BASIC BEHAVIORAL AND COGNITIVE SCIENCE RESEARCH: APPROACHES TO THE STUDY OF
HIV/AIDS AND DRUG ABUSE

Release Date: June 10, 1998

RFA NUMBER:  DA-99-002

P.T.

National Institute on Drug Abuse

Letter of Intent Receipt Date:  December 15, 1998
Application Receipt Date:  January 15,  1999

PURPOSE

The National Institute on Drug Abuse (NIDA) requests applications for research
projects in the basic behavioral and cognitive sciences that can address the
complex relationship between drug abuse/addiction and HIV/AIDS transmission and
progression.  Research is needed to characterize the antecedent variables and
processes associated with increased risk for contracting HIV/AIDS and to
determine the behavioral and cognitive consequences caused by potential combined
effects of the virus, drugs of abuse, drug abuse pharmacotherapies, and anti-HIV
medications.  In addition, the recent development of anti-HIV medications
requires adherence to complex medication regimens.  It is important, therefore,
to understand the basic cognitive and behavioral processes associated with
treatment compliance, and the influence of drug abuse and addiction on these
fundamental processes.  Knowledge gained from basic behavioral and cognitive
science research will aid in the development and refinement of treatment and
prevention interventions.

This Request for Applications (RFA) will support individual research projects or
mentored scientist development award grants.  Research projects exploring basic
behavioral and cognitive variables involved in drug abuse and HIV/AIDS
transmission and progression are encouraged.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000" a PHS-led national
activity for setting priority areas.  This RFA, Basic Behavioral and Cognitive
Science Research:  Approaches to the Study of HIV/AIDS and Drug Abuse, is related
to the priority areas of alcohol and other drugs.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0
or Summary Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202)
512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and nonprofit
organizations, public and private; such as, colleges, universities, hospitals,
laboratories, units of state and local government, and eligible agencies of the
Federal Government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.  Foreign
institutions are not eligible for career development (K-series) awards.  Awards
to foreign institutions under other research (R-series) mechanisms are generally
limited to 3 years.

MECHANISM OF SUPPORT

Research support mechanisms are the National Institutes of Health (NIH) research
project grant (R01), exploratory/developmental grant (R21), and small grant
(R03), as well as Mentored Research Scientist Development (K01) and Mentored
Clinical Scientist Development (K08) Awards.  In addition, competitive
supplements to add a research component to an existing NIDA grant will be
eligible.

The total project period for an application submitted in response to this RFA may
not exceed 5 years.  The anticipated award date is July 1, 1999.  This RFA is a
one-time solicitation.  Future unsolicited competitive supplement applications
will compete with all investigator-initiated applications and be reviewed
according to standard  peer review procedures.

The small grant (R03) is limited to 2 years, non-renewable, and the
exploratory/developmental grant (R21) is limited to 3 years and limited in direct
cost amount per year (R03, $50,000; R21, $90,000).  The R03 mechanism is intended
for newer, less experienced investigators, for investigators at institutions
without a research tradition, or for experienced investigators wishing to change
research directions or test new methods or techniques.  The R21 mechanism is
intended to encourage exploratory research projects with sound methodology and
strong rationales in underdeveloped research areas of drug abuse.  Mentored
Research Scientist Development Award (K01) and Mentored Clinical Scientist
Development Award (K08) mechanisms are intended to provide a period of sponsored
research experience that will then enable the applicant to pursue an independent
research career.  The K01 and K08 awards support 3-5 years of mentored research
experience, and applicants are required to devote at least 75% time to the
program.  K01 Awards require a research or a health-professional doctorate or
equivalent, while K08 Awards require a clinical degree or equivalent.  There are
additional special requirements for these mechanisms; if any applicant intends
to apply for either award under this RFA, he or she should contact the program
official listed under the INQUIRIES section for further information.  Specific
information on individual research mechanisms can be obtained from the NIDA home
page at: http://www.nida.nih.gov/Funding.html.

The competitive supplements will be reviewed in accordance with NIH standard
review procedures; i.e., peer review/Council review. Competitive supplement
requests are to be submitted on the RFA receipt date.

