EXPLORATORY/DEVELOPMENTAL TRANSLATIONAL GRANTS FOR BORDERLINE PERSONALITY

RELEASE DATE:  August 28, 2002 (see reissuance RFA-MH-04-006)

RFA:  MH-03-001

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

LETTER OF INTENT RECEIPT DATE:  January 13, 2003
APPLICATION RECEIPT DATE:       February 12,2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism(s) of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Mental Health (NIMH) and the National Institute on 
Drug Abuse (NIDA) are undertaking efforts to increase research concerning 
borderline personality disorder, a disorder that has not received research 
attention commensurate with its prevalence in clinical settings and its 
seriousness.  In this Request for Applications (RFA), NIMH and NIDA extend their 
translational research initiatives to borderline personality disorder research, 
inviting exploratory/ developmental R21 applications for new, innovative 
translations of basic science theories, methods and findings to clinical 
research concerning borderline personality disorder, its features, and its 
relationship to co-occurring disorders, e.g., depression, post-traumatic stress 
disorder, and drug dependence.  Applicants for these R21 grants should be 
committed to pursuing the proposed line of research subsequently through R01 and 
other appropriate grant mechanisms with benefit of the data developed through 
the exploratory/developmental work.  The areas of basic science for possible 
translation include modern psychometrics and measurement theory, basic 
behavioral science, social science and neuroscience.  The specific clinical 
focus chosen by an applicant should reflect the potential for innovative, 
important, scientifically sound translations of basic science to clinical 
research concerning borderline personality disorder.

RESEARCH OBJECTIVES

Borderline personality disorder (BPD) is a complex, serious, disabling disorder 
with significant mortality that is frequently encountered in clinical settings; 
however, it has not received commensurate research attention.  Only a small 
number of investigators have undertaken research concerning this disorder, with 
the result that the institute portfolios do not reflect its importance as a 
public health problem.  With few researchers working in an area of study, there 
are in turn few opportunities for training and mentoring new researchers, which 
perpetuates the limited amount of research and NIMH and NIDA grants for the 
field of study.  Recently, several developments have occurred that offer the 
potential for increasing NIMH and NIDA support for research concerned with BPD.

First, in 1999 the Borderline Personality Disorder Research Foundation (BPDRF) 
generated a significant increase in BPD research when this new foundation 
initiated support for research centers concerned with BPD in the United States 
and in Europe.  Subsequently, the BPDRF has sought to encourage government 
research funders in the United States and in Europe to increase their support 
for BPD research and to encourage early career researchers to undertake programs 
of research concerning BPD.

Second, several years ago NIMH and NIDA launched translational research 
initiatives to encourage the involvement of basic researchers and clinical 
scientists in the translation of basic science theories, methods and findings to 
the clinical arena.  The magnitude, scientific merit, innovativeness, and 
potential contributions of the subsequent translational research applications 
have demonstrated the readiness and ability of the field to enhance and 
strengthen the clinical research enterprise in this way.

This RFA seeks to build on the two developments mentioned above:  the increased 
research activity and interest concerning BPD that the BPDRF has generated, and 
the new energy and cutting edge methods that the institute's translational 
research initiatives have brought to clinical research.  Specifically, the RFA 
seeks to extend the institute's translational research initiatives to BPD 
research, and thereby bring cutting edge theories, methods and findings from 
modern psychometrics and measurement theory, behavioral science, social science 
and neuroscience to clinical research concerning BPD.  Such extensions offer 
considerable promise for enabling advances in better measuring and understanding 
the complexities of this disorder and its core features   the pervasive 
instabilities in affect, interpersonal relationships, behavior, concept of self, 
and cognitions, and the co-occurrence of BPD with other disorders, e.g., 
depression, post-traumatic stress disorder, and drug dependence.  Such 
extensions also offer the promise of new, science based treatment models and 
procedures for development and preliminary testing.

