kristoff@GENBANK.BIO.NET (Dave Kristofferson) (08/23/90)
NIH GUIDE - Vol. 19, No. 31, August 24, 1990
NOTICES
NIH REGIONAL CONFERENCE IN GRANTS ADMINISTRATION .........(84/117).......... 1
National Institutes of Health
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CLINICAL CENTERS FOR AN ASSESSMENT OF THE EFFICACY OF MINOCYCLINE IN THE
TREATMENT OF RHEUMATOID ARTHRITIS (RFP) ..................(123/152)......... 1
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES
DETAILED DRUG EVALUATION OF ANTI-AIDS AGENTS (RFP) .......(161/219)......... 2
National Cancer Institute
Index: CANCER
INVESTIGATIONAL NEW DRUG TOXICOLOGY FOR DRUGS TO TREAT AIDS AND
OPPORTUNISTIC INFECTION ASSOCIATED WITH AIDS (RFP) .......(222/272)......... 2
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
RESYNTHESIS OF COMPOUNDS FOR SCREENING (RFP) .............(275/340)......... 3
National Cancer Institute
Index: CANCER
COMPREHENSIVE SICKLE CELL CENTER PROGRAM (RFA HL-90-15-B) ..(343/382)....... 4
National Heart, Lung, and Blood Institute (1723/2292)
Index: HEART, LUNG, BLOOD
MOLECULAR BIOLOGICAL TECHNIQUES FOR STUDYING CLASS I AND II HLA
ANTIGENS (RFA HL-90-14-B) .......................(385/442, 2295/2650)....... 4
National Heart, Lung, and Blood Institute
Index: HEART, LUNG, BLOOD
ANIMAL FACILITY IMPROVEMENTS FOR SMALL RESEARCH PROGRAM (RFA RR-90-03) ..... 5
National Center for Research Resources (445/541, 3296/3881)
Index: RESEARCH RESOURCES
RECOGNITION AND MANAGEMENT OF PERILYMPHATIC FISTULA (RFA DC-90-02) ......... 6
National Institute on Deafness and Other Communication Disorders
Index: DEAFNESS, COMMUNICATION DISORDERS (544/638, 3884/4493)
ONGOING PROGRAM ANNOUNCEMENTS
ALCOHOL-RELATED TRAUMA: RESEARCH ON REFERRAL AND TREATMENT (PA-90-26) ..... 8
National Institute on Alcohol Abuse and Alcoholism (644/832)
Index: ALCOHOL ABUSE, ALCOHOLISM
APPLIED RESEARCH INTO THE PROCESS OF ALCOHOLISM TREATMENT (PA-90-27) ......10
National Institute on Alcohol Abuse and Alcoholism (835/1062)
Index: ALCOHOL ABUSE, ALCOHOLISM
SMALL GRANTS FOR INNOVATIVE TECHNOLOGY (PA-90-28) ....(1065/1198)...........13
National Center for Research Resources (1604/1720)
Index: RESEARCH RESOURCES
MINORITY CLINICAL ASSOCIATE PHYSICIAN SUPPLEMENTS TO GENERAL CLINICAL
RESEARCH CENTER GRANTS (PA-90-29) ...............(1201/1314, 2653/2995).....15
National Center for Research Resources
Index: RESEARCH RESOURCES
CLINICAL ASSOCIATE PHYSICIAN SUPPLEMENTS TO GENERAL CLINICAL RESEARCH
CENTER GRANTS (PA-90-30) ........................(1317/1412, 2998/3293).....16
National Center for Research Resources
Index: RESEARCH RESOURCES
ERRATUM
NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS (RFA HS-90-01) ........17
Agency for Health Care Policy and Research (1418/1428)
POLICY NOTICE
NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN IN STUDY POPULATIONS ........18
National Institutes of Health (1444/1539)
Alcohol, Drug Abuse, and Mental Health Administration
NOTE: The NIH Guide for Grants and Contracts will not be published
on August 31. The next issue will be September 7.
NOTICES
NIH REGIONAL CONFERENCE IN GRANTS ADMINISTRATION
P.T. 42; K.W. 1014006
National Institutes of Health
A two-day conference on National Institutes of Health grants administration is
planned for October 11-12, 1990 at the University of Washington, Seattle,
Washington. The conference is hosted by the University of Washington and is
targeted for research administrators at institutions in the Pacific Northwest
region of the U.S.
Although the focus of the conference is on grants administration, program
topics will also be of interest to researchers. On the first day, the morning
session concentrates on the peer review process including trends, application
development, and electronic grant application development. In the afternoon,
discussions feature special interest topics in extramural research such as
initiatives for underrepresented minorities and current issues in training
programs.
The second day begins with a session on funding issues including a budget case
study. In addition, the Federal Demonstration Project will be discussed as
well as specific issues relating to grants administration. Program income and
lab safety are two topics to be addressed in the afternoon.
Mr. Geoffrey Grant, Grants Policy Officer in the Office of Extramural Research
at NIH, representatives from the Division of Research Grants, and grants
management and program staff of several awarding components of NIH are
featured speakers.
Conference schedule and fee information will be mailed in late August 1990.
Mr. Donald Allen, University of Washington, is chairman of the conference.
For more information, contact Mr. Allen or Ms. Ginger Draper at (206)
543-4043.
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CLINICAL CENTERS FOR AN ASSESSMENT OF THE EFFICACY OF MINOCYCLINE IN THE
TREATMENT OF RHEUMATOID ARTHRITIS
RFP AVAILABLE: RFP-NIH-NIAMS-90-1
P.T. 34; K.W. 0715010, 0755015, 0740025
National Institute of Arthritis and Musculoskeletal and Skin Diseases
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) is seeking organizations to serve as the clinical centers for a
multicenter, randomized, double-blind, placebo-controlled clinical trial that
will assess the efficacy of minocycline hydrochloride in the treatment of
rheumatoid arthritis. The clinical centers shall participate with a
coordinating center and the NIAMS in all phases of the clinical trial. NIAMS
plans to fund one to three centers from this solicitation.
Request for Proposal (RFP) No. NIH-NIAMS-90-1 will be issued on or about
August 21, 1990. Proposals will be due on November 20, 1990. To receive a
copy of this RFP, please supply this office with two self-addressed mailing
labels, and cite the RFP number referenced above. Requests for the RFP must
be in writing and addressed to:
Shirley A. Shores
Contracting Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 602
Bethesda, MD 20892
This advertisement does not commit the Government to make an award.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 1
DETAILED DRUG EVALUATION OF ANTI-AIDS AGENTS
RFP AVAILABLE: NCI-CM-17525-27
P.T. 34; K.W. 0715008, 0740018, 0740020
National Cancer Institute
The Developmental Therapeutics Program (DTP), Division of Cancer Treatment
(DCT), National Cancer Institute (NCI), is seeking contractors to conduct a
number of specialized in vitro and in vivo studies on compounds that are known
to inhibit the growth and/or cytopathic effects of human immunodeficiency
virus (HIV) and other similar retroviruses. Studies will be conducted to
assess the antiviral efficacy of potential anti-HIV agents newly identified by
the DTP anti-HIV in vitro screen. Emphasis will be placed on experiments to
determine the influence of dose, exposure time, and route of administration on
the antiviral activity of new agents in small animal retroviral model(s), and
to compare the in vivo effects with the in vitro effects obtained with the
same virus. Additional studies may include those to evaluate compound
tolerance in small animals, compare efficacies of related compounds, and
determine the synergistic potential of compounds in combination. Information
gathered by the contract will be used to help in the determination of the most
appropriate candidate compound(s) for development and to devise and recommend
treatment strategies for clinical trial. In order to protect the laboratory
environment and safety of personnel, any offeror proposing to conduct studies
using HIV (or other retroviruses with similar pathogenic potential in man),
must utilize facilities meeting Biosafety Level 3 criteria. Compounds to be
studied will be selected and assigned by the Government. As compounds of a
commercially confidential nature (discreet) may be evaluated, pharmaceutical
and chemical firms will be excluded from the competition. Also, since
structural formulae of discreet materials may be provided by the Government on
occasion, the organization must be willing to sign a confidentiality of
information statement.
