kristoff@GENBANK.BIO.NET (Dave Kristofferson) (01/17/91)
NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution. The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
----------------------------------------------------------------------
NIH GUIDE - Vol. 20, No. 3, January 18, 1991
NOTICES
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ...(84/204)............ 1
National Institutes of Health
Food and Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
SMALL GRANTS PROGRAM - REVISED GUIDELINES ..............(207/223)........... 2
National Heart, Lung, and Blood Institute
Index: HEART, LUNG, BLOOD
NOTICES OF AVAILABILITY (RFPs AND RFAs)
ALZHEIMER'S DISEASE AND RELATED CEREBRAL DEGENERATIVE DISORDERS
(RFA NS/AG-91-03) ...............................(244/328, 884/1313)........ 3
National Institute of Neurological Disorders and Stroke
National Institute on Aging
Index: NEUROLOGICAL DISORDERS, STROKE, AGING
MANAGEMENT OF ALZHEIMER'S DISEASE SYMPTOMS (RFA NR/AG-91-01) ............... 4
National Center for Nursing Research (331/490, 1316/1802)
National Institute on Aging
Index: NURSING RESEARCH, AGING
ANALYSES AND PHYSIOLOGY OF ANTICARCINOGENS IN SOYBEANS (RFA CA-91-06) ...... 6
National Cancer Institute (493/612, 1805/2213)
Index: CANCER
SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS
(RFA AG-91-04) ..................................(615/733, 2215/2603)....... 7
National Institute on Aging
Index: AGING
SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS:
COMPANION STUDIES OF PATHOPHYSIOLOGY AND MECHANISMS (RFA AG-91-08) ......... 9
National Institute on Aging (736/840, 2606/2869)
Index: AGING
NOTICES
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS"
P.T. 42; K.W. 0783005
National Institutes of Health
Food and Drug Administration
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) are continuing to sponsor a series of workshops on the responsibilities
of researchers, Institutional Review Boards (IRBs), and institutional
officials for the protection of human subjects in research. The workshops are
open to everyone with an interest in research involving human subjects. The
meetings should be of special interest to those persons currently serving or
about to begin serving as a member of an IRB. Issues discussed at these
workshops are relevant to all other Public Health Service agencies. The
current schedule includes the following:
I. WEST COAST WORKSHOP
DATES: February 4-5, 1991
WORKSHOP SITE:
Meridien Hotel
50 Third Street
San Francisco, CA 94103
SPONSOR:
University of California at San Francisco
Box 0400
San Francisco, CA 94143
REGISTRATION CONTACT:
Ms. Phyllis Colbert
Workshop Contact Person
University of California at San Francisco
Box 0400
San Francisco, CA 94143
Telephone: (415) 476-1881
TOPIC: "The Use of Human Subjects in Research: AIDS as a Model of
Complexity"
II. MIDEAST WORKSHOP
DATES: March 4-5, 1991
WORKSHOP SITE:
Friday Center
Laurel Hill Parkway
Chapel Hill, NC 27599-1020
SPONSORS:
University of North Carolina at Chapel Hill
300 Bynum Hall
Chapel Hill, NC 27599-4100
Shaw University
118 E. South Street
Raleigh, NC 27611
REGISTRATION CONTACT:
Mr. Al Dawson
Director
Friday Center
Laurel Hill Parkway
C. B. 1020
Chapel Hill, NC 27599-1020
Telephone: (919) 962-1106
TOPIC: "Interpreting the Federal Code for the Protection of Human Subjects"
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 1
III. MIDWEST WORKSHOP
DATES: April 11-12, 1991
WORKSHOP SITE:
Ramada Inn, Lakeshore
4900 South Lake Shore Drive
Chicago, IL 60615
SPONSORS:
University of Chicago
970 East 58th Street
Chicago, IL 60637
Chicago State University
95th Street at King Drive
Chicago, IL 60628
REGISTRATION CONTACT:
Mr. Arnold L. Aronoff
Associate Director
Faculty and Administrative Services
University Research Administration
University of Chicago
970 East 58th Street
Chicago, IL 60637
Telephone: (312) 702-8669
TOPIC: "Cultural Diversity, Ethics, and Research: A Workshop on Human
Subject Protection"
NIH/FDA have planned national human subject protections workshops in other
parts of the United States. For further information regarding these workshops
contact:
Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B59
Bethesda, MD 20892
Telephone: (301) 496-8101
SMALL GRANTS PROGRAM - REVISED GUIDELINES
P.T. 34; K.W. 1014006
National Heart, Lung, and Blood Institute
The National Heart, Lung, and Blood Institute (NHLBI) announces the
availability of revised guidelines for the NHLBI Small Grants Program
originally announced in the NIH Guide for Grants and Contracts, Vol. 19, No.
