Assessing the quality of human research protection programs to improve protection of human subjects participating in clinical trials

Clinical Trials

Volumn 12, Issue 3, 2015, Pages 224-231

  Tsan, Min Fu ^a   Tsan, Linda W ^a  

^a VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

human research protection program; Human subject protection; institutional review board; quality improvement; quality indicators

Indexed keywords

ACCREDITATION; ARTICLE; CLINICAL TRIAL (TOPIC); EDUCATION; HUMAN; INSTITUTIONAL REVIEW; MEDICAL AUDIT; METHODOLOGY; ORGANIZATION; PRIORITY JOURNAL; PROTECTION; RESEARCH ETHICS; RESEARCH SUBJECT; SCOPE OF PRACTICE; TOTAL QUALITY MANAGEMENT; VULNERABLE POPULATION; CONFIDENTIALITY; ETHICS; GOVERNMENT; HEALTH CARE QUALITY; HUMAN EXPERIMENT; HUMAN RIGHTS; IN SERVICE TRAINING; PROFESSIONAL STANDARD; STANDARDS; UNITED STATES;

CLINICAL TRIALS AS TOPIC; CONFIDENTIALITY; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; INSERVICE TRAINING; QUALITY INDICATORS, HEALTH CARE; UNITED STATES; UNITED STATES DEPARTMENT OF VETERANS AFFAIRS;

EID: 84929178382     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514568688     Document Type: Article

References (22)

1. Federal Policy for the Protection of Human Subjects. 1991 ; 46 :
2. The Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: Government Printing Office ; 1979 :
3. Preserving public trust: accreditation and human research participant protection programs. Washington, DC: National Academic Press ; 2001 :
4. Anderson JA, Sawatzky-Girling B, McDonald M, et al. Research ethics broadly writ: beyond REB review. Health Law Review. 2011 ; 19: 12-24
5. Department of Veteran Affairs. Requirements for the protection of human subjects in research. VHA Handbook 1200.05, http://www1.va.gov/vhapublications/ (2012, accessed 1 May 2014).
6. Kizer KW. Statement on oversight in the Veterans Health Administration before the Subcommittee on Veterans' Affairs. Washington, DC: U.S. House of Representatives ; 1999 :
7. Steinbrook R.. Protecting research subjects - the crisis at Johns Hopkins. N Engl J Med. 2002 ; 346: 716-720
8. Kranish M.. System for protecting humans in research faulted. Boston Globe. 2002 ;: A1
9. Shalala D. Protecting research subjects - what must be done. N Engl J Med. 2000 ; 343: 808-810
10. Steinbrook R. Improving protection for research subjects. N Engl J Med. 2002 ; 346: 1425-1430
11. Tsan MF, Smith K, Gao B. Assessing the quality of human research protection programs: the experience at the Department of Veterans Affairs. IRB. 2010 ; 32: 16-19
12. Tsan MF, Nguyen Y, Brooks R. Using quality indicators to assess human research protection programs at the Department of Veterans Affairs. IRB. 2013 ; 35: 10-14
13. Tsan MF, Nguyen Y, Brooks R. Assessing the quality of VA human research protection programs: VA vs. affiliated university institutional review board. J Empir Res Hum Res Ethics. 2013 ; 8: 153-160
14. Nguyen Y, Brooks R, Tsan MF. Human research protection programs at the Department of Veterans Affairs: quality indicators and program size. IRB. 2014 ; 36: 16-19
15. Tsan MF, Nguyen Y, Brooks R. Using quality indicators to assess and improve human research protection programs: experience of the Department of Veterans Affairs. Fed Prac.: in press
16. Tsan MF, Nguyen Y. Lapse in institutional review board continuing review approval. IRB.: in press
17. Association for Accreditation of Human Research Protection Programs. 2012 metrics on HRPP performance for academic institutions, https://www.aahrpp.org/apply/resources/metrics-on-hrpp-performance (2013, accessed 1 May 2014).
18. Department of Veteran Affairs. Research and Development Committee. VHA Handbook 1200.01, http://www1.va.gov/vhapublications/ (2009, accessed 1 May 2014).
19. Research Compliance Officer Audit Tools, Office of Research Oversight, Department of Veterans Affairs, http://www.va.gov/ORO/Research-Compliance-Education.asp (2013, accessed 1 May 2014).
20. Department of Veterans Affairs. Research Compliance Reporting Requirements. VHA Handbook 1058.01, http://www1.va.gov/vhapublications/ (2010, accessed 1 May 2014).
21. Nightingale SL. An update from FDA. Plenary address at PRIM&R IRB conference ; Boston, MA ;..
22. Scientific research - continued vigilance critical to protecting human subjects. 1996 ;: