SACHRP’s March 22-23 Meeting to Feature GAO Report, FDA Guidance on Children
During its first meeting of the year, scheduled for March 22-23, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will review a Government Accountability Office (GAO) report that faulted both the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) for spotty oversight of institutional review boards (IRBs). The 11-member committee, which currently has three vacancies, will hear from a “panel of expert speakers addressing the topic of defining stakeholders and evaluating” the quality and effectiveness of human research protection programs and IRBs, according to the agenda described in a March 2 Federal Register notice.
SACHRP will also discuss draft FDA guidance, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children Guidance for Industry, Sponsors, and IRBs.” The meeting will be held via webcast. Links to watch the webcast will be posted on SACHRP’s meeting webpage.
