BIOMEDICAL FACTORS IN DRUG ABUSE ETIOLOGY AND CONSEQUENCES

NIH GUIDE, Volume 22, Number 9, March 5, 1993



PA NUMBER:  PA-93-060



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Etiology 

  Epidemiology 



National Institute on Drug Abuse



PURPOSE



The National Institute on Drug Abuse (NIDA) is soliciting

applications for exploratory/developmental grants for research on the

Biomedical Factors in Drug Abuse Etiology and Consequences.  The

purpose is to encourage investigations into biomedical factors in the

etiology, escalation, consequences, and epidemiology of drug abuse.

Exploratory/Developmental grants (R21) are intended to encourage new

research activities which will be building blocks in the development

of future, more intensive and larger research studies.



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 program

announcement, Biomedical Factors in Drug Abuse Etiology and

Consequences, is related to the priority area of alcohol and other

drug abuse.  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:  202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by foreign and domestic, non-profit and

for-profit organizations, public and private, such as colleges,

universities, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.  Woman

and minority investigators are encouraged to apply.



MECHANISM OF SUPPORT



The research support mechanism is limited to

Exploratory/Developmental grants (R21).  This mechanism is intended

to encourage new research projects in undeveloped subject areas.  It

is expected that applicants will be experienced investigators whose

previous research may be in related areas (of substance abuse

including alcohol) or more distantly related areas (e.g., mental

health), but whose expertise is applicable to research objectives for

this announcement.  Grants supported under this mechanism are limited

to a two-year effort and a maximum of $90,000 in direct costs per

year.  However, well-justified costs exceeding $90,000 may be

considered only in exceptional cases (e.g., PET imaging technology).

(New investigators or investigators with established research in

related areas should apply under other appropriate mechanisms.)  A

no-cost extension of up to one year may be effected by the grantee

institution prior to expiration of the project period.  Annual awards

will be made subject to continued availability of funds and progress

achieved.



It is estimated that funds will be available for approximately four

to five exploratory/developmental awards each year under this

announcement.  The final number of applications will depend on

appropriated funds and program priorities at the time of award.



RESEARCH OBJECTIVES



The objectives of the exploratory/developmental grants (P21) are to

explore, discover, and document relationships with biomedical factors

that are possible causes or consequences of substance abuse.

Biomedical, in this sense, refers to biologically based factors

(which are separate from, but may be influenced by, environmental

factors) that may be related to a medically relevant condition.

These objectives are to:



(1) Plan and conduct research that will assess the prevalence,

distribution, and epidemiology of biomedical risk factors underlying

the vulnerability to abuse drugs, following the initial exposure.



(2) Plan and conduct research that will assess the type and

distribution of the biomedical consequences of abusing drugs.



(3) Conduct pilot studies leading to new programs that would enhance

the prediction of factors contributing to the biomedical etiology of

drug abuse.



(4) Modify and further develop existing technologies and

methodologies for studying the biomedical risk factors of drug abuse.

In addition, NIDA is interested in projects that focus on biomedical

aspects of drug abuse that might be unique to special groups such as

women, neonates and infants, adolescents and youth, the elderly, and

minority or ethnic populations.



Applications solicited by this announcement are pertinent to a broad

range of measurement and methodological issues, including the

creation, development, modification, or enhancement of instruments,

techniques and analytic strategies to assist in research on the

epidemiology, etiology, vulnerability, or consequences of drug abuse.

Basic research projects should develop new information about how

individual differences for biomedical profiles are predictive of drug

abuse or, alternatively, protection from drug abuse.



Specific goals may include, but are not limited to:



1.  Identifying concomitants for drug craving to determine if

individuals may be distinguished on this basis, thereby improving

chances for prevention and treatment.



2.  Modifying technologies that have been traditionally used in other

applications (e.g., alcohol) so that they may be applied to the

biomedical aspects of drug abuse.



3.  Analyzing appropriate variables collected in large data sets that

would provide preliminary information on the epidemiology, etiology,

and consequences of drug use.



4.  Developing promising avenues of inquiry for understanding the

multiple consequences of drug abuse for several variables including

biological, physiological, and other biomedical factors.



5.  Determining individuals at risk for vulnerability to drug-induced

organ and tissue damage which lead to neurological,

psychopathological, neurophysiological, hormonal, metabolic,

immunological, or physiological dysfunction.  Studies may include

genetic susceptibilities as well as developmental or degenerative

mechanisms.



6.  Determining whether maternal drug use potentiates abnormalities

in offspring for physiological, development, and cognitive

conditions.



7.  Determining whether psychological or neuropsychological function

or dysfunction, or psychopathological disorders are associated with

physiological conditions predictive of drug abuse.



8.  Determining whether familial or environmental factors contribute

to physiological changes that influence drug abuse.  Examples include

(but are not limited to) stress factors, dietary practices,

preventive health care, and environmental toxins or teratogens.



9.  Determining whether individual differences in brain metabolism,

neuroanatomical structures, or patterns of neurophysiological

function (e.g., neuronal firing, neurotransmitter efficiency) are

predictive of escalation of drug use, or protection from drug abuse.



