MENTORED CLINICAL RESEARCH SCHOLAR PROGRAM AWARD

Release Date:  November 6, 2001

RFA NUMBER:  RFA-RR-02-001

National Center for Research Resources
 (http://www.ncrr.nih.gov)

Letter of Intent Date:     January 22, 2002
Application Receipt Date:  February 20, 2002

PURPOSE

The purpose of the National Center for Research Resources (NCRR) Mentored 
Clinical Research Scholar (CRS) Program Award (K12) is to support an 
institutional career development program for physicians and dentists to develop 
the skills to become independent patient-oriented clinical investigators. The 
institutional programs are to include activities that will provide candidates a 
comprehensive understanding of clinical research approaches that are fundamental 
and not necessarily disease-specific.  Under this award, recently trained 
physicians and dentists will be selected to participate in an integrated didactic 
and mentored research program and be overseen by the Program Director and Program 
Advisory Committee.  Candidates selected for the program must have a clinical 
doctorate (e.g., M.D. D.O., D.D.S./D.M.D.).  Funds provided by this award may be 
used to support full or partial completion of an advanced degree in health-
related research (e.g. M.S., M.P.H., Ph.D.). 

In concert with a proposed mentor, an applicant for the CRS program proposes a 
comprehensive, individualized career development program that will prepare the 
physician or dentist candidate for an independent career in clinical research 
including patient-oriented research.  The didactic and research phases of this 
program must include acquiring expertise across a broad spectrum of research 
methodologies, technologies, concepts, use and management of large datasets, 
bioinformatics and other research tools as well as communication skills required 
for a participating physician or dentist to be well trained in their selected 
research discipline.  The program should be designed to accommodate candidates 
with varying levels of research experience.  If appropriate, candidates should be 
exposed to both research that is typically undertaken with a few investigators 
and to research approaches that require a multidisciplinary team to address 
complex research questions.  The team research approach fosters cross-
disciplinary collaborations. 

For the purposes of this award, patient-oriented research is defined as research 
conducted with human subjects (or on material of human origin such as tissues, 
specimens and cognitive phenomena) for which an investigator (or colleague) 
directly interacts with human subjects. Excluded from this definition are in 
vitro studies that utilize human tissues that cannot be linked to a living 
individual.  Patient-oriented research includes mechanisms of human disease, 
therapeutic interventions, clinical trials, and development of new technologies 
(http://www.nih.gov/news/crp/97report/execsum.htm). 

ELIGIBILITY REQUIREMENTS

INSTITUTIONS: Applications will be accepted from domestic, non-profit 
organizations, public and private, such as universities, or medical or dental 
schools, or from comparable institutions of higher education that have strong, 
well-established clinical research and training programs.  The applicant 
institution must have an adequate pool of highly trained faculty investigators in 
clinical research and who have the commitment and capability to provide career 
development guidance to promising physicians and dentists who aspire to become 
independent clinical investigators.  The environment must stimulate and enhance 
interactions among basic scientists and clinical investigators.  Institutions 
with an NCRR-supported General Clinical Research Center (GCRC) are strongly 
encouraged to use the resources of that Center in the career development of 
physicians and dentists selected for this program.   Applicant institutions 
without an NCRR-funded GCRC are to identify comparable resources to facilitate 
clinical or patient-oriented research for candidates.     
    
PROGRAM DIRECTOR (PD)/PRINCIPAL INVESTIGATOR: The CRS Program Director/Principal 
Investigator must be an established patient-oriented researcher who can provide 
both administrative and scientific leadership to the Program. Minorities, women 
and individuals with disabilities are encouraged to apply as program 
directors/Principal Investigators.

MENTORS: A Lead Mentor should be an established clinical or patient-oriented 
research investigator who holds a faculty position. The Lead Mentor must interact 
closely with the candidate in order to develop a tailored career development 
plan. A CRS Advisory Committee will review the credentials of the proposed Lead 
Mentor. The Advisory Committee and PD must approve both the plan and proposed 
mentor before a candidate is accepted into the program.

