title: Health research oversight in Africa.
abstract: Increased research involving human participants in developing countries has resulted in commensurate rise in needs for functional research oversight activities. The importance of developing countries regulatory and ethical review authorities to demonstrate capability in reviewing clinical trials, quality of the products as well as clinical data obtained through well-coordinated oversight systems cannot be over-emphasized. According to the recent international changes in regulatory frameworks and evolving manufacture's strategies, African countries are now responsible to review applications and license new products without necessarily having them licensed in the north so long as they are not intended to be used there. This paper reviews the status of health research oversight in Africa and gives an overview of some mechanisms that are being put in place in an effort to strengthen oversight of health research. Practical challenges that are prevailing in the field will be highlighted.
authors.affiliation: African Malaria Network Trust (AMANET), Dar Es Salaam, Tanzania. ramanoor@gmail.com
authors.forename: Ramadhani Abdallah
authors.initials: RA
authors.lastname: Noor
mesh_terms: D000349:Africa; D035843:Biomedical Research / Q000191:economics / Q000941:ethics* / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D032984:Ethics, Research; D006801:Humans; D017387:Investigational New Drug Application; D012108:Research Personnel