RESEARCH ON ANABOLIC STEROID ABUSE

NIH GUIDE, Volume 21, Number 18, May 15, 1992



PA:  PA-92-80



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Social Psychology 

  Neurophysiology 

  Steroids 

  Risk Factors/Analysis 

  Chemistry, Analytical 



National Institute on Drug Abuse

National Institute of Child Health and Human Development

National Institute of Diabetes and Digestive and Kidney Disease

National Cancer Institute

National Institute of Arthritis and Musculoskeletal and Skin Diseases



PURPOSE



The purpose of this announcement is to stimulate research and provide

information to combat the misuse and abuse of anabolic steroids.



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, Research on Anabolic Steroid Abuse, is related to the

priority area of alcohol and other drugs.  The specific goal stated in

"Healthy People 2000" is the reduction of anabolic steroid use among

male high school seniors to three percent.  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 domestic and foreign, public or

private, non-profit or profit-making organizations such as

universities, colleges, hospitals, laboratories, units of State and

local governments, and eligible agencies of the Federal Government.

Women and minority investigators are encouraged to apply.  Foreign

organizations are not eligible for the R29 award.



MECHANISMS OF SUPPORT



Support mechanisms include:  Research Project (R01), small grant (R03),

and First Independent Research Support and Transition (FIRST) Awards.

Most investigator-initiated research are supported by research project

grants.  A research project grant is awarded to an institution on

behalf of a Principal Investigator who has designed and will direct a

specific project or set of projects.  A research project grant can be

renewed at intervals or supplemented through the formal submission and

review process described below.  An investigator may apply for a

renewal (competing continuation) of an R01 grant by submitting an

application for further support, including a report of progress and

specific plans for future work.  For information on the special

requirements of the FIRST Award (R29) and the National Institute on

Drug Abuse Small Grant (R03), contact the program staff listed at the

end of this announcement.



RESEARCH OBJECTIVES



The widespread abuse of anabolic-androgenic steroids [derivatives of

testosterone possessing both androgenic (virilizing) and anabolic

(tissue building) properties, hereafter referred to as anabolic

steroids] is a significant public health concern. Anabolic steroids are

taken to enhance athletic performance and/or physical appearance.  Of

particular concern is the widespread use of anabolic steroids by

adolescents.



In order to develop effective prevention efforts for anabolic steroid

abuse, epidemiological and etiological studies are needed to

characterize: the nature and extent of anabolic steroid use among the

variety of sub-populations who use these drugs, the motivations for use

by these subgroups, and the effectiveness of urine testing and other

discouragement policies.  Prevention efforts also are hampered by the

lack of credible information on the consequences of anabolic steroid

abuse.  Data are needed on both short- and long-term health effects;

psychological effects, including the possibility of dependence; and

social consequences.  In addition, the use of injectable steroids

raises the possibility of human immunodeficiency virus (HIV)

transmission through needle-sharing.  Therefore, data are needed on the

prevalence of needle-sharing among the sub-populations of anabolic

steroid users.



Examples of research topics relevant to this announcement include:



o  Studies to determine whether or not there are significant

neuropsychiatric and psychosocial effects of anabolic steroid use.

Examination of the profile of behavioral activity, elucidation of

underlying neurobiological effects.



o  Studies to determine both the long-term sequelae and short-term

biomedical effects of use and abuse of anabolic steroids in both male

and female adolescents and adults.  The occurrence and nature of these

effects should be correlated with such factors as the particular

steroid(s) used, doses and dosing regimens, and duration of steroid

exposure.  Areas of interest include effects on the

hypothalamic-pituitary-gonadal axis, peri- and post-pubertal growth and

body composition, effects on hepatic lipid metabolism and lipoproteins,

cancer etiology studies examining cellular and molecular effects on the

liver and other susceptible tissues.



o  Determination of the incidence and prevalence of anabolic steroid

use in the general population and its determinants.  Characterization

of anabolic steroid users, e.g., socioeconomic status, race,

educational level, and participation in competitive athletics.



o  Prevention research with focus on the following objectives:  (1)

measurement of the extent of the drug problem, (2) identification of

salient psychosocial risk factors, and (3) development and testing of

the efficacy of theory-based preventive interventions.



o  Improved techniques for analytical testing of anabolic steroids.

