Informed consent, confidentiality, and subject rights in clinical trials

Proceedings of the American Thoracic Society

Volumn 4, Issue 2, 2007, Pages 189-193

  Smith Tyler, June ^a  

^a Schulman Associates Institutional Review Board Inc   (United States)

Author keywords

Clinical trial; Ethics; Vulnerable populations

Indexed keywords

CLINICAL RESEARCH; COMPENSATION; FOOD AND DRUG ADMINISTRATION; GENETIC ANALYSIS; GENETICS; GOVERNMENT; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; LANGUAGE; MEDICAL ETHICS; MEDICAL SOCIETY; PRACTICE GUIDELINE; PRIVACY; REVIEW; RISK ASSESSMENT; CONFIDENTIALITY; LAW; MEDICAL RESEARCH; NOTE;

ADULT; CHILD; CLINICAL TRIALS; CONFIDENTIALITY; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; LANGUAGE;

EID: 34248326097     PISSN: 15463222     EISSN: None     Source Type: Journal    
DOI: 10.1513/pats.200701-008GC     Document Type: Review

References (6)

1. Code of Federal Regulations, Title 21, Chapter 1-U.S. Food and Drug Administration, DHHS, Part 50: Protection of Human Subjects. Philadelphia, PA: Clinical Research Resources, LLC; April 1, 2006.
2. Code of Federal Regulations, Title 21, Chapter 1-U.S. Food and Drug Administration, DHHS, Part 56: Institutional Review Boards. Philadelphia, PA: Clinical Research Resources, LLC; April 1, 2006.
3. Code of Federal Regulations, Title 45-Department of Health and Human Services, Part 46: Protection of Human Subjects. Philadelphia, PA: Clinical Research Resources, LLC; April 1, 2006.
4. Exculpatory Language in Informed Consent; The Office for Protection from Research Risk (OPRR) Cooperative Oncology Group, chairpersons meeting, November 15, 1996.
5. US Food and Drug Administration. Information Sheets. Guidance for institutional review boards and clinical investigators, 1998 update. frequently asked questions. Available at: http://www.fda.gov/oc/ohrt/irbs/faqs.html. Accessed November 16, 2006.
6. American Medical Association, Code of Ethics; E-8.0315 Managing Conflicts of Interest in the Conduct of Clinical Trials [Internet]. Available from http://www.ama-assn.org/ama/pub/category/8288.html (accessed November 16, 2006).