MENTORED MEDICAL STUDENT CLINICAL RESEARCH PROGRAM

Release Date:  December 22, 1999

PA NUMBER:  PAR-00-035

National Center for Research Resources

Application Receipt Date: February 15, 2000

PURPOSE

Patient-oriented clinical research is an essential component for translation 
of basic scientific knowledge into new avenues of clinical diagnosis and 
treatment.  The Mentored Medical Student Clinical Research Program is 
intended to serve as a catalyst for medical students to introduce them to the 
potential of a career in patient-oriented research.  The institutional 
General Clinical Research Center (GCRC) is a focal point for exposure of 
medical students to both didactic training and the clinical practice of 
patient-oriented research, and provides the necessary infrastructure to 
provide case examples of the design, methodology, and analysis of clinical 
trials.  In a mentored one-year program of study usually conducted between 
their third and fourth year of medical school, medical students will be 
engaged in a variety of clinical activities within the institutional GCRC.  
These activities may range from supervised participation in clinical trials, 
didactic coursework related to patient-oriented research, or acquisition of 
laboratory skills that can be applied to patient-oriented clinical research 
efforts.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," a PHS-
led national activity for setting priority areas.  This PA, Mentored Medical 
Student Clinical Research Program, is related to the priority area of human 
resource development.  Potential applicants may obtain a copy of "Healthy 
People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY

Institution:  Applications must be submitted by the lead mentor on behalf of 
the medical student.  If there is more than one mentor for a medical student, 
a lead mentor must be identified.  The lead mentor will be the principal 
investigator for the grant award and must be affiliated with the GCRC at the 
institution at which the medical student is receiving his/her medical 
education. A medical student is eligible to participate in the Mentored 
Medical Student Clinical Research Program if he/she is currently enrolled in 
medical education courses at an accredited medical school that is affiliated 
with an institutional GCRC.

A maximum of three applications may be submitted per institution.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply, as medical students who desire training in patient-
oriented research or as the mentor for a medical student.

Both medical students and mentors must be citizens or noncitizen nationals of 
the United States, or must have been lawfully admitted to the United States 
for permanent residence (i.e., in possession of a currently valid Alien 
Registration Receipt Card I-551, or other legal verification of such status).  
Noncitizen nationals are generally persons born in outlying possessions of 
the United States (i.e., American Samoa and Swains Island).  Individuals on 
temporary visas are not eligible.

Medical students cannot receive concurrent support from any other PHS award 
while being supported by the Mentored Medical Student Clinical Research 
Program.

A medical student is not eligible for participation in this program if he/she 
is a current or former principal investigator on NIH research project (R01), 
FIRST Award (R29), sub-project of program project (P01) or center grants 
(P50), and the equivalent.  Medical students who are former principal 
investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants 
(R21) remain eligible.  There are no restrictions on the category of grant 
support held by the mentor; it is required, however, that the mentor has 
peer-reviewed funding support from some source.  It is also expected that the 
mentor(s) will allot 3-5% percent effort to supervise the medical student 
during his/her year of research on the GCRC.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) R25 (Education 
Projects) mechanism.  The project period for an application submitted in 
response to this PA may not exceed one year.  Awards are not renewable.

RESEARCH OBJECTIVES

A.  Background:  In many developing and emerging fields of patient-oriented 
research, scientists must function within interdisciplinary teams rather than 
as isolated investigators.  Preparing junior clinicians for this new type of 
research environment will require education and career development 
experiences in highly inter-disciplinary and collaborative clinical research 
settings that are integrated within a specialized curriculum.  The 
institutional GCRC provides both educational and career development 
experience, and typically involves patient-oriented investigators from an 
array of disciplines.  The GCRC environment provides concerted leadership and 
dedicated time of interdisciplinary faculty in order to sustain effective 
interactions.  Furthermore, for medical students lacking any prior research 
training, these experiences may need to be augmented by additional course 
work beyond that which is offered in their medical education training or by 
exposure to basic laboratory techniques that are pertinent to patient-
oriented research.

B.  Program:  The award provides support to the medical student via his/her 
lead mentor, where the lead mentor serves as the principal investigator. 
Percent effort by the medical student is 100% for this award.  The mentor(s) 
are expected to allot up to 3-5% effort to supervise the medical student on 
the GCRC, and will supervise, coordinate and evaluate the research program 
during the year that the medical student will spend on the GCRC.  This 
program should provide opportunities for both didactic and patient-oriented 
collaborative research training experiences for the medical student.  It 
should also demonstrate to the medical student the research and communication 
skills necessary to conduct patient-oriented research in an inter-
disciplinary and collaborative team research setting on the GCRC.