Studies of how sports organizations integrate anabolic steroid testing

into overall drug testing programs.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements will be required to include

minorities and women 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 diseases, disorders

and conditions which disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale should be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information should be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5 Human

Subjects.



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 research

projects to include representation of the full array of United States

racial/ethnic minority populations (i.e., Native Americans (including

American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,

Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research includes human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.



All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.



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 receipt dates for

applications for AIDS-related research are found in the PHS 398

instructions.  The number and title of this announcement, "Research on

Anabolic Steroid Abuse, PA-92-80," must be typed in item number 2a of

the face page of the PHS 398 application form.



Application kits containing the necessary forms and instructions may be

obtained from business offices or offices of sponsored research at most

universities, colleges, medical schools, and other major research

facilities.  These forms may also be obtained from the Office of Grants

Inquiries, Division of Research Grants,  National Institutes of Health,

Westwood Building, Room 240, Bethesda, MD 20892, telephone

301/496-7979.



The signed original and five permanent legible copies of the completed

application must be sent to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



The Division of Research Grants, NIH, serves as a central point for

receipt of applications for most discretionary PHS grant programs.

Applications received under this announcement will be assigned to an

initial review group (IRG) in accordance with established Public Health

Service Referral Guidelines.  The IRG, consisting primarily of

non-Federal scientific and technical experts, will review the

applications for scientific and technical merit.  Notification of the

initial review recommendations will be sent to the applicant after the

initial review.  Applications will receive a second-level review by the

appropriate National Advisory Council.  Only applications recommended

for further consideration by the Council may be funded.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to the Institute/Center/Division.  The following

will be considered when 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



INQUIRIES



Direct inquiries regarding programmatic issues to:



Lynda Erinoff, Ph.D.

Neuroscience Research Branch

Division of Preclinical Research

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-19

Rockville, MD  20857

Telephone:  (301) 443-6975



Gilman Grave, M.D.

Chief, Endocrinology, Nutrition and Growth Branch

Center for Research for Mothers and Children

National Institute of Child Health and Human Development

Executive Plaza North, Room 637

Bethesda, MD  20892

Telephone:  (301) 496-5593



Philip F. Smith, Ph.D.

Director, Endocrinology Research Program

Division of Diabetes, Endocrinology, and Metabolic Diseases

National Institute of Diabetes and Digestive and Kidney Diseases

Westwood Building, Room 621

Bethesda, MD  20892

Telephone:  (301) 496-7341



Lea Sekely, Ph.D.

Chemical Carcinogenesis Branch

Division of Cancer Etiology

National Cancer Institute

Executive Plaza North, Room 700

Bethesda, MD  20892

Telephone:  (301) 496-5471



Stephen Gordon, Ph.D.

Musculoskeletal Diseases Program Director

National Institute of Arthritis and Musculoskeletal and Skin Diseases

5333 Westbard Avenue, Room 407

Bethesda, MD  20892

Telephone:  (301) 402-3338



Direct inquiries regarding fiscal matters to:



Shirley Ann Denney

Chief, Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



E. Douglas Shawver

Office of Grants and Contracts

National Institute of Child Health and Human Development

Executive Plaza North, Room 501

Bethesda, MD  20892

Telephone:  (301) 496-1303



Bruce Butrum

Grants Management Branch

Division of Extramural Activities

National Institute of Diabetes and Digestive and Kidney Diseases

Westwood Building, Room 649

Bethesda, MD  20892

Telephone:  (301) 496-7467



Jean Cahill

Team Leader, Grants Administration Branch

National Cancer Institute

Executive Plaza South, Room 243

Bethesda, MD  20892

Telephone:  (301) 496-7800, ext. 47



Diane Watson

Grants Management Officer

National Institute of Arthritis and Musculoskeletal and Skin Diseases

5333 Westbard Avenue, Room 403

Bethesda, MD  20892

Telephone:  (301) 402-3352



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

Nos. 93.279, 93.399, 93.849, 93.865, 93.846.  Awards are made under

authorization of the Public Health Service Act, sections 301 and 515

(42 USC 241 and 290cc) and administered under PHS grants policies and

Federal Regulations 42 CFR 92 and 45 CFR Part 74.  This program is not

subject to the intergovernmental review requirements of Executive Order

12372 or Health Systems Agency review.



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