STUDY POPULATIONS



NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS

IN RESEARCH



Applications for grants and cooperative agreements that involve human

subjects are required to include minorities and both sexes in study

populations so that research findings can be of benefit to all

persons at risk of the disease, disorder, or condition under study;

special emphasis should be placed on the need for inclusion of

minorities and women in studies of disease, disorders and conditions

which disproportionately affect them.  This policy applies to all

research involving human subjects and human materials, and applies to

males and females of all ages.  If one sex and/or minorities are

excluded, or are inadequately represented in this research,

particularly in proposed population-based studies, a clear compelling

rationale for exclusion or inadequate representation should be

provided.  The composition of the proposed study population must be

described in terms of sex and racial/ethnic group, together with a

rationale for its choice. In addition, sex and racial/ethnic issues

should be addressed in developing a research design and sample size

appropriate for the scientific objectives of the study.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However,

NIH recognizes that it may not be feasible or appropriate in all

clinical research projects to include representation of the full

array of United States racial\ethnic minority populations (i.e.,

American Indians or Alaskan Natives, Asians or Pacific Islanders,

Blacks, Hispanics).  Investigators must provide the rationale for

studies on single minority population groups.



Applications for support of research involving human subjects must

employ a study design with minority and/or sex representation (by age

distribution, risk factors, incidence/prevalence, etc.), appropriate

to the scientific objectives of the research.  It is not an automatic

requirement for the study design to provide statistical power to

answer the questions posed for men and women and racial/ethnic groups

separately; however, whenever there are scientific reasons to

anticipate differences between men and women, and racial/ethnic

groups, with regard to the hypothesis under investigation, applicants

should include an evaluation of these sex and minority group

differences in the proposed study.  If adequate inclusion of one sex

and/or minorities is impossible or inappropriate with respect to the

purpose of the research, because of the health of the subjects, or

other reasons, or if in the only study population available, there is

a disproportionate representation of one sex or minority/majority

group, the rationale for the study population must be well explained

and justified.



The NIH funding components will not make awards of grants,

cooperative agreements or contracts that do not comply with this

policy.  For research awards which are covered by this policy,

awardees will report annually on enrollment of women and men, and on

the race and ethnicity of the subjects.



APPLICATION PROCEDURES



Applications are to be submitted on the grant application form PHS

398 (rev. 9/91) and will be accepted at the standard application

deadlines as indicated in the application kit.  The receipts dates

for AIDS-related research are found in the PHS 398 instructions.



Application kits are available at most institutional offices of

sponsored research and may be obtained from the Office of Grants

Inquiries, Division of Research Grants, National Institutes of

Health, Westwood Building, Room 249, Bethesda, MD 20892, telephone

(301) 496-7441.  The title and number of the announcement must be

typed in Item 2a on the face page of the application.



The completed original application and five legible copies of the

research application) must be sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



The Division of Research Grants (DRG) serves as a central point for

receipt of applications for most discretionary PHS grant programs.

Applications received under this announcement will be assigned on the

basis of established Public Health Service referral guidelines.

Applications will be reviewed for scientific and technical merit by

an Initial Review Group (IRG) in accordance with the review criteria

described below.  Notification of the review recommendations will be

sent to the applicant after the initial review.  Applications will

receive a second-level review by an appropriate National Advisory

Council, whose review may be based on policy considerations as well

as scientific merit.  The following criteria will be considered when

assessing the merit of an exploratory/developmental application:



1.  The expected significance of the proposed research to provide a

basis for future development of the research area.



2.  The cogency of the hypotheses on which the proposed research is

based.



3.  The appropriateness and adequacy of the experimental design,

including the adequacy of the methodology for selection of subjects

and/or collection of data, overall research scheme, instrumentation,

and statistical analysis.



4.  The adequacy of the qualifications (including level of education

and training) and relevant research experience of the principal

investigator and key research personnel.



5.  The availability of adequate facilities, general environment or

the conduct of proposed research, other resources, and collaborative

arrangements necessary for the research.



6.  The appropriateness of budget estimates for the proposed research

activities.



AWARD CRITERIA



Applications will compete for available funds with all other

applications recommended for further consideration assigned to the

Institute.  The following will be considered in making funding

decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement



Terms and Conditions of Support



Grant funds may be used for expenses clearly related and necessary to

conduct research projects, including both direct costs that can be

specifically identified with the project and allowable indirect costs

of the institution.  Funds may not be used to establish, add a

component to, or operate a treatment, rehabilitation, or prevention

intervention service program.  Support for research-related

treatment, rehabilitation, or prevention services and programs may be

requested only for costs required by the research.  These costs must

be justified in terms of research objectives, methods, and designs

which promise to yield generalizable knowledge and/or make a

significant contribution to theoretical concepts.  These awards are

not renewable.



Grantees are expected to submit to their project officer three copies

of the final reports of their research within 90 days of the

project's termination.  The final report should contain at least the

following:  a literature review, a clear statement of methodology

employed, and a clear exposition of the practical implications for

further research.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is

welcomed.



Direct inquiries on programmatic issues to:



Harold Gordon, Ph.D. or Meyer D. Glantz, Ph.D.

Division of Epidemiology and Prevention Research

National Institute on Drug Abuse

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-2974



The National Institute of Neurological Disorders and Stroke (NINDS)

supports research focusing on the determinants of normal and

pathological development of the nervous system from the genetic to

the environmental.



Direct inquiries to:



Giovanna M. Spinella, M.D.

Division of Convulsive Developmental, and Neuromuscular Disorders

National Institute of Neurological Disorders and Stroke

Federal Building, Room 8C10

Bethesda, MD  20892

Telephone:  (301) 496-5821



Direct inquiries regarding fiscal matters to:



Shirley A. Denney

Grants Management Branch

National Institute on Drug Abuse

Parklawn Building, Room 8A-54

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-6710



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, Section 301 (42 USC 241).  Federal

regulations at 42 CFR Part 52, "Grants for Research Projects," and

Title 45 CFR Parts 74 and 92, generic requirements concerning the

administration of grants, are applicable to these awards. The program

is not subject to the intergovernmental review requirements of

Executive Order 12372 or Health Systems Agency review.



.

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