Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community
Slack, C.M.
Journal of Empirical Research on Human Research Ethics Jerhre 9(1): 83-95
2014
ISSN/ISBN: 1556-2646 PMID: 24572086 DOI: 10.1525/jer.2014.9.1.83Document Number: 623635
There has been debate about sponsor-investigator ethical responsibilities to address participants' medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for "moral negotiation" recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns.