If research is funded by the NIH, the following special considerations are required:
- All personnel including faculty must complete required training.
- The PI is expected to ensure that human subjects research activities described in the grant proposal are congruent with those in the Cayuse Human Ethics submission. ORCA does not compare IRB studies to the related grants.
- The NIH issues a Certificate of Confidentiality for research collecting identifiable information. See Informed Consent Templates to insert CoC language into your consent documents. See the NIH Certificates of Confidentiality page for more information.
- The NIH mandates a single IRB review for all sites for multi-center studies; see the NIH Single IRB Policy Reminder. The NIH program officer will provide guidance regarding which institution will conduct IRB review or the PI will need to make this clear in grant proposal submission materials. Contact orca@ucsc.edu for sIRB questions.
- Confirm whether the study meets the NIH definition of a clinical trial using the NIH clinical trial decision tool. If so, ORCA and NIH program officers can help PIs address additional requirements including:
- Registering the trial on clinicaltrials.gov or regulations.gov.
- Posting the consent form on a publicly available federal website within a specific time frame.
- Ensuring Informed Consent Templates include required “clinicaltrials.gov” language.
- Completing a Good Clinical Practices (GCP) course on the CITI Program website – see CITI Program Training for more information.
- See NIH Clinical Trial Requirements for Grants and Contracts for full clinical trials requirements.