Waiver of certain human subject protections for research on prisoners. (Regulatory Update).

The Department of Health and Human Services (HHS) has proposed waiving the applicability of certain human subject protections [see 45 CFR 46.305(a)(1) and 46.306(a)(2)] for certain research conducted or supported by HHS. These are epidemiological studies in which the sole purposes are to describe the prevalence or incidence of a disease by identifying all cases, or to study potential risk factor associations for a disease. To obtain this waiver, the institution responsible for the conduct of the research would certify that an IRB has approved the research; an IRB has determined and documented that the research presents no more than minimal risk and no more than inconvenience to …