MENTAL HEALTH DISSERTATION RESEARCH GRANTS TO INCREASE DIVERSITY IN THE MENTAL 
HEALTH RESEARCH ARENA  

RELEASE DATE:  April 21, 2003 (see clarification NOT-MH-03-008)

PA NUMBER:  PAR-03-110  (Replaced by PAR-06-217)

EXPIRATION DATE:  March 3, 2006

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

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

APPLICATION RECEIPT DATES:  April 22, August 22, December 22

PURPOSE OF THIS PA

This Program Announcement (PA) replaces PAR-99-139, "Minority Dissertation 
Research Grants in Mental Health."  The purpose of this PA is to increase the 
diversity of the Mental Health Research workforce.  The Mental Health 
Dissertation Research Grant will enable doctoral candidates from racial and 
ethnic groups underrepresented in biomedical and behavioral science to pursue 
research careers in any area relevant to the research mission of the National 
Institute of Mental Health (NIMH).  Eligible doctoral candidates will receive 
support through the NIH Dissertation Award (R36) mechanism to facilitate 
completion of their doctoral research and dissertation.  This research support 
is for students who are not currently receiving support from a National 
Research Service Award (NRSA) individual fellowship or training grant or NIH 
research project grant.  This program will be of particular interest to eligible 
students where support from NRSA institutional training awards, NIH research 
project grants, or other Federal research support is not available at their 
home institutions.

RESEARCH OBJECTIVES

A primary objective of the dissertation research grant is to increase the 
numbers of students from underrepresented racial and ethnic populations who 
will become successful investigators in areas of biomedical or behavioral 
science relevant to the mission of the NIMH.  The usual mechanisms used for the 
support of doctoral dissertation research have attracted only limited numbers of 
students from underrepresented racial and ethnic populations to mental health 
research.  A dissertation represents the most extensive research experience 
formulated and carried out by doctoral candidates, with the advice and guidance 
of mentors.  Dissertation research involves a major investment of the doctoral 
student's time, energy, and interest and its substance is often the basis for 
launching a research career.  The Mental Health Dissertation Research grant 
will provide full-time salary support and research funds for eligible students 
to facilitate completion of their doctoral research project and dissertation.  
The Dissertation Research Grant is designed to encourage and stimulate 
applications from students for whom support from the current NIH training and 
research mechanisms is not or may no longer be available.  The Dissertation 
Research Grant mechanism includes an expedited submission, review and award 
process.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) Dissertation Award 
(R36) mechanism.  The applicant will be solely responsible for planning, 
directing, and executing the proposed project.  Grants to support dissertation 
research will provide up to $30,000 per year in direct costs for a maximum 
period of two years.

This PA uses just-in-time concepts and the non-modular budgeting format. Follow 
the instructions for non-modular research grant applications.  This program 
does not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

ELIGIBLE INSTITUTIONS

The applicant may submit an application if the student's institution is a 
domestic public or private non-profit university, college or professional 
school with an accredited doctoral degree granting program.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The student applying for a Mental Health Dissertation Research Grant must be 
enrolled in an accredited doctoral degree program in an area or discipline 
relevant to the mission of the NIMH, and must be conducting dissertation 
research relevant to that mission.  The student applicant must be a doctoral 
candidate (advanced to candidacy) for whom all requirements for the doctoral 
degree (excluding the clinical internship requirement) other than the 
dissertation have been completed by the time of the award.  Documentation of 
the applicant's advancement to candidacy for the doctorate degree and an 
approved dissertation project must be provided at the time of application 
(see SUBMITTING AN APPLICATION).

For the purpose of this PA, eligible students are those individuals from an 
ethnic or racial group that has been determined by the grantee institution to 
be underrepresented in biomedical or behavioral research.  The doctoral 
candidate must be a citizen or non-citizen national of the United States or 
have been lawfully admitted for permanent residence (i.e., in possession of an 
Alien Registration Receipt Card) at the time of application.  Individuals on 
student or temporary visas are not eligible, nor is anyone already receiving 
predoctoral support under a National Research Service Award (NRSA) unless such 
support is terminated prior to acceptance of the dissertation award.  Academic 
institutions are encouraged to facilitate submission of applications from 
qualified doctoral candidates.

Applicants for the Mental Health Dissertation Research Grant are expected to 
pursue full-time research and career development activities directly relevant 
to the mission of the NIMH.  Applications with marginal or no mental health 
relevance will be considered unresponsive to these programs.  Such applications 
will not be considered further and will be returned to the applicant.  
Therefore, prior to preparing and submitting an application, it is suggested 
that prospective applicants contact the NIMH staff listed under INQUIRES to 
discuss any aspects of this program that need clarification.

