Key Dates
January 17, 2025
Related Announcements
- September 4, 2024 - Clinical and Translational Science Award (UM1 Clinical Trial Optional). See NOFO PAR-24-272.
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
The purpose of this Notice is to clarify instructions in PAR-24-272 "Clinical and Translational Science Award (UM1 Clinical Trial Optional)" about applications proposing to conduct research with Human Subjects and/or to conduct a clinical trial within the proposed project period.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
PHS Human Subjects and Clinical Trials Information
Currently Reads:
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Element D: CTS Resources & Pilots
Note: Specific pilot projects should not be included in the UM1 application. Pilot projects will be solicited and awarded by the hub after the UM1 hub award has been received.
New UM1 CTSA Program Pilot Projects that include human subjects research deemed by the Institutional Review Board (IRB) to be Greater Than Minimal Risk or meet the criteria for an NIH-defined Clinical Trial continue to require entry of the study into the eRA Human Subjects System (HSS) and official notification of NCATS prior approval before the project can begin.
The entry of all studies into the eRA HSS along with modified NCATS-specified documentation continues to be required. For studies that are non-NIH defined clinical trial with minimal risk or exempt (45 CFR 46), NCATS prior approval will not be provided, but studies may not begin until all required documentation has been submitted into the eRA HSS. Failure to submit the required documentation prior to initiating the pilot study will result in non-compliance enforcement actions.
The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/human-subjects-research
(Note that a separate process for Pilot Projects conducting research with live vertebrate animals is described here: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/prior-approval)
Element E: Clinical and Translational Science Research Program
Note: For Element E project(s) described in the application, if the research project(s) involve human subjects or an NIH-defined Clinical Trial please see the instructions in Section PHS Human Subjects and Clinical Trials Information in the Application Guide Instructions (https://grants.nih.gov/grants/how-to-apply-application-guide.html) Further for Element E project(s) that are described in the application, applicants must determine whether any proposed human subjects study, meets the definition of delayed start or delayed onset and submit accordingly. A delayed start study involves a study that can be described at the time of application, even if it will not begin immediately (will occur later in the funding period). As such, applicants should add a complete study record for each proposed study involving human subjects if your described project(s) would classify as being delayed start. Additional Element E projects not described in application and undertaken after award, if they are conducting research with Human Subjects and/or Vertebrate Animals, will still require prior approval in similar method as Element D pilot projects.
As a reminder, if any part of the application (Element D and/or Element E) meets, or could meet, the definition of a clinical trial, then the entire application should be submitted accordingly.
All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the “NIH Policy on Dissemination of NIH-Funded Clinical Trial Information”.
Funds may not directly support any clinical trials beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. See NOT-TR-18-025.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.
Revised to Read:
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
All applicants must answer Yes to the involvement of Human Subjects during the period of award and complete all related sections. Applications that do not answer Yes to the involvement of Human Subjects and complete all related sections are incomplete and will not be reviewed.
Applicants must answer “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, and must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Element D: CTS Resources & Pilots
Note: Specific pilot projects should not be included in the UM1 application. Pilot projects will be solicited and awarded by the hub after the UM1 hub award has been received.
New UM1 CTSA Program Pilot Projects that include human subjects research deemed by the Institutional Review Board (IRB) to be Greater Than Minimal Risk or meet the criteria for an NIH-defined Clinical Trial continue to require entry of the study into the eRA Human Subjects System (HSS) and official notification of NCATS prior approval before the project can begin.
The entry of all studies into the eRA HSS along with modified NCATS-specified documentation continues to be required. For studies that are non-NIH defined clinical trial with minimal risk or exempt (45 CFR 46), NCATS prior approval will not be provided, but studies may not begin until all required documentation has been submitted into the eRA HSS. Failure to submit the required documentation prior to initiating the pilot study will result in non-compliance enforcement actions.
The recipient institution will follow the process as described: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/human-subjects-research
(Note that a separate process for Pilot Projects conducting research with live vertebrate animals is described here: https://ncats.nih.gov/research/research-activities/ctsa/ctsa-program-governance-guidelines/prior-approval)
Element E: Clinical and Translational Science Research Program
Note: For Element E project(s) described in the application, if the research project(s) involve human subjects or an NIH-defined Clinical Trial please see the instructions in Section PHS Human Subjects and Clinical Trials Information in the Application Guide Instructions (https://grants.nih.gov/grants/how-to-apply-application-guide.html) Further for Element E project(s) that are described in the application, applicants must determine whether any proposed human subjects study, meets the definition of delayed start or delayed onset and submit accordingly. A delayed start study involves a study that can be described at the time of application, even if it will not begin immediately (will occur later in the funding period). As such, applicants should add a complete study record for each proposed study involving human subjects if your described project(s) would classify as being delayed start. Additional Element E projects not described in application and undertaken after award, if they are conducting research with Human Subjects and/or Vertebrate Animals, will still require prior approval in similar method as Element D pilot projects.
All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information".
Funds may not directly support any clinical trials beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. See NOT-TR-18-025.
Delayed Onset Study
Research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.
Since the CTSA (UM1 Clinical Trial Optional) (PAR-24-272) supports clinical and translational science pilots (Element D: Clinical and Translational Resources & Pilots, Clinical and Translational Pilot Module) and at least one translational science research project (Element E: Clinical and Translational Science Research Program), it should be anticipated that research projects involving clinical trials might be initiated during the seven-year grant period. If there is any potential for research projects involving clinical trials to be initiated during the seven-year grant period, then appropriate information must be provided. For delayed onset studies, all applicants should check the Anticipated Clinical Trial box and complete all related sections. Please see the instructions in G.500 PHS Human Subjects and Clinical Trials Information. As a reminder, if any part of the application (Element D and/or Element E) meets, or could meet, the definition of a clinical trial, then the entire application should be submitted accordingly.
If no clinical trials are anticipated at the time of application and the application is awarded, NIH policy may prevent the recipient from conducting a clinical trial under the award unless the trial is supported through a competitive NOFO.
Inquiries
Please direct all inquiries to:
Scientific/Research Contact(s)
Christopher M. Hartshorn, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-0264
Email: CTSANOFOQuestions@mail.nih.gov
Peer Review Contact(s)
Victor Henriquez, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0813
Email: CTSANOFOQuestions@mail.nih.gov
Financial/Grants Management Contact(s)
Stacia Fleisher
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0851
Email: CTSANOFOQuestions@mail.nih.gov
and Human Services (HHS)
