- Why do grantees need prior approval for pilot studies involving human subjects?
- What is the goal of this policy?
- Which human subjects projects require prior approval?
- How do potential grantees obtain prior approval?
- What information and documents are required in a prior approval request?
- Who should submit prior approval request documents and to whom?
- How long does it take to receive approval?
- How will grantees be notified of decisions regarding prior approval requests?
- What happens if NCATS denies the request for prior approval?
- If a grantee has not received a response to a prior approval request, may the grantee proceed with the pilot study or K-scholar project?
- Is prior approval required for studies that have been determined by the local IRB to fall under Human Subjects Research Exemption 4 (45 CFR 46.101)?
Consistent with NIH policy on Human Subjects Protections, NCATS grantees should seek approval from NCATS to conduct research involving human subjects that could not be described in the original peer-reviewed grant application.
Recipients who are part of large clinical research networks or consortia that plan to add new protocols (e.g., small future research projects, pilot projects) after the award has been made must follow the awarding Institute or Center’s procedures for approval of new protocols. For more information, please refer to Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (Delayed Onset Awards): Updated Notice (NOT-OD-18-590).
NCATS grantees and their authorized organization representative (AOR) should contact their NCATS program officer and grants management official before submitting the request to obtain prior approval for pilot projects.
The goal of this policy is to allow grantees to conduct human subjects research through the pilot award program or K-scholar projects that were not a part of the peer-reviewed application and to ensure the protection of human subjects involved in research.
Prior approval is required for human subjects research with all pilot projects funded by NCATS, in full or partially, and for any pilot projects using institutional commitment specifically mentioned in the grant application. Also, prior approval for human subjects research is required for all K-scholar projects.
For K-scholar projects, if the time devoted to the research project is supported by the grant and it involves human subjects, it is subject to the prior approval process and must be submitted to NCATS.
NCATS has provided information regarding the prior approval process to its grantees. Those who have additional questions should contact their grants management specialists and program officers.
NCATS will provide a document transmittal letter with file naming conventions to facilitate this process. Required information and documents include:
- If applicable to the CTSA Program, the CTSA Program Hub
- Investigator last name/first initial
- Protocol title
- NIH biosketch of pilot project investigator or KL2 scholar performing clinical study
- Complete clinical research protocol
- Informed consent document
- Assent document (if applicable)
- Identification of specific amendment/portion of protocol supported by NCATS funding (if entire parent protocol is included in submission)
- Explanation of exactly what is being supported by NCATS pilot or KL2 scholar funding
- Product information: clinical investigator brochure, package insert or description of device
- Documentation that Investigational New Drug (IND) or Investigational Device Exemption (IDE) has been obtained or letter from the Food and Drug Administration that the study is IND-exempt or the IDE has a waiver
- New or revised human subjects section that clearly describes the risk, protections, benefits and importance of the knowledge to be gained by the revised or new activities (as described in Part II of NIH competing application instructions)
- Inclusion plans for women, minorities and children (if applicable)
- Targeted Enrollment Table or Inclusion Data Record (optional)
- Data and Safety Monitoring Plan or Board, if applicable
- Certification that the pilot project awardee or KL2 scholar and any key personnel directly involved in the study have taken appropriate education in protection of human subjects, if not provided previously
- Although not required, NCATS strongly recommends submitting the institutional review board (IRB) approval letter (including IRB approvals from each participating site if proposing multi-site trial). If IRB approval is pending, in some cases, NCATS may make a prior approval decision pending final IRB approval.
The AOR submits a prior approval packet via e-mail to the grants management specialist assigned to the grant. The packet will go from the business office to the grants management specialist, with a copy to the program officer.
NCATS has up to 30 days, after receipt of a complete packet, to respond to a prior approval request. It is our goal to expedite the prior approval review process, so it is important for grantees to submit all necessary documents and to promptly follow up on messages asking clarifying questions or requesting additional information.
Please note that grantees are not required to include an IRB approval as part of the submitted packet, to allow for parallel processes. However, when possible, we encourage grantees to submit prior approval requests to NCATS after receiving IRB approval. If a grantee submits an application packet to NCATS prior to obtaining IRB approval, then NCATS approval is given pending the IRB approval.
NCATS will email the AORs and copy the principal investigators notifying grantees of prior approval request decisions.
There are two options:
- Work with the NCATS program officer to determine whether barriers to prior approval could be eliminated by revising the proposed pilot project.
- Conduct the project without use of any NCATS funds or NCATS-supported infrastructure. This prohibition includes use of NCATS funding for personnel costs associated with the research.
If a grantee has not received a response to a prior approval request, may the grantee proceed with the pilot study or K-scholar project?
No. The grantee must wait for NCATS to provide a decision in writing to the grantee’s AOR.
Is prior approval required for studies that have been determined by the local IRB to fall under Human Subjects Research Exemption 4 (45 CFR 46.101)?
No. Studies that fall under Exemption 4 of 45 CFR part 46.101(b) are still human subjects research; however, if the local IRB Office notifies the grantee that the IRB determined the project is exempt from formal IRB Committee review under 45 CFR part 46.101(b) (4) (Exemption 4), then NCATS’ prior approval is not required for that research project.
While NCATS’ prior approval is not necessary for studies that an IRB determines fall under Exemption 4, the grantee does need to (1) notify NCATS of the study and (2) submit to NCATS the IRB confirmation/approval letter with the Exemption 4 determination for inclusion in the official grant file.