MENTORED CLINICAL SCIENTISTS DEVELOPMENT PROGRAM AWARD (K12 AWARD)

RELEASE DATE:  March 11, 2002

PA NUMBER:  PAR-02-076 

(Reissued as PAR-07-346)

(See Notice NOT-DA-06-013 NIDA Policy Update Mentored and Career Development (K) Awards)
(see extension of expiration date NOT-DA-06-010)
                       (see update, NOT-DA-05-005) 
                       (see update NOT-DA-05-001)

EXPIRATION DATE:  July 1, 2006. (Extended to January 3, 2007 per NOT-DA-06-031)

National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov/)
 
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This PA replaces, in its entirety, the Mentored Clinical Scientist 
Development Program Award (MCSDPA), PA-95-054, published in the NIH Guide for 
Grants and Contracts, Volume 24, Number 15, April 28, 1995.  This MCSDPA is 
an award to an educational institution or professional organization to 
support career development experiences for clinicians leading to research 
independence. Under this award, newly trained clinicians are to be selected 
and appointed to this program by the grantee institution.  In other respects, 
the research experience of the research candidates selected for support under 
this award should resemble those supported by the individual Mentored 
Clinical Scientist Development Award (K08) or the Mentored Patient-Oriented 
Career Development Award (K23).

Applications for this award should propose a research plan that has: (1) 
intrinsic research importance, and (2) will serve as a suitable vehicle for 
learning the methodology, theories, and concepts needed for a well-trained 
independent clinician-researcher.  The program should be designed to 
accommodate research candidates with varying levels of experiences.  For 
example, a prospective research candidate with limited experience in a given 
field of research may find it appropriate to engage in a structured, phased 
developmental program, including a designated period of didactic training 
followed by a period of supervised research experience.  The entire program 
should be comparable in scope and rigor to meeting the requirements for an 
advanced research degree.

The National Institutes of Health's (NIH) institutes have modified this award 
to accommodate the career pathways of researchers in fields related to their 
unique missions.  All applicants and potential research candidates are 
strongly advised to contact the prospective NIH awarding component for 
information about eligibility and the specific provisions of this award.

RESEARCH OBJECTIVES

Program Environment and Components -
The applicant organization must have a well-established research and clinical 
career development program and qualified faculty to serve as mentors. The 
research candidate, mentor, and institution must develop innovative programs 
to maximize the available research and educational resources.

The program award provides five years of renewable support.  The award is 
intended to support research candidates who receive three to five years of 
support consisting of consecutive 12-month appointments.  In general, the 
support is often divided into two distinct phases: Phase I, the didactic 
component; and Phase II, an intensive research experience under the guidance 
of a qualified mentor.  During Phase I the candidate will acquire knowledge 
and research skills in scientific areas relevant to the career development 
goals of the research candidate. This phase must include relevant didactic 
and laboratory experiences that are consistent with the research candidate's 
prior experience and needs.  During Phase II the candidates will carry out 
their research experiences.

Program Director -
The proposed Program Director should possess the scientific expertise, 
leadership and administrative capabilities required to coordinate and 
supervise an interdisciplinary research and development program.  The 
Director should be experienced in the design and management of programs for 
developing investigators, and should be able to demonstrate a superior record 
of preparation of clinicians for independent research.  In addition, 
applicants are encouraged to form a committee with representatives from 
appropriate basic and/or clinical science departments to advise the Program 
Director on management of the program. 

Mentors -
Each research candidate appointed in the program award must have a primary 
sponsor who: (1) is recognized as an accomplished investigator, (2) is 
actively involved in basic or clinical research, and (3) has a successful 
record of providing the type of training required under this award.  An 
assigned mentor will provide guidance for the development of each research 
candidate assigned to the program.  The mentor must be committed to continue 
this involvement throughout the candidate's total period of development under 
the award.

Candidates -
At least 75 percent of the candidate's full-time professional effort must be 
devoted to the program and the remainder devoted to developing other clinical 
and teaching pursuits consonant with the objectives of the award. 

