Notice Number: NOT-RM-10-001
Key Dates
Release Date: December 9, 2009
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-09-019 with regard to Research Design, Epidemiology, Biostatistics and Clinical Research Ethics. The modification recognizes the critical role that biostatistics plays in the continuum of the clinical research process. .
The section of RFA-RM-09-019 on Research Design, Epidemiology, Biostatistics and Clinical Research Ethics in “2. Key Functions and Components of an Institutional CTSA” currently reads:
Research Design, Epidemiology, Biostatistics and Clinical Research Ethics
Optional activities include developing, validating and integrating research designs and statistical methodologies essential to clinical and translational studies, limiting risks to research subjects, preventing bias, improving recruitment and retention, developing innovative methods of enhancing the power of studies, capturing appropriate data, developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects, informed consent, and issues in diseases with limited treatment options. These topics offer opportunities for research as well as collaborations with CTSA users.
This is now modified to read:
Biostatistics and sound research design are of critical value to clinical research, and strengths in this area are essential to a CTSA, whether funded through the award or through institutional funds. Relevant activities include developing, validating and integrating research designs and biostatical methodologies essential to clinical and translational studies, limiting risks to research subjects, preventing bias, improving recruitment and retention, developing innovative methods of enhancing the power of studies, capturing appropriate data, developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects, informed consent, and issues in diseases with limited treatment options. These topics offer opportunities for methodologic research as well as collaborations and consultations with CTSA users.
The “Key Function Areas” of the Review Criteria for this topic currently reads:
Research Design, Biostatistics, and Clinical Research Ethics: What types of support and resources will be in place to ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will this training include conflict of interest, federal codes requirements and guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? Are there plans for creation and innovation in developing the application of these topics to clinical research? As applicable, will this resource be sufficient for intra- and inter-institutional operations?
This is now modified to read:
Research Design, Biostatistics, and Clinical Research Ethics: Are adequate types of support and resources in place to ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will consultative support and collaborative activities in biostatistics and research design for investigators be adequate for the scale of CTSA that is proposed? Will training opportunities be adequate and will they include conflict of interest issues, federal codes requirements, and guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? Are there plans for creativity and innovation in developing the application of these topics to clinical and translational research? As applicable, will this resource be sufficient for intra- and inter-institutional operations?
All other aspects of the FOA remain unchanged.
Inquiries
We encourage your inquires concerning this Notice and welcome the opportunity to answer questions from potential applicants:
Dr. Anthony Hayward
Division for Clinical Research Resources, NCRR
6701 Democracy Boulevard
Room 906, MSC 4874
Bethesda, MD 20892
Telephone: (301) 435-0790
Fax: (301) 480-3661
Email: [email protected]
and Human Services (HHS)
