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Stakeholders’ Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials
Published online by Cambridge University Press: 01 January 2021
Extract
Technological innovation has led to important advancements in medical care. Nonetheless, patients continue to receive many health services for which the evidence regarding whether the service is effective is inadequate. Recognizing the need for robust evidence to support clinical and health policy decision-making, increasing attention has focused on comparative effectiveness research (CER). To support such efforts and to underscore the public's interest in having such evidence, the federal government has recently devoted substantial resources to support CER.
CER has been defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings.” Understanding how different interventions work in the real world generally requires that CER studies be closely integrated with clinical practice. Further, although some CER questions can be answered with observational studies, generating robust evidence will, at times, require randomized controlled trials (RCTs).
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References
Tunis, S. R. et al., “Comparative Effectiveness Research: Policy Context, Methods Development and Research Infrastructure,” Statistics in Medicine 29, no. 19 (2010): 1963–1976.CrossRefGoogle Scholar
Institute of Medicine, Initial National Priorities for Comparative Effectiveness Research (Washington, D.C.: National Academies Press, June 2009).Google Scholar
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).Google Scholar
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).Google Scholar
Mullins, C. D. et al., “Generating Evidence for Comparative Effectiveness Research Using More Pragmatic Randomized Controlled Trials,” Pharmacoeconomics 28, no. 10 (2010): 969–976.CrossRefGoogle Scholar
Luce, B. R. et al., “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. et al., “Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy,” JAMA 290, no. 12 (2003): 1624–1632.CrossRefGoogle Scholar
Faden, R. et al., “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. et al., “Informed Consent, Comparative Effectiveness and Learning Health Care,” New England Journal of Medicine 370, no. 8 (2014): 766–768; Kass, N. et al., “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. et al., “Ethics, Regulation, and Comparative Effectiveness Research: Time for a Change,” JAMA 311, no. 15 (2014): 1497–1498.CrossRefGoogle Scholar
Faden, R. R. Beauchamp, T. L., A History and Theory of Informed Consent (New York: Oxford University Press, 1986): At 294.Google Scholar
Kass, N. E. et al., “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.CrossRefGoogle Scholar
United States Department of Health, Education, and Welfare, Code of Federal Regulations, Title 45, Part 46.116 (2009).Google Scholar
Braddock, C. H. et al., “Informed Decision Making in Outpatient Practice: Time to Get Back to Basics,” JAMA 282, no. 24 (1999): 2213–2320; and Braddock, C. H. et al., “How Doctors and Patients Discuss Routine Clinical Decisions,” Journal of General Internal Medicine 12, no. 6 (1997): 339–345.Google Scholar
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. et al., “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.CrossRefGoogle Scholar
See for example Davis, T. C. et al., “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. et al., “Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form,” IRB: Ethics & Human Research 32, no. 4 (2010): 1–9.CrossRefGoogle Scholar
Van Staa, T. P. et al., “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. et al. (2014), Kass, et al. Platt, et al. supra note 8.Google Scholar
Damschroder, L. J. et al., “Patients, Privacy and Trust: Patients' Willingness to Allow Researchers to Access Their Medical Records,” Social Science and Medicine 64, no. 1 (2007): 223–235.Google Scholar
Olsen, L. W. Aisner, D. McGinnis, J. M., eds,. The Learning Healthcare System: Workshop Summary (Washington, D.C.: National Academies Press, 2007).Google Scholar
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).+(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++(last+visited+April+30,+2015).>Google Scholar
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).+(last+visited+June+22,+2014);+and+Institute+of+Translational+Health+Sciences,+“RoMP+Study+Assesses+Public+Acceptability+of+Research+Policies,”+available+at++(last+visited+April+30,+2015).>Google Scholar