Summary -
The Mentored Clinical Scientist Development Program Award (MCSDPA) is an 
award to an educational institution to support career development experiences 
for clinicians leading to research independence. Examples of research areas 
of interest of the supporting NIH institutes can be found in their strategic 
plans:  National Institute on Aging (http://www.nia.nih.gov/AboutNIA/StrategicPlan/
or National Institute on Drug Abuse  
(http://www.nida.nih.gov/StrategicPlan/Index.html).

Allowable Costs

The National Institute on Aging limits K12 programs to no more than $500,000 
per year in direct costs.

Salary –
For the National Institute on Drug Abuse, the information is available at
http://grants.nih.gov/grants/guide/notice-files/not99-132.html. 

For the National Institute on Aging, the information is available at: 
http://www.nia.nih.gov/ResearchInformation/
FundingAndTraining/ResearchTrainingSupport/#Costs.  

These funds may be used for: (a) tuition, fees, and books related to career 
development; (b) research expenses, such as supplies, equipment and technical 
personnel; (c) travel to research meetings or training; and (d) statistical 
services including personnel and computer time.  

The total salary requested for each research candidate must be based on a 
full-time, 12-month staff appointment.  It must be consistent both with the  
established salary structure at the institution and with salaries actually 
provided by the institution from its own funds to other staff members of 
equivalent qualifications, rank, and responsibilities in the department 
concerned.  If full-time, 12-month salaries are not currently paid to 
comparable staff members, the salary proposed must be appropriately related 
to the existing salary structure.

Facilities and Administrative (F&A) Costs -
These costs, which were formerly called indirect costs, will be reimbursed at 
eight percent of modified total direct costs or at the actual F&A cost rate, 
whichever is less.

Under this PA, the K12 grant is not subject to the Streamlined Noncompeting 
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 that carryover of funds from one fiscal year to 
the next must be approved by the Grants Administration staff (see INQUIRIES).

Other Income -
The candidate may not retain any fees resulting from clinical practice, 
professional consultation, or other comparable activities required by the 
research and research-related activities of this award.  Such fees must be 
assigned to the grantee institution for disposition by any of the following 
methods: (1) expended by the grantee institution in accordance with the NIH 
policy on supplementation of career award salaries 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; (2) used for health-related research purposes; or (3) 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 the 
payment.

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

Usually funds budgeted in an institute-supported research or training grant 
for the salaries or fringe benefits of individuals, but freed as a result of 
a career award, may not be rebudgeted.  An institute will consider the 
approval for use of released funds only under unusual circumstances.  Any 
proposed retention of funds released as a result of an NIH career award must 
receive prior written approval of the institute awarding component. 

Award Termination -
The Director of the NIH may discontinue an award upon determination that the 
purpose or terms of the award are not being fulfilled.  In the event an award 
is terminated, the Director of the NIH will notify the grantee institution 
and career award recipient in writing of this determination, the reasons 
therefore, the effective date, and the right of the program director to 
appeal the decision.

MECHANISM OF SUPPORT

This PA will use the NIH Mentored Clinical Scientist Development Program 
Award (K12).  As the applicant institution, you will be solely responsible 
for the planning, direction, and execution of the proposed program.  The PA 
provides up to five years of support and is renewable based on a successful 
competing continuation application, programmatic needs and the availability 
of funds. 

The awards pursuant to this PA are contingent upon the availability of funds 
and the receipt of a sufficient number of applications of outstanding 
scientific and technical merit.

ELIGIBILE INSTITUTIONS

You may submit an application if your institution has any of the following 
characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
professional organizations, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign

The applicant institution or organization must have adequate numbers of 
highly trained faculty in clinical and basic sciences with interest and 
capability to provide guidance to clinically trained individuals in the 
development of research independence.  