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:

For overall NIMH policy with regard to this initiative, direct your questions 
to:

Michael A. Sesma, Ph.D.
Chief, Research Scientist Development Program
Office for Special Populations
National Institute of Mental Health
6001 Executive Boulevard, Room 8125, MSC 9659
Bethesda, MD  20892
Telephone:  (301) 443-2847
FAX:  (301) 443-8022
Email:  msesma@mail.nih.gov

Direct your questions about scientific/research issues to the following training 
staff:

Mark Chavez, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6207, MSC 9623
Bethesda, MD  20892
Telephone:  (301) 443-3563
FAX:  (301) 443-6000
Email:  mchavez1@mail.nih.gov

Debra Wynne, MSW
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7195, MSC 9645
Bethesda, MD  20892
Telephone: (301) 443-3563
FAX:  (301) 443-1731
Email:  dwynne1@nih.gov

Enid Light, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD  20892
Telephone: (301) 443-1185
FAX: (301) 443-4045
Email:  elight@mail.nih.gov

Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6139, MSC 9608
Bethesda, MD  20892-9608
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  mkozak@nih.gov

Direct your questions about financial or grants management matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  dtrunnel@mail.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.  Further, an application that does not conform to the instructions, 
including the special instructions provided below, will be returned without 
review.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES:  Applications must be submitted by the application 
receipt dates listed in the heading of the program announcement.  Applications 
received late will be returned to the applicant.

SPECIAL INSTRUCTIONS FOR THIS MENTAL HEALTH DISSERTATION RESEARCH GRANT 
APPLICATION:  In addition to the above instructions the following specific 
instructions must be followed.  The narrative portion of the application that 
describes the research plan (Sections A-D) of the dissertation may not exceed 10 
pages.  This does not include material on human subjects, vertebrate animals, 
consultants/collaborators, consortium/contractual arrangements, or literature 
cited.  The information in the required narrative project description must be 
presented in a form suitable for detailed scientific and technical review.  
Appendices may not be used to exceed the page limitation.

The Modular Application concept is not applicable to this dissertation research 
grant program.  A detailed budget will be required.

Scope of Awards:  A Mental Health Dissertation Research Grant will be awarded 
for a period of up to 24 months.  Within this time frame the applicant may 
request support for the amount of time necessary to complete the dissertation.  
Expenses usually allowed under PHS research grants will be covered by the NIMH 
dissertation research grant but may not exceed $30,000 per year in direct costs 
for the project for a maximum period of two years.  An application that exceeds 
this period and cost will be returned.  Details on allowable costs are 
described below.

Letter of Certification:  A letter from the faculty advisor, dissertation 
committee or university official directly responsible for supervising the 
dissertation research must be submitted with the application.  The letter must 
(a) fully identify the members of the dissertation committee and certify their 
approval of the dissertation proposal; (b) certify that all requirements for 
the doctoral degree, except the dissertation and, if necessary, the clinical 
internship, are completed or will be completed by the time the grant award 
starts; (c) note that the university official or faculty committee expects the 
doctoral candidate to proceed with the approved project proposal with or 
without NIMH support; and (d) certify that the institution's facilities and 
general environment are adequate to conduct the proposed research.

Additional Material:  A transcript of the applicant's graduate school record 
should be included with the application as an appendix.  The Biographical 
Sketch Section of the Form PHS 398 must contain a scientific autobiography.  
This autobiography must provide a statement of career goals, including reference 
to their interest in the specific area of mental health/mental disorders 
research, and a description of their intended career trajectory.  A biographical 
sketch of the mentor or dissertation supervisor must also be provided.  The 
mentor's biographical data should not exceed two pages and should also include 
information in the Other Support pages according to the instructions in the 
PHS 398.

APPLICATION FORMAT AND ORGANIZATION:

See PHS 398, rev. 5/01 - C. Specific Instructions (starting on page 6). However, 
note that not all of the Sections and Items are covered here.  For those 
Sections and Items not covered below, follow the instructions in the PHS 398).

Section 1 (Pages 6-10).  Face Page:

Item 2.  Response to Specific Program Announcement: Check "YES" and enter the 
number and the title of this program announcement.

Item 3a.  Name of Principal Investigator:  The doctoral candidate must be listed 
as principal investigator.  Designate by name the doctoral candidate who is to 
be directly involved in carrying out the proposed research.

Item 3d.  Position Title:  Enter "Doctoral Candidate."

Item 3f.  Department, Service, Laboratory or Equivalent: Enter the name of the 
department or program in which the principal investigator is candidate for a 
doctoral degree.

Item 6.  Dates of Proposed Period of Support: Applicants may propose a total 
project period of 24 months for the research project and its support.