All applications submitted in response to this RFA will use the Just-In-Time
submission procedures.  These procedures were published in the NIH Guide, Vol.
25, No. 10, March 29, 1996, with additional instructions published in Vol. 25,
No. 16, May 17, 1996.  Copies of these two Guide notices are available from the
contact person listed under INQUIRIES.

FUNDS AVAILABLE

It is anticipated that approximately $1.5 million will be available to support
projects submitted under this RFA.  Because the nature and scope of the research
proposed in response to this RFA may vary, the size of the awards will also vary. 
However, it is anticipated that approximately six to eight new awards will be
made under this RFA.

RESEARCH OBJECTIVES

It is well established that drug abuse is a major risk factor for contracting the
HIV/AIDS virus.  In the context of drug abuse and addiction, research is needed
to enhance our understanding of the behavioral and cognitive antecedent variables
associated with HIV transmission.  Basic behavioral and cognitive science
research can enhance our understanding of the complex interrelationship between
drug abuse and addiction, impulsive and risk-taking behaviors, and decision-
making processes that can lead to contracting the virus.  Basic research aimed
at characterizing and better understanding basic behavioral and cognitive
processes associated with risk-taking is also needed.  Research in this area
could involve either animal subjects or human volunteers.  Understanding these
fundamental processes in the context of drug abuse and addiction will lead to a
better understanding of decisions, attitudes, beliefs, and behaviors involved in
unsafe needle sharing and in risky sexual encounters, for example.  Once these
fundamental processes are determined, steps can be taken to modify or reduce
their occurrence.  Information gained from research in this area will aid in
developing and refining prevention interventions.

Once the HIV/AIDS virus is contracted, little is known about potential behavioral
and cognitive deficits produced by the combination of the virus and drugs of
abuse in humans.  Similarly little is known about behavioral and cognitive
deficits that might be produced by the combination of the virus and drugs of
abuse in animal models of HIV/AIDS.  Research is needed to determine (1) the
effects of the various combinations of anti-HIV medications, drug abuse
pharmacotherapies, and drugs of abuse on behavioral and cognitive processes; (2)
how virus exposure, anti-HIV medications and drugs of abuse, and/or drug abuse
pharmacotherapies affect behavioral and cognitive development following prenatal
exposure; and (3) how central nervous system disease progression affects drug
seeking, subjective effects of drugs of abuse, or drug withdrawal.  Approaches
using animal models of HIV [e.g., transgenic animal models, SIV, FIV, severe
combined immunodeficient (SCID) mice, or other animal models related to HIV/AIDS]
would be most appropriate for studying the consequences of HIV/AIDS progression
and drugs of abuse on basic behavioral and cognitive processes.  For some aspects
of this research, less invasive studies involving human volunteers may also be
appropriate.  Information gained from basic research will prove valuable for
developing and refining rehabilitation and treatment interventions.

Recent advances in effective treatment for the virus often involve strict and
complex anti-HIV medication regimens.  Research is needed to determine the
fundamental behavioral and cognitive processes that underlie adherence to anti-
HIV medication regimens.  Research is needed to determine how drug abuse and/or
drug abuse pharmacotherapies influence or modulate these behavioral and cognitive
processes.  Research in this area needs to progress in order to assist in the
development of effective behavioral and cognitive strategies to improve adherence
to anti-HIV medication regimens in substance abusing or substance-abuse treatment
populations.

Illustrative examples of research within the scope of this RFA are outlined
below.  The following examples serve as a guide and are not meant to subsume all
research topics that would be appropriate under this RFA.

o  Identify and determine the importance of antecedent variables that lead to
increased (or reduced) risk taking, impulsivity, and discounting as they relate
to contracting HIV/AIDS. Examples of possible antecedent variables include:  drug
use patterns, episodes of craving, attitudes toward injection drug use and
HIV/AIDS, psychosocial factors, emotional and motivational factors, levels/types
of psychiatric symptoms and psychiatric diagnoses, and environmental or
situational factors.

o  Characterize the cognitive and behavioral deficits associated with the
combined effects of drugs of abuse and HIV/AIDS progression, and explore and
evaluate the effects of cognitive and behavioral rehabilitation procedures on
reversing these deficits.

o  Use animal models of HIV to study changes in cognition and behavior as a
function of the combined effects of infection (and its progression), drugs of
abuse, and/or environmental factors (e.g., social hierarchy, exposure to acute
or chronic stress).