The Principal Investigator (PI) should have: an M.D., D.V.M., or Ph.D. in one
of the relevant biological sciences (or equivalent experience). He/She should
have managerial experience and experience either in managing an in vivo
screening program utilizing small animals or in evaluating the efficacy,
toxicity, or mechanism of antiviral agents. The PI should devote
approximately 25 percent of his/her time to the project. The NCI expects to
award one incrementally funded contract for three (3) years. Each increment
will be for one year. The contract will be written on a "level of effort"
basis specifying that the contractor is to furnish approximately 31,500 direct
labor hours over three years (10,500 labor hours per year).
RFP No. NCI-CM-17525-27 will be available on or about September 13, 1990.
Responses will be due November 2, 1990. Copies of the RFP may be obtained by
sending a written request to:
Mr. Johnny Jordan
Contract Specialist
Treatment Contracts Section
Research Contracts Branch, OAM
National Cancer Institute
Bethesda, MD 20892
This project is a recompetition of the work being done under contract number
N01-CM-87274 Southern Research Institute, Alabama. No collect calls will be
accepted.
INVESTIGATIONAL NEW DRUG TOXICOLOGY FOR DRUGS TO TREAT AIDS AND OPPORTUNISTIC
INFECTION ASSOCIATED WITH AIDS
RFP AVAILABLE: NIH-NIAID-DAIDS-91-11
P.T. 34; K.W. 0715008, 0740020, 1007009, 0715125
National Institute of Allergy and Infectious Diseases
The Developmental Therapeutics Branch (DTB) of the Division of AIDS (DAIDS),
National Institute of Allergy and Infectious Diseases (NIAID), NIH, is seeking
contractors with expertise in providing for preclinical toxicology studies in
rodents and large-animal models (dogs). The resources to be obtained will
complement the National Cooperative Drug Discovery Group effort, contract
screening programs for opportunistic infections (OI) within NIAID, and other
drug development resources already in place within the Division of AIDS and
will complete the basic drug development capability needed by the Institute.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 2
These resources will facilitate the development of promising OI therapies and
encourage the pharmaceutical sector to assume the sponsorship of these agents
as rapidly as possible. The studies MUST be conducted under Good Laboratory
Practice (GLP) conditions as mandated by the Food and Drug Administration
(FDA) and will include: range finding studies; single and multiple dose
toxicology studies; pharmacokinetics in both rodents and large animals; and
immunotoxicity studies in rodents. Offerors must have GLP certification from
the FDA at the time of proposal. Sample protocols previously approved by FDA
and used for this kind of testing (and indicative of the kind of protocol that
may be required), will be provided with the RFP.
This announcement is a new solicitation. The proposed project would be a
completion-type, cost-reimbursable contract (one award expected) for a period
of five years, to begin approximately April 15, 1991. Copies of
RFP-NIH-NIAID-DAIDS-91-11 will be available on or about August 28, 1990, with
offers due approximately October 16, 1990.
To receive a copy of the RFP, please supply this office with a written request
and two self-addressed mailing labels:
Mr. Bruce E. Anderson, Contract Specialist
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Contract Management Branch
AIDS Preclinical Contracts Section
6003 Executive Blvd., Rm 222P
Bethesda, MD 20892
Telephone: (301) 496-8371
All responsible sources may submit a proposal which will be considered.
This advertisement does not commit the Government to make an award.
RESYNTHESIS OF COMPOUNDS FOR SCREENING
RFPs AVAILABLE: NCI-CM-17528-19 and NCI-CM-17517-19
P.T. 34; K.W. 0740020, 1003006, 1003012
National Cancer Institute
The Drug Synthesis and Chemistry Branch of the Developmental Therapeutics
Program, Division of Cancer Treatment, National Cancer Institute (NCI), is
seeking contractors with established expertise in the field of synthesis of
organic and inorganic compounds to prepare those compounds deemed of interest
to the program for evaluation as antitumor and AIDS antiviral agents.
Compounds chosen for synthesis will include: known compounds chosen from
literature on the basis of biological activity or structural interest; samples
required for follow-up testing and which are no longer available from the
original source; and small series of compounds, which are closely related
structurally to an active lead. Compounds assigned for synthesis will
include: carbocycles; heterocycles typically containing nitrogen, oxygen, and
sulfur; carbohydrates; nucleosides; and metal coordination complexes. As many
as 200 compounds may be assigned over the life of this project. Amounts of
compounds to be synthesized will vary widely but will usually be in the range
from 100 mg to 5 grams.
The Contractor's Principal Investigator should be trained in synthetic organic
chemistry at the Ph.D. level and have experience in the design and efficient
synthesis of complex molecules which possess multiple chiral centers.
The NCI signs legally binding agreements with some suppliers (often
pharmaceutical or chemical companies) that state that all information on
compounds donated by those suppliers will be held confidential. The
successful offeror may be assigned a confidential compound as a synthesis or
modification target. A chemical or pharmaceutical company could gain valuable
data on confidential new lead compounds. The NCI believes that, in order to
honor the confidentiality agreement with suppliers and in order to avoid any
chance of transmitting privileged data to a competitor, pharmaceutical and
chemical companies are excluded from this procurement. For the purpose of the
solicitation, a pharmaceutical/chemical company is defined as an organization
which manufactures and/or sells drugs and/or chemicals.
Two related RFP's for the "Resynthesis of Compounds for Screening" are
currently available. RFP No. NCI-CM-17528-19 is an open competition and RFP
No. NCI-CM-17517-19 is a 100 percent Small Business Set-Aside. Offerors who
qualify as a small business are encouraged to submit proposals under both
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 3
RFP's, however, not more than one award of the total available two to three
awards (under both RFPs) will be made to any single offering organization.
RFP Nos. NCI-CM-17528-19 and NCI-CM-17517-19 will be issued upon written
request to Zetherine Gore, Contract Specialist, on or about August 20, 1990.
Proposals will be due approximately seven weeks thereafter. The contract
period is to be three years, beginning approximately September 1991. The
incumbent Contractors are New Mexico State University, Las Cruces, New Mexico;
Southern Research Institute, Birmingham Alabama; and Starks Associates, Inc.,
Buffalo, New York.
