- Why do awardees need prior approval for pilot studies and KL2 projects involving human subjects?
- Which studies require prior approval?
- How do I submit a prior approval request?
- What information and documents should be included in a prior approval request?
- Is IRB approval always required for NCATS prior approval?
- Who should submit prior approval request documents and to whom?
- Do research studies involving human cell lines or tissue repositories need prior approval?
- If an investigator has not received a response to a prior approval request, may the investigator proceed with the pilot study or K-scholar project?
- In general, how long does the prior approval process take?
- How will investigators be notified of decisions regarding prior approval requests?
- How can an investigator request additional information about the prior approval process and/or requirements?
- What can investigators do to maximize the efficiency of the review process?
- When NCATS requests clarification on a prior approval request, should the institution resend only the questioned/corrected documents?
- Is prior approval required for studies that have been determined by the IRB to fall under Human Subjects Research Exemption 4 (45 CFR 46.101)?
- Is prior approval for delayed onset human subjects research required for TL1 awardees?
Consistent with the HHS regulations (45 CFR 46.120) and NIH policies on human subjects protections, NCATS awardees must seek approval from NCATS to conduct research involving human subjects that was not described in the original, peer-reviewed grant application.
To ensure appropriate protections for human subjects in activities proposed under the pilot award or KL2-scholar programs, awardees proposing human subjects research activities that were not part of the original peer-reviewed application must follow NCATS procedures for approval of new protocols.
For more information, please refer to NOT-OD-15-129: Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement.
Prior approval is required for all pilot studies and KL2-scholar projects involving human subjects supported by NCATS, including full funding support, partial funding support or voluntary committed cost share.
Human Subjects Research Prior Approval requests must be submitted via the eRA Human Subjects System (HSS).
All requests must include the completed NCATS Human Subjects Research Prior Approval Addendum as an attachment in HSS Section 5.1. The Addendum specifies that the following items be included/embedded:
- IRB-approval documentation
- Summary of request and line item budget for the specific aspects of the proposed study that will be supported by NCATS funds
- Summary of parent study, if applicable
- Biosketches for Study Principal Investigator (PI) & and each Key Personnel involved in the proposed study. Only relevant Biosketches not already included in the grant application need to be attached.
- Institutional letter attesting to Human Subjects Protection Training completed by the Study PI and Key Personnel
If the study meets the NIH definition of a clinical trial or involves the participation of pregnant women, human fetuses or neonates, prisoners, children or individuals with impaired decision-making capacity, NCATS also requires that PIs/Signing Officials include with the request the following documents, within the Addendum:
- IRB-approved protocol
- IRB-approved informed consent, verbal consent transcript, assent and parental permission documents, or documentation of IRB waiver, if applicable
The Institutional Signing Official (SO) should submit prior approval requests via the eRA Human Subjects System (HSS), including the completed NCATS Human Subjects Research Prior Approval Addendum.
Research with human cell lines or tissue repositories that meet the definition of human subjects research requires prior approval. The NIH Glossary defines human subjects as “A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Regulations governing the use of human subjects in research extend to use of human organs, tissues and body fluids from identifiable living individuals and to graphic, written or recorded information derived from such individuals.”
If an investigator has not received a response to a prior approval request, may the investigator proceed with the pilot study or K-scholar project?
No. The investigator must wait for NCATS Office of Grants Management (OGM) staff to provide a decision in writing to the grantee institution’s SO.
Generally, NCATS will respond within 30 days of receiving a complete request. Please note that if a request is returned for any reason, the 30-day turnaround time resets.
NCATS OGM staff will email the Institutional SO with a copy to the CTSA Program PI, to notify the grantee institution of prior approval request decisions.
How can an investigator request additional information about the prior approval process and/or requirements?
The investigator may contact NCATS via the following email address: NCATSDOPAinquiry@mail.nih.gov.
It is NCATS’ goal to complete the prior approval review process efficiently, so it is important for investigators to submit all necessary documents and to promptly respond to inquiries.
When NCATS requests clarification on a prior approval request, should the institution resend only the questioned/corrected documents?
Yes. Only the pertinent documents or attachments should be submitted in response to the request via the eRA HSS module.
Is prior approval required for studies that have been determined by the IRB to fall under Human Subjects Research Exemption 4 (45 CFR 46.101)?
For human subjects research studies that meet the criteria for Exemption 4 under 45 CFR part 46.101(b), the investigator must submit the request via the eRA HSS with the Exemption 4 determination. The completed NCATS Human Subjects Research Prior Approval Addendum, as an attachment in HSS Section 5.1, is required.
Most TL1 awardees are working on their mentors’ funded studies, and prior approval is not required. If a postdoctoral trainee is funded directly through the NCATS CTSA Program hub to conduct an independent research study involving human subjects, please notify NCATS via the following email address: NCATSDOPAinquiry@mail.nih.gov.