RESEARCH EDUCATION GRANTS IN DRUG ABUSE AND ADDICTION

RELEASE DATE:  February 2, 2004

PA NUMBER:  PAR-04-054

EXPIRATION DATE:  September 18, 2006 (See PAR-06-550 for modification)

(Also see NOT-OD-06-104)

Department of Health and Human Services (DHHS) 

PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.279

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

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

PURPOSE OF THIS PA

This PA replaces PAR-99-093, published in the NIH Guide for Grants and 
Contracts, April 29, 1999, at 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-093.html.

The National Institute on Drug Abuse (NIDA) Research Education grant is a 
flexible and specialized mechanism designed to foster the development of drug 
addiction researchers through creative and innovative educational programs.  
Programs that focus on preparing researchers in cross-disciplinary 
integration and/or translational research of neuroscience, basic behavioral, 
prevention, clinical, treatment, and services research are particularly 
encouraged.  Of particular interest are educational experiences that will 
attract, train, and further the career development of physician scientists 
and other clinical professionals, underrepresented minority scientists, and 
adolescent, pediatric and geriatric researchers interested in pursuing 
research relevant to the mission of NIDA.  NIDA invites grant applications to 
support innovative educational programs that focus on preparing researchers 
in clinical research careers relevant to drug abuse and addiction. 

This mechanism of support is not to be used to substitute the Ruth L. 
Kirschstein National Research Service Award training and fellowship 
mechanisms and policies supported by the NIH. 

RESEARCH OBJECTIVES

This PA invites applications using the R25 mechanism that will focus on 
providing creative and innovative education research experiences at all 
levels of professional career development (i.e., independent scientists, 
postdoctoral fellows, clinical residents, medical students and/or graduate 
students).  This educational training experience must hold the promise of 
fostering new research approaches that advance the current drug abuse and 
addiction field.  

It is expected that these institutional research sites will develop or 
enhance research training opportunities for individuals, selected by the 
institution, who are training for careers as researchers, as clinicians, or, 
optimally, as a combination of the two. Educational partnerships between 
institutions—such as, research institutions, drug abuse treatment 
organizations, primary care organizations--are highly encouraged in order to 
broaden research training and educational opportunities and, as a result, 
increase the number of well-trained clinical and health services researchers 
in the drug abuse and addiction field at large. 

EDUCATION PROGRAM OBJECTIVES

There is a serious shortage of well-qualified individuals prepared to conduct 
needed clinical, prevention, health services, and treatment research with 
drug abusers and underserved populations of children and adolescents, women, 
elderly, and racial and ethnic minorities affected by drug abuse.  At 
present, few academic institutions have a coordinated curriculum and other 
essential elements relevant to preparing individuals for a career in clinical 
research with drug abusers and related populations.  A related need is for 
increased numbers of service providers who are sufficiently sophisticated 
consumers of research to evaluate and apply research-based findings.

Drug Abuse and Addiction Research Education Grants support only educational 
activities focused on basic, clinical, prevention, and health services and 
treatment research, and may not be used for support of non-research clinical 
training.  This mechanism may be used, however, to provide drug addiction 
research education to those in clinical training or in a clinical research 
track within a clinical training program.  Formats for the research training 
programs may vary to include a series of short courses, seminars, workshops, 
or structured short-term or long-term research experiences; or curriculum 
development, design, implementation and evaluation.

NIDA expects applicant institutions to propose their own creative and 
innovative research training programs.   Examples of potential programs 
include, but are not limited to, the following:

1.  Educational/research experiences that enhance the participation and 
commitment of clinical researchers to careers in addiction research.  
Examples include educational programs that:

o Provide mentored clinical research opportunities designed specifically for 
students enrolled in medical or graduate school degree programs and clinical 
residents.

o Encourage clinical doctoral-level or equivalent (e.g., MD, PhD, MD/PhD, DO, 
DSW, DSN, DDS) students and/or postdoctoral fellows/residents to embark on 
research projects directly applicable to clinical practice.

o Develop or enhance the research curricula and mentoring provided during 
residency training and/or create research training tracks within residency 
programs.

o Improve the quality of mentoring in drug abuse and addiction research 
areas, particularly improvements in the retention and advancement of 
physician scientists as well as adolescent, pediatric, and geriatric 
researchers.

o Provide educational experiences relevant to the conduct of drug abuse 
related clinical, prevention, treatment and services research.  

o Provide clinical research career enhancement opportunities for new clinical 
doctoral-level or equivalent students at the intersection of basic, clinical, 
treatment and services research.