Institutions with a MCSPDA may recruit and select candidates on a local basis 
rather than submitting a separate application on behalf of each prospective 
research candidate.  In all aspects, the PA is intended to provide support 
for the development of clinical scientists in the same manner and under the 
same conditions as the individual Mentored Clinical Scientist Development 
Award (K08) and the Mentored Patient-Oriented Research Career Development 
Award (K23).  Therefore, research candidates for support under this PA must 
have the following: (1) a clinical degree or its equivalent, (2) initiated 
internship and residency training (or its equivalent), (3) a mentor(s) who 
has extensive research experience and a record of providing the type of 
training required under this award, and (4) willingness to spend a minimum of 
75 percent of full-time professional effort conducting research, career 
development, and/or research related activities.

Minorities and women are encouraged to apply. The following groups have been 
identified as underrepresented in biomedical and behavioral research 
nationally:  African Americans, Hispanic Americans, Native Americans, Alaska 
Natives, and Pacific Islanders. Use of the term "minority" in this 
announcement will refer to these groups.

Research candidates appointed under this 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.

Research candidates, who are or have been former principal investigators on 
NIH individual mentored career awards (K01, K08, K22, K23), research projects 
(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.  Exceptions may be made for individuals who are reentering the 
research field after an extended absence or are making a significant shift in 
their research focus that requires that they have additional training. 
Research candidates may not concurrently hold any other PHS award that 
duplicates the provisions of this award. MCSDPA research candidates are 
encouraged to apply for independent research grant support during the period 
of support under this award.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Dr. Dorynne Czechowicz 
Division of Treatment and Research Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4231, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 443-2237
E-mail:  dczechow@nida.nih.gov
 
Dr. Robin A. Barr
Office of Extramural Affairs
National Institute on Aging
7201 Wisconsin Avenue, Room 2C218, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-9322
Email:   BarrR@mail.nih.gov

o Direct your questions regarding peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
E-mail:  tlevitin@nida.nih.gov

Dr. Mary Nekola
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Telephone:  (301) 496-9666
FAX:  (301) 402-0066
Email:  NekolaM@nia.nih.gov 

o Direct your questions regarding financial or grants management matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
E-mail:  gf6s@nih.gov

Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  WhippL@nia.nih.gov

SUBMITTING AN APPLICATION

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

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package 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)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm

This is a generic PA for the NIH MCSDPA. Therefore, it is strongly 
recommended that prospective applicants contact the staff person in the 
appropriate institute listed under "INQUIRIES" early in the planning phase of 
application preparation.  Such contact will ensure that applications are 
responsive to the career development goals of individual institutes and 
centers.  It should be noted that not all institutes support the MCSDPA.

The CSR will not accept any application in response to this PA 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 a substantial revision of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.

SPECIAL APPLICATION INSTRUCTIONS FOR K12 APPLICANTS

Applications should follow the PHS 398 (05/2001) instructions for research 
grants with the following variations:

Key Personnel -
Key personnel include the principal investigator and all other individuals 
contributing substantively to the mentoring activities.  They do not include 
the candidates.

Table of Contents -
Use the Substitute Form Page 3 Research Career Table of Contents.

Section 1: Basic Administrative Data

1-3. Face Page, Description and Key Personnel (Form pages 1 and 2 and this 
Table of Contents)

4. Detailed budget for initial budget period (Form Page 4)

5. Budget for Entire Proposed Period of Support (Form Page 5)

6. Biographical sketches (Candidates and faculty -- biographical sketch 
format page; not to exceed four pages.)

7. Resources (Resources Format Page)

Section II:  Specialized Information

1.  Introduction to Revised Application (not to exceed three pages) or 
Introduction to Supplemental Application (not to exceed one page).

