Background: Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social and behavioral research is relatively…

"The Belmont Report" was written in 1979 to address the abuse of human participants in biomedical research. In the report, three ethical principles were described: (1) "beneficence," which describes an act of charity or kindness that maximizes possible benefits while minimizing possible harms; (2) "justice," described…

For the first time in twenty years the U.S. Department of Health and Human Services (DHHS, 2009) is considering changes to federal regulations governing research. The Common Rule provides the basis for government regulations and Institutional Review Boards (IRB). Proposed changes will have a significant impact on Institutional Review Board…

On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on…