2. Cross-disciplinary educational and research experiences that prepare drug 
abuse and addiction researchers to conduct interdisciplinary research (e.g., 
behavioral, neuroscience, genetic, epidemiological, clinical, etc.) or to 
translate approaches from basic behavioral, social science, cognitive 
neuroscience, and biomedical fields to clinical, prevention, treatment and 
services research.  Examples of cross-disciplinary and translational 
approaches include:

o The use of cognitive, affective, and social neuroscience in the development 
and evaluation of behavioral and pharmacological treatment interventions for 
drug abuse and addiction.

o Interdisciplinary approaches to the development, adaptation, and 
modification of treatment and preventive interventions to enhance and 
facilitate the rapid advancement of research from bench to clinical research 
settings and then to community treatment programs and services settings. 

This PA further encourages collaborative programs involving academic clinical 
research departments and basic science departments, as well as clinical or 
community treatment settings and multiple academic or research institutions 
such as schools of public health, departments of preventive and community 
medicine, primary care organizations or other entities with appropriate 
expertise for the development and establishment of educational training 
programs in drug abuse clinical, prevention, health services, and treatment 
research and practice.  

Applicants should describe planned processes for:  (a) conducting and 
monitoring recruitment and selection of students, (b) planning research 
activities and selecting mentors for students, (c) evaluating student 
progress, and (d) assessing the quality and effectiveness of the overall 
training program.  Schools, departments, and clinical sites participating in 
the joint applications should be involved in the planning, implementation, 
and assessment processes listed above.

These cross-disciplinary educational programs are likely to involve active 
collaborations or special arrangements between institutions and/or 
departments such as those with drug abuse research center support grants, 
schools of public health, departments of community and preventive medicine, 
and other departments and institutions that have the necessary expertise and 
resources to fulfill the objectives of this PA.  Any of these entities may 
act as the applicant organization, as long as the qualifications of the 
participants and the focus of the program are on the training of clinical 
researchers to work with drug abusing and related populations.

MECHANISM OF SUPPORT

This PA will use the NIH Education Research Program Grant (R25) award 
mechanism.  Awards will be limited to a maximum of $350,000 in direct costs 
per year.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  

This PA uses just-in-time concepts.  

ELIGIBILIBILITY REQUIREMENTS

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 institutions/organizations
o Foreign institutions are not eligible to apply
o Faith-based or community-based organizations

It is anticipated that in most cases these programs will complement other 
ongoing research training occurring at the applicant institution and that a 
substantial number of program faculty would have active research projects in 
which students can gain relevant experiences.  If multiple sites are to be 
used, the applicant institution must be one of those sites and a strong 
justification must be included.  Institutions with existing Institutional 
National Research Training Grants (T32) or other federally funded training 
programs may apply for an education research grant provided the proposed 
educational experiences are distinct from those training programs receiving 
NIH support.  This program announcement will support the research education 
of United States citizens only.

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.   
 
SPECIAL REQUIREMENTS

An active research base that includes funded drug abuse research projects 
should be available for the education of candidates enrolled in the program.  
The requisite faculty and the commitment of sufficient faculty time are 
critical factors for this educational program.  Graduates of the program 
should have some fundamental knowledge of at least the following areas, with 
in-depth knowledge of some of them:

o Neurobiology, cognitive, affective, and social neuroscience
 
o Genetic and environmental vulnerability

o Principles of pharmacology, including the pharmacokinetics and 
pharmacodynamics of major drugs of abuse.

o Clinical aspects of drug abuse, including knowledge of screening, 
assessment, and diagnostic methods, direct and indirect effects of drug 
abuse, major prevention and treatment (e.g., behavioral, pharmacological) 
modalities, consequences of drug use (e.g., medical, psychiatric, social), 
treatment of drug abusers with comorbid medical and/or psychiatric disorders 
and development of modes of integrated care.

o Research methodologies such as epidemiology, biostatistics, structural 
equation modeling, multilevel analysis, IRT, Rasch, qualitative and 
quantitative measurement models applied to research design and analysis, drug 
abuse surveillance, and data use.

o Health service delivery, including prevention, referral, screening, 
assessment, and treatment; organizational dynamics, culture, and climate; 
quality management; provider career development; patient satisfaction, 
financing; cost-effectiveness; and dissemination of research to practice.

o Prevention science and health education; developmentally appropriate 
intervention design and strategies.

o Racial/minority, health disparity, cultural, and gender issues.

o Protection of human subjects and related ethical issues in the conduct of 
research.  

ALLOWABLE COSTS

Allowable costs must be consistent with NIH policy and be reasonable, 
allowable, and well-documented and justified for the research education 
program.  Grant funds may not be used to supplant funds otherwise available 
at the applicant institution.