CANDIDATES: Institutions awarded a Mentored CRS Program Award (K12) must recruit 
and select candidates with the potential to develop into independent patient-
oriented investigators.  Candidates must have an M.D., D.O., or D.D.S./D.M.D. 
degree, must have completed residency training (or its equivalent) and must be 
committed to a career in clinical or patient-oriented research.  The candidate 
also must be willing to spend a minimum of 75 percent (preferably, 90 percent) of 
full-time professional effort conducting didactic training, research, career 
development, and/or research related activities. Candidates may have initiated 
clinical specialty or subspecialty training but to be eligible, must devote from 
2 to 5 years to this full-time career development program.  Funds provided by 
this award may support full or partial completion of an advanced degree in 
health-related research (e.g., M.S. or Ph.D. in clinical investigation, M.P.H.). 
Candidates with fewer than 3 years of support under this award will remain 
eligible to compete for individual career development awards such as the K08 and 
K23. The maximum duration of support for a candidate cannot exceed 5 years.  
Candidates selected for the Mentored Clinical Research Scholar (CRS) Program may 
be eligible for the Loan Repayment Program (LRP) for clinical investigators that 
provides for repayment of the educational loan debt of physicians and dentists.  
Information regarding the eligibility requirements and benefits for the program 
may be obtained via the LRP website (http://lrp.info.nih.gov) 

Candidates appointed under this CRS program award must be U.S. citizens or non-
citizen nationals, or have been lawfully admitted for permanent residence and 
possess an Alien Registration Receipt Card (I-151 or I-551) or some other 
verification of legal admission as a permanent resident. Non-citizen nationals, 
although not U.S. citizens, owe permanent allegiance to the U.S.  They are 
usually born in lands that are not states, but are under U.S. sovereignty, 
jurisdiction, or administration.  Individuals on temporary or student visas are 
not eligible.

Candidates who were former Principal Investigators on NIH Small Grants (i.e., 
R03s) or Exploratory/Developmental Grants (i.e., R21s) are eligible.  However, 
Principal Investigators who have current or prior support on NIH research 
projects grants (R01), FIRST Awards (R29), sub-projects of program project (P01) 
or center grants (P50), or the equivalent, are not eligible for appointment under 
this program. Candidates who have been previously supported on NIH or non-NIH 
career development awards dedicated to training patient-oriented researchers are 
not eligible. However, candidates whose prior training did not focus on patient-
oriented research but wish to shift focus to this area are eligible. Candidates 
may not concurrently hold any other PHS award that duplicates the provisions of 
this award. 

CRS candidates are encouraged to apply for independent research grant support 
during the period of support under this award.

MECHANISM OF SUPPORT

Support for this National Center for Research Resources (NCRR) Mentored Clinical 
Research Scholars (CRS) Program award is through a K12 mechanism.  Responsibility 
for the planning, direction, and execution of the proposed institutional program 
will be that of the CRS Program Director and CRS Program Advisory Committee on 
behalf of the applicant institution(s). Institutions in close proximity may form 
a consortium; however, one institution must be identified as the lead institution 
and be the applicant. The program award provides five years of support.  This 
Request for Applications (RFA) is for a pilot CRS program that may become an on-
going activity after an initial evaluation in two to three years to assess key 
aspects of the CRS program. At that time, the program may be expanded. 

The NCRR initially intends to make approximately ten CRS K12 awards. Although the 
financial plans of the NCRR provide support for this program, awards pursuant to 
this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of applications of outstanding scientific and technical merit. 
 
RESEARCH OBJECTIVES

Background:  Over the last 30 years, the number of physician scientists 
submitting NIH research grant applications has decreased significantly. In the 
1970s, 40% of NIH research applications were submitted by MDs.  Of concern is 
that less than twenty percent of research applications are now submitted by MDs. 
The submission rate for dentists is extremely low. Since MDs are critical for the 
interface between basic and clinical research, it is essential that well-trained 
physician and dental investigators assure that the findings of basic research are 
translated to clinical settings. The recent National Research Council Report, 
Addressing the Nation’s Changing Needs for Biomedical and Behavioral Sciences 
(http://grants.nih.gov/training/nas_report/index.htm), recommended that NIH and 
other research agencies intensify their efforts to train and retain physicians in 
clinical research in order to reverse the dramatic decline of clinical 
investigators entering the clinical research workforce. 