Copies of the RFP may be obtained by sending a written request to:
Ms. Zetherine Gore, Contract Specialist
National Institutes of Health
National Cancer Institute
Research Contracts Branch,TCS
Executive Plaza South, Room 603
9000 Rockville Pike
Bethesda, MD 20892
COMPREHENSIVE SICKLE CELL CENTER PROGRAM
RFA AVAILABLE: HL-90-15-B
P.T. 04; K.W. 0715032, 0745020, 0745027, 0745070, 0403004
National Heart, Lung, and Blood Institute
Application Date: September 16, 1991
The Division of Blood Diseases and Resources of the National Heart, Lung, and
Blood Institute (NHLBI), National Institutes of Health, announces the
availability of a Request for Application (RFA) for the Comprehensive Sickle
Cell Center Program. New applications and applications for renewal of
existing programs are invited. Copies of the RFA and Instructions for the
Preparation of Applications are currently available from NHLBI staff.
The major objective of this program is to provide an environment in which
resources, facilities, and manpower can be coordinated to expedite the
development and application of new knowledge for improved diagnosis,
treatment, and prevention of complications related to sickle cell disease.
These Centers bring together research (basic, clinical, clinical application)
and demonstrations programs in education, counseling, and diagnosis designed
to bridge the gap between scientific inquiry and service and reduce the
morbidity and mortality from sickle cell disease.
In proposed studies involving humans, females should be included in the study
population, otherwise a clear rationale for their exclusion must be provided
in the application.
The requirements and format for application submitted in response to the
announcement and copies of the RFA may be obtained from:
Charles A. Wells, Ph.D.
Health Scientist Administrator
Sickle Cell Disease Branch
National Heart, Lung, and Blood Institute
Federal Building, Room 508
Bethesda, MD 20892
Telephone: (301) 496-6931
MOLECULAR BIOLOGICAL TECHNIQUES FOR STUDYING CLASS I AND II HLA ANTIGENS
RFA AVAILABLE: HL-90-14-B
P.T. 34; K.W. 1002008, 0710070, 0745065
National Heart, Lung, and Blood Institute
Application Receipt Date: November 29, 1990
The Division of Blood Diseases and Resources (DBDR), National Heart, Lung, and
Blood Institute (NHLBI), invites grant applications for a single competition
to support research and development to: (1) apply molecular biological
techniques to the determination of HLA class I and class II alleles; (2)
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 4
compare these type designations with the currently used serological results;
and (3) emphasize especially the application of these procedures to the HLA
class I and II typing of minority population groups.
The NHLBI has assumed responsibility for the National Marrow Donor Program
(NMDP), which has as a major goal the provision of carefully HLA-matched,
unrelated bone marrow donors for patients in need of a transplant, but without
related donors. As part of this responsibility, the NHLBI would like to
encourage the application of molecularly-based HLA class I and II typing of
patients and donors. It is particularly important to define various alleles
at the molecular level, comparing these findings with those obtained by
serological techniques and determining the importance to bone marrow
transplantation of the degree and characteristics of molecular matching. For
appropriate projects and under appropriate circumstances, cultured cells from
donor-recipient pairs (now greater than 315) in the NMDP repository may be
made available to qualified investigators. The outcome of the marrow
transplant is known for each of these pairs.
Women and minority individuals should be included in the study population,
otherwise a clear rationale for their exclusion must be provided in the
application. Minority institutions are encouraged to apply and other
institutions should attempt to establish collaborative arrangements with
minority institutions.
The requirements and format for applications submitted in response to this
announcement, and copies of the RFA, may be obtained from:
Paul R. McCurdy, M.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
Federal Building, Room 516
Bethesda, MD 20892
Telephone: (301) 496-8387
Luiz H. Barbosa, D.V.M.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
Federal Building, Room 504
Bethesda, MD 20892
Telephone: (301) 496-1537
ANIMAL FACILITY IMPROVEMENTS FOR SMALL RESEARCH PROGRAMS
RFA AVAILABLE: RR-90-03
P.T. 34; K.W. 1002002
National Center for Research Resources
Application Receipt Date: December 3, 1990
BACKGROUND
The National Center for Research Resources (NCRR) is announcing a competitive
grant program to assist institutions with small biomedical research programs
using animals to upgrade and develop their animal facilities. The NCRR
anticipates that $1.5 million may be available to support approximately 15
animal facility improvement grants in Fiscal Year 1991.
RESEARCH GOALS AND SCOPE
Institutional animal resource improvement grants are awarded to assist
biomedical research and educational institutions in upgrading their animal
facilities and developing a centralized animal care program. A major
objective is to enable institutions to comply with the USDA Animal Welfare Act
and DHHS policies on the care and use of animals. These awards are limited to
Alterations and Renovations (A&R) to improve laboratory animal facilities, and
related major resource equipment, such as animal cages and cage washers. It
is not the purpose of the improvement grant to provide general operating costs
for the resource.
To gain approval and support, both the need for resource improvement as well
as a sound plan to meet the requirements of the Public Health Service Policy
on Humane Care and Use of Laboratory Animals must be presented and described
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 5
in the context of the biomedical research and research training program of the
institution.
ELIGIBILITY AND REVIEW
Any domestic public, or private institution, organization or association
receiving less than $500,000 (direct costs) in the institution's current
fiscal year, for one or more research projects supported by agencies of the
Public Health Service and involving the use of animals, is eligible to apply.
Institutions are expected to develop a single proposal for campus-wide
service.
Applications will be received by the Division of Research Grants. Applicants
must use Form PHS 398 (Revised 10/88), "Application for Public Health Service
Grant." There will be a single receipt date of December 3, 1990.
Applications received after this date will be returned. The Request for
Applications (RFA) label available in the Application Form PHS 398 (Revised
10/88) must be affixed to the bottom of the face page. All applications
submitted in response to this RFA will be reviewed by Special Review
Committees managed by NCRR for scientific merit, and the National Advisory
Research Resources Council for program considerations. Earliest possible
funding will be July 1991.
MECHANISM OF SUPPORT
Awards will be made as competitive resource grants for a project period of one
year. It is expected that approximately 15 awards will be made in Fiscal Year
1991. The number of grants and the specific amount of the awards will depend
on the merit and scope of the applications received, as well as the
availability of funds. All policies and requirements which govern the grant
programs of the PHS apply.
TERMS OF AWARD
Institutions may request major equipment items for their animal resources as
well as funds for A&R. Support for new construction is not authorized. The
award is limited to $100,000 for A&R and $150,000 for equipment. Matching
funds are not required.
INQUIRIES
A copy of the complete RFA, which describes the research goals and scope,
terms and conditions, review procedures and criteria, and method of applying,
may be obtained by contacting the Animal Resources Program at the following
address:
Director
Laboratory Animal Sciences Program
Animal Resources Program
National Center for Research Resources
5333 Westbard Avenue, Room 857
Bethesda, MD 20892
Telephone: (301) 496-5175
This program is described in the Catalog of Federal Domestic Assistance No.
13.306, Laboratory Animal Sciences Primate Research. Awards will be made
under the authority of the Public Health Service Act, Title III, Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This
program is not subject to the intergovernmental review of Executive Order
12372 or Health Systems Agency review.
