Responsible conduct of radiology research. Part III. Exemptions from regulatory requirements for human research

Radiology

Volumn 237, Issue 1, 2005, Pages 3-7

  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

ETHICS; FOOD AND DRUG ADMINISTRATION; LEGAL ASPECT; MEDICAL RESEARCH; PRIORITY JOURNAL; RADIOLOGY; REVIEW;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; RADIOLOGY; UNITED STATES; UNITED STATES DEPT. OF HEALTH AND HUMAN SERVICES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 25144487694     PISSN: 00338419     EISSN: None     Source Type: Journal    
DOI: 10.1148/radiol.2371031636     Document Type: Review

References (16)

1. Cooper JA. Responsible conduct of radiology research. II. Regulatory requirements for human research. Radiology 2005;236:748-752.
2. Protection of human subjects', federal policy for the protection of human subjects. 45 CFR §46 (1991).
3. Protection of human subjects. 21 CFR §50 (2002).
4. Institutional review boards. 21 CFR §56 (2002).
5. Definitions: protection of human subjects-federal policy for the protection of human subjects. 45 CFR §46.102 (1991).
6. To what does this policy apply? protection of human subjects: federal policy for the protection of human subjects. 45 CFR §46.101 (1991).
7. Pritchard IA. Searching for "research involving human subjects": what is examined? what is exempt? what is exasperating? IRB 2001; 23(3):5-13.
8. Amdur RJ, Speers MA. Identifying research intent. In: Amdur RJ, Bankert E, eds. Institutional review board: management and function. Sudbury, Mass: Jones & Bartlett, 2002.
9. Office of human research protections compliance activities: common findings and guidance. Department of Health and Human Services, Offices for Human Research Protections (OHRP) Web site. http://ohrp .osophs.dhhs.gov/ references/findings.pdf. Published July 10, 2002. Accessed May 19, 2005.
10. Exemptions from IRB requirement: protection of human subjects, 21 CFR §56.104 (2002).
11. Definitions: protection of human subjects. 21 CFR §56.102 (2002).
12. Information sheets: guidance for institutional review boards and clinical investigators-emergency use of an investigation drug or biologic. U.S. Food and Drug Administration Web site. http://www.fda.gov/oc /ohrt/irbs/drugsbiologics. html#emergency. Updated 1998. Accessed May 19, 2005.
13. Information sheets: guidance for institutional review boards and clinical investigators-emergency use of unapproved medical devices. U.S. Food and Drug Administration Web site. http://www.fda.gov/oc /ohrt/irbs/devices. html#emergency. Updated 1998. Accessed May 19, 2005.
14. Information sheets: guidance for institutional review boards and clinical investigators-"off-label" and investigational use of marketed drugs, biologics, and medical devices. U.S. Food and Drug Administration Web site. http://www.fda.gov/oc/ohrt/irbs /offlabel.htrm. Updated 1998. Accessed March 14, 2004.
15. Exception from general requirements: institutional review boards. 21 CFR §50.23 (2002).
16. Definitions: investigational device exemptions. 21 CFR §812.3 (2002).