Furthermore, the Clinical Research Enhancement Act authorized the NIH to develop 
a graduate training program in clinical investigation.  This program is intended 
to address the declining number of physician scientists and to provide them with 
the fundamental skills needed for a broad spectrum of clinical or patient-
oriented research.  To attain these objectives, well-designed career development 
programs are essential.  Patient-oriented research has become more complex, 
requiring an integrative or systems approach conducted by a multidisciplinary 
research team with complementary expertise.  Candidates for this program, when 
appropriate, should be trained in order to conceptualize and conduct cutting-edge 
clinical research.  The scope of research tools available for patient-oriented 
research is unparalleled.  To take advantage of those research tools, CRS 
programs need to include research and didactic training expertise that represent 
multiple disciplines.  

General Requirements

Applicant institutions are required to include the following elements in 
their proposal:

Program Description:  Applications must include a description of the activities, 
including didactic courses that will be incorporated into the career development 
and mentored research experience.  The courses should be relevant to diverse 
areas of patient-oriented clinical research and should provide opportunities in 
more than one discipline (e.g., genetics, neuroscience, biostatistics, 
psychology, bioethics, epidemiology). Both the didactic and research experiences 
provided by the award are expected to allow participants to acquire the necessary 
knowledge and research skills in scientific areas relevant to the career goals of 
the candidate.  The institutional program should be designed to accommodate 
candidates with varying levels of research experience that may require 
development programs that range between two and five years.  For example, a 
candidate with limited research experience may require a structured, phased 
developmental program, including a block of staged time to participate in 
didactic training followed by a period of supervised research. Programs also are 
to provide instruction and mentoring in Federal regulations/policies on the 
protection of human subjects and bioethics. In addition, candidates must learn 
how to communicate their research and develop coherent research applications that 
will aid the candidate in transitioning to an independent research career.

Instruction in the Responsible Conduct of Research:  Every individual supported 
by a research career development award must receive instruction in the 
responsible conduct of research. Applications must include a description of a 
program to provide formal or informal instruction in bioethics, scientific 
integrity and the responsible conduct of research.  Applications without such 
plans will be considered incomplete and will be returned to the applicant without 
review. Although NCRR does not establish specific curricula or formal 
requirements, all institutional CRS programs are encouraged to include 
instruction in the following areas: conflict of interest, responsible authorship, 
policies for handling misconduct, policies and regulations that impact clinical 
and animal research, and security in data management.  Plans must address the 
subject matter of the instruction, the format of the instruction, the extent of 
faculty participation, trainee attendance, and the frequency of instruction.  The 
rationale for the scope of the proposed plan of instruction must be provided.  
Program reports on the type of instruction provided, topics covered, and other 
relevant information, such as attendance by appointees and faculty/mentors, must 
be included in future competing continuation and non-competing applications. 
 
The institutional CRS Plan for the recruitment and retention of underrepresented 
minorities, individuals with disabilities, and women must be included in the 
proposal: The NCRR is committed to increasing the participation of women and 
individuals from ethnic or racial groups underrepresented in the biomedical and 
behavioral sciences. The following groups have been identified as under-
represented in biomedical and behavioral research nationally: American Indian or 
Alaska Native, Asian, Black or African American, Hispanic or Latino, and Native 
Hawaiian or Other Pacific Islander.  Full descriptions of these categories can be 
found in Form PHS 398 (Rev. 05/01.)

