Notice Number: NOT-RM-10-005
Key Dates
Release Date: March 16, 2010
Issued by
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov)
Purpose
The purpose of this Notice is to modify the language of RFA-RM-10-001 with regard to research subject advocacy in the Regulatory Knowledge and Support section and in the review criteria, and to correct a reference to the RFA number in the Format of the Application section.
In RFA-RM-10-001 Regulatory Knowledge and Support language currently states:
Regulatory support should include an individual independent of the IRB or compliance officer who acts as a sounding board for potential research participants, serves as an advocate for research participants, and works with investigators, trainees, and research teams to ensure that research involving human subjects accords the highest priority to human subject protections.
This is now modified to read:
Regulatory support should include research subject advocacy functions through a designated department or office independent of the IRB function, to serve as an advocate for research participants, and work with investigators, trainees, and research teams to ensure that research involving human subjects accords the highest priority to human subject protections.
RFA-RM-10-001 review criteria currently state:
Are criteria for identifying a research subject advocate sound?
This is now modified to read:
Are criteria for research subject advocacy functions sound?
In RFA-RM-10-001 Format of the Application language currently states:
Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Institutional CTSA Program. On Line 2, provide the number of this Request for Applications, RFA-RM-09-004, and the FOA title “Institutional Clinical and Translational Science Awards.”
This is now modified to read:
Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Institutional CTSA Program. On Line 2, provide the number of this Request for Applications, RFA-RM-10-001, and the FOA title “Institutional Clinical and Translational Science Awards.”
All other aspects of this FOA remain unchanged.
Inquiries
We encourage your inquiries concerning this Notice and welcome the opportunity to answer questions from potential applicants:
Dr. Anthony HaywardDivision for Clinical Research Resources, NCRR
6701 Democracy Boulevard
Room 906, MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0790
Fax: (301) 480-3661
Email: haywarda@mail.nih.gov
and Human Services (HHS)