RECOGNITION AND MANAGEMENT OF PERILYMPHATIC FISTULA
RFA AVAILABLE: DC-90-02
P.T. 34; K.W. 0715050, 0745070
National Institute on Deafness and Other Communication Disorders
Letter of Intent Receipt Date: October 8, 1990
Application Receipt Date: November 16, 1990
The National Institute on Deafness and Other Communication Disorders (NIDCD)
invites applications for assistance awards to support two-phase studies
leading first to the development and validation of a marker to be used for the
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 6
intraoperative diagnosis of perilymphatic fistula (PLF), and subsequently, to
studies of the clinical diagnosis and treatment efficacy of PLF.
Perilymphatic fistulae are abnormal communications between the fluid
surrounding the membranous labyrinth of the inner ear and the normally
air-filled middle ear space, causing a constellation of symptoms including
sudden or progressive hearing loss and dizziness or vertigo. The diagnosis
and management of PLF has become one of the most controversial issues in
clinical otolaryngology. At the present time there is no generally accepted
radiologic, laboratory, or electrophysiologic test that provides objective,
unequivocal evidence of the defect; there is no pathologic specimen that can
be subjected to laboratory analysis; and photographic documentation techniques
have been inadequate. Currently, surgical exploration of the middle ear is
the only means by which the presence of PLF can be verified, but the
indications for surgical exploration are not uniform and, once the middle ear
is exposed, perilymph cannot be distinguished visually from other adventitious
fluids. As a result, estimates of the incidence and prevalence of PLF vary
widely, although it is possible that it is a significant and often
unrecognized factor in the sudden onset or progression of hearing loss and of
idiopathic, nonspecific dizziness in adults and children.
The goals of this Request for Applications (RFA) are threefold, encompassed
within a two-phase program. Phase 1 is intended to assist groups of
investigators in their attempts to develop and validate a marker substance or
procedure to identify and differentiate perilymph in the middle ear. The
goals for Phase 1 must be met before proceeding to Phase 2 studies. Phase 2
has two goals: first, to conduct clinical studies on objective diagnostic
tests for perilymphatic fistula, leading to the establishment of clinical
criteria for middle ear exploration; and second, to evaluate the relative
efficacy of surgical and non-surgical treatments in alleviating symptoms. All
applicant groups are expected to participate fully in both phases of the
project.
Awards will be made as cooperative agreements which create an assistance
relationship with substantial involvement of NIDCD staff during the
performance of the project, as outlined in this RFA. This mechanism is used
when the NIDCD wishes to stimulate investigator interest and proposes to
advise or assist in an important and opportune area of research. The NIDCD
anticipates making 3-5 awards for project periods of five years. Although
this project is provided for in the financial plans of the NIDCD, the award of
cooperative agreements pursuant to the RFA is contingent on the availability
of funds appropriated in fiscal year 1991.
Inclusion of women and minorities as investigators and/or members of study
populations is encouraged. If they are excluded, reasons for this exclusion
must be specified in the application.
This RFA is a one-time solicitation with a specified deadline of November 16,
1990, for receipt of applications.
The RFA label available in the 10/88 revision of Application Form PHS 398 must
be affixed to the bottom of the face page. Failure to use this label could
result in delayed processing of your application such that it may not reach
the review committee in time for review. In addition, the RFA number and
title should be typed on line 2 of the face page of the application form.
A copy of the complete RFA describing eligibility criteria, the research goals
and scope, the cooperative agreement mechanism, the review criteria, and the
method of applying should be obtained before beginning the application
process. Copies of the complete RFA can be obtained from:
Maureen Hannley, Ph.D.
Program Administrator
Division of Communicative Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
Federal Building, Room 1C-04
7550 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-5061
Inquiries concerning this RFA are encouraged and should be directed to Dr.
Hannley at the address or telephone number listed above.
Awards will be made under the authority of the Public Health Service Act,
Section 301 (42 USC241), and administered under PHS grant policies and Federal
Regulation 42 CFR Part 52, and 45 CFR Part 74. This program is not subject to
review by a Health Systems Agency or to the intergovernmental review
requirements of Executive Order 12372.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 7
ONGOING PROGRAM ANNOUNCEMENTS
ALCOHOL-RELATED TRAUMA: RESEARCH ON REFERRAL AND TREATMENT
PA: PA-90-26
P.T. 34; K.W. 0404003, 0715210, 0745070
National Institute on Alcohol Abuse and Alcoholism
PURPOSE
Given the severity and extent of alcohol-related trauma and the current level
of understanding of related state-of-practice issues, additional research is
sought toward developing effective mechanisms for detection, appropriate
referral, and treatment of patients with trauma related to alcohol
consumption.
RESEARCH OBJECTIVES
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites studies
that examine the trauma setting as a promising but under-utilized arena for
facilitating entry into alcoholism treatment by alcohol-abusing and alcoholic
trauma victims.
In this regard, NIAAA encourages systematic investigations of: (1) methods
for utilizing screening procedures, blood alcohol, urine, and other body fluid
tests and the trauma-related medical history, as well as other laboratory
procedures in the trauma setting for detecting alcoholism, i.e., what methods
(alone and in combination) are found to be the most effective in detecting
alcoholism in the emergency care setting; (2) early management of patients
with alcohol-related trauma in terms of withdrawal considerations and their
effect on the likelihood of entering alcoholism treatment; (3) various factors
that may influence emergency staff referral behavior; and (4) current
techniques for exploiting the trauma event as an opportunity for initiating
treatment for suspected alcohol abuse and dependence in the injured patient.
INCLUSION OF MINORITIES IN STUDY POPULATIONS
Applicants are encouraged to give added attention (where feasible and
appropriate) to the inclusion of minorities in study populations for research
into the etiology of diseases, research in behavioral and social sciences,
clinical studies of treatment and treatment outcomes, research on the dynamics
of health care and its impact on disease, and appropriate interventions for
disease prevention and health promotion. If minorities are not included in a
given study, a clear rationale for their exclusion should be provided.
INCLUSION OF WOMEN IN STUDY POPULATIONS
Applicants are encouraged to consider the inclusion of women in the study
populations for all clinical research efforts. Exceptions would be studies of
diseases that exclusively affect males or where involvement of pregnant women
may expose the fetus to undue risks. Gender differences should be noted and
evaluated. If women are not to be included, a clear rationale should be
provided for their exclusion. In order to provide more precise information to
the treatment community, it is recommended that publications resulting from
research in which the study population was limited to one sex for any reason
other than the disease or condition studied exclusively affects that sex,
should state, in the abstract summary, the gender of the population studied,
e.g., "male patients," "male volunteers," "female patients," or "female
volunteers."
MECHANISMS OF SUPPORT
Research grant support may be requested for a period of up to 5 years
(renewable for subsequent periods). Annaul awards will be made subject to
continued availablity of funds and progress achieved. Grant funds may be used
for expenses clearly related and necessary to carry out research projects,
including both direct costs, which 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 service program. Support for research-related treatment,
rehabilitation, or prevention services and programs may be requested only for
those particular costs and for that period of time required by the research.
