Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Clinical Trials

Volumn 12, Issue 6, 2015, Pages 692-695

  Lorell, Beverly H ^a   Mikita, J Stephen ^b   Anderson, Annick ^c   Hallinan, Zachary P ^c   Forrest, Annemarie ^d  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Patient Representative   (United States)

^c Center for Information and Study on Clinical Research Participation   (United States)

^d Clinical Trials Transformation Initiative (CTTI)   (United States)

Author keywords

clinical research; decision making; health policy; Informed consent; institutional review board; research ethics

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CONSENSUS DEVELOPMENT; GOVERNMENT REGULATION; HUMAN; INFORMATION RETRIEVAL; INFORMED CONSENT; MEDICAL ETHICS; PARTICIPANT OBSERVATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARDS REVIEW ORGANIZATION; TELEPHONE INTERVIEW; UNITED STATES; ADVISORY COMMITTEE; CONSENSUS; ETHICS; INTERVIEW; MEDICAL RESEARCH; QUALITATIVE RESEARCH; STANDARDS;

ADVISORY COMMITTEES; BIOMEDICAL RESEARCH; CONSENSUS; HUMANS; INFORMED CONSENT; INTERVIEWS AS TOPIC; QUALITATIVE RESEARCH; UNITED STATES;

EID: 84947060660     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774515594362     Document Type: Article

References (18)

1. Protection of human subjects: see 21 C.F.R. Part 50 and 45 C.F.R. Part 46.
2. Flory J, Emanuel E,. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 2004; 292: 1593-1601.
3. Meade CD,. Improving understanding of the informed consent process and document. Semin Oncol Nurs 1999; 15: 124-137.
4. Nishimura A, Carey J, Erwin PJ, et al. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics 2013; 14: 28.
5. The Center for Information and Study on Clinical Research Participation (CISCRP). 2013 perceptions & insights study: report on the informed consent process., https://www.ciscrp.org/wp-content/uploads/2014/01/2013-CISCRP-Study-the-Informed-Consent-Process.pdf (2013,. accessed 9 March 2015).
6. Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. 76 Federal Register 44512., 26 2011, http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf
7. Clinical Trials Transformation Initiative (CTTI), http://www.ctti-clinicaltrials.org/ (. accessed 7 May 2015).
8. Clinical Trials Transformation Initiative (CTTI). Informed consent project summary., http://www.ctti-clinicaltrials.org/what-we-do/study-start-up/informed-consent (. accessed 29 June 2015).
9. The Center for Information and Study on Clinical Research Participation (CISCRP), https://www.ciscrp.org/ (. accessed 6 May 2015).
10. Elements of informed consent: see 21 C.F.R. §50.25 and 45 C.F.R. §46.116.
11. US Food and Drug Administration, Department of Health and Human Services. Draft guidance: informed consent information sheet. Guidance for IRBs, clinical investigators, and sponsors. Silver Spring, MD: US Food and Drug Administration, Department of Health and Human Services, 2014.
12. Institute of Medicine. Transforming clinical research in the United States: challenges and opportunities: workshop summary. Washington, DC: National Academies Press, 2010.
13. Institute of Medicine. Envisioning a transformed clinical trials enterprise in the United States: establishing an agenda for 2020: workshop summary. Washington, DC: National Academies Press, 2012.
14. Brehaut JC, Carroll K, Elwyn G, et al. Informed consent documents do not encourage good-quality decision making. J Clin Epidemiol 2012; 65: 708-724.
15. Documentation of informed consent: see 21 C.F.R. §50.27 and 45 C.F.R. §46.117.
16. Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS ONE 2013; 8: e54999.
17. National Center for Advancing Translational Sciences, National Institutes of Health. IRB reliance: a new model for accelerating translational science., http://www.ncats.nih.gov/news-and-events/features/irb-reliance.html (2014,. accessed 9 March 2015).
18. General provisions respecting control of devices intended for human use: see 21 U.S.C. §360j(g)(3)(A) http://ncats.nih.gov/pubs/features/irb-reliance (. accessed 29 June 2015).