NIH Funded Research

• All personnel including faculty must complete required training.
• Ensuring federal grant congruency: please note that unlike IACUC protocols, ORCA has stopped conducting IRB grant protocol comparisons for federally funded research per the change in federal regulations January 19, 2019. However, federal funders (PHS, NIH, NSF, etc.) now expect the PI to ensure that human subjects research activities described in the grant proposal are congruent with those in the Cayuse Human Ethics submission.
• If you are collecting identifiable data (even if you use a coding system to protect identifiers), the NIH now issues a Certificate of Confidentiality. Please see our Informed Consent Templates to ensure you insert CoC language into your consent documents. See the NIH Certificates of Confidentiality page for more information.
• If you apply for a multicenter study, the NIH mandates that a single IRB review for all sites; see the NIH Single IRB Policy Reminder. The NIH program officer will inform you which institution will conduct IRB review or you will need to state this in your grant proposal submission materials. The Reviewing IRB should be where the majority of human research takes place, and may not always be the prime awardee. Note that if PI is planning for UCSC to be the lead research site, the PI will need to list Western IRB as Reviewing IRB and include a Study Record and sIRB plan in the Initial Submission. Note that Lead study site must list a researcher who is the overall site coordinator communicating regularly with the other research sites. If our IRB is relying on another site, the Reviewing IRB will contact us for a reliance, and the PI will need to provide information regarding the reliance in the Initial Submission in Cayuse Human Ethics. Please contact orca@ucsc.edu if requesting to use WIRB as Reviewing IRB or for sIRB questions. 
• The NIH revised its definition of a clinical trial to: A research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (note that OHRP supports the definition).
  • See the NIH clinical trial decision tool to determine whether your study meets the definition - if so please work with your NIH program officer so you are aware of the many additional steps you must take such as:
    • Registering your trial on clinicaltrials.gov or regulations.gov
    • Posting your consent form on a publicly available federal website within a specific time frame
    • See our Informed Consent Templates to ensure you insert "clinicaltrials.gov" language into your consent documents.
    • The required good clinical practices training can be found by selecting the appropriate Good Clinical Practices (GCP) course on the CITI Program website. See Accessing CITI Program for more information on accessing CITI Program courses.
    • See NIH Clinical Trial Requirements for Grants and Contracts for full clinical trials requirements.

Additional Resources

NIH Human Subjects Research - Home page 
Protocol Template for Behavioral and Social Sciences Research
NIH Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Question