Modification of RFA-RM-10-020: Institutional Clinical and Translational Science Award (CTSA) (U54)

Notice Number:  NOT-RM-11-016

Release Date: May 6, 2011

National Center for Research Resources (NCRR)

This Notice modifies the language of RFA-RM-10-020 with regard to the section on Special Program Requirements part 20 (Required Institutional Letters) and the section on Format of the Application part I (Human Subjects) to address reporting of serious and unexpected adverse events.

In RFA-RM-10-020, part 20 (Required Institutional Letters) of the section on Special Program Requirements currently reads:

20. Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and its affiliates that:

• commit the institutions to the CTSA's goals, indicating that the program will be integral to a broad institutional vision for clinical and translational research
• supply evidence of active clinical and translational research facilities, faculty and research projects; an integrated training environment; and other resources
• indicate institutional support. There is no cost sharing requirement under this FOA. However, indication of institutional support will be considered as a strength in the review of these applications. Co-funding or matching funds from other sources (including industry) are encouraged, as long as these funds do not limit faculty or trainee choices at any point and there are methods in place to ensure transparency, prevent misuse of federal funds, and ensure that NIH policies with respect to sharing of data and resources, academic freedom, and publication rights are not violated
• state how trainees' and investigators' time commitments to clinical and translational research will be supported, managed and protected
• commit the institution(s) to working towards adopting and implementing best practices identified through CTSA Key Function committees
• commit the PI and all the appropriate technology transfer offices to the data and resource sharing plans specified in the application
• specify any collaborative arrangements made with another CTSA that share workload or goals.

This is hereby replaced with:

20. Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution(s) and its affiliates that:

• commit the institutions to the CTSA's goals, indicating that the program will be integral to a broad institutional vision for clinical and translational research
• supply evidence of active clinical and translational research facilities, faculty and research projects; an integrated training environment; and other resources
• indicate institutional support. There is no cost sharing requirement under this FOA. However, indication of institutional support will be considered as a strength in the review of these applications. Co-funding or matching funds from other sources (including industry) are encouraged, as long as these funds do not limit faculty or trainee choices at any point and there are methods in place to ensure transparency, prevent misuse of federal funds, and ensure that NIH policies with respect to sharing of data and resources, academic freedom, and publication rights are not violated
• state how trainees' and investigators' time commitments to clinical and translational research will be supported, managed and protected
• commit the institution(s) to working towards adopting and implementing best practices identified through CTSA Key Function committees
• commit the PI and all the appropriate technology transfer offices to the data and resource sharing plans specified in the application
• specify any collaborative arrangements made with another CTSA that share workload or goals
• commit to notify NCRR of adverse events in all clinical studies supported by the CTSA that are both serious and unexpected.

In RFA-RM-10-020, part I (Human Subjects) of the section on Format of the Application currently

does not have content:

I. Human Subjects

This is hereby replaced with:

I. Human Subjects

Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects in studies supported by the CTSA. If studies that involve clinical trials (biomedical and behavioral intervention studies) are to be supported by the CTSA, include a general description of the plan for data and safety monitoring of such studies and adverse event reporting to the IRB, NCRR, NIH, and others, as appropriate, to ensure the safety of subjects.

Please direct all inquiries to:

Dr. Anthony Hayward
Division for Clinical Research Resources
National Center for Research Resources
Democracy One, Room 906
6701 Democracy Blvd.
Bethesda, MD 20892-4874
Telephone: (301) 435-0790
FAX: (301) 480-3661
Email: haywarda@mail.nih.gov