These costs must be justified in terms of research objectives, methods, and
designs which promise to yield important generalizable knowledge and/or to
make a contribution to theoretical concepts.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 8
ELIGIBILITY
Applications for alcohol research grants may be made by public or private
non-profit or profit-making organizations such as universities, colleges,
hospitals, laboratories, units of State or local governments, and eligible
agencies of the Federal Government. Women and minorities are encouraged to
apply.
APPLICATION PROCEDURES
Applicants should use the standard research grant application form PHS 398
(rev. 10/88). The title of this announcement, ALCOHOL-RELATED TRAUMA:
RESEARCH ON REFERRAL AND TREATMENT, PA-90-26, should be typed in item number 2
on the face page of the PHS 398 application form.
Application kits containing the necessary forms and instructions (PHS 398) may
be obtained from institutional business offices or offices of sponsored
research at most universities, colleges, medical schools, and other major
research facilities. Application kits may also be obtained from the:
National Clearinghouse for Alcohol and Drug Information
P.O. Box 2345
Rockville, MD 20852
Telephone: (301) 468-2600
The signed original and six permanent, legible copies of the complete
application should be submitted to:
Division of Research Grants, NIH
Westwood Building, Room 240
Bethesda, MD 20892**
REVIEW PROCESS
The Division of Research Grants, NIH, serves as the central point for receipt
of applications under this announcement. Applications received 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 application for
scientific and technical merit. Notification of the review recommendations
will be sent to the Principal Investigator after the initial review.
Applications will receive a second-level review by the relevant National
Advisory Council, whose review may be based on policy as well as scientific
considerations. Only applications recommended for approval by Council may be
considered for funding.
REVIEW CRITERIA
Criteria to be used in the merit review of alcohol research grant applications
will include the following:
1. The overall scientific and technical merit of the proposal.
2. The adequacy of the methodology to carry out the proposed research
including the adequacy of the design for collection and analysis of
data.
3. The adequacy of qualifications (including level of education and
training) and the research experience of the Principal Investigator
and key personnel.
4. Availability of adequate facilities, general environment for the
conduct of the proposed research, other resources, and
collaborative arrangements necessary for the research.
5. Appropriateness of budget estimates for the proposed research
activities.
6. Where applicable, adequacy of procedures to protect or minimize
effects on human subjects.
AWARD CRITERIA AND AVAILABILITY OF FUNDS
Applications recommended for approval will be considered for funding on the
basis of overall scientific and technical merit of the proposal as determined
by peer review, program needs and balance, and availability of funds.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 9
No funds have been set aside specifically for this purpose. Applications
received under this announcement will compete for general FY 1991 funds. The
amount of funding available will depend on appropriated funds and program
priorities at the time of award.
INQUIRIES
Direct inquiries may be addressed to the following NIAAA program staff at 5600
Fishers Lane, Rockville, Maryland 20857:
Fulton Caldwell, Ph.D., C.A.C.
Treatment Research Branch
Division of Clinical and Prevention Research
Room 16C-03
Telephone: (301) 443-0796
John Allen, Ph.D., M.P.A.
Chief, Treatment Research Branch
Division of Clinical and Prevention Research
Room 16C-03
Telephone: (301) 443-0796
This program is described in the Catalog of Federal Domestic Assistance, No.
13.273. Grants will be awarded under the authority of Sections 301 and 510 of
the Public Health Service Act, as amended (42 USC 241 and 290bb) and
administered in accordance with the PHS Grants Policy Statement and Federal
Regulations at 42 CFR Part 52 and 45 CFR Part 74.
Applications submitted in response to this announcement are not subject to the
intergovernmental review requirements of Executive Order 12372, as implemented
through Department of Health and Human Service (HHS) regulations at 45 CFR
Part 100 and are not subject to Health Systems Agency review.
APPLIED RESEARCH INTO THE PROCESS OF ALCOHOLISM TREATMENT
PA: PA-90-27
P.T. 34; K.W. 0404003, 0745070
National Institute on Alcohol Abuse and Alcoholism
PURPOSE
In the field of alcoholism most of the interest in treatment has focused on
patient outcomes, especially drinking status. Near- exclusive emphasis on
assessing outcome at the expense of assessing process may however, impede our
understanding of the nature of effective alcoholism treatment. Furthermore,
studying the process of treatment in its own right may explain why a
particular treatment is or is not effective. While there is some research on
the impact of alcoholism program strategies, little has been done on what may
be key variables, such as therapist/patient interactions, therapist
characteristics, or "extra-treatment" factors in the lives of patients
undergoing treatment. Therefore, the National Institute on Alcohol Abuse and
Alcoholism (NIAAA) is soliciting applications for grants for applied research
designed to investigate the process of alcoholism treatment.
RESEARCH OBJECTIVES
The following are examples of possible areas of study. Applicants should keep
in mind that this list is not intended to be exhaustive and that other areas
of study that relate to the process of alcoholism treatment are encouraged:
o To improve the degree of treatment participation, information is
sought to identify barriers to entering and remaining in treatment.
o To improve treatment planning, under what conditions and at what
point in the treatment process should psychological tests or other
patient informational inventories be administered?
o Studies are encouraged that examine the role that "milieu" (i.e.,
the ethos of treatment as experienced by the patient) plays in the
treatment of alcoholism.
o What type of alcoholism therapist characteristics are most
associated with patient cooperation and treatment completion, as
well as what counselor characteristics are associated with the
patient learning treatment.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 10
o How do certain elements of the treatment process differentially
influence outcomes for racial and ethnic minorities.
o Studies are encouraged which address the issue of patient
satisfaction (i.e., the degree to which patients perceive that they
are receiving the kind of treatment they expect or deserve to
receive).
o Studies are sought that evaluate various methods of assuring and
enhancing treatment compliance on the part of individuals
undergoing treatment for alcohol abuse and alcoholism.
o Studies are sought that investigate the reasons alcoholic patients
completing an inpatient or highly intensive phase of treatment
enter or decline to enter the aftercare phase of treatment.
o Because of it's influential status in recovery from alcoholism, and
despite the methodological challenges inherent to it's informal
membership structure and it's tradition of anonymity, investigators
are invited to conduct studies on Alcoholics Anonymous (AA) and
other mutual help groups.
INCLUSION OF MINORITIES IN STUDY POPULATIONS
Applicants are encouraged to give added attention (where feasible and
appropriate) to the inclusion of minorities in study populations for research
into the etiology of diseases, research in behavioral and social sciences,
clinical studies of treatment and treatment outcomes, research on the dynamics
of health care and its impact on disease, and appropriate interventions for
disease prevention and health promotion. If minorities are not included in a
given study, a clear rationale for their exclusion should be provided.
INCLUSION OF WOMEN IN STUDY POPULATIONS
Applicants are encouraged to consider the inclusion of women in the study
populations for all clinical research efforts. Exceptions would be studies of
diseases that exclusively affect males or where involvement of pregnant women
may expose the fetus to undue risks. Gender differences should be noted and
evaluated. If women are not to be included, a clear rationale should be
provided for their exclusion. In order to provide more precise information to
the treatment community, it is recommended that publications resulting from
research in which the study population was limited to one sex for any reason
other than the disease or condition studied exclusively affects that sex,
should state, in the abstract summary, the gender of the population studied,
e.g., "male patients," "male volunteers," "female patients," or "female
volunteers."
