Responsible conduct of radiology research. Part II. Regulatory requirements for human research

Radiology

Volumn 236, Issue 3, 2005, Pages 748-752

  Cooper, Jeffrey A ^a,b  

^a Association for the Accreditation of Human Research Protection Programs   (United States)

^b UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; PATIENT SELECTION; PRIORITY JOURNAL; REVIEW;

BIOMEDICAL RESEARCH; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; RADIOLOGY; RESEARCH DESIGN;

EID: 23844492484     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiol.2363031634     Document Type: Review

References (21)

1. Protection of human subjects: federal policy for the protection of human subjects. 45 CFR §46 (1991).
2. Protection of human subjects. 21 CFR §50 (2002).
3. Institutional review boards. 21 CFR §56 (2002).
4. Protection of human subjects: IRB review of research. 45 CFR §46.109 (1991).
5. IRB review of research: institutional review boards. 21 CFR §56.109 (2002).
6. Protection of human subjects: suspension or termination of IRB approval of research. 45 CFR §46.113 (1991).
7. Institutional review boards: suspension or termination of IRB approval of research. 21 CFR §56.113 (2002).
8. Protection of human subjects: IRB membership. 45 CFR §46.107 (1991).
9. Institutional review boards: IRB membership. 21 CFR §56.107 (2002).
10. Protection of human subjects: criteria for IRB approval of research. 45 CFR §46.111 (1991).
11. Institutional review boards: criteria for IRB approval of research. 21 CFR §50.111. (2002).
12. Levine RJ. Informed consent: ethics and regulation of clinical research. 2nd ed. New Haven, Conn: Yale University Press, 1986.
13. Protection of human subjects: general requirements for informed consent. 45 CFR §46.116 (1991).
14. Protection of human subjects: general requirements for informed consent. 21 CFR §50.20 (2002).
15. Protection of human subjects: definitions. 45 CFR §46.102 (1991).
16. Protection of human subjects: definitions. 21 CFR §50.3 (2002).
17. Weil CJ. Human research protections under multiple project assurance (MPA) M-115: Office for Human Research Protections-letter to Dr Neal Nathanson, June 10, 2002. Available at: http://ohrp.osophs .dhhs.gov/detrmJetrs/YR02/ jun02b.pdf. Accessed March 14, 2004.
18. Protection of human subjects: documentation of informed consent. 45 CFR §46.117 (1991).
19. Protection of human subjects: documentation of informed consent. 21 CFR §50.27 (2002).
20. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003;348:721-726.
21. Certificates of confidentiality kiosk. National Institutes of Health, Office of Extramural Research Web site. http://grants1 .nih.gov/grants/policy/ coc/. Accessed March 14, 2004.