2013
DOI: 10.4172/2155-6113.1000260
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Preparing for HIV Vaccine Trials in Nigeria: Building the Capacity of the Community and National Coordinating, Regulatory and Ethical Bodies

Abstract: Background: There is paucity of high-level clinical trials in Nigeria for several reasons, which include: lack of trained investigators and mentorship in the implementation of Clinical trials at international standard; inadequate investment and trained regulatory agencies to provide oversight. Therefore, the need for capacity of the national coordinating agencies (NCA); the investigative team, supporting research laboratory and the community to be developed in preparation for future HIV prevention trials inclu… Show more

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Cited by 3 publications
(4 citation statements)
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“…Some research studies previously conducted in Nigeria, such as the failed Pfizer trials of 1996, lacked the required IRB regulatory approvals and documented evidence of informed consent [11–13]. Any future trials and vaccine studies, therefore, must ensure appropriate community engagement, site preparedness and adherence to the principles of Good Participatory Practice (GPP) to restore the trust of the community [14].…”
Section: Introductionmentioning
confidence: 99%
“…Some research studies previously conducted in Nigeria, such as the failed Pfizer trials of 1996, lacked the required IRB regulatory approvals and documented evidence of informed consent [11–13]. Any future trials and vaccine studies, therefore, must ensure appropriate community engagement, site preparedness and adherence to the principles of Good Participatory Practice (GPP) to restore the trust of the community [14].…”
Section: Introductionmentioning
confidence: 99%
“…There are plenty of methods available, among which some of them are discussed below [39][40][41][42][43].…”
Section: Bioinformatics Methods For Viral Genomicsmentioning
confidence: 99%
“…The research pointed out that there was a paucity of high-level clinical trials in Nigeria for several reasons, including the lack of trained investigators and mentorship in implementing clinical trials at an international standard. Moreover, there was an inadequate investment and trained regulatory agencies to provide oversight (Okpokoro, Osawe & Dantong, 2013). To address these challenges, the study collaborated with the University of Ottawa to identify three regulatory agencies in Nigeria: NAFDAC (National Agency for Food and Drug Administration Control), NHREC (National Health Research Ethics Committee), and NACA (National Agency for Control of AIDS).…”
Section: Engagement With Regulatory and Supervisory Bodies For Microf...mentioning
confidence: 99%
“…These trainees also conducted a 2-day site assessment of an ongoing sero-discordant study in Jos, Nigeria, with full community engagement. The trained research team became a member of the national HIV vaccine plan implementation committee, and the supporting research laboratory updated all standard operating manuals for ISO15198 accreditation (Okpokoro, Osawe & Dantong, 2013).…”
Section: Engagement With Regulatory and Supervisory Bodies For Microf...mentioning
confidence: 99%