MECHANISMS OF SUPPORT
Research grant support may be requested for a period of up to 5 years
(renewable for subsequent periods). Annual awards will be made subject to
continued availablity of funds and progress achieved. Grant funds may be used
for expenses clearly related and necessary to carry out research projects,
including both direct costs, which 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 service program. Support for research-related treatment,
rehabilitation, or prevention services and programs may be requested only for
those particular costs and for that period of time required by the research.
These costs must be justified in terms of research objectives, methods, and
designs which promise to yield important generalizable knowledge and/or to
make a contribution to theoretical concepts.
ELIGIBILITY
Applications for alcohol research grants may be made by public or private
non-profit or profit-making organizations such as universities, colleges,
hospitals, laboratories, units of State or local governments, and eligible
agencies of the Federal Government. Women and minorities are encouraged to
apply.
APPLICATION PROCEDURES
Applicants should use the standard research grant application form PHS 398
(rev. 10/88). The title of this announcement, APPLIED RESEARCH INTO THE
PROCESS OF ALCOHOLISM TREATMENT, PA-90-27, should be typed in item number 2 on
the face page of the PHS 398 application form.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 11
Application kits containing the necessary forms and instructions (PHS 398) may
be obtained from institutional business offices or offices of sponsored
research of most universities, colleges, medical schools, and at other major
research facilities. Application kits may also be obtained from the:
National Clearinghouse for Alcohol and Drug Information
P.O. Box 2345
Rockville, MD 20852
Telephone: (301) 468-2600
The signed original and six permanent, legible copies of the complete
application should be submitted to:
Division of Research Grants, NIH
Westwood Building
Room 240
Bethesda, MD 20892**
REVIEW PROCESS
The Division of Research Grants, NIH, serves as the central point for receipt
of applications under this announcement. Applications received 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 application for
scientific and technical merit. Notification of the review recommendations
will be sent to the Principal Investigator after the initial review.
Applications will receive a second-level review by the relevant National
Advisory Council, whose review may be based on policy as well as scientific
considerations. Only applications recommended for approval by Council may be
considered for funding.
REVIEW CRITERIA
Criteria to be used in the merit review of alcohol research grant applications
will include the following:
1. The overall scientific and technical merit of the proposal.
2. The adequacy of the methodology to carry out the proposed research
including the adequacy of the design for collection and analysis of
data.
3. The adequacy of qualifications (including level of education and
training) and the research experience of the Principal Investigator
and key personnel.
4. Availability of adequate facilities, general environment for the
conduct of the proposed research, other resources, and
collaborative arrangements necessary for the research.
5. Appropriateness of budget estimates for the proposed research
activities.
6. Where applicable, adequacy of procedures to protect or minimize
effects on human subjects.
AWARD CRITERIA AND AVAILABILITY OF FUNDS
Applications recommended for approval by the appropriate National Advisory
Council will be considered for funding on the basis of overall scientific and
technical merit of the proposal as determined by peer review, program needs
and balance, and availability of funds.
No funds have been set aside specifically for this purpose. Applications
received under this announcement will compete for general FY 1991 funds. The
amount of funding available will depend on appropriated funds and program
priorities at the time of award.
INQUIRIES
Direct inquiries may be addressed to the following NIAAA program staff at 5600
Fishers Lane, Rockville, Maryland 20857:
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 12
Fulton Caldwell, Ph.D., C.A.C.
Treatment Research Branch
Division of Clinical and Prevention Research
Room 16C-03
Telephone: (301) 443-0796
John Allen, Ph.D., M.P.A.
Chief, Treatment Research Branch
Division of Clinical and Prevention Research
Room 16C-03
Telephone: (301) 443-0796
This program is described in the Catalog of Federal Domestic Assistance, No.
13.273. Grants will be awarded under the authority of Sections 301 and 510 of
the Public Health Service Act, as amended (42 USC 241 and 290bb) and
administered in accordance with the PHS Grants Policy Statement and Federal
Regulations at 42 CFR Part 52 and 45 CFR Part 74.
Applications submitted in response to this announcement are not subject to the
intergovernmental review requirements of Executive Order 12372, as implemented
through Department of Health and Human Service (HHS) regulations at 45 CFR
Part 100 and are not subject to Health Systems Agency review.
SMALL GRANTS FOR INNOVATIVE TECHNOLOGY
PA: PA-90-28
P.T. 34; K.W. 0706000, 0790000
National Center for Research Resources
Application Receipt Dates: February 1, October 1
The Biomedical Research Technology (BRT) Program identifies and develops
advanced technologies needed in biomedical research. Through grants and
contracts, it supports an extremely broad and innovative array of
technologies. Areas of emphasis in the Program are biomedical computing,
biomedical engineering, and technologies for the study of biomolecular and
cellular structure and function. To further its mission, the BRT Program
supports a small grant award for pilot studies in relevant biomedical
technologies.
DESCRIPTION OF THE AWARD
This is a one-year, non-renewable award for a pilot project in a high
technology area in engineering, instrumentation, physics, or computer science
related to biomedical research. The project should involve a feasibility
study of an innovative or hig- risk idea in a high technology. Innovative is
considered to be an unusually imaginative or a drastically different approach
to a problem. High risk is having uncertain chances for success because no
historical base exists for the proposed technological approach. High
technology is defined here as working at the frontier (limits of
understanding) of a technology. The project should be oriented towards new
instrumental or methodological approaches and provide a basis for more
extended research in the relevant technology.
The purposes of the small grants program are to:
1. Provide an opportunity to test new ideas in a high technology that would
lead to an expanded research project or implementation of the technology in a
working environment; or
2. Develop significant changes in an existing high technology important to
biomedical research; or
3. Translate scientific notions into a basis for a future technology.
The award may not be used to supplement support for an ongoing project.
Because of the high-risk, feasibility-testing nature of the proposals, support
of salaries for student employees working on a dissertation is discouraged.
ELIGIBLE APPLICANTS
This program is open to both non-profit and for-profit organizations and is
designed to support engineers and other scientists for work in high
technological projects in the biomedical research area.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 13
APPLICATION AND REVIEW PROCEDURE
Applications should be submitted on Form PHS 398 (Rev. 10/88), available at
most institutional business offices or from the Division of Research Grants,
NIH. Because the format for preparing the small grant application is
different from that used for regular research grants, additional information
and instructions must be obtained from the BRT Program office listed below.
Applications must adhere to this format to be responsive. Unresponsive
applications will be returned to the applicant without review.
The review schedule is:
Receipt Date NCRR Committee Council Earliest Date
Annually Review Review for Funding
February 1 April June July
October 1 November February April
REVIEW CRITERIA
Applications will be evaluated using the following criteria: adequacy of
scientific merit; characterization as an innovative or high-risk pilot project
in a high technology area in engineering, instrumentation, physics, or
computer science related to biomedical research; probability the study will
provide a basis for more extended research in the relevant technology;
adequacy of proposed experimental methods, equipment, or materials; adequacy
of the investigator's background and training; adequacy of the available and
requested facilities; and appropriateness of budget justifications.