The potential for extending NIMH's translational research initiative to BPD 
research and for involving more researchers, particularly early career 
investigators, was explored in the summer of 2001 at a conference, New 
Directions in Borderline Personality, at Rockefeller University that was 
co-sponsored by NIMH and the BPDRF.  This possibility was further explored in 
the early summer of 2002 at a follow through conference, New Directions in 
Borderline Personality II, that the University of Minnesota Department of 
Psychiatry hosted.  This RFA reflects the growing interest in translational 
research for BPD and among researchers in pursuing research concerning BPD.

The potential translations of basic science for BPD clinical research are broad, 
and include advances in understanding, measurement, and the development and 
preliminary testing of new, science based treatments, pharmacological and 
psychosocial.  For this RFA, NIMH will consider translational research 
applications for BPD across this entire spectrum.  For this RFA, NIDA's focus is 
on the translation of basic science findings for the development and preliminary 
testing of new behavioral treatments for persons with co-occurring BPD and drug 
dependence, a group that is frequently encountered in drug dependence programs, 
and for which treatments of demonstrated efficacy do not yet exist.

The areas of basic science for possible translation include modern 
psychometrics, measurement theory, basic behavioral science, social science, and 
neuroscience.  The exploratory/development grants are to enable the researchers 
to develop procedures and data that will enable R01 applications.  The potential 
focuses for NIMH support under this announcement encompass all aspects of BPD, 
including but not limited to better specification of the disorder and the 
criteria for this diagnosis; determination of possible subtypes of BPD and their 
associated features and correlates; illumination of the role of gender, SES and 
culture in the ways in which the disorder is manifest; elucidation of the 
mechanisms of expression and moderation of the extreme temperament and 
behavioral traits that are presumed to substantially account for this disorder; 
clarification of the relationship of BPD to other disorders and their 
mechanisms; identification of factors that are involved in the onset, escalation 
and cessation of BPD features; development of more complete, accurate and 
on-going measurement of the pervasive instabilities of affect, interpersonal 
relationships, concept of self, behavior, and cognitions and determination of 
factors involved in variations in time between extremes, in the duration of 
extreme states, and in the moderation of expressions of extreme states of these 
features; the role of learning, biological factors and the brain in the 
instabilities that characterize BPD; and elucidation of factors that account for 
periods of self-injury and the mechanisms that support this type of behavior; 
and the development and preliminary testing of new treatment models and 
procedures that are based on translations of basic science.  The specific BPD 
focuses should reflect the opportunity for the innovative and scientifically 
meritorious translation of basic science to advance BPD clinical research.

Applications submitted under this RFA must meet the following criteria to be 
considered responsive:

1.  The proposed research must have as a major feature the translation 
(application) of basic science (theory, methods, or findings) to clinical 
research concerning BPD.

2.  The research principal(s) for the proposed research must have substantial 
expertise in both the area of basic science from which the translation is to be 
made and in relevant clinical research.  Collaborations of basic and clinical 
scientists are encouraged.  Collaborating scientists need not be at the same 
institution, but in such cases, the procedures for achieving collaboration 
during the project must be specified.  Substantial expertise in the areas of 
science involved in the research is required so that the research team can look 
beyond the immediate research to other possibilities for translation and 
consider other clinical issues that might benefit from new basic research, and 
so that there can be broad training in translational research (see below).

3.  Consistent with the need to develop a cadre of translational researchers, 
the project must include provision for an advanced graduate student, a post doc, 
or an early career researcher to receive additional training in the basic 
science area from which the translation for the research project is drawn (e.g., 
in modern measurement theory for the translation of item response theory to 
developing a measure of a BPD latent construct) and similarly to receive 
training in the clinical science involved in the research.  The goal for this 
training is to prepare this person to initiate translational research upon the 
completion of the project.  The project budget must include provision for this 
training and a potential training plan must be briefly described.  The training 
may utilize various modalities, including courses, directed readings, tutorials, 
and visits to labs of other scientists, as well as active involvement in the 
proposed research as a collaborating junior colleague.

4.  The proposed research must have clear, immediate and compelling relevance to 
the clinical phenomena of borderline personality disorder.  (It is anticipated 
that this requirement will most often be met by having persons who meet 
diagnostic criteria for BPD as the primary subjects.)

