• BPD studies at the University of Minnesota with Dr. Charles Schulz, MD
& Richelle Moen-Moore.

• Borderline Personality Disorder and eating disorders, University of Washington

• Mood and Personality Special Evaluation Program, Mount Sinai Hospital, Bronx VA

EXPLORATORY/DEVELOPMENTAL TRANSLATIONAL GRANTS FOR BORDERLINE PERSONALITY



RELEASE DATE:  August 28, 2002



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:  jbreilin@mail.nih.gov



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:  cmcnamar@mail.nih.gov



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:  mkozak@nih.gov



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:  albertib2@mail.nih.gov



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: jbreilin@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.  

For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 

GrantsInfo@nih.gov.



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:  jnoronha@mail.nih.gov



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.