National Institutes of Health (NIH) Funded Human Subjects Research
Human subjects research funded by the NIH must adhere to some requirements that are not necessary for other sponsors. These include use of a Single IRB in certain circumstances, inclusion of language about Certificates of Confidentiality in consent forms and in the event the study is considered to be a clinical trial, specific requirements for clinical trials.
All researchers with NIH funded human subjects research should review information about these requirements.
An NIH requirement for completing grant applications (new, renewal, revision or resubmission) with receipt dates on or after January 25, 2018, requires that certain human subjects research protocols be reviewed by a single IRB (sIRB). Ongoing non-competing awards are not covered until there is an application for a competing renewal.
This requirement applies to human subjects research that is:
- wholly or partially supported by NIH grants, cooperative agreements, contracts or NIH Intramural programs;
- conducted in the United States; and
- where the same research protocol is being conducted at more than one site.
The requirement does not apply to human subjects research that is:
- funded by NIH career development, research training or fellowship awards; or
- categorized as an Exempt protocol by the IRB.
Actions Necessary to Meet NIH's sIRB Requirement
Prior to Proposal Submission
- Confirm with the CMU IRB that your work meets the requirement for sIRB.
- Consult with the CMU IRB and your collaborators to identify the “IRB of Record/sIRB” for the study.
- Develop an sIRB plan for inclusion in your Funding Proposal.
- Describe the use of a single IRB that will be selected to serve as the IRB of record for all study sites. Where possible, identify the IRB that will serve as the single IRB. For delayed-onset research, where the IRB cannot be identified, applications/proposals should include a statement indicating that award recipients will follow the NIH single IRB policy and will provide a single IRB plan to the funding NIH Institute or Center prior to initiating a multi-site protocol.
Prior to Beginning Human Subjects Research
- Finalize the plans for the sIRB.
- Confirm with the CMU IRB that a reliance agreement is in place.
- Finalize the communication plan between the parties (see template).
- Submit and obtain IRB approval from the sIRB.
After Research has Commenced
- Report any unanticipated problems or adverse events to the CMU IRB.
- Notify the CMU IRB of any modifications of the protocol, including change in study personnel.
- Follow the communication plan.
Consult the CMU IRB and/or the sIRB with questions.
Certificates of Confidentiality
Certificates of Confidentiality (CoCs) protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations. NIH funded researchers are automatically issued a CoC through their award. Other Department of Health and Human Services (HHS) agencies issue CoCs to researchers they fund. Researchers not funded by HHS can continue to apply to NIH or the FDA as appropriate to request a CoC for HHS-mission relevant research.
See the Certificates of Confidentiality webpage regarding Certificates of Confidentiality and to find suggested Consent Language Describing the CoC Protections.
NIH Notice: NOT-OD-17-109 Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality.