of Bio-ethics 15, no. 9 (2015): 34–42.CrossRefGoogle Scholar

45 CFR 46 Part A (2019); Clayton, E. W. and Malin, B.A., “Assessing Risks to Privacy in Biospecimen Research,” in Bierer, B.A., Lynch, H.F., Cohen, I. Glenn, and Rivera, S.M., eds., Specimen Science: Ethical and Policy Implications (Boston: MIT Press, 2017) 143–158.Google Scholar

Faden, R.R. et al., “An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics,” Hastings Center Report Special 43, no. S1 (2013): S16–27.CrossRefGoogle Scholar

Wilkins, C.H., “Effective Engagement Requires Trust and Being Trustworthy,” Medical Care 56, no. 10 Suppl 1 (2018): S6; Yarborough, M. et al., “Relationships Hold the Key to Trustworthy and Productive Translational Science: Recommendations for Expanding Community Engagement in Biomedical Research,” Clinical and Translational Science 6, no. 4 (2013): 310–313.CrossRefGoogle Scholar

Rothman, D. J., Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York, NY: Basic Books, 1991).Google Scholar

Klitzman, R., “‘Members of the Same Club’: Challenges and Decisions Faced by US IRBs in Identifying and Managing Conflicts of Interest,” PLoS One 6, no. 7 (2011): e22796.Google Scholar

45 CFR § 46.111(a)(2)(2019).Google Scholar