Personnel Costs - individuals participating in the design and implementation 
of the research education program may request salary and fringe benefits 
appropriate for the percent of time devoted to the program.  Normally, all 
personnel costs (including administrative and clerical costs) associated with 
directing, coordinating, and administering the program are not expected to 
exceed 25% of the total direct cost.  Salaries requested may not exceed the 
levels commensurate with the institution's policy for similar positions and 
may not exceed the congressionally mandated cap.  (If mentoring interactions 
and other activities with students is considered a regular part of an 
individual's academic duties, then mentoring and other interactions with 
students are non-reimbursable from grant funds.)

Limited administrative and clerical salary costs associated distinctly with 
the program that are not normally provided by the applicant organization may 
be direct charges to the grant only when specifically identified and 
justified.  Consultation costs, equipment, supplies, necessary travel, and 
other program-related expenses must be justified as specifically required by 
the program proposed and not duplicate items generally available for 
educational programs at the host institution.

Participant Support - participants in the education program may receive 
subsistence allowance, which includes partial costs of meals and lodging 
(unless furnished as part of the fee for registration).  They may also 
receive partial tuition, other education-related and travel expenses, 
including foreign travel, if strongly justified.  Note that effort and how 
the dollar amount is determined must be included when describing the 
participant support and also be listed in the budget justification area.

Individuals supported by NIH training and career development mechanisms (K, T 
or F Grants) may not receive stipend or salary support from the Research 
Education Grant in Drug Abuse and Addiction.  However, if funds are not 
available from other sources, limited support to defray participation costs 
(e.g., travel, meals, lodging) may be provided.

Partial costs for off-site rental space will be considered if it is short-
term and shown to be necessary for the implementation and execution of the 
educational program (seminar, workshop, etc.).  Matching funds from applicant 
institutions or other organizations for such off-site costs are strongly 
encouraged.

Facilities and Administrative (F&A) Costs, formerly known as "indirect 
costs," may be allowed for the applicant organization and any approved 
subcontract based on 8% of total direct costs exclusive of tuition and fees 
and expenditures for equipment.

Normally, funds will not be provided for fringe benefits or health insurance 
for participants involved in this education program.

Note that all costs associated with consortium/contractual arrangements, both 
direct and F&A costs are considered direct costs and are included in the 
$350,000 direct costs ceiling limitation for this program.  Normally, funds 
for the research education evaluation plan are not expected to exceed 5% of 
the total direct costs.

WHERE TO SEND INQUIRIES

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

o Direct inquiries regarding scientific/research issues to:

Suman A. Rao, Ph.D.
Deputy Research Training Coordinator
Office of Science Policy and Communications
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5230, MSC 9591
Bethesda, Maryland 20892-9591
Telephone: (301) 443-6071
FAX:  (301) 443-6277
Email: SRao@mail.nih.gov

M. Beth Grigson Babecki, M.A.
Deputy to Training Coordinator
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard. Room 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone: (301) 435-0899
FAX: (301) 594-6043
Email: mb128t@nih.gov

William J. Bukoski, Ph.D.
Office of the Director
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5153, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 402-1526
FAX:  (301) 443-2636
Email:  bb75h@nih.gov

Paul A. Coulis, Ph.D.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5199, MSC 9593
Bethesda, Maryland 20892-9593
Phone: (301) 443-1801
FAX: (301) 594-6566
Email: pc58q@nih.gov

Dorynne Czechowicz, M.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4231, MSC 9551
Bethesda, Maryland 20892-9551
Phone: (301) 443-0107
FAX: (301) 443-6814
Email: dc97d@nih.gov

Pamela Goodlow, Ph.D.
Special Populations Office
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4216 MSC 9567
Bethesda, MD 20892-9567
Phone:  (301) 443-0441
FAX:  (301) 480-8179 
Email:  pg46n@nih.gov

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

Direct inquiries regarding financial or grants management matters to:

Gary Fleming, J.D., M.A.
Chief, Grants Management Officer
National Institute on Drug Abuse/NIH/DHHS 
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD 20892-8403  
Phone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@nih.gov

COURIER/EXPRESS DELIVERY ADDRESS:  
Rockville, MD 20852

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. 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.

SUPPLEMENTARY INSTRUCTIONS

Applications that do not conform to the specific instructions detailed below 
will be returned without review.

1.  Application face page:  item number two on this page must include the 
program announcement number and the title, Research Education Grants in Drug 
Abuse and Addiction (R25).

2.  Description, Performance Sites, and Key Personnel (Form Page 2):  under 
Performance Sites include "Consortium/Contractual Arrangements," with a 
description of plans for collaborating with other institutions for purposes 
of exchange and sharing of resources, including faculty, equipment, and 
facilities. If multiple sites are to be used, the applicant institution must 
be one of those sites and for other sites a strong justification must be 
included.

