Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa

Clinical Trials

Volumn 8, Issue 1, 2011, Pages 103-111

  White, Rhonda ^a   Chileshe, Modesta ^b   Dawson, Liza ^c   Donnell, Deborah ^d   Hillier, Sharon ^e   Morar, Neetha ^f   Noguchi, Lisa ^g   Dixon, Dennis ^c  

^a FAMILY HEALTH INTERNATIONAL   (United States)

^b CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA   (Zambia)

^c NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

^e UNIVERSITY OF PITTSBURGH   (United States)

^f SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^g Microbicide Trials Network   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFRICA; ARTICLE; CLINICAL RESEARCH; COMMUNITY CARE; DECISION MAKING; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION PREVENTION; MEDICAL EDUCATION; NATIONAL HEALTH ORGANIZATION; PHASE 2 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH ETHICS;

AFRICA; ANTI-HIV AGENTS; CLINICAL TRIALS, PHASE II AS TOPIC; EARLY TERMINATION OF CLINICAL TRIALS; EDUCATION; HEALTH EDUCATION; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH PROMOTION; HIV INFECTIONS; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); RESIDENCE CHARACTERISTICS; SOCIAL MARKETING; THERAPEUTIC EQUIPOISE; TIME; UNITED STATES;

EID: 79951896168     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774510387170     Document Type: Article

References (5)

1. US Department of Health & Human Services. Elements of informed consent. Code of Federal Regulations Title 21 Pt. 50. 25. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.25 (accessed 28 January 2010 ).
2. US Department of Health & Human Services. General requirements for informed consent. Code of Federal Regulations Title 45, Pt46.116 (b)(5). Available at: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf (accessed 24 August 2010 ).
3. Unaids. Good participatory practice: guidelines for biomedical HIV prevention trials, ONLINE. 2007. UNAIDS, Joint United Nations Programme on HIV/AIDS. Available at: http://data.unaids.org/pub/manual/2007/jc1364-good- participatory-guidelines-en.pdf (accessed 24 August 2010 ).
4. Editorial Team. Phase III anti-HIV microbicide trial in Africa and India stopped as preliminary results show gel may increase risk of infection. Euro Surveill 2007 ; 12: pii=3137. Available at: http://www.eurosurveillance.org/ ViewArticle.aspx?ArticleId=3137 (accessed 24 August 2010 ).
5. Karlawish JH, Lantos J. Community equipoise and the architecture of clinical research. Camb Q Healthc Ethics 1997 ; 6: 385-96. (Pubitemid 127685122)