7, February 16, 1990. Copies are available from:
Director
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 7A17
Bethesda, MD 20892
Telephone: (301) 496-7416
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 2
NOTICES OF AVAILABILITY (RFPs AND RFAs)
ALZHEIMER'S DISEASE AND RELATED CEREBRAL DEGENERATIVE DISORDERS
RFA AVAILABLE: NS/AG-91-03
P.T. 34; K.W. 0715180, 0705010, 0710010, 1002030, 0755030, 0765033
National Institute of Neurological Disorders and Stroke
National Institute on Aging
Letter of Intent Receipt Date: April 1, 1991
Application Receipt Date: May 6, 1991
Background
The Division of Demyelinating, Atrophic, and Dementing Disorders of the
National Institute of Neurological Disorders and Stroke (NINDS) and the
Neuroscience and Neuropsychology of Aging Program of the National Institute on
Aging (NIA) jointly announce the availability of a Request for Applications
(RFA) on Alzheimer's Disease and Related Cerebral Degenerative Disorders. The
NINDS and NIA are interested in enhancing the support of innovative research
projects designed to elucidate the etiology or pathogenesis of cerebral
degenerative disorders such as Alzheimer's disease, to improve diagnosis, and
eventually to provide sound bases for effective therapy. Topics of interest
include studies in genetics, mechanisms of cell death, nerve growth factors,
animal modeling, neuroimaging, and various aspects of differential diagnosis.
Applications on related topics or other problem areas are also encouraged.
Mechanism of Support
The support mechanism for this program will be the regular research grant
(R01). The Institutes expect to make at least 20 awards.
Review Procedures
All applications should be submitted on form PHS 398 (10/88 revision).
Applications judged by staff to be nonresponsive to the RFA will be
administratively withdrawn and returned to the applicant. All applications
that are complete and responsive to this RFA will be evaluated by an NINDS
peer review group. Applications judged competitive for award will be
subsequently reviewed by the National Advisory Neurological Disorders and
Stroke Council and the National Advisory Council on Aging.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided. Applications without such documentation will not be accepted for
review.
Method of Application
Applications must be received by May 6, 1991. The review for scientific and
technical merit of applications judged responsive to the RFA will take place
in June/July 1991 and Council review will be in September 1991. Awards will
begin prior to October 1, 1991.
Potential applicants may receive the full RFA by E-Guide or on request from:
Eugene J. Oliver, Ph.D.
Health Scientist Administrator
Division of Demyelinating, Atrophic, and Dementing Disorders
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Federal Building, Room 806
Bethesda, MD 20892
Telephone: (301) 496-1431
or
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 3
Carl D. B. Banner, Ph.D.
Program Director, Etiology of Alzheimer's Disease
Dementias of Aging Branch, NNA
National Institute on Aging
National Institutes of Health
Building 31, Room 5C35
Bethesda, MD 20892
Telephone: (301) 496-9350
MANAGEMENT OF ALZHEIMER'S DISEASE SYMPTOMS
RFA AVAILABLE: NR/AG-91-01
P.T. 34; K.W. 0715180, 0785035, 0404000
National Center for Nursing Research
National Institute on Aging
Letter of Intent Receipt Date: April 8, 1991
Application Receipt Date: May 20, 1991
The National Center for Nursing Research (NCNR) and the National Institute on
Aging (NIA) invite applications for R01 research proposals for preliminary
investigations that will lead to large-scale clinical studies on the
assessment and nonpharmacological management of secondary symptoms exhibited
by patients with Alzheimer's disease and related disorders (AD). The
Alzheimer's Association is cooperating with NCNR and NIA in this Request for
Applications (RFA).
