Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols

Human Gene Therapy

Volumn 17, Issue 4, 2006, Pages 448-454

  Scharschmidt, Tiffany ^a   Lo, Bernard ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT DNA;

CLINICAL PROTOCOL; DRUG MONITORING; DRUG SAFETY; GENE TRANSFER; HUMAN; MEDICAL RESEARCH; PATIENT SAFETY; PATIENT SELECTION; RECOMBINANT DNA TECHNOLOGY; REVIEW; STATISTICAL ANALYSIS;

CLINICAL PROTOCOLS; CLINICAL TRIALS; ETHICS COMMITTEES, RESEARCH; GENE THERAPY; GENE TRANSFER TECHNIQUES; GOVERNMENT REGULATION; HUMANS; META-ANALYSIS; NATIONAL INSTITUTES OF HEALTH (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33645953638     PISSN: 10430342     EISSN: None     Source Type: Journal    
DOI: 10.1089/hum.2006.17.448     Document Type: Review

References (13)

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2. KING, N.M., HENDERSON, G.E., CHURCHILL, L.R., DAVIS, A.M., HULL, S.C., NELSON, D.K., PARHAM-VETTER, P.C., ROTHSCHILD, B.B., EASTER, M.M., and WILFOND, B.S. (2005) Consent forms and the therapeutic misconception: The example of gene transfer research. IRB 27, 1-8.
3. NATIONAL INSTITUTES OF HEALTH. (2000). Enhancing the Protection of Human Subjects in Gene Transfer Research at the National Institutes of Health. Available at http://www.nih.gov/about/director/07122000.htm. Accessed February 2006.
4. NATIONAL INSTITUTES OF HEALTH. (2002). NIH Guidelines for Research Involving Recombinant DNA Molecules. Appendix M-I-B: RAC Review Requirements. Available at http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M. htm#_Toc7255840. Accessed February 2006.
5. NATIONAL INSTITUTES OF HEALTH. (2003). NIH Guidance on Informed Consent for Gene Transfer Research. Available at: http://www4.od.nih.gov/oba/rac/ic/ index.html. Accessed February 2006.
6. NATIONAL INSTITUTES OF HEALTH. (2004). Frequently Asked Questions (FAQs) about the NIH Review Process for Human Gene Transfer Trials. Available at http://www4.od.nih.gov/oba/RAC/RAC_FAQs.htm. Accessed February 2006.
7. OFFICE OF BIOTECHNOLOGY ACTIVITIES. (2004). Human Gene Transfer Protocols. Version updated December 6, 2004. Available at: http://www4.od.nih. gov/oba/rac/PROTOCOL.pdf. Accessed February 2006.
8. RAC MEMBER. (December 15, 2000). Recombinant DNA Advisory Committee Public Hearing: Meeting transcript. Can be accessed by Webcast (http://www.webconferences.com/nihoba/).
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11. RAC MEMBER. (September 17, 2003b). Recombinant DNA Advisory Committee Public Hearing: Meeting transcript. Can be accessed by Webcast (http://www.webconferences.com/nihoba/).
12. RAC MEMBER. (September 20, 2003). Recombinant DNA Advisory Committee Public Hearing: Meeting transcript. Can be accessed by Webcast (http://www.webconferences.com/nihoba/).
13. RAC MEMBER. (December 3, 2003). Recombinant DNA Advisory Committee Public Hearing: Meeting transcript. Can be accessed by Webcast (http://www. webconferences.com/nihoba/).