2.  Research Career Program Plan (Do not exceed 25 pages for items a through 
d.  For revised or supplemental applications, use substitute title. 

a.  Career Development Program
The application should describe the overall theme of the program, the 
particular career development activities planned for candidates and the 
expected outcomes for candidates. It should document the experience of the 
program director and other faculty as mentors including information on the 
career outcomes of former candidates. It should include a clear commitment of 
staff time.  Particular developmental activities mentioned such as seminars, 
scientific meetings, training in responsible conduct of research, and 
presentations should be linked to the overall theme and goals of the program. 
This section should identify explicitly the advantages to this site of a 
program-based career development award as opposed to, or in addition to, 
creating environments supportive of individual efforts by junior faculty to 
obtain career development and similar awards.

The application should indicate what other teaching and/or clinical 
responsibilities, if any, are expected of the candidates and the extent to 
which these activities complement or enrich the research and research 
development experiences proposed in the award.  

Responsible Conduct of Research:  The application must describe plans to give 
instruction in the responsible conduct of research.  These plans must detail 
the proposed subject matter, format, frequency, and duration of instruction, 
and amount and nature of senior staff participation.  No award will be made 
if an application lacks this component.  Candidates and the sponsor may wish 
to explore the availability of the following courses offered by the 
Intramural Research Program (IRP):  Introduction to the Principles and 
Practice of Clinical Research, the Clinical Electives Program Course on 
Bioethics, and the Ethics Training provided by each individual institute.  
For more information visit the website of the Office of Research Integrity at 
http://ori.dhhs.gov. 

b. Research Activities
Applicants should describe the funded research activities of the mentoring 
team.  The description should include an account of how the ongoing research 
offers opportunities for candidates to develop research ideas and strategies 
and offers ways for them to combine methods or concepts from different funded 
projects that will further their own research careers. The research plan 
should show how the ongoing research exemplifies the organizing theme of the 
program and offers candidates ways to establish research consonant with that 
theme.

The research plan should detail how individual candidates' research 
experiences will be/have been solicited and evaluated prior to initiation. If 
an outside advisory committee is used to select projects, applications should 
not name advisors in the application but describe how they will be chosen. 

Applications should describe research plans for at least two candidates.  The 
individual descriptions should each be no more than three pages and should 
include: (1) a Statement of Hypothesis and Specific Aims, (2) Background, 
Significance and Rationale, and (3) Research Design and Methods.  No 
preliminary data or results are expected in these descriptions.  Literature 
citations may be included in a single section covering all citations in the 
application and are not a part of the three-page limit.  Supporting material 
(not part of the three-page limit) should include a description of how the 
individual plans relate both to the K12 program and to the career objectives 
of the candidate, and should describe the particular mentors and mentoring 
resources that will be assigned to the candidate during this project.

c. Progress Report/Ongoing Activities

Existing resources and programs relevant to the program should be identified.  
These may include existing training grants, institutional clinical research 
curriculum awards or centers with resources for supporting junior faculty.  
The application should indicate how the K12 program will interact with these 
existing activities and add to existing capacity to advance clinical research 
at the institution. Support letters from other resource directors should be 
included at this point in the application. The letters are not included in 
the 25-page limit on items a through d.

Competing continuation and supplemental applications should use this section 
to provide a progress report on the current funded activities. The aims of 
the current award should be briefly summarized. Significant accomplishments 
of current and past candidates should be described, including present 
appointment, past faculty positions, and grant funding. Published work 
relevant to their training should be summarized. Emphasis should be placed on 
how the program aspects of the K12 have facilitated or are facilitating the 
progress of the candidates.

Progress reports are submitted using the Form PHS 2590, which can be obtained 
at: http://grants.nih.gov/grants/funding/2590/2590.htm.

d. Environment and Institutional Commitment 
Beyond the research activities described in the research plan, the 
institution must describe what current and future resources are or will be 
used to encourage research by junior faculty and facilitate developing their 
research careers.  It should document what equipment, facilities and 
resources will be made available to the candidates (see Resource Format Page 
in PHS 398).  In addition, for each candidate identified in the application, 
and for future appointments to the K12 program, the institution must submit 
the Agreement to support the candidate as described in the PHS 398 form 
(05/2001) Section IV, pp. 60-61, with signatures as described in that 
section. For candidates named in the application, the form must be included 
with the application. It is not part of the 25-page limit for items a through 
d.