Estimates indicate that 4 million Americans presently suffer from Alzheimer's
disease or related dementias. The impact of AD on patients, families, and
society is severe and is anticipated to grow as older persons, the group most
at risk for AD, continue to increase in number. Although it may not yet be
possible to prevent, treat, or permanently alter the course of the underlying
disease, interventions can be developed and systematically tested that reduce
the patient's secondary symptoms and preserve function. In addition to
cognitive symptoms, non-cognitive secondary symptoms, which are frequently
seen across the course of Alzheimer's disease and present significant
management problems, are of special concern. These may include, but are not
limited to, wandering, disturbed sleep, pacing, agitation, feeding and
dressing difficulties, incontinence and toileting difficulties, screaming and
other vocalizations, aggression and violence, and inappropriate sexual
behavior. These symptoms not only contribute to decisions to institutionalize
affected individuals, but also lead to the use of chemical and physical
restraints.
While there exists a great deal of clinical and anecdotal information about
methods that can effectively deal with individual symptoms, little data exist
that have been obtained with the rigor of design and procedures of the
controlled clinical trial. Therefore, applications are solicited for
preliminary investigations and feasibility studies that will lay the
groundwork for the development of rigorously controlled clinical trials to
test interventions for the management of the secondary symptoms. Applications
are invited for support of projects to address issues including, but not
limited to:
o the identification of underlying factors in research subjects that
result in behavioral symptoms and methods to address these factors.
o the development of preliminary work and early investigations that
will lead to the nonpharmacologic management and treatment of the
secondary symptoms exhibited by patients with Alzheimer's disease
and related disorders.
o provision of a rigorous scientific base that will lead to
controlled clinical trials in institutional or noninstitutional
settings by delineating approaches for the management of symptoms,
the duration of change, and the procedures required to maintain the
change, if possible.
o development of instruments to assess behavioral problems and
monitor changes.
o careful scientific observations of the natural history/ clinical
course of the behavioral changes that occur during the progression
of Alzheimer's disease.
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 4
MECHANISM OF SUPPORT
NCNR and NIA are allocating up to $75,000 in direct costs for each award for
each funding year, not to exceed three years. The intent is to fund ten to
fifteen R01 grants by September 30, 1991.
Following the standard NIH peer review process, Principal Investigators may
submit their applications and summary statements to the Alzheimer's
Association for funding consideration. The Alzheimer's Association may fund
selected grants at a maximum level of $45,000 total costs each year with a 10
percent ceiling on indirect costs, for a maximum of three years. The
Alzheimer's Association project start dates for funding may not coincide with
the NCNR or NIA award dates. Applicants may not receive funding from both NIH
and the Alzheimer's Association for the same application.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINCAL RESEARCH
STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included or represented in the
study populations for clinical studies, a special justification for this
exclusion or inadequate representation must be provided. Applications without
such documentation will not be accepted for review.
REVIEW PROCEDURES AND CRITERIA
The individual research grant application form PHS-398 (revised 10/88 or 9/89)
must be used to apply for these grants. Upon receipt, applications will be
reviewed by NIH staff for completeness and responsiveness. Incomplete
applications will be returned to the applicant without further consideration.
Applications not responsive to the scientific intent identified in the RFA or
to the timeframe and budget guidelines will be returned to DRG for review with
other unsolicited grant applications during the next available NIH review
cycle.
Applications may be subjected to triage by a peer review group to determine
their scientific merit relative to other applications received in response to
this RFA. The NIH will administratively withdraw those applications judged to
be noncompetitive and notify the applicant and institutional official. Those
applications judged to be complete, responsive, and competitive will be
evaluated in accordance with the NIH review criteria for scientific/technical
merit by an appropriate peer review group convened by the NCNR and NIA. The
second level of review will be provided by the NCNR and NIA National Advisory
Councils.
