Clarification, Institutional Clinical and Translational Science Award (U54), RFA-RM-10-020


Notice Number: NOT-RM-11-012

Key Dates

Release Date:   March 23, 2011

Issued by

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Research Resources (NCRR)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Rare Diseases (ORD)
Office of Research on Women’s Health (ORWH)
Common Fund (Roadmap)

Purpose

This Notice is issued to make 3 amendments to the current funding opportunity announcement for Clinical and Translational Science Awards, RFA-RM-10-020 under the following headings:

Mentored Research Career Development Component (K12)

This Notice amends the current CTSA RFA-RM-10-020 to change the minimum of 9 person-months (equivalent to 75%) of full-time professional effort conducting research for scholars with select clinical specialty appointments.

The original version of RFA-RM-10-020, Section III 1. Eligible Research Education, Research Training and Research Career Development Trainees, Scholars and Mentors, reads:

KL2 scholars must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 9 person-months (equivalent to 75%) conducting research career development and research activities associated with the program. The remaining 3 person-months (equivalent to 25 %) can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the KL2 program.

This is amended to read:

KL2 scholars must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 9 person-months (equivalent to 75%) full-time professional effort conducting research career development and research activities associated with the program. The remaining 3 person-months (equivalent to 25 % can be divided among other research, clinical and teaching activities only if these activities are consistent with the proposed goals of the KL2 program. KL2 scholars with appointments in certain clinical specialties can have less than 9 person-months, but no less than 6 person-months (equivalent 50 %) protected time for this Program if sufficiently justified and programmatically approved (for example, surgical specialties requiring 50 percent direct patient care time to maintain surgical skills and board eligibility).

Review criteria

The Review Criteria currently include the statement:

Environment:

Is a program for awarding higher degrees in clinical research in place? Will the academic and scientific environments contribute to the probability of success in establishing or maintaining a home for clinical and translational science? Is there a strong training record at both institutional and faculty levels? Does the proposal provide strong evidence that the CTSA will provide resources that would not otherwise be possible? If applicable, are there adequate cooperative arrangements between affiliated institutions to ensure that the CTSA program performs effectively as one activity across institutional boundaries? Are there unique features of the scientific environment or in the available human subject populations or collaborative arrangements? Is infrastructure in place indicating a likelihood of success of the proposed C/D/I?

This is modified to read:

Environment:

Is a program for awarding higher degrees in clinical research in place? Will the academic and scientific environments contribute to the probability of success in establishing or maintaining a home for clinical and translational science? Is there a strong training record at both institutional and faculty levels? Does the proposal provide strong evidence that the CTSA will provide resources that would not otherwise be possible? Have the applicants described an effective administration and governance structure that will promote the discipline of clinical and translational science? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the CTSA and the expertise of each of the PD/PIs? Is the governance structure designed to ensure both accountability of multiple PD/PIs, and integration of the components of the C/D/I into a coherent program? Is the organization of the External Advisory Committee within the structure of the CTSA conducive to providing critical, stimulating, and thoughtful advice for the overall CTSA performance and CTSA key functions? If applicable, are there adequate cooperative arrangements between affiliated institutions to ensure that the CTSA program performs effectively as one activity across institutional boundaries? Are there unique features of the scientific environment or in the available human subject populations or collaborative arrangements? Is infrastructure in place indicating a likelihood of success of the proposed C/D/I?

Format of the Application

Section G of “Format of the Application” currently reads:

G. Literature cited

(a) Bibliography and References Cited – Provide a bibliography of any references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application.

The references should be limited the relevant and current literature. While there is not a page limitation, it is important to be concise and select only those literature references pertinent to the proposed research.

(b) Progress Report Publication List – For Renewal applications list the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.

This is amended to read:

G. Literature cited

(a) Bibliography and References Cited – Provide a bibliography of any references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application.

The references should be limited to the relevant and current literature. While there is not a page limitation, it is important to be concise and select only those literature references pertinent to the proposed research.

(b) Progress Report Publication List – For Renewal applications list the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.  Applicable papers directly supported by CTSAs are subject to the Public Access Policy (see http://publicaccess.nih.gov/determine_applicability.htm for criteria), and awardees are required to ensure papers are submitted and PMCIDs are included in citations of these papers in renewal applications.

Inquiries

Please direct all inquiries to:

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


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