C.  Environment:  The participating institution must be affiliated with a 
GCRC and have well-established research programs and faculty qualified in 
curriculum development.  The research environment should be team-oriented and 
highly collaborative with a strong potential for a dynamic two-way exchange 
of information and ideas within and across diverse and disparate disciplines 
of clinical research.  Finally, the institution must demonstrate a commitment 
to provide sustained leadership and dedicated faculty time to the development 
and implementation of research protocols, and commitment to the development 
of junior investigators at all levels of training into productive, 
independent investigators.

D.  Curriculum:  A specialized curriculum, not otherwise available at the 
institutional medical school, must be developed by the medical student and 
his/her mentor.  Activities should provide a broad exposure to diverse 
aspects of patient-oriented research.  These may include, but are not limited 
to: 1) exposure to current protocols on the GCRC, with supervised 
participation in selected clinical trials; 2) didactic education, either 
through an institutional course curriculum, attendance at clinical rounds or 
seminars sponsored by the GCRC, or participation in data analysis or clinical 
trial protocol design; and 3) acquisition of basic science skills that are 
relevant to patient-oriented research by supervised training in a laboratory, 
processing of clinical samples for selected protocols, and exposure to 
methodologies and instrumentation that represent the interdisciplinary 
contribution of the basic sciences to translational research on the GCRC.
 
E.  Mentor(s):  The lead mentor must be involved in active participation at 
the institutional GCRC.  The student may spend time with mentors not 
affiliated with the GCRC (e.g., to learn a technique in a basic science 
laboratory that is relevant to patient-oriented research), but at least 75% 
of the medical student's time should be committed to participation in 
activities directly linked to patient-oriented research on the GCRC.

F.  Evaluation:  A plan must be provided for progress and outcome evaluation 
of the program of study.

SPECIAL REQUIREMENTS

A.  Allowable costs:

1. Medical student support: The medical student under this program may be 
provided a stipend of up to $20,000 per year commensurate with the 
institution's full-time salary for persons of equivalent qualifications, 
experience and rank.  These costs should be budgeted for in the "other 
expenses" category.  The institution may supplement the NIH contribution to 
the student's stipend up to a level that is consistent with the institution's 
salary scale.  Institutional supplementation must not require extra duties or 
responsibilities that would interfere with the purpose of the award.  Note:  
Fringe benefits for the medical student will be an allowable cost only if 
he/she will be an employee of the recipient organization during the period of 
support.  

2. Salary for mentor(s): Salary support plus associated fringe benefits will 
be awarded to the mentor(s) at a level commensurate with the 3-5% effort that 
is stated in the grant application.

3. Other expenses: Up to $4,000 in direct costs per medical student will be 
provided to support travel and other research-related expenses that are 
directly related to activities of the medical student.  Expenses for 
equipment and salary support for technical personnel are not allowed.

4. Tuition support: Up to $5,000 in direct costs will be provided for tuition 
costs for course work that is necessary for the continuing education of the 
medical student in patient-oriented research.  Justification for such course 
work must be provided in the application for this award. 

5. Ancillary personnel support: Salary for secretarial and administrative 
assistance, etc., is not allowed.

6. Facilities and Administrative costs: These costs, which were formerly 
called indirect costs, will be reimbursed at 8 percent of modified total 
direct costs.

B.  Special Leave: Leave to another institution of an appointee, including a 
foreign laboratory, may be permitted if directly related to the purpose of 
the award.  Only local, institutional approval is required if such leave does 
not exceed 3 months.  For longer periods, prior written approval from NCRR is 
required.  To obtain prior approval, the medical student must submit a letter 
to the NCRR describing the plan, countersigned by his or her medical school 
institutional official, the Program Director of the institutional GCRC, and 
the lead mentor.  A copy of a letter or other evidence from the institution 
where the leave is to be taken must be submitted to assure that satisfactory 
arrangements have been made.  Support from the award will continue during 
such leave.  NCRR Program staff should be contacted prior to submitting the 
request for leave.

C.  Termination: If a medical student plans to terminate an award prior to 
the 12-month project period, the mentor must notify NCRR in writing at the 
earliest possible time so that appropriate instructions can be given for 
termination.

D.  Change of institution: The Mentored Medical Student Clinical Research 
Program award can not be transferred from one institution to another.