Although not a prerequisite for applying, potential applicants are encouraged
to submit a non-binding letter of intent by April 8, 1991, to John C. Chah,
PhD, National Center for Nursing Research, Building 31, Room 5B19, 9000
Rockville Pike, Bethesda, MD 20892. The letter of intent should include a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the names of other key personnel, and
any other participating institution(s). Applications must be received by May
20, 1991.
Potential applicants are strongly encouraged to obtain the full Request for
Applications (RFA) and to direct inquiries to:
Mary D. Lucas, PhD, RN Teresa S. Radebaugh, Sc.D.
Chief, Acute & Chronic Chief, Dementias of Aging
Illness Branch Neuroscience and
National Center for Nursing Neuropsychology of Aging
Research National Institute on Aging
Building 31, Room 5B03 Building 31, Room 5C21
Bethesda, MD 20892 Bethesda, MD 20892
Telephone: (301) 496-0523 Telephone: (301) 496-9350
Other institutes and agencies are also interested in research dealing with
Alzheimer's disease and related disorders, including:
The National Institute of Mental Health (NIMH) is interested in research
dealing with the behavioral and emotional consequences of Alzheimer's disease
and related disorders. The scope of NIMH interest is delineated in the
announcement "Alzheimer's Disease Treatment and Family Stress." For more
information, contact Enid Light, PhD, NIMH, Room 11C-03, 5600 Fishers Lane,
Rockville, MD 20857, telephone (301) 443-1185.
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 5
The National Institute of Neurological Disease and Stroke program contact for
Alzheimer's disease related research is Dr. Eugene J. Oliver, NINDS, Federal
Building, Room 806, Bethesda, MD 20892, telephone (301) 496-1431.
This RFA is in addition to the ongoing program announcement on "Alzheimer's
Disease and Related Disorders: Issues in Caregiving," published in the NIH
Guide for Grants and Contracts, Vol. 18, No. 6, February 24, 1989, sponsored
by the National Institute on Aging, National Center for Nursing Research,
National Institute of Mental Health, and the National Center for Health
Services Research (now the Agency for Health Care Policy Research).
ANALYSES AND PHYSIOLOGY OF ANTICARCINOGENS IN SOYBEANS
RFA AVAILABLE: CA-91-06
P.T. 34; K.W. 0715035, 1007009, 0745027, 0710095
National Cancer Institute
Letter of Intent Receipt Date: March 1, 1991
Application Receipt Date: April 29, 1991
The Division of Cancer Prevention and Control, National Cancer Institute
(NCI), invites applications for grants to quantify levels of total and
individual anticarcinogens in soybeans and soy products and to study their
absorption and metabolism in humans.
BACKGROUND
Epidemiologic and animal studies suggest soybean-rich diets may reduce cancer
risk. Populations consuming predominantly plant-based diets, for whom legumes
frequently represent an important protein source, tend to have lower rates of
several cancers than populations who rely heavily on animal products. One
legume, soybeans, via a variety of soy products (tofu, miso, tempeh, soymilk,
natto), is commonly consumed throughout much of East Asia where breast and
colon cancer rates are low in comparison to Western countries. Soybeans
contain several classes of compounds in particularly high concentrations with
demonstrated anticancer activity, such as isoflavones, protease inhibitors,
phytosterols, saponins, and inositol hexaphosphate. Others may also exist.
Basic research on the absorption and metabolism of these compounds in humans
and accurate analytical data on the levels of these compounds in commonly
consumed soy products are needed. These data will help to determine the
potential impact of soybeans on cancer prevention.
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000", a PHS-led national
activity for setting priority areas. This RFA, "Analyses and Physiology of
Anticarcinogens in Soybeans," is related to the priority area of cancer
prevention.