Plan for on-going evaluation of the program:  The application must include a plan 
for program evaluation in terms of recruitment and retention goals, the 
curriculum and program staff, appointee completion success, and overall outcome. 
Input for these evaluations should be obtained from faculty mentors, staff, and 
candidates.  Applicants are encouraged to: prospectively set benchmarks for the 
goals of their institutional programs; provide a brief summary of the research 
opportunities available to candidates and course work to be offered to 
participating physicians and dentists; and provide a summary of the research 
degrees earned and relationship with career research goals. For purposes of 
evaluating the impact of the Mentored CRS Program, awardees must agree to provide 
NCRR with information on the career outcomes for those appointed to the program. 
This information must be provided annually in the progress report and include 
information for each candidate regarding academic appointments, awards related to 
scholarly activity, publications, and research grants and contracts received.

CRS Program Advisory Committee: Plans must be provided for the appointment of an 
advisory body to monitor the progress of participants in the career development 
program.  Composition, responsibilities, frequency of meetings and other relevant 
information should be included.  An annual evaluation of the program by the CRS 
Advisory Committee is recommended.

OTHER REQUIREMENTS

Environment:  The primary institution must have well-established research and 
clinical career development programs and highly qualified faculty mentors in 
clinical research with an emphasis on patient-oriented research.  The academic 
setting is to include opportunities for research collaborations that exemplify a 
dynamic two-way exchange of information and ideas between basic and clinical 
investigators.  The research environment should stimulate the development of new 
research hypotheses, novel experiments, and foster exploration of fundamental 
mechanistic questions that build on clinical observations. Finally, the 
institution must demonstrate a commitment to the development of promising 
physicians and dentists as productive, independent patient-oriented clinical 
investigators.

Number of Candidate Positions:  The applicant institution can request support for 
up to three candidates in each of the initial and second year of the award.  Up 
to two additional candidates may be added in each subsequent year, but the 
collective total should not exceed twelve five-year equivalents  (For example, if 
one candidate is supported for three years and another supported for two years, 
that combination is one five-year equivalent.)   The award provides support to 
institutions for up to five consecutive 12-month periods. Appointments of 
candidates to the program are provided in 12-month increments.  The Mentored CRS 
Program requires at least 75 percent (preferably, 90 percent) of candidate’s time 
and effort for participation in didactic training, research experiences, and 
supervised research.  A Statement of Appointment form (PHS 2271) must be 
completed and sent to the NCRR whenever an individual is appointed or reappointed 
to the program.

ALLOWABLE COSTS

Salary:  Physician and dentist program candidates may be provided salary support 
of up to $90,000 (for 90 per cent effort) each year  commensurate with the 
applicant institution’s salary structure for persons of equivalent 
qualifications, experience, and rank. The institution may supplement the NCRR 
contribution; however, the supplementation may not be from Federal funds unless 
specifically authorized by the Federal program from which such funds are derived. 
In no case may PHS funds be used for salary supplementation. Institutional 
supplementation of salary may not require extra duties or responsibilities that 
would interfere with the purpose of this award.  The total salary requested must 
be based on a full-time, 12-month staff appointment.

Research and Development Support: Up to $30,000 per candidate can be requested 
for the following types of expenses: (a) research supplies, equipment and 
technical personnel; (b) tuition and fees and books related to didactic courses 
or career development; (c) travel to research meetings or training; and, (d) 
statistical services including personnel and computer time. If an applicant 
institution has a GCRC, biostatistical and related computation costs can 
generally be provided at no charge to the investigator through the GCRC.  These 
costs must be specifically documented for each proposed candidate and must be 
specifically and directly related to the candidate’s research activities and 
individualized career development program.  They cannot be pooled and used for 
advertising, recruitment, or other programs unrelated or indirectly related to 
the research activities of individual candidates or appointees.

Ancillary Salary Support: Salary for the Program Director (up to .10 FTE) and the 
Lead Mentor (up to .05 FTE) plus fringe benefits will be allowed---unless the PD 
or Mentor holds an NIH-funded K24 award, which provides mid-career, established 
clinical investigators with salary support to mentor promising clinical 
investigators.  Typically, there will be one Lead Mentor per candidate. Salary 
for a part time secretary (up to .25 FTE) may be requested, but no other 
administrative assistants or other ancillary staff salaries are allowed.