5.  The proposed research will be a new line of investigation for BPD, and so, 
consistent with the R21 exploratory/development mechanism, preliminary data, 
while always desirable, is neither expected nor required.  The proposed research 
should be scientifically sound and the qualifications of the research team 
appropriate.  It is expected that funded projects will need to make adjustments 
based on their initial work, and the work plan and budget should provide for 
this.

6.  The principal researcher(s) of the team should be committed to pursuing this 
line of research beyond the exploratory/development grant period if the data 
developed with the R21 grant support this course.  The further research that 
would be enabled by the requested R21 grant support must be indicated.

Applicants are strongly encouraged to contact one of the NIH program staff 
listed under INQUIRIES with any questions regarding the responsiveness of their 
proposed project to the goals of this RFA.

Possible Research Topics

The following research areas are presented only as illustrations of possible 
topics.  The list is not intended to be comprehensive or restrictive.  The 
topics are expected to reflect the opportunities for new and innovative 
applications of basic science to BPD and its features:

o  The application of taxonomic science to BPD to explore the possibility of 
subtypes of BPD and shared and distinct biological, development, clinical, and 
social factors.  The DSM criteria for the diagnosis of BPD are that any 5 (or 
more) of 9 symptom criteria be met.  Thus, scores of diverse combinations of 
symptom criteria enable the diagnosis of this disorder, suggesting the 
possibility that the disorder is not homogenous but consists of two or more 
subtypes.  Identification of valid subtypes and their shared and distinct 
factors would advance diagnosis, treatment and research.

o  The use of measurement theory and behavioral science to develop accurate, 
ongoing measures of one or more of the core features of BPD, e.g., instability 
in concept of self.  The availability of such measures could enhance the 
accuracy of diagnosis and evaluation of intervention and advance the study of 
factors associated with potentially important facets of instability such as 
variation in the time between extremes.  The availability of validated measures 
for two or more such features would enable research on the relationship of 
variations in one to the other and the shared and unique factors associated with 
the expression of these features.

o  The use of systematic observations of behavior and emotions to determine 
patterns of dyadic interactions and to test learning theory, pharmacological and 
other intervention methods to determine the role of different approaches and 
factors in preventing the escalation of anger and aggression and in obtaining 
therapeutic change in interpersonal relationships.

o  The use of item response theory (irt) to develop items measuring the latent 
constructs of BPD that are not influenced by gender, socioeconomic status (SES) 
and culture/ethnicity, and thus reflect pure expressions.  And, conversely, to 
identity sets of items that reflect gender, SES and culture/ethnicity specific 
expressions of BPD so that the mechanisms by which these factors affect the 
differential expression of BPD symptoms can be investigated.

o  Application of methods and principles from affective neuroscience to explicate 
dimensions of mood and emotional response in BPD, employing standard paradigms 
for which normative data exist and recording multiple response systems in order 
to contribute to an integrative understanding of the biobehavioral organization 
of affect and/or social cognition in BPD.

o  Studies that attempt to define more precisely the relevant temperament and 
other biobehavioral dimensions relevant to BPD, and to specify which 
combinations of dimensional characteristics may contribute to subtypes, 
severity, or risks for disorder.  Such studies might employ designs that are 
intended to explore the full range of these dimensions by combining patient 
groups, non-clinical subjects at high risk or with elevated scores on screening 
questionnaires, and non-clinical subjects scoring low of screening measures.

o  The translation of new basic science findings in to a new treatment model or 
procedure, and the development and preliminary testing of this approach.  NIDA's 
focus in the spectrum of areas for such new, science based treatment models and 
procedures is on co-morbid BDP and drug abuse.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Exploratory/ 
Developmental Grant (R21) award mechanism.  As an applicant you will be solely 
responsible for planning, directing, and executing the proposed project.  This
RFA is a one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer review 
procedures.  The anticipated award date is December 1, 2003.

This RFA uses just-in-time concepts.  It also uses the modular budgeting format. 
(see http://grants.nih.gov/grants/funding/modular/modular.htm).