OBJECTIVES AND SCOPE
The purpose of this Request for Applications (RFA) is to solicit applications
from qualified investigators to quantify levels of total and individual
anticarcinogens in soybeans and soy products and to study their absorption and
metabolism in humans. The analytical work should focus only on those
compounds in soybeans and soy products that have demonstrated anticancer
activity and are unique to soybeans and soy products or present at
substantially high levels (relative to other foods). Total as well as
individual anticarcinogens (e.g., total isoflavones and individual
isoflavones, daidzein, genistein) should be quantified. All factors
potentially effecting anticarcinogen levels/activity should be considered for
investigation.
For the clinical work, studies on the absorption and metabolism of compounds
in soybeans and soy products with demonstrated anticancer activity are to be
conducted. When feasible, dose-response relationships between soy
product/anticarcinogen intake and anticarcinogen levels in blood and urine,
and/or feces and bile should be conducted. When available, both commonly
consumed soy products as well as soybean extracts or pure soybean
anticarcinogens should be studied. Both long-term feeding studies, in which
anticarcinogen levels in subjects consuming soy products/extracts over an
extended period of time, and short-term studies, in which anticarcinogen
levels for a minimal period after the consumption of a single administration
of soy products, extracts, or pure compounds are studied, are appropriate
under this RFA.
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 6
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included or adequately
represented in the study populations for clinical studies, a specific
justification for this exclusion or inadequate representation must be
provided. Applications without such documentation will not be accepted for
review.
MECHANISM OF SUPPORT
The support mechanism for this program will be the individual research grant
(RO1). This RFA is a one-time solicitation. Future unsolicited competing
renewal applications will compete with all investigator-initiated applications
and be reviewed by the Division of Research Grants (DRG). Approximately
$900,000 in total costs per year for 3 years will be committed to specifically
fund applications that are submitted in response to this RFA. It is
anticipated that 3 to 4 awards will be made.
REVIEW PROCESS
All applications submitted in response to this RFA will be evaluated for
scientific and technical merit by an initial review group that will be
convened for this purpose by the Division of Extramural Affairs. Those
applications judged to be both competitive and responsive will be further
evaluated for scientific and technical merit by an appropriate peer review
group convened by the Division of Extramural Activities, NCI. The second
level of review by the National Cancer Advisory Board considers the special
needs of the Institute and the priorities of the National Cancer Program.
METHOD OF APPLYING
Potential applicants are asked to submit a letter of intent and that includes
a descriptive title of the proposed research, the name and address of the
principal investigator, the names of other key personnel, the participating
institutions, and the number and title of the RFA in response to which the
application is being submitted. This letter should be received no later than
March 1, 1991. Potential applicants should write or phone the individual
listed below for the full RFA document:
Mark J. Messina, Ph.D., Program Director
National Cancer Institute, DCPC
9000 Rockville Pike, EPN 212C
Bethesda, MD 20892
Telephone: (301) 496-8573
The RFA label available in the 10/88 revision of Application Form 398 must be
affixed to the bottom of the face page. Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review.
SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS
RFA AVAILABLE: AG-91-04
P.T. 34; K.W. 0705050, 0745027, 0755015, 0710010
National Institute on Aging
Letter of Intent Receipt Date: March 15, 1991
Application Receipt Date: April 29, 1991
The National Institute on Aging (NIA) invites applications for cooperative
agreements to develop and test interventions to lessen, prevent, or reverse
loss of bone strength in the hip to reduce risk of hip fractures in older
persons.
BACKGROUND, GOALS, SCOPE, AND ELIGIBILITY REQUIREMENTS
The enormous public health impact of osteoporosis is concentrated heavily
among persons 65 years old and older. In particular, the vast majority of hip
fractures occur in this age range. Several clinical trials of interventions
against osteoporosis have reported promising results, but trials have included
few subjects over age 65, few trials have studied effects on bone density in
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 7
the hip, and no trials have adequate statistical power to determine the effect
of interventions on hip fractures in this population.
