Stakeholders' Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials

Tunis S. R. , “Comparative Effectiveness Research: Policy Context, Methods Development and Research Infrastructure,” Statistics in Medicine 29, no. 19 (2010): 1963–1976.

Institute of Medicine, Initial National Priorities for Comparative Effectiveness Research (Washington, D.C.: National Academies Press, June 2009).

American Recovery and Reinvestment Act of 2009 , Pub. L. No. 111–5, 123 Stat. 115 (February 17, 2009); and Patient Protection and Affordable Care Act of 2010 , Pub. L. No. 111–148, 124 Stat. 727 (March 23, 2010).

Federal Coordinating Council for Comparative Effectiveness Research, Report to the President and to Congress (Washington, D.C.: Department of Health and Human Services, June 2009).

Mullins C. D. , “Generating Evidence for Comparative Effectiveness Research Using More Pragmatic Randomized Controlled Trials,” Pharmacoeconomics 28, no. 10 (2010): 969–976.

Luce B. R. , “Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change,” Annals of Internal Medicine 151, no. 3 (2009): 206–209; and Tunis S. R. , “Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy,” JAMA 290, no. 12 (2003): 1624–1632.

See Mullins , supra note 5.

Faden R. , “Ethics and Informed Consent for Comparative Effectiveness Research with Prospective Electronic Clinical Data,” Medical Care 51, no. 8, Supp. 3 (2013): S53–S57; Faden R. R. , “Informed Consent, Comparative Effectiveness and Learning Health Care,” New England Journal of Medicine 370, no. 8 (2014): 766–768; Kass N. , “Addressing Low-Risk Comparative Effectiveness Research in Proposed Changes to US Federal Regulations Governing Research,” JAMA 307, no. 15 (2012): 1589–1590; and Platt R. , “Ethics, Regulation, and Comparative Effectiveness Research: Time for a Change,” JAMA 311, no. 15 (2014): 1497–1498.

Faden R. R. Beauchamp T. L. , A History and Theory of Informed Consent (New York: Oxford University Press, 1986): At 294.

Kass N. E. , “The Research-Treatment Distinction: A Problemmatic Approach for Determining Which Activities Should Have Ethical Oversight,” Hastings Center Report Special Report 43, no. 1 (2013): S4–S15; and Baily M. A. , “Harming through Protection?” New England Journal of Medicine 358, no. 8 (2008): 768–769.

United States Department of Health, Education, and Welfare, Code of Federal Regulations, Title 45, Part 46.116 (2009).

Braddock C. H. , “Informed Decision Making in Outpatient Practice: Time to Get Back to Basics,” JAMA 282, no. 24 (1999): 2213–2320; and Braddock C. H. , “How Doctors and Patients Discuss Routine Clinical Decisions,” Journal of General Internal Medicine 12, no. 6 (1997): 339–345.

The only other study of which we are aware to look at stakeholder perceptions of alternatives to informed consent for minimal-risk trials was Rogers C. G. , “Conventional Consent with Opting In Versus Simplified Consent with Opting Out: An Exploratory Trial for Studies That Do Not Increase Patient Risk,” Journal of Pediatrics 132, no. 4 (1998): 606–611.

See for example Davis T. C. , “Informed Consent for Clinical Trials: A Comparative Study of Standard Versus Simplified Forms,” Journal of the National Cancer Institute 90, no. 9 (1998): 668–674; Dresden G. M. Levitt M. A. , “Modifying a Standard Industry Clinical Trial consent Form Improves Patient Information Retention as Part of the Informed Consent Process,” Academic Emergency Medicine 8, no. 3 (2001): 246–252; and Stunkel L. , “Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form,” IRB: Ethics & Human Research 32, no. 4 (2010): 1–9.

Van Staa T. P. , “Pragmatic Randomized Trials Using Routine Electronic Health Records,” BMJ 344 (2012): e55–e62; Wendler D. Grady C. , “What Should Research Participants Understand to Understand They Are Participants in Research?” Bioethics 22, no. 4 (2008): 203–220. See also Faden R. R. (2014), Kass Platt supra note 8.

See Rogers supra note 13.

Damschroder L. J. , “Patients, Privacy and Trust: Patients' Willingness to Allow Researchers to Access Their Medical Records,” Social Science and Medicine 64, no. 1 (2007): 223–235.

See Kass supra note 8.

Olsen L. W. Aisner D. McGinnis J. M. , eds,. The Learning Healthcare System: Workshop Summary (Washington, D.C.: National Academies Press, 2007).

For instance, the Patient Centered Outcomes Research Institute recently issued a funding announcement for large pragmatic clinical trials. For more information on this initiative, see Patient Centered Outcomes Research Institute, “Large Pragmatic Studies to Evaluate Patient-Centered Outcomes – Winter 2015 Cycle”, available at <http://www.pcori.org/announcement/large-pragmatic-studies-evaluate-patient-centered-outcomes-winter-2015-cycle> (last visited June 22, 2014). Additionally, the National Institutes of Health (NIH) Collaboratory is currently funding several large pragmatic trial demonstration projects and is working to create the infrastructure needed to support collaborative research. For more information on this initiative, see: NIH Collaboratory, “The HCS Collaboratory,” available at <https://www.nihcollaboratory.org/about-us/Pages/default.aspx> (last visited April 30, 2015).

Faden R. , Stakeholder Views of Streamlined Informed Consent Options for CER Studies, available at <http://www.pcori.org/research-results/2012/stakeholder-views-streamlined-informed-consent-options-cer-studies> (last visited June 22, 2014); and Institute of Translational Health Sciences, “RoMP Study Assesses Public Acceptability of Research Policies,” available at <https://www.iths.org/news/story/romp-study-assesses-public-acceptability-research-policies> (last visited April 30, 2015).