FUNDS AVAILABLE

The NIMH intends to commit approximately $1.2 million in FY 2003 to fund up to 
eight new grants in response to this RFA.  NIDA intends to commit approximately 
$250,000 to fund up to two new grants for the development and preliminary 
testing of new behavioral treatment models or procedures based on the 
translation of basic science findings for persons with co-occurring BPD and drug 
dependence.  An applicant may request a project period of up to 3 years and a 
budget for direct costs of up to $125,000 (5 modules) per year.  Direct costs of 
up to $150,000 (six modules) per year may be requested to allow for facilities 
and administrative (F&A) costs on consortium arrangements.  Because the nature 
and scope of the proposed research will vary from application to application, it 
is anticipated that the size and duration of each award will also vary.  
Although the financial plans of the NIMH 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 meritorious applications.  

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) 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, 
and laboratories
o  Units of State and local governments
o  Eligible agencies of the Federal government
o  Domestic
o  Faith-based or community based organizations

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 inquiries concerning this RFA 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 mental health scientific/research issues to:

James Breiling, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS (DMDBA)
National Institute of Mental Health
6001 Executive Boulevard, Room 6-179
Bethesda, MD  20892
Telephone:  (301) 443-3527
FAX:  (301) 443-4611
Email:  [email protected]

o  Direct your scientific/research questions about the development and 
preliminary testing of new, science-based behavioral treatments for persons with 
co-occurring BPD and drug dependence to:

Cecelia L. McNamara, Ph.D.
Division of Treatment Research and Development
Behavioral Treatment Development Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4219
Bethesda, MD  20892-9551
Telephone:  (301) 402-1488
FAX:  (301) 443-6814
Email:  [email protected]

o  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 6138, MSC 9608
Bethesda, MD  20892
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  [email protected]

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

Brian Albertini
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD  20892-9625
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email:  [email protected]

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel
o  Participating institutions
o  Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows NIMH staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Dr. James Breiling
Division of Mental Disorders, Behavioral Research and AIDS (DMDBA)
National Institute of Mental Health
6001 Executive Boulevard, Room 6179
Bethesda, MD  20892
Telephone:  (301) 443 3527
FAX:  (301) 443 4611
Email: [email protected]

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) 710-0267, Email: 
[email protected].

PLEASE NOTE THAT THE RESEARCH PLAN IS LIMITED TO 15 PAGES.  APPENDIX MATERIAL IS 
LIMITED TO 3 ITEMS.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  The modular grant concept 
establishes specific modules in which direct costs may be requested as well as a 
maximum level for requested budgets.  Only limited budgetary information is 
required under this approach.  The just-in-time concept allows applicants to 
submit certain information only when there is a possibility for an award.  It is 
anticipated that these changes will reduce the administrative burden for the 
applicants, reviewers and NIH staff.  The research grant application form PHS 
398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is 
to be used in applying for these grants, with modular budget instructions 
beginning on page 13 of the application instructions.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the Checklist, 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 G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9663
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (303) 443-4720
Email:  [email protected]

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this 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 
applications already reviewed, but such applications will be considered as new, 
rather than revised.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the NIMH.  Incomplete applications will be returned to the 
applicant without further consideration.  And, if the application is not 
responsive to the RFA, CSR staff may contact the applicant to determine whether 
to return the application to the applicant or submit it for review in 
competition with unsolicited applications at the next appropriate NIH review 
cycle.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIMH and NIDA in accordance with the review criteria stated below.  As part 
of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will 
be discussed and assigned a priority score
o  Receive a second level review by the National Advisory Councils of the NIMH 
or NIDA, as appropriate.

REVIEW CRITERIA

The goals of NIH-supported research are 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 
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  Innovation
o  Investigator
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 your study address an important problem? If the aims of 
your application are achieved, how do they advance scientific knowledge?  What 
will be the effect of these studies on the concepts or methods that drive this 
field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does your project challenge existing 
paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR:  Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?

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

o  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.

o  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)

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    January 13, 2003
Application Receipt Date:         February 12, 2003
Peer Review Date:                 June 2003
Council Review:                   September 2003
Earliest Anticipated Start Date:  December 1, 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic 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.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.

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.

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 RFA 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 Nos. 93.242 and 93.279 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.  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 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. 

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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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