The Request for Applications (RFA) solicits projects which will test the
efficacy of interventions (or combinations of interventions) against
osteoporosis of the hip in persons aged 65 or older. Proposed studies must
measure effects in the hip but may also include measures of effects at
additional skeletal sites. Subjects for inclusion in proposed trials must be
age 65 or over. Studies may also measure effects of osteoporosis treatment on
fractures of the hip and other sites. A pilot phase for safety and
feasibility testing and protocol refinement of intervention studies may be
proposed. The Principal Investigators and key staff of STOP/IT (Sites Testing
Osteoporosis Prevention/Intervention Treatments) projects, under the terms of
awards, will meet with the NIA Program Administrator every six months to
review the progress of their studies. Funds for such travel will be included
in awards.
A maximum of $550,000 first year total (direct plus indirect) costs may be
requested per application and a total of no more than $3.1 million may be
requested per application for the entire project duration. This RFA is a
one-time solicitation. Up to $2.1 million (total cost) for first-year
expenses and additional approved expenses for up to five years will be
committed in Fiscal Year 1991 to fund applications in response to this RFA.
It is anticipated that up to four awards will be made in FY 1991. Additional
proposals in response to this RFA may be funded in Fiscal Year 1992 depending
on quality of applications and availability of funds. Issuance of awards
pursuant to this RFA is contingent on the availability of funds for this
purpose. The earliest feasible start date for the initial awards will be
September 30, 1991.
Applicants responding to this RFA are also encouraged to submit concurrent
companion research project grant applications for studies on the
pathophysiology of osteoporosis in advanced age and the mechanisms affecting
response to treatment in older persons, as described in NIA RFA AG-91-08 in
this issue of the NIH Guide for Grants and Contracts. No elements of these
proposed companion studies should duplicate any elements of studies proposed
in response to this RFA (AG-91-04).
MECHANISM OF SUPPORT
Support of this program will be through cooperative agreements (U01) between
each awardee and NIA. Under the terms of these cooperative agreements, the
awardee defines the design and details of the project under the terms of this
RFA, retains primary responsibility for performance of the research and for
analyzing and publishing results, and agrees to accept assistance from the NIA
Program Administrator in the following:
o Participation in the monitoring of intervention study issues
relating to recruitment, treatment, follow-up, quality control, and
adherence to protocol.
o Consideration of adjustments of intervention study designs and
protocols.
o Assistance in analysis and reporting of intervention study results.
REVIEW PROCEDURES AND CRITERIA
Applications will be received by the NIH Division of Research Grants and will
be assigned to the NIA. Responsive applications will be assigned to a special
review group organized by NIA. Following this review, applications will be
considered by the National Advisory Council on Aging. Applications will be
evaluated on customary criteria for scientific merit and the adequacy of
applicants' plans for meeting the special program requirements of this RFA.
Applications will be evaluated regarding issues relating to inclusion of women
and minorities. (Note following special instructions.)
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included or adequately
represented in the study populations for clinical studies, a specific
justification for this exclusion or inadequate representation must be
provided. Applications without such justification will not be accepted for
review.
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 8
METHOD OF APPLYING: Applicants should request the full RFA from the NIA staff
contact listed below. A letter of intent to submit an application, while not
required, is requested to be sent to the same staff contact by March 15, 1991.
The deadline for receipt of applications is April 29, 1991. The full RFA may
be obtained from:
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Building 31, Room 5C27
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-6761
SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS: COMPANION
STUDIES OF PATHOPHYSIOLOGY AND MECHANISMS
RFA AVAILABLE: AG-91-08
P.T. 34; K.W. 0705050, 0745027, 0710010, 0765035
National Institute on Aging
Application Receipt Date: April 29, 1991
BACKGROUND: The National Institute on Aging (NIA) has issued a Request for
Applications (RFA): SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION
TREATMENTS (STOP/IT) (AG-91-04), soliciting projects to test the efficacy of
interventions (or combinations of interventions) against osteoporosis in the
hip, in persons aged 65 or more. That RFA provides funds for intervention
studies only. Because evidence is increasing that the disease process may
differ in significant respects in this age range compared to younger ages, and
because much remains to be learned about mechanisms accounting for these
differences, NIA wishes to increase gains in knowledge from these intervention
studies by supporting companion studies to explore mechanisms underlying the
interaction of the disease process with interventions being explored in the
clinical trials funded under AG-91-04. Therefore, only institutions
responding to AG-91-04 may submit applications in response to this RFA. Those
not eligible for this RFA who wish support for studies on osteoporosis in
advanced age are encouraged to submit applications at any regularly scheduled
submission deadline, as described in the NIA/NIAMS program announcement: Type
II Osteoporosis (NIH Guide for Grants and Contracts 17, No. 28, September 2,
1988).
