Addendum to Institutional Clinical and Translational Science Award RFA

Notice Number: NOT-RM-06-008

Key Dates
Release Date: December 1, 2005

Issued by
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)

This notice is an addendum to RFA-RM-06-002, “Institutional Clinical and Translational Science Award”, which was released in the NIH Guide for Grants and Contracts on October 12, 2005 at http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-002.html. It clarifies requirements for the T32 component of CTSA Research Education, Training and Career Development activities to ensure their compatibility with the NIH Roadmap Pre-doctoral Clinical Research Training Program (T-32), posted as http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-05-015.html.

In Part II, Section I, 2. Key Functions of an Institutional CTSA, Subheading ‘Research Education, Training and Career Development', the fourth paragraph is amended to allow for (1) predoctoral training where a clinically-related research masters degree is given with a health-professional doctoral degree in a combined program and (2) short, 2-3 month, practical experiences in clinical research for health professional predoctoral trainees such as medical and dental students. The revised paragraph reads:

An Institutional Predoctoral Research Training (T32 training) component could provide predoctoral students with coursework in clinical and translational research as part of formal advanced degree requirements. Institutional NRSA training grants are designed to allow the director of the program to select the trainees and to provide a curriculum of study and research experiences necessary to provide high quality research training. Appropriate advanced degrees include research doctoral degrees (e.g., PhD, DNSc) in a clinical research-related program and a combined clinical research masters degree given with a health professional doctoral degree such as a MD, DDS, DO, DNP, or PharmD in a combined program. Predoctoral research training must emphasize fundamental research training in clinically related areas of biomedical and behavioral sciences. The training may include, for example, courses in clinical and translational science, biostatistics, research ethics, epidemiology and regulations governing clinical research. The Ph.D. program could provide each trainee with a minimum of three years of full-time research training support. If a combined clinical research master's and health-professional doctoral degree is offered, all institutional requirements for the combined degree must be completed by the trainee by the time the health-professional doctoral degree is completed/conferred. The grant offsets the cost of stipends and tuition support for the appointed trainees. The T32 training component may also offer health-professional predoctoral level students a 2-3 month full-time practical experience in clinical research through summer or elective rotations each year. The curricula of the rotations should have clearly outlined goals and, ideally, a student should have a research project that will serve as the core of the rotation, and be exposed to many phases of clinical research (design, implementation, data analysis, etc.).

Part II, Section II. Award Information 1. Mechanism(s) of Support, subheading ‘Predoctoral Research Training Component-T32' paragraph 2 is amended to read:

The T32 component will support research training experiences for at least 4 predoctoral trainees who are interested in pursuing research careers in multi-disciplinary clinical and translational science. Only predoctoral NRSA positions may be requested and supported through the T32 part of this initiative. Trainees are selected by a Program Director normally for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds. Short-term, health-professional predoctoral trainees such as MD, DDS, DO, DNP, PharmDs will be funded on pro-rated stipends for the 2-3 months they are in the program, based on the 12-month predoctoral stipend level. The institution may supplement the NIH stipend up to a level that is consistent with the institution's scale from non-Federal sources only. It is expected that total stipends must be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

In Part II, Section III, subsection 1.B.3. ‘Eligible Research Education, Training and Career Development trainees, scholars and mentors,' paragraph 3 is similarly amended to allow eligibility of combined doctoral level professional degree plus research MS degree, to read as follows:

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA trainee appointment, and must be training at a post-baccalaureate level and enrolled in a program leading to a Ph.D. in a clinical research-related doctoral degree program, or a combined doctoral level professional degree plus a clinical research-related advanced degree, such as a MD, DDS, DO, DNP, PharmD/MS or MD, DDS, DO, DNP, PharmD/PhD. NRSA traineeships are not provided for study leading to a MD, DO, DDS, DNP, PharmD or other similar professional clinical degrees, or a master's degree that is not pursued in a combined program with a professional level doctorate. Individuals currently supported by other Federal funds are not eligible for trainee support from the T32 program at the same time.

Trainees are customarily appointed for full-time, 12-month continuous periods. No trainee may be appointed for less than nine months without prior approval of the NIH program staff except for predoctoral health-professional students that are participating in approved, formal short-term research training experiences. All trainees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

The National Center for Research Resources will air a technical grant writing videocast/videoconference for the NIH Roadmap Clinical and Translational Science Award program from 12:30 p.m. to 3:00 p.m. on December 7, 2005 . This workshop is being held to answer CTSA-related questions, which viewers will be able to submit during the meeting by telephone, e-mail or videoconference link.

If you wish to participate via videoconference, please e-mail John Heckler at hecklerj@mail.nih.gov at your earliest convenience, and he will arrange for the preparation of videoconference links. Those who wish to view the workshop via webcast/videocast may access the workshop on December 7th from http://videocast.nih.gov/ without contacting NCRR in advance.

For additional information, please contact

Anthony Hayward M.D., Ph.D.
Division for Clinical Research Resources. NCRR
6701 Democracy Blvd
Democracy 1, Room Number 906
Bethesda , MD 20892
Telephone: (301) 435 0790
FAX: 301 480 3661
Email: mhaywarda@mail.nih.gov


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