E.  Change of mentor: If the GCRC lead mentor moves to another institution or 
resigns from his/her mentoring position, award support may be continued 
provided that the GCRC Program Director has submitted a written request on 
behalf of the medical student for a change of mentor.  During this interim 
period, the GCRC Program Director or Associate Program Director should 
request that he/she be named temporary Principal Investigator for the grant.  
The request must describe the reasons for the change of mentor, and be 
countersigned by the appropriate institutional business official prior to 
submission to program staff at the NCRR.  A biographical sketch of the 
proposed new lead mentor must also be provided, and include a listing of 
active grant support and of participation in clinical protocol(s) on the 
institutional GCRC.  The information provided must establish that the 
specific aims of the original peer-reviewed research program to be conducted 
under the direction of the new mentor will remain unchanged, and that the new 
mentor has the appropriate research and administrative expertise to lead the 
program of study.  NCRR program staff will review the proposed plan of study 
to ensure that it remains within the scope of the original peer-reviewed 
research application.  If the proposed plan of study does not satisfy this 
requirement and no resolution of study plan deficiencies can be made with the 
NCRR program staff, the award may be terminated.

F.  Progress Reports: A final progress report is required upon termination of 
an award.  This report should include a summary of the accomplishments and a 
description of the research and progress of each medical student.

G.  Evaluation:  In carrying out its stewardship of human resource related 
programs, the NCRR may request information essential to an assessment of the 
effectiveness of this program.  Accordingly, recipients are hereby notified, 
that they may be contacted after the completion of this award for periodic 
updates on various aspects of their employment history, publications, support 
from research grants or contracts, honors and awards, professional 
activities, and other information helpful in evaluating the impact of the 
program.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research" which have been published in the Federal register of March 28, 1994 
(FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, 
No. 11, March 18, 1994 available on the web at the following URL address:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

Investigators may obtain copies from these sources or from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH GUIDE FOR 
GRANTS AND CONTRACTS, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 
(revised 4/98).  Application kits are available at most institutional offices 
of sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, 
MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: 
grantsinfo@nih.gov.  Application forms and instructions are also available on 
the internet at: http://grants.nih.gov/grants/funding/phs398/forms_toc.html.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

The completed original application and three legible copies must be sent to 
or delivered to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

An additional two copies with all accompanying materials are to be sent to:

David Wilde, M.D., Ph.D.
National Center for Research Resources
Rockledge I, Room 6030
6705 Rockledge Drive MSC 7965
Bethesda, MD 20892-7965 (zip code 20817 for express/courier service).

The information summarized below must be provided in this application:

o A letter of recommendation from the proposed mentor(s), including a table 
of trainees, a table of current grant support, a description of the training 
environment of the medical student, a curriculum vitae, and an assessment of 
the applicant's potential as a biomedical researcher;

o A letter from the Dean of the applicant's medical school, endorsing the 
application;

o Two letters of reference from persons other than the research mentor(s) and 
dean;

o An Education and Career Development Plan for the medical student;

o Justification for the proposed time commitment of ancillary support staff 
(e.g., GCRC staff involved in the planning or conduct of a clinical trial);

o Core Curriculum, to include a research plan and any scheduled coursework;

o Provisions for training of the medical student on the protection of human 
subjects and vertebrate animals in clinical research;

o Plans for training in ethical conduct of research;

o Budget.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center 
for Scientific Review (CSR) for responsiveness in two areas by NCRR.  
Incomplete and/or non-responsive applications will be returned to the 
applicant without review.  Applications that are complete and responsive to 
the PA will be evaluated for scientific and technical merit by an appropriate 
peer review group convened by the Office of Review, NCRR, in accordance with 
the standard NIH peer-review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Research Resources Council 
(NARRC).

Review Criteria

The review criteria that will be applied to the application are:
 
o  Appropriateness and adequacy of the proposed curriculum for the 
educational and research career development objectives of the proposed R25 
educational program;

o  Appropriateness and adequacy of the funded research activities, resources, 
facilities and mentors affiliated with the program;

o  Adequacy of the percent commitment of the mentor and faculty;

AWARD CRITERIA

The following will be considered in making decisions: quality of the proposed 
project as determined by peer review, availability of funds, and program 
priority.  The earliest possible award date is July 1, 2000.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.  

Direct inquiries regarding programmatic issues to:

David Wilde, M.D., Ph.D.
General Clinical Research Centers Program
National Center for Research Resources
One Rockledge Centre, Room 6030
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone: (301) 435-0790
FAX: (301) 480-3661
Email: dw171w@nih.gov

For inquiries about fiscal matters, please contact:

Ms. Mary Niemiec
Section Grants Management Officer
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone: (301) 435-0844
FAX:  (301) 480-3777
Email: MaryN@ncrr.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.333.  Awards are made under authorization of the Public Health Service 
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 
USC 241 and 285) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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