RESEARCH GOALS AND SCOPE: The screening and recruitment of subjects over age
65, as requested in AG-91-04, will provide opportunities for studies on the
pathophysiology of osteoporosis in advanced age, and the mechanisms affecting
response to treatment in older persons. Studies are encouraged on factors
affecting the progress of the disease in women many years after menopause and
in older men, as well as studies of factors specifically affecting bone loss
in the hip in this age range. Applicants responding to this RFA are also
invited to explore or verify mechanisms underlying the effects (or lack of
effects) of interventions on bone mass, bone density, and/or bone strength in
older persons. Because comorbidity and use of multiple medications are
extremely common among persons over age 65, studies of the impact of these
complicating factors on the disease process and responses to interventions are
also appropriate.
MECHANISM OF SUPPORT: Support of this program will be through the Public
Health Service grant-in-aid. Only the RO1 grant mechanism can be used.
Awards will be administered under PHS grants policy as stated in the Public
Health Service Grants policy statement, DHHS Publication No. (OASH) 82-50,000,
revised October 1, 1990.
This RFA is a one-time solicitation. Up to $1.2 million has been set aside
for total (direct plus indirect) first-year costs and additional approved
expenses for up to five years to fund applications submitted in response to
this RFA. (NIA and the National Institute of Arthritis, Musculoskeletal and
Skin Diseases will contribute equal shares of this funding.) No single
proposal should request more than $150,000 (direct plus indirect costs) for
first-year expenses. Future year annual increases will generally be limited
to no more than four percent. Multiple proposals may be submitted by each
applicant institution. It is anticipated that approximately 8 awards will be
made in Fiscal Year 1991. Additional applications submitted in response to
this RFA may be funded in Fiscal Year 1992. The award of grants pursuant to
this RFA is contingent on receipt of applications of high scientific merit and
the availability of funds for this purpose.
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 9
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included in the study populations
for clinical studies, a specific justification for this exclusion must be
provided. Applications without such documentation will not be accepted for
review.
REVIEW PROCEDURES AND CRITERIA: Applications will be received by the NIH
Division of Research Grants and will be assigned to NIA. Responsive
applications will be assigned to a special review group convened by NIA for
review. Following this review, applications will be considered by the
National Advisory Council on Aging. Scientific review criteria to be used in
the evaluation of the applications received in response to this RFA are listed
in the full RFA.
METHOD OF APPLYING: Applicants should request the full RFA from the NIA staff
contact listed at the end of this announcement. A letter of intent to submit
an application, while not required, is requested to be sent to the same staff
contact by March 15, 1991. Applications should be submitted on the standard
PHS 398 application form (revised October 1988), available at most
institutional business offices and the Division of Research Grants, NIH,
telephone (301) 496-7441. On item 2 of the face page of the application,
applicants should enter: NIA (STOP/IT) Companion Studies, AG-91-08. The RFA
label available in the 10/88 revision of the Application Form 398 must be
affixed to the bottom of the face page. Failure to use this label could
result in delayed processing of the application and prevent it from reaching
the review committee in time for review. The deadline for receipt of
applications is April 29, 1991.
The full RFA may be obtained from:
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Room 5C27, Building 31, NIH
Bethesda, MD 20892
Telephone: (301) 496-6761
NIH GUIDE - Vol. 20, No. 3, January 18, 1991 - Page 10
------------------------- Full text of RFAs -------------------------
SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS:
COMPANION STUDIES OF PATHOPHYSIOLOGY AND MECHANISMS
RFA AVAILABLE: AG-91-08
P.T. 34; K.W. 0705050, 0745027, 0710010, 0765035
National Institute on Aging
Application Receipt Date: April 29, 1991
I. BACKGROUND
The enormous public health impact of osteoporosis continues to grow.