Investigators should be aware that NIH urges applicants to give added
attention, where feasible and appropriate, to the inclusion of minorities and
women in study populations. If minorities and/or women are not included in a
given study involving human subjects, a clear rationale for their exclusion
should be provided.
Those criteria which are emphasized in the review of small grant applications
are:
o adequacy of scientific merit,
o degree of innovation evident in the proposed approach, and
o degree of risk or uncertain chance of success because no historical
base exists for the proposed technological approach.
FUNDING CRITERIA
Applications will compete in accordance with the purposes of the small grant
program. Approximately 10 to 20 awards are made per year, contingent on
receipt of meritorious applications and appropriated funds.
TERMS OF THE AWARD
The award will provide a maximum of $35,000 (direct costs) for personnel,
consultants, supplies, small equipment, and travel required by the project.
The award will be for one year and, in most cases, can be extended for an
additional year without additional funds.
INSTRUCTIONS FOR APPLICANTS
Additional instructions are needed to prepare a small grant application.
These are supplementary to those given with PHS 398 (Rev. 10/88). To receive
these instructions, please contact:
Biomedical Research Technology Program
National Center for Research Resources
National Institutes of Health
5333 Westbard Avenue, Room 8A11
Bethesda, MD 20892**
Telephone: (301) 496-5411
This program is described in the Catalog of Federal Domestic Assistance No.
13.371, Biotechnology Research. Awards will be made under the authority of
the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as
amended; 42 USC 241) and administered under PHS grant policies and Federal
Regulations 42 CFR Part 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.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 14
MINORITY CLINICAL ASSOCIATE PHYSICIAN SUPPLEMENTS TO GENERAL CLINICAL RESEARCH
CENTER GRANTS
PA: PA-90-29
P.T. 04, FF; K.W. 0785035
National Center for Research Resources
Application Receipt Dates: October 1, February 1, June 1
INTRODUCTION
The National Center for Research Resources (NCRR) hereby notifies physicians
and dentists of a new NCRR career development program that is to be funded as
a competing supplement to a currently funded General Clinical Research Center
(GCRC). This new program is the Minority Clinical Associate Physician (MCAP)
Program.
PURPOSE
The purpose of the MCAP Program is to provide up to three years of support to
minority physicians or dentists to promote their development towards becoming
independent clinical investigators under the direction of senior clinical
scientist sponsors.
BACKGROUND
The 1989 NIH Task Force on Physician Scientist Training expressed concern that
inadequate numbers of individuals with M.D.s or the other professional
doctorates are entering into research careers and that, overall, M.D.s have
low NIH grant application and award rates. The MCAP Program provides the
opportunity for physicians and dentists to develop clinical research skills
and knowledge by conducting scientifically meritorious research projects under
the guidance of qualified sponsors. The impetus for establishing the MCAP
Program is the recognition of the urgent need to increase the number of
underrepresented minority scientists participating in biomedical research as a
means of addressing the national problem of a declining scientific pool.
Moreover, underrepresented minorities constitute only about 3% of the faculty
at U.S. medical schools; thus, relatively small numbers are exposed to the
conduct of clinical research in the traditional setting. The eligibility
criteria, eligible costs, and application and review procedures for the MCAP
Program are discussed below.
ELIGIBILITY
The MCAP applicant must have earned the M.D. or D.D.S. degree or equivalent
and completed a residency. Completion of subspecialty (fellowship) training
for two years is preferred but not required. The applicant must be a U.S.
citizen or hold a permanent immigration visa and should be a member of an
underrepresented minority group. The applicant may not hold independent
peer-reviewed grant support, as the principal investigator, prior to or
concurrently with funding of the MCAP application. An underrepresented
minority group is one that has been determined by the grantee institution to
be underrepresented in biomedical or behavioral research. In making awards,
NIH will give priority to applicants who are Black, Hispanic, Native American,
Pacific Islanders, or other ethnic or racial group members who have been found
to be underrepresented in biomedical research nationally.
ELIGIBLE COSTS
MCAP applicants who have completed subspecialty (fellowship) training, can
request a maximum salary of $42,500 plus fringe benefits for the first year of
the award and salary increments of $1,000 for each of the second and third
years of the award. MCAP applicants with no subspecialty training can request
a maximum salary of $40,000 plus fringe benefits for the first year of the
award and salary increment of $1,000 for each of the second and third years of
the award. In each case, at least 80 percent time and effort is required for
participation in the program. The salary request must be commensurate with
institutional salary policies for individuals with comparable experience.
Funds for small scientific equipment, supplies, and domestic travel to
scientific meetings may be requested up to a maximum of $5,000 per year
(domestic travel portion not to exceed $1,000).
REVIEW PROCEDURE AND CRITERIA
Primary review of applications will be by the NCRR General Clinical Research
Centers Committee. It will be based on the scientific merit of the proposal,
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 15
the qualifications of the applicant, expertise to be gained by the applicant,
suitability of the sponsor, and the likelihood that the applicant will become
an independent investigator capable of successfully competing for independent
peer-reviewed grant support. Secondary review will be by the National
Advisory Research Resources Council. Applicants should note that NIH urges
the inclusion of minorities and women in study populations. If minorities and
women are not included in a protocol, a clear rationale for their exclusion
should be provided.
METHOD OF APPLYING
The initial application for MCAP support must be submitted by the Principal
Investigator of a funded GCRC (M01) grant as a competing supplement to that
grant, using Form PHS 398 (Rev. 10/88) and supplemental GCRC instructions.
Three deadlines exist for filing this application: October 1, February 1, and
June 1. Applications filed by those dates have the corresponding earliest
beginning dates of July 1, December 1, and April 1. In each review cycle,
each GCRC may submit either one Clinical Associate Physician application, one
MCAP application, or one of each (for two different individuals).
INQUIRIES
Requests for supplemental instructions, information about currently funded
GCRCs, and further information on the MCAP Program, including potential
sponsors, should be directed to:
Harriet Gordon, M.D.
Medical Officer
General Clinical Research Centers Program
National Center for Research Resources
Westwood Building, Room 10A03
5333 Westbard Avenue
Bethesda, MD 20892
Telephone: (301) 496-6595
CLINICAL ASSOCIATE PHYSICIAN SUPPLEMENTS TO GENERAL CLINICAL RESEARCH CENTER
GRANTS
PA: PA-90-30
P.T. 04; K.W. 0785035
National Center for Research Resources
Application Receipt Dates: October 1, February 1, June 1
INTRODUCTION
The National Center for Research Resources (NCRR) hereby notifies physicians
and dentists of an ongoing NCRR career development program which is funded as
a competing supplement to a currently funded General Clinical Research Center
(GCRC). This ongoing program is the Clinical Associate Physician (CAP)
Program.
PURPOSE
The purpose of the CAP Program is to provide up to three years of support to
physicians or dentists to promote their development towards becoming
independent clinical investigators, under the direction of senior clinical
scientist sponsors.