Items 7 and 8.  Costs Requested for Initial Budget Period; and Costs Requested 
for the Proposed Period of Support: Dissertation research grant applications 
may request no more than $30,000 in direct costs per year, and $60,000 for two 
years.

Item 9.  Applicant Organization: Indicate where the project will be conducted.  
If there is more than one performance site, list all of them.  Note that no 
additional costs will be provided when more than one performance site is 
involved.

Item 15.  Principal Investigator/Program Director Assurance: The applicant must 
sign here.

Item 16.  Applicant Organization Certification and Acceptance:  The official 
signing for the applicant organization must sign here.

Sections 4 and 5 (Pages 11-13).  Detailed Budget for Initial Budget Period; and 
Budget for Entire Proposed Period of Support:

Follow the PHS 398 (rev. 5/01) instructions for the budget pages.  Expenses 
usually allowed under PHS research grants will be covered by the NIMH
dissertation research grant but may not exceed $30,000 per year in direct costs 
for the project, for a maximum period of two years.  An application that exceeds 
this amount will be returned.  Allowable costs include the candidate's salary 
for 12 months full-time effort.  This salary must not exceed the current NRSA 
stipend level for predoctoral students ($19,968 in 2003; http://grants.nih.
gov/grants/guide/notice-files/NOT-OD-03-033.html); fringe benefits may be 
added to this amount.  Additionally, up to $5,000 may be requested for research 
project expenses, such as data processing, supplies, payments to subjects, and 
dissertation costs (e.g., printing and binding).  Such budgets must be 
justified in specific detail.  The candidate may request up to $1,000 travel to 
one scientific meeting; any additional travel costs in connection with research 
at a remote performance site must be fully justified and included in the 
research project expenses.  Specific costs not allowed on dissertation research 
grants are permanent equipment items, tuition, alterations/renovations, space 
rental, contracting or consortium costs, dissertation defense or deposit fees, 
membership fees and faculty/advisor mentor supervision.  This listing is not 
exclusive, and the applicant institutions should contact the NIMH staff 
regarding any other cost item being considered. The applicant must provide 
detailed justification for each budget item requested on the detailed budget 
page for the total period of support being requested.

Level of Effort:  It is expected that students will devote 100 percent time and 
effort (based on 40 hours per week) on the dissertation.  Any level of effort 
that is less than full time must be fully justified, and the student's salary 
must be prorated accordingly.

Facilities and Administrative costs are limited to eight percent of approved 
direct costs, less any equipment costs.

Section 9 (Page 14).  Research Plan:

The principal investigator must provide a narrative project description that 
contains a detailed scientific and technical discussion of the following 
specific points.  This must not exceed 10 pages (Items addressing human 
subjects and/or regarding vertebrate animals must be provided if human subjects 
and/or vertebrate animals are to be involved).  ADDRESS THE FOLLOWING POINTS 
RATHER THAN THOSE SHOWN IN THE PHS 398 INSTRUCTIONS:

a.  A description of the research project and what it is intended to 
accomplish; the relevance of the project to mental health/mental disorders

b.  A summary of related published research that addresses the identified 
problem(s)

c.  The questions to be answered or the hypotheses to be tested by the project

d.  The methodological procedures to be followed and, whenever applicable, 
information on such matters as sampling procedures, including the size and 
composition of the population to be studied and the size and composition of the 
sample and control groups, as well as a description of the types and sources of 
data to be gathered, methodological problems to be encountered, specific 
statistical analyses to be made, and steps that will be taken to protect human 
subjects or research animals as appropriate

e.  The management of the project, including a schedule or time-line of the 
main steps of the proposed investigation

f.  The facilities and resources that will be available in the project.

AMENDED APPLICATIONS:  If not awarded the applicant may submit one amended 
application.  The amended application must include an Introduction (limited to 
1 page) that addresses the issues and problems raised in the reviews contained 
within the summary statement.  Refer to specific instructions on the preparation 
of an Introduction to a revised application in the PHS Form 398 (Rev 5/01).  The 
Introduction page is not included in the 10-page limit for the research plan 
narrative for the Dissertation Research Grant Application.  The submission dates 
for amended applications are the same as for new applications.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the checklist and supporting documentation, and three 
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)

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

Jean Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154 MSC 9609
Bethesda, MD  20892-9609

APPLICATION PROCESSING:  Applications must be postmarked on or before the 
receipt dates listed on the first page.  Applications will be reviewed for 
completeness by the Center for Scientific Review (CSR).  Incomplete applications 
will be returned to the applicant without further consideration.  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 an application must include an Introduction addressing the previous 
critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 
8 weeks.