Facilities and Administrative Costs:  These costs, which were formerly called 
indirect costs, will be reimbursed at 8 percent of modified total direct costs. 
The Mentored CRS Program award, using a K12 mechanism and administered by the 
NCRR, is not subject to the Streamlined Non-competing Application Process (SNAP). 
In general this means that all reporting of budgetary information and program 
progress are provided in greater detail in an annual progress report. While the 
K12 is subject to Expanded Authorities, the one exception to this is carry 
forward of funds from one fiscal year to the next must be approved by the NCRR 
Grants Administration staff (see INQUIRIES).

Other Income: Fees resulting from clinical practice, professional consultation, 
or other comparable activities required by the research and research-related 
activities of this award may not be retained by the career award recipient. Such 
fees must be assigned to the grantee institution for disposition by any of the 
following methods:

The funds may be expended by the grantee institution in accordance with the NIH 
policy on supplementation of career award salaries and to provide fringe benefits 
in proportion to such supplementation. Such salary supplementation and fringe 
benefit payments must be within the established policies of the grantee 
institution.

The funds may be used for health-related research.

The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks 
should be made payable to the Department of Health and Human Services, NIH and 
forwarded to the Director, Division of Financial Management, NIH, Bethesda, 
Maryland 20892. Checks must identify the relevant award account and reason for 
payment.

Awardees may retain royalties and fees for activities such as scholarly writing, 
service on advisory groups, or honoraria from other institutions for lectures or 
seminars, provided these activities remain incidental and provided that the 
retention of such pay is consistent with the policies and practices of the 
grantee institution.

Leave: In general, appointees may receive salary during the normal periods of 
vacation and holidays observed by individuals in comparable positions at the 
grantee institution. For the purpose of these awards, however, the period between 
the spring and fall semesters is considered to be an active time of research and 
is not considered to be a vacation or holiday. Appointees may receive salary for 
annual and sick leave, according to the institution’s policy.  Appointees also 
may receive salaries for up to 30 calendar days of parental leave per year for 
the adoption or birth of a child when those in comparable positions at the 
grantee institution have access to paid leave for this purpose and the use of 
parental leave is approved by the Program Director.

A period of terminal leave is not permitted and payment may not be made from 
grant funds for leave not taken. Individuals requiring periods of time away from 
their research career development experience longer than specified here must seek 
approval from the NCRR for an unpaid leave of absence.

PROGRESS REPORTS

An Annual Progress Report for the grant is required. This report should provide 
information about changes in the Program, a summary of the on-going evaluation 
results, a summary report from the Program Advisory Committee, and a description 
of the research and career progress of each candidate.  These Annual Progress 
Reports will be closely monitored by NCRR staff to ensure that the grant is 
achieving the goals of the Mentored CRS Program. Progress reports are submitted 
using the Form PHS 2590, which can be obtained at the following website address: 
http://grants.nih.gov/grants/funding/2590/2590.htm. Forms are also available at 
most institutional offices of sponsored research.

LETTER OF INTENT
 
Prospective applicants are asked to submit, by January 22, 2002, a letter of 
intent that includes a descriptive title of the proposed research; the name, 
address, and telephone number of the principal investigator; the identities of 
other key personnel; and the number and title of this RFA. Although a letter of 
intent is not required, the information that it contains allows Center staff to 
estimate the potential review workload. The letter of intent is not binding, does 
not commit the sender to submit an application, and does not enter into the 
review of a subsequent application. The letter of intent is to be sent (e-mail, 
fax, or post) to Dr. John Meyer at the address listed under INQUIRIES.
 
APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used 
in applying for these grants. This version of the PHS 398 is available in an 
interactive, searchable format. For further assistance contact GrantsInfo, 
Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

The instructions in the Form PHS 398 do not fully apply to the special needs of 
this grant application. Therefore, please follow the modified instructions in 
preparing an application for a Mentored Clinical Research Scholar Program Award 
(K12). These instructions have been adapted to accommodate the Form PHS 398 and 
the special needs of the K12 grant and can be obtained at the following website 
address: http://www.ncrr.nih.gov/clinical/cr_crcd.asp

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

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

At the time of submission, two additional copies must also be sent to:

Dr. John Meyer
Deputy Director, Office of Review 
National Center for Research Resources
6705 Rockledge Drive, Room 6116
Bethesda, MD  20892-7965
Telephone:  (301) 435-0807 
FAX:  (301) 480-3660
Email:  meyerj@ncrr.nih.gov

Applications for the initial submission in response to this RFA must be received 
by February 20, 2002. Applications received later than that date will be returned 
without review. 

The Center for Scientific Review (CSR) will not accept any application in 
response to the RFA that is essentially the same as one currently pending initial 
review, unless the applicant withdraws the pending application.  The CSR will not 
accept any application that is essentially the same as one already reviewed.  
This does not preclude the submission of substantial revisions of an application 
already reviewed, but such applications must include an Introduction addressing 
the previous critique.                                   

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for 
Scientific Review and by the NCRR for adherence to the guidelines. Applications 
that are complete will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the 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, generally the top 
half of applications under review, will be discussed, assigned a priority score, 
and receive a second level of review by the National Advisory Research Resources 
Council. 

Review Criteria

All applications are evaluated for merit based on the following criteria:

Purpose and Objectives:

Clarity of the CRS Program's objectives
o  Adequacy in meeting the NCRR intent to prepare candidates who can design and 
implement all phases of patient-oriented research and effectively lead a 
cross-disciplinary research team
o  Track record of the institution in the development of trainees as productive 
independent patient-oriented researchers                
o  Track record of the consortium institution, if applicable
o  Adequacy of the commitment of the institution assuring that candidates will 
spend a minimum of 75% of a full-time professional effort in research or 
research-related career development

Career Development Program Description:

o  Adequacy of the nature and duration of required didactic for training 
appointees in clinical research
o  Adequacy of the nature and duration of required research experiences and 
forums in clinical approaches
o  Adequacy of the cooperative arrangements between consortium institutions, if 
applicable
o  Adequacy of the nature and duration of any specialized didactic, research 
forums, or research experiences
o  Evidence of a multi-disciplinary program faculty and their involvement in 
didactic, research forums, and research experiences.
o  Evidence of the availability and commitment of the faculty mentors now and for 
the duration of the program to provide high-quality mentoring in patient-
oriented research
o  Evidence that the didactic and research experiences are distinct yet 
integrated with other training programs at the institution, such as K30 or T32 
programs.

Research Environment, Resources, and Facilities:

o  Adequacy of the funded patient-oriented research activities
o  Adequacy of the interactive nature of the research environment, including 
evidence of interdisciplinary research collaborations among the program 
faculty
o  Adequacy of the available research infrastructure, access to technologies and 
methodologies, equipment, facilities, clinical resources, and patient 
populations
o  Quality of the faculty mentors? research experience, productivity, and track 
record in training patient-oriented researchers

Program Management:

o  Program Director - adequacy of the Program Director's qualifications to 
provide scientific leadership in patient-oriented research and administrative 
direction and coordination of the Program; experience in or potential for 
managing research career development programs; evidence of availability and 
commitment, both now and for the duration of the program.

o  Lead Mentor - adequacy of qualifications; likelihood for providing high-
quality mentoring in patient-oriented research. Evidence of commitment to 
mentoring.

o  CRS Program Advisory Committee - appropriateness of the experience of the 
membership; adequacy of involvement in the oversight of the program's 
candidate selection, didactic and curricula, research experiences and 
mentoring, and evaluating appointee progress and overall program 
effectiveness.

o  Recruitment/ Retention Plans - adequacy of plans to recruit and select 
candidates; adequacy of plans for recruiting and retaining candidates from 
underrepresented minorities.

o  Instruction in the Responsible Conduct of Research - adequacy of plans for 
providing formal and informal instruction in the bioethics, scientific 
integrity, and the responsible conduct of research.

o  Evaluation Plan - adequacy of the plans to be followed by the Program 
Director, faculty mentors, staff, and appointees in evaluating program 
recruitment and retention strategies, curriculum and mentoring, appointee 
progress and completion, and overall program effectiveness.  