o  Assess combined effects of anti-HIV medications and drugs of abuse and/or
pharmacotherapies (e.g., methadone) on basic cognitive and behavioral processes.

o  Study in the context of drug abuse and addiction basic behavioral and
cognitive processes that relate to adherence issues associated with anti-HIV
medication regimens.

o  Use animal models of HIV to determine the effects of the infection (and its
progression) on drug self-administration and subjective effects of drugs of
abuse.

o  Assess the effects of prenatal exposure to the various combinations of anti-
AIDS medications, drugs of abuse, and drug abuse pharmacotherapies on postnatal
behavioral and cognitive performance and development.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification are provided 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 research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which were published in the Federal Register on March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.  Investigators also may obtain copies of the policy from the
program staff listed under INQUIRIES. Program staff may also provide additional
relevant information concerning the policy.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research conducted or supported by 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 was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.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 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 "What's New" or may be obtained
by calling (301) 443-2755.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 15, 1998, a letter of
intent that includes a descriptive title of the proposed research; the name,
address, and telephone number of the Principal Investigator; the identities of
other key personnel and participating institutions; and the number and title of
the RFA in response to which the application is being submitted.  Although a
letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application.

The letter of intent is to be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
5/95).  Application kits are available at most institutional offices of sponsored
research and may be obtained from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email:
[email protected].

The RFA label available in the PHS 398 (rev. 5/95) application form must be
affixed to the bottom of the face page of the application.  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 Item 2 of the face page of the application form and the
"YES" box must be marked.

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:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857

Applications must be received by January 15, 1999.  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. This
does not preclude the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing the
previous critique.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the CSR and for responsiveness
by the NIDA.  Applications judged to be incomplete and/or non-responsive to the
RFA will be returned to the applicant without further consideration. 
Applications that are complete and responsive will be evaluated for scientific
and technical merit by an appropriate peer review group convened by the NIDA in
accordance with NIH peer review procedures.  As part of the initial merit review,
all applications will receive a written critique and undergo a process in which
only those applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed, assigned a priority
score, and receive a second level review by the National Advisory Council on Drug
Abuse.  Small grant applications (R03) do not receive a second-level Council
review.

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 the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that the 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, an investigator 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 this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? 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?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

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

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

(5) Environment:  Does the scientific environment in which the 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?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research, or
justification for exclusion.  Plans for the recruitment and retention of subjects
will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research.

o  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.

The above criteria apply to R01 applications, there are additional criteria for
other mechanisms.  When applying under other mechanisms, the applicants should
obtain a copy of the relevant announcement from the Grants Management Branch at
NIDA (301-443-6710), or NIDA's homepage (http://www.nida.nih.gov).  These
announcements contain instructions for the preparation of grant applications that
must be strictly adhered to and describe review criteria that will be used by a
peer review committee in evaluating submitted applications.

Schedule

Letter of Intent Receipt Date:  December 15, 1998
Application Receipt Date:       January 15, 1999
Peer Review Date:               March 1999
Council Review:                 May 1999
Earliest Start Date:            July 1, 1999

AWARD CRITERIA

Award criteria that will be used to make award decisions include: scientific
merit (as determined by peer review), availability of funds, and programmatic
priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify issues
or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

David Shurtleff, Ph.D.
Division of Basic Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-31
Rockville, MD  20857
Telephone:  (301) 443-1887
FAX:  (301) 594-6043
Email:  [email protected]

Applicants who may be interested in applying topics in this RFA to clinical
issues may contact:

Sander Genser, M.D., M.P.H.
Division of Clinical and Services Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-08
Rockville, MD  20857
Telephone:  (301) 443-1801
FAX:  (301) 443-6566
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  [email protected]

Although not participating in this RFA, the Demographic and Behavioral Sciences
Branch of NICHD also funds research on sexual behaviors related to HIV (see
Program Announcement PA-97-093).  NICHD has a longstanding commitment to research
focusing on sexual behavior, behavior change and HIV prevention, especially among
men and women of reproductive age (including adolescents), and among vulnerable
populations.

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.279.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241
and 285), and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  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 promote the non-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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