PEER REVIEW PROCESS

Applications that are complete will be evaluated for scientific and technical 
merit by an appropriate peer review group convened by NIMH in accordance with 
standard NIH review procedures.  Reviewers will take into account the 
applicant's stage of development and the importance of the dissertation as a 
learning experience that is part of the applicant's graduate education. 
Emphasis will be given to the scientific merit, feasibility, and relevance of 
the project to mental health research areas.  The qualifications of the 
candidate will also be emphasized in the review.

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.  

It is the intent to provide review results and announce funding decisions within 
four months after the receipt date.  Review criteria, award criteria, and 
continuation of support are described below.

REVIEW CRITERIA FOR DISSERTATION RESEARCH GRANT APPLICATIONS:  The overall goal 
of NIH-supported research is to advance our understanding of biological systems, 
improve the control of disease, and enhance health.  In the written comments 
reviewers will be asked to discuss the following aspects of the application in 
order to judge the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.  For dissertation research grants, using 
the five criteria below reviewers will assess the significance of problem; 
scientific quality of the proposal; relationship of proposed research to 
expanding the knowledge base in mental health research areas; research design 
and research methods; personal qualifications of the candidate; supervision of 
the candidate; institutional facilities and support structure; and 
appropriateness of budget. Each of these criteria will be addressed and 
considered in the assignment of the overall score:

(1) Significance.  Does the proposed project address an important problem in 
mental health/mental disorders?  If the aims of the application are achieved, 
how will scientific knowledge be advanced?  Will the results have heuristic 
value?

(2) Approach.  Are the conceptual framework, hypothesis to be tested, research 
design, methodology, and analyses adequately developed, clearly defined, and 
appropriate to the aims of the project?  Does the proposal describe the main 
steps of the investigation within the project period, acknowledge potential 
problem areas and consider alternative approaches?  Does the proposal reflect 
a grasp of scientific principles and adequate knowledge of other research 
related to the problem?

(3) Innovation.  Within the context of dissertation research and training 
experience, does the proposed project employ novel concepts, approaches or 
methods?  Within the same context, are the aims original and innovative?

(4) Investigator.  Is the student applicant appropriately trained and well 
suited to carry out the dissertation research?  Does the student show promise 
as a research investigator in areas relevant to the proposal?  Is the experience 
and training of the student sufficient to carry out the research, and is the 
proposed research project consistent with the long-term research interests of 
the applicant?  Is the work proposed appropriate to the experience level of the 
student?

(5) Environment.  Does the scientific and training environment in which the 
work will be done contribute to the probability of success?  Does the proposed 
project take advantage of unique features of the scientific and training 
environment?  Will the faculty advisor provide the necessary supervision and 
mentoring to the student?  Is there evidence of institutional support including 
available facilities appropriate to the research?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

BUDGET:  The appropriateness of the proposed budget in relation to the proposed 
research will be evaluated.  The allocation of time and money reflects an 
understanding of the research tasks to be accomplished and of the problems 
likely to arise.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK:  The involvement of human 
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH:  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 will be assessed.  Plans for the recruitment and retention of subjects 
will also be evaluated. (See Inclusion Criteria in the sections on Federal 
Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.  

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 NIMH program priorities

In addition, there are Terms and Conditions Specific To Mental Health 
Dissertation Research Grants:

o  Continuation of support without additional funds: under expanded authorities, 
the grantee institution may extend this grant up to one year without additional 
funds.  However, notification of an extension to the NIMH staff must include 
information documenting the progress of the awardees during the first two years 
of support and the circumstances leading to the extension.  The grantee 
institution may provide a one-year extension of the grant, without additional 
funds, only if there is evidence of acceptable progress and the need for 
additional time.

o  Since this is a dissertation grant, the NIMH Program staff must be 
immediately informed if there is a change of mentor.  A biographical sketch 
and material on the new mentor's research support should be provided to NIMH 
for approval.

o  Dissertation Research Grants may not be transferred to another institution, 
unless under unusual and compelling circumstances.  One example is if the 
mentor moves to a new institution and both the mentor and the student wish to 
move together.

o  The dissertation constitutes the final report of the grant.  As a part of the 
closeout process, two copies of the dissertation must be submitted to the NIMH 
within 90 days of the termination of the grant.  The dissertation must be 
officially accepted by the faculty committee or university official responsible 
for the candidate's dissertation, and it must be signed by the responsible 
official.

o  Concurrent Support: An applicant who receives support for dissertation 
research under a grant from the NIMH may not at the same time receive support 
under a predoctoral training grant or fellowship grant awarded by any Federal 
agency, nor be supported under any other research project grant.

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

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 "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.htm.  
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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards 
are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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


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Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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