Last month, Associate Vice President for Research, Candice Yekel, sent a memo to NIH-funded investigators to remind them of their research responsibilities. Following is a brief review:
- Investigators should be cognizant of their obligations for obtaining regulatory committee review for their research, whether that's for human subjects (IRB), vertebrate animals (IACUC), biohazardous materials (IBC), or others. All required compliance committee approvals must be obtained prior to commencing research.
- Investigators conducting NIH-funded clinical research are required to submit a data collection form for demographic information and an IRB protocol that includes relevant plans for the enrollment of women and minorities in the research, or they must provide a justification in the IRB protocol regarding why women and/or minorities will not be included in the research. For such an exception, the relevant NIH Institute/Center Director must approve the exception. Learn more about the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research and the reporting requirements.
- Any changes to an active NIH award that involves human subjects may require prior NIH approval. The guidance states, “In general, any change in research procedures in an active award that would result in an increased risk to human subjects will require prior NIH approval before implementation.” The guidance also provides examples and descriptions of the types of changes that would require prior NIH approval before implementation.
We want to ensure that all researchers are aware of and complying with their sponsor responsibilities and remind investigators to review the terms and conditions of their award.