For the following sections, follow instructions on PHS 398 (05/2001) 
beginning on p.17 as appropriate.

e. Human Subjects Research 
-   Special Populations
-   Human Subjects Research Section

f. Vertebrate Animals

g. Literature Cited

h. Consortium/Contractual Arrangements

i. Consultants

Budget Instructions - 

All applications should follow budget instructions for non-modular 
applications.

Personnel - 
Starting with the principal investigator, list the names of all applicant 
organization employees who are involved on the project during the initial 
budget period, regardless of whether a salary is requested.  Include all 
named candidates. Indicate any remaining slots as "to-be-named".

Percent of Effort on Project - 
Each candidate must spend at least 75 percent effort on this program.

Budget for Entire Proposed Period of Support - 
All K12 applications should follow a non-modular format.

Biographical sketches -
Complete biographical sketches for all key personnel and all named 
candidates.  Indicate on each candidate's biosketch whether the candidate is 
a U.S. citizen or a permanent resident.  If the candidate is a permanent 
resident of the United States, a notarized statement to that effect must be 
provided by the time of award.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

Although the goals of NIH-supported research are to advance our understanding 
of biological systems, improve the control of disease, and enhance health, 
the reviewers are reminded that the primary purpose of this PA is training 
rather than conducting research.  In the written comments, reviewers will be 
asked to discuss the following aspects of your application in order to judge 
the likelihood that the proposed research will have a substantial impact on 
the pursuit of these goals: 

o Significance 
o Approach 
o Candidates
o Program Directors/Mentors
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

1.  SIGNIFICANCE:  Does the proposed program offer training and career 
development experiences in an important area of research and/or public health 
significance? Are the needs for additional researchers and a K12 program well 
justified?

2.  APPROACH:  Are the planned activities adequately developed, consistent 
with the theme of the program, and sufficient to achieve the aims of the 
program? Are they appropriately tailored to the experience and interests of 
the candidates? Is the proposed training in the responsible conduct of 
research adequate? Competing continuations and supplements: Do current and 
past activities demonstrate prior success in advancing the careers of 
candidates?

3.  CANDIDATES:  Are the recruitment and selection processes adequate to 
achieve high-quality candidates? Are the accomplishments of named candidates 
and the quality of their planned research activities appropriate to their 
level of experience and expected progress during the award? Are the efforts 
to recruit candidates from racial or ethnic groups underrepresented in 
biomedical, behavioral or clinical research adequate? Competing continuations 
and supplements: Do current and past appointments show evidence of success at 
recruitment and training?

4.  PROGRAM DIRECTOR AND CO-MENTORS:  Is the proposed program director an 
acknowledged research leader/administrator with a track record of mentoring 
successful researchers? Do the proposed co-mentors complement the skills and 
experience of the principal investigator? Is their experience in research and 
prior success in training appropriate to their role? Is the need for 
particular mentors well justified by the aims of the program? Has the 
mentoring team committed sufficient time to ensure the success of the 
program?

5.  ENVIRONMENT:  Do existing facilities and resources enrich the potential 
of the proposed K12 award to provide strong research mentoring and 
development experiences for the candidates? Are support letters available 
from individuals who control access to these resources that show their 
willingness to collaborate? Does the institution indicate that the candidates 
will be provided a minimum of 75 percent time for the career development 
experiences and show how they will be protected from other administrative, 
teaching or clinical duties? 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht
m.   The amended policy incorporates: the use of an NIH definition of 
clinical research; updated racial and ethnic categories in compliance with 
the new OMB standards; clarification of language governing NIH-defined Phase 
III clinical trials consistent with the new PHS Form 398; and updated roles 
and responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

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.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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 PA 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.

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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.279 for NIDA and 93.866 for NIA, and is 
not subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.  Awards are made under authorization 
of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 
241 and 284) and administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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