Budget:

Appropriateness of the budget to achieve the objectives of the proposed Program
Appropriateness of the number of appointees proposed for each year of the 
Program.

ADDITIONAL REVIEW CONSIDERATIONS FOR ALL APPLICATIONS	

Recruitment Plan for Underrepresented Minorities: Reviewer evaluation of the 
recruitment of underrepresented minorities will be included in an administrative 
note in the summary statement. If the minority recruitment plan or if the record 
of recruitment and retention of minorities is judged to be unacceptable, funding 
will be withheld until a revised plan that addresses the deficiencies is 
received. Staff within the NCRR will determine whether amended plans and reports 
submitted after the initial review are acceptable.                               
                                         
Training in the Responsible Conduct of Research:  Reviewer evaluation 
of the training in the responsible conduct of research will be 
described in an administrative note in the summary statement. Regardless of the 
priority score, applications with unacceptable plans will not be considered for 
funding until the applicant provides a revised, acceptable plan.  NCRR staff will 
judge the acceptability of the revised plan.                                     
               
Notification:  Shortly after the review meeting, each applicant will be sent 
notification of the Initial Review Groups recommendation and the name and phone 
number of the NCRR official responsible for the application. When the NCRR 
official receives the summary statement of the review, prepared by the Scientific 
Review Administrator after the review meeting, a copy will be forwarded to the 
applicant. Following the review by the National Advisory Research Resources 
Council, the NCRR program official will notify each applicant of the final 
disposition of the application.

Schedule

Letter of Intent Receipt Date:    January 22, 2002
Application receipt Date:         February 20, 2002
Earliest Anticipated Start Date:  August, 2002

AWARD CRITERIA

Applications are selected for funding primarily on the basis of scientific and 
educational merit and sound administrative organization. However, other factors 
are considered, such as: availability of funds, research program priorities, the 
balance among types of research training and career development supported by 
NCRR, the acceptability of the plan for minority recruitment, and the 
acceptability of the plan for instruction in the responsible conduct of research.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to clarify and 
issues or question from potential applications is welcome.                       

Direct inquiries regarding programmatic issues to:

Dr. Geoffrey Cheung
Division of Clinical Research
National Center for Research Resources
6705 Rockledge Drive, Room 6118
Bethesda, MD  20892-7965
Telephone:  (301) 435-0768 
FAX:  (301) 480-3661
Email:  cheungG@ncrr.nih.gov                                                      
            
Direct inquiries regarding fiscal matters to:

Ms. Mary Niemiec
Office of Grants Management
National Center for Research Resources
6705 Rockledge Drive, Room 6208
Bethesda, MD  20892-7965
Telephone:  (301) 435 - 0844 
FAX:  (301) 480-3777
Email:  niemiecm@ncrr.nih.gov

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas.  This Request for Applications (RFA), 
Mentored Clinical Research Scholar Program Award, is related to the priority area 
of human resource development. Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

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 are 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on August 
2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The 
revisions relate to NIH defined Phase III clinical trials and require (a) all 
applications or proposals and/or protocols to provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender and/or 
racial/ethnic groups, including subgroups if applicable; and (b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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 the 
NIH, unless there are 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

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

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the Internet sites. 
Reviewers are cautioned that their anonymity may be compromised when they 
directly access an Internet site.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human subjects. 
This policy announcement is found in the NIH Guide for Grants and Contracts 
Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information 
Act(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2)cited 
publicly and officially by a Federal agency in support of an action that has the 
force and effect of law (i.e., a regulation) may be accessed through FOIA.  It is 
important for applicants to understand the basic scope of this amendment.  NIH 
has provided guidance at: 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the application. In 
addition, applicants should think about how to structure informed consent 
statements and other human subjects procedures given the potential for wider use 
of data collected under this award.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.333. Awards are made under authorization of title III, Section 301 of the 
Public Health Service Act as amended. The Code of Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92 are applicable to this program. 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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