3.  Resources (Resources Format Page):  describe the educational environment; 
include a description of the facilities, laboratories, participating 
departments, computer services, and any other resources to be used in the 
conduct of the proposed education program.  Use continuation pages, as 
necessary.

4.  Research Plan: part "d" of this section should be re-titled "Research 
Education Program Plan" and should contain material organized under the 
following subheadings, as appropriate to the specific program:

a) Program Direction - describe arrangements for administration of the 
program; provide evidence that the Program Director is actively engaged in 
research and/or teaching in an area related to drug abuse and addiction, and 
can organize and administer the education program, as well as evidence of 
institutional and community commitment and support for the proposed program.

b) Program Faculty/Staff - describe the characteristics and responsibilities 
of the faculty; provide evidence that participating faculty and preceptors 
are actively engaged in research or other scholarly activities related to 
drug abuse and addiction. NIDA recommends forming a multidisciplinary 
Clinical Addiction Research Education Committee, which is essential to the 
overall administration of a Clinical Research Education Program in Drug Abuse 
and Addiction.  A primary responsibility of this committee is the recruitment 
and selection of students, procedures for the selection of research 
activities and mentors for students, and evaluation of student progress.  The 
committee should consist of experts representing basic, behavioral and 
clinical disciplines concerned with drug abuse and its treatment and 
prevention.  Schools, departments, and clinical sites participating in joint 
applications should be represented on the Committee.  Evidence should be 
provided of the Committee's function, structure, composition and frequency of 
meetings.  

c) Proposed Research Education Program - provide programmatic detail on the 
special activities proposed (e.g., courses, curricula), including a 
description of plans to provide education to participants regarding the 
responsible conduct of research.

d) Program Participants - provide detail about the proposed participants; 
include a description of plans for recruiting as participants individuals 
from underrepresented racial/ethnic groups, women and persons with 
disabilities.  Competing continuation applications must include a detailed 
account of experiences in recruiting and retaining individuals from 
underrepresented groups during the previous award period.

e) Research Education Evaluation Plan - include evaluation plans for 
determining success of the program in achieving its goals and objectives.  
The inclusion of evaluation instruments is encouraged.  Please note that 
applications that do not have an adequate evaluation plan will be considered 
non-responsive to this program announcement. 

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

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm  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 unfunded version of an application 
already reviewed, but such 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 submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.   Appropriate scientific review groups 
convened by the National Institute on Drug Abuse in accordance with the 
standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will 
evaluate applications for scientific and technical merit. 

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

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate National Advisory Council 
on Drug Abuse

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 evaluate application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of the following criteria in assigning 
the application’s overall score, weighting them as appropriate for each 
application.

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

Grant applications to the Research Education Grants in Drug Abuse and 
Addiction should be characterized by innovation, scholarship, and 
responsiveness to the special and/or changing needs of drug abuse and 
addiction research.  In the written comments, reviewers will be asked to 
discuss the following aspects of your application in order to judge the 
likelihood that the proposed research will have a substantial impact on the 
pursuit of these goals:

SIGNIFICANCE:  Does the proposed research education program address the 
objectives stated in this program announcement?

APPROACH:  Is the proposed specialized curriculum appropriate and adequate to 
achieve the research education goals outlined?  Are the course requirements 
and sequence, and timetable for completing the planned activities also 
appropriate?  Is there an adequate plan for evaluating the effectiveness of 
the program in achieving its objectives?  Will a multidisciplinary Clinical 
Addiction Research Education Committee be involved in the overall 
administration of the grant?  For competing continuation applications, has 
the program been adequately evaluated and has the level of success been 
satisfactory?  Is the need for further R25 support clear? 

INNOVATION:  Does the curriculum include original and unique approaches or 
methods for addressing the needs put forth in the goals and objectives?  Are 
plans to challenge existing paradigms or develop new approaches or techniques 
described?

INVESTIGATOR:  Does the program leadership demonstrate a record of 
achievements and are their qualifications appropriate to meeting the proposed 
goals and implementing the stated plan?

ENVIRONMENT:  Is the scientific/education environment described, indicating 
the unique features and probability of success of the program?  Is 
institutional commitment to the proposed program documented?  Is the 
institute able to attract and recruit appropriate trainees?  If multiple 
sites are to be used, is this adequately justified in terms of the 
educational experiences provided?  Are plans provided for the coordination 
and communication between multiple sites? 

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.

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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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.  

ADDITIONAL REVIEW CONSIDERATIONS 

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

AWARD CRITERIA

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

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

REQUIRED FEDERAL CITATIONS 

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

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing.  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing service for persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at http://www.nida.nih.gov) under the Funding, or may be obtained by 
calling (301) 443-2755.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project 
description and elsewhere in the application as appropriate, 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.healthypeople.gov/.

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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