BACKGROUND
The 1989 NIH Task Force on Physician Scientist Training expressed concern that
inadequate numbers of individuals with M.D.s or the other professional
doctorates are entering into research careers and that, overall, M.D.s have
low NIH grant application and award rates. The CAP Program provides the
opportunity for physicians and dentists to develop clinical research skills
and knowledge by conducting scientifically meritorious research projects under
the guidance of qualified sponsors. The eligibility criteria, eligible costs,
and application and review procedures for the CAP Program are discussed below.
ELIGIBILITY
The CAP applicant must have earned the M.D. or D.D.S. degree or equivalent and
completed residency and at least two years of subspecialty (fellowship)
training. The applicant must be a U.S. citizen or hold a permanent
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 16
immigration visa. The applicant may not hold independent peer-reviewed grant
support, as the principal investigator, prior to or concurrently with funding
of the CAP application.
ELIGIBLE COSTS
The CAP Program requires at least 80 percent of time and effort and allows for
a maximum salary of $42,500 plus fringe benefits for the first year of the
award; salary increases of $1000 for each of the second and third years of the
CAP award can be requested. The salary request must be commensurate with
institutional salary policies for individuals with comparable experience.
Funds for small scientific equipment, supplies, and domestic travel to
scientific meetings may be requested up to a maximum of $5,000 per year
(domestic travel portion not to exceed $1,000).
REVIEW PROCEDURE AND CRITERIA
Primary review of applications will be by the NCRR General Clinical Research
Centers Committee. It will be based on the scientific merit of the proposal,
the qualifications of the applicant, expertise to be gained by the applicant,
suitability of the sponsor and the likelihood that the applicant will become
an independent investigator capable of successfully competing for independent
peer-reviewed grant support. Secondary review will be by the National
Advisory Research Resources Council.
METHOD OF APPLYING
The initial application for CAP support must be submitted by the Principal
Investigator of a funded GCRC (M01) grant as a competing supplement to that
grant, using Form PHS 398 (Rev. 10/88) and supplemental GCRC instructions.
Three deadlines exist for filing this application: October 1, February 1, and
June 1. Applications filed by those dates have the corresponding earliest
beginning dates of July 1, December 1, and April 1. In each review cycle,
each GCRC may submit either one CAP application, one MCAP application, or one
of each (for two different individuals). Applicants should note that NIH
urges the inclusion of minorities and women in study populations. If
minorities and women are not included in a protocol, a clear rationale for
their exclusion should be provided.
INQUIRIES
Requests for supplemental instructions, information about currently funded
GCRCs, and further information on the CAP Program should be directed to:
Bernard Talbot, M.D., Ph.D.
Medical Officer
General Clinical Research Centers Program
National Center for Research Resources
Westwood Building, Room 10A03
5333 Westbard Avenue
Bethesda, MD 20892
Telephone: (301) 496-6595
ERRATUM
NATIONAL RESEARCH SERVICE AWARD-INSTITUTIONAL GRANTS
RFA: HS-90-01
P.T. 44; K.W. 0720005, 0730050
Agency for Health Care Policy and Research
This announcement was published in the NIH Guide for Grants and Contracts on
August 17, 1990, Vol. 19, No. 30, and contained an incorrect application
receipt date. The correct receipt date is October 15, 1990.
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 17
POLICY NOTICE
NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN IN STUDY POPULATIONS
P.T. 34, II; K.W. 1014002, 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and
Mental Health Administration (ADAMHA) recognize that most researchers
adequately and appropriately consider gender representation in clinical
research design. Nevertheless, the following statement is published as a
reiteration and further interpretation of the existing NIH/ADAMHA policy
concerning inclusion of women in study populations. Clinical research
findings should be of benefit to all persons at risk of the disease,
regardless of gender. This policy was previously published in the NIH Guide
for Grants and Contracts on October 24, l986; January 23, l987; March 27,
l987; January l5, l988; and June l6, l989. For the purpose of this policy,
clinical research includes human studies of etiology, treatment, diagnosis,
prevention, and epidemiology of disease, including but not limited to clinical
trials. While this policy statement refers to inclusion of women, applicants
are strongly reminded that a similar policy exists regarding the inclusion of
minorities (NIH Guide for Grants and Contracts - September 25, l987; January
l5, l988; and June l6, l989). Both policies must be considered when preparing
clinical research applications/proposals for submission to the NIH/ADAMHA.
Public concern requires that clinical studies include both genders in such a
way that results are applicable to the general population; exceptions would be
those diseases or conditions that occur only in one gender. Therefore,
applications/proposals for NIH/ADAMHA support of clinical research should
employ a study design with gender representation appropriate to the known
incidence/prevalence of the disease or condition being studied. If inclusion
of women is impossible or inappropriate with respect to the purpose of the
research, the health of the subjects, or other reasons, or if in the only
study population available there is a disproportionate representation of one
gender, these reasons for excluding women or men must be well explained and
justified by the applicant. Similar justification is required if women will
not be included in numbers appropriate to the incidence/prevalence of the
disease.
In conducting peer review for scientific and technical merit, members of
Initial Review Groups (IRGs)/Technical Evaluation Groups (TEGs) will be
instructed to evaluate the proposed gender composition of the study
population.
1) If there is an inadequate number of women in a study design AND
this affects the potential to answer the scientific question(s)
addressed, that will be considered a weakness or deficiency in the
study design and should be reflected in the assigned score given to
the application/proposal, and in the summary statement of the
review.
2) If an applicant proposes that there is justification for conducting
a study in men only, or in a study population in which the
proportion of women does not reflect the gender prevalence of the
disease or condition under study, a strong scientific rationale, an
explanation of the need to protect the health of the subjects, or
other well-supported justification must be provided. The IRG/TEG
will be instructed to evaluate the merit of such justifications.
Appropriate justification will not adversely affect the assigned
score. The NIH/ADAMHA will not fund such applications/proposals
unless the justification provided is compelling.
3) If the gender composition of the study population is not described,
BUT the study otherwise has the potential to answer the scientific
question(s) posed and translate the findings to all persons at risk
of the disease, the omission will be documented by the Executive
Secretary of the IRG/TEG in an administrative note, and will not
adversely affect the scientific assessment and the assigned score.
If there is inadequate information on the study population to allow
evaluation of the scientific question(s), the review may be
deferred. The NIH/ADAMHA funding components will not fund/award
grants or contracts until the applicant provides sufficient
information on the study population to assure compliance with the
NIH/ADAMHA policy on inclusion of women in study populations.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 18
Since the need to modify sample design could delay award and affect
the costs of the study, applicants are strongly advised to address
this issue in the initial submission. If costs or study designs
are significantly affected by such modification, submission of an
amended application/proposal for IRG/TEG review and/or
reconsideration by the appropriate National Advisory Council or
Board may be necessary.
Whenever there are scientific reasons to anticipate differences between men
and women with regard to the hypothesis under investigation, applicants should
consider the inclusion of an evaluation of gender differences in the proposed
study. However, if men and women are enrolled in numbers that reflect the
gender proportion of the disease under study, it is not an automatic
requirement for the study design to include statistical power for men and
women separately.
It is important to note that regardless of the program relevance of the
proposed research, the NIH/ADAMHA funding components will not fund/award
grants or contracts that do not comply with this policy.
NIH GUIDE - Vol. 19, No. 31, August 24, 1990 - Page 19