To respond to contract solicitations—that is, requests for proposals and broad agency announcements—issued by NIAID on or after January 25, 2018, you’ll need to follow as applicable NIH’s new Clinical Trial (CT) Requirements for Grants and Contracts, including the NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research.
Unlike investigator-initiated grant applications, which give you discretion over much of your Research Plan, proposals in response to contract solicitations are much more structured. To ensure compliance with the policy changes, the rule of thumb is simple: adhere to the solicitation’s requirements.
NIAID will write contract solicitations such that by closely following their instructions you will be in compliance with the changing policies.
What Will Be Different?
As you complete your next proposal, expect to find the following requirements in the solicitation:
- All NIH-funded investigators and staff involved in conducting, overseeing, or managing clinical trials to be trained in Good Clinical Practice (GCP), per NIH’s Policy on GCP Training for NIH Awardees Involved in NIH-Funded Clinical Trials
- Prohibition on disclosure of names of research subjects or any identifiable research information, documents, or biospecimens to anyone not connected with the research except under very specific circumstances, as detailed in Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality
- Submission of a plan to ensure all NIH-defined clinical trials are registered and reported to ClinicalTrials.gov, in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- Preparation for sIRB oversight of clinical research with multiple domestic sites, as specified by NIAID and in compliance with NIH’s sIRB policy, linked above. You may need to address both how your institution could provide the sIRB and your means of compliance should NIAID select another institution’s sIRB.
- Provision of additional information needed for the New Human Subjects and Clinical Trial Information Form, completed using an interface within the electronic Contract Proposal Submission (eCPS) system that will prompt upload of the new CT form
Addressing these new requirements may increase the time you need to complete your proposal, so start early. Contact a solicitation’s listed primary point of contact if you have questions.