Variability in IRBs regarding parental acceptance of passive consent

Pediatrics

Volumn 134, Issue 2, 2014, Pages

  Higgerson, Renee A ^a   Olsho, Lauren E W ^b   Christie, LeeAnn M ^a   Rehder, Kyle ^c   Doksum, Teresa ^b   Gedeit, Rainer ^d   Giuliano Jr , John S ^e   Brennan, Beth ^b   Wendlandt, Rachael ^b   Randolph, Adrienne G ^f  

^a DELL INC   (United States)

^b ABT ASSOCIATES   (United States)

^c DUKE CHILDREN S HOSPITAL   (United States)

^d Children's Hospital of Wisconsin   (United States)

^e YALE NEW HAVEN CHILDREN S HOSPITAL   (United States)

^f HARVARD UNIVERSITY   (United States)

Author keywords

Epidemiologic research design; Ethics committees; Federal regulations; Opt out; Research ethics standards

Indexed keywords

ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; FEASIBILITY STUDY; HEALTH CARE ORGANIZATION; HUMAN; INFECTION RISK; INSTITUTIONAL REVIEW; INSTITUTIONAL REVIEW BOARD; MEDICAL DOCUMENTATION; MEDICAL RECORD; PARENTAL CONSENT; PEDIATRIC HOSPITAL; PRIORITY JOURNAL; REFUSAL TO PARTICIPATE; RISK ASSESSMENT; RISK FACTOR; SOCIAL ACCEPTANCE; SOCIAL PARTICIPATION;

EPIDEMIOLOGIC RESEARCH DESIGN; ETHICS COMMITTEES; FEDERAL REGULATIONS; OPT-OUT; RESEARCH/ETHICS/STANDARDS;

CHILD; EPIDEMIOLOGIC RESEARCH DESIGN; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HOSPITALS, PEDIATRIC; HUMANS; INFORMED CONSENT; MULTICENTER STUDIES AS TOPIC; PARENTS; PATIENT SELECTION; SELECTION BIAS; UNITED STATES;

EID: 84905276157     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2013-4190     Document Type: Article

References (23)

1. Junghans C, Feder G, Hemingway H, Timmis A, Jones M. Recruiting patients to medical research: double blind randomised trial of "opt-in " versus "opt-out " strategies. BMJ. 2005;331(7522):940
2. Silberman G, Kahn KL. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Q. 2011;89(4):599-627
3. US Department of Health and Human Services, Office for Human Research Protections, Secretary 's Advisory Committee on Human Research Protections (SACHRP). Appendix C. Washington, DC: US Department of Health and Human Services. Available at: www.hhs.gov/ohrp/sachrp/appendixc.html. Accessed September 23, 2013
4. US Department of Health and Human Services. SACHRP recommendation regarding application of 45 CFR 46 and 21 CFR 56 to early processes in research, such as identifying potential subjects, contacting subjects, and recruiting subjects. Washington, DC: US Department of Health and Human Services; July 2011. Available at: www.hhs.gov/ohrp/sachrp/commsec/attachmentc: approvedbysachrpjuly202011. pdf. Accessed September 23, 2013
5. Newgard CD, Hui SH, Stamps-White P, Lewis RJ. Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research. Health Serv Res. 2005;40(4):1247-1258 (Pubitemid 41040672)
6. Dziak K, Anderson R, Sevick MA, Weisman CS, Levine DW, Scholle SH. Variations among institutional review board reviews in a multisite health services research study. Health Serv Res. 2005;40(1):279-290 (Pubitemid 40229360)
7. Mansbach J, Acholonu U, Clark S, Camargo CA Jr. Variation in institutional review board responses to a standard, observational, pediatric research protocol. Acad Emerg Med . 2007;14(4):377-380 (Pubitemid 46464032)
8. Green LA, Lowery JC, Kowalski CP, Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Serv Res . 2006;41(1):214-230
9. Petersen LA, Simpson K, Sorelle R, Urech T, Chitwood SS. How variability in the institutional review board review process affects minimal-risk multisite health services research. Ann Intern Med. 2012;156(10):728-735
10. Silverstein M, Banks M, Fish S, Bauchner H. Variability in institutional approaches to ethics review of community-based research conducted in collaboration with unaffiliated organizations. J Empir Res Hum Res Ethics. 2008;3(2):69-76
11. US Department of Health and Human Services. How can covered entities use and disclose protected health information for research and comply with the privacy rule? Washington, DC: US Department of Health and Human Services; 2007. Available at: http://privacyruleandresearch.nih.gov/pr-08.asp. Accessed September 23, 2013
12. US Department of Health and Human Services. Clinical research and the HIPAA privacy rule. Washington, DC: US Department of Health and Human Services; 2004. Available at: http://privacyruleandresearch.nih.gov/clin-research.asp. Accessed September 23, 2013
13. Littenberg B, MacLean CD. Passive consent for clinical research in the age of HIPAA. J Gen Intern Med . 2006;21(3):207-211
14. Vellinga A, Cormican M, Hanahoe B, Bennett K, Murphy AW. Opt-out as an acceptable method of obtaining consent in medical research: a short report. BMC Med Res Methodol. 2011;11:40
15. Treweek S, Pitethly M, Cook J, et al. Strategies to improve recruitment to randomized controlled trials. Cochrane Database Syst Rev. 2010;(4):MR000013
16. Berry JG, Ryan P, Gold MS, Braunack-Mayer AJ, Duszynski KM; Vaccine Assessment Using Linked Data (VALiD) Working Group. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage. J Med Ethics. 2012;38(10):619-625
17. Trevena L, Irwig L, Barratt A. Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial. J Med Ethics. 2006;32(8):473-477 (Pubitemid 44210083)
18. Pokorny SB, Jason LA, Schoeny ME, Townsend SM, Curie CJ. Do participation rates change when active consent procedures replace passive consent. Eval Rev. 2001;25 (5):567-580 (Pubitemid 33602824)
19. Kelly BJ, Fraze TK, Hornik RC. Response rates to a mailed survey of a representative sample of cancer patients randomly drawn from the Pennsylvania Cancer Registry: a randomized trial of incentive and length effects. BMC Med Res Methodol. 2010;10:65
20. Ritvo P, Perez DF, Wilson K, et al; University of Toronto Joint Centre for Bioethics-Pandemic Ethics Working Group. Canadian national surveys on pandemic influenza preparations: pre-pandemic and peripandemic findings. BMC Public Health. 2013;13:271
21. Marshall MN. Sampling for qualitative research. Fam Pract . 1996;13(6):522-525 (Pubitemid 27060089)
22. Black T. Identifying Populations and Samples. Doing Quantitative Research in the Social Sciences. London, UK: Sage Publications; 2005:110-139
23. Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; other modifications to the HIPAA rules. Fed Regist . 2013;78(17):5565-5702