This burden is concentrated heavily among persons over 65 years old. In
particular, the vast majority of hip fractures occur in this age range,
causing hospitalization and temporary disability for over 215,000
persons per year, and long-term loss of independence for a significant
proportion of these.
The National Institute on Aging (NIA) has issued a Request for
Applications (RFA): SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION
TREATMENTS (STOP/IT) (AG-91-04) that solicits projects to test the
efficacy of interventions (or combinations of interventions) against
osteoporosis in the hip in persons aged 65 or more. That RFA provides
funds for intervention studies only. Because evidence is increasing
that the disease process may differ in significant respects in this age
range compared to younger ages, and because much remains to be learned
about mechanisms accounting for these differences, NIA wishes to
increase gains in knowledge from these intervention studies by
supporting companion studies to explore mechanisms underlying the
interaction of the disease process with interventions being explored in
the clinical trials funded under AG-91-04. Therefore, only institutions
responding to AG-91-04 may submit applications in response to this RFA.
Investigators not eligible for this RFA who wish support for studies on
osteoporosis in advanced age are encouraged to submit applications at
any regularly scheduled submission deadline, as described in the
NIA/NIAMS program announcement: Type II Osteoporosis (NIH Guide for
Grants and Contracts 17, No. 28, September 2, 1988).
II. RESEARCH GOALS AND SCOPE
The screening and recruitment of subjects age 65 and older, as requested
in AG-91-04, will provide opportunities for studies on the
pathophysiology of osteoporosis in advanced age and the mechanisms
affecting response to treatment in older persons. All studies should
include subjects (or tissues from subjects) over age 65, and may also
include subjects (or tissues from subjects) of younger ages, as needed.
Studies are encouraged on factors affecting the progress of the disease
in women many years after menopause and in older men, as well as studies
of factors specifically affecting bone loss in the hip in this age
range. Applicants responding to this RFA are also invited to explore or
verify mechanisms underlying the effects (or lack of effects) of
interventions on bone mass, bone density, and/or bone strength in older
persons. Because comorbidity and use of multiple medications are
extremely common among persons over age 65, studies of the impact of
these complicating factors on the disease process and responses to
interventions are also appropriate.
Applications submitted in response to this RFA should fully describe all
resources, personnel, and methods to be used in proposed studies, so
that applications may be reviewed without extensive cross-referencing to
the proposed intervention studies solicited in RFA AG-91-04.
III. ELIGIBILITY AND MECHANISM OF SUPPORT
Only institutions responding to AG-91-04 may submit applications in
response to this RFA. Those not eligible for this RFA who wish support
for studies on osteoporosis in advanced age are encouraged to submit
applications at any regularly scheduled submission deadline, as
described in the NIA/NIAMS program announcement: Type II Osteoporosis
(NIH Guide to Grants and Contracts 17, No. 28, September 2, 1988).
Support of this program will be through the Public Health Service
grant-in-aid. Only the RO1 grant mechanism can be used. Awards will be
administered under PHS grants policy as stated in the Public Health
Service Grants policy statement, DHHS Publication No. (OASH) 82-50,000,
revised October 1, 1990.
This RFA is a one-time solicitation. Up to $1.2 million has been set
aside for total (direct plus indirect) first-year costs and additional
approved expenses for up to 5 years, to fund applications submitted in
response to this RFA. (NIA and the National Institute of Arthritis,
Musculoskeletal and Skin Diseases will contribute equal shares of these
funds.) No single proposal may request more than $150,000 (direct plus
indirect costs) for first-year expenses. Future year annual increases
will generally be limited to no more than 4 percent. Multiple proposals
may be submitted by each applicant institution. It is anticipated that
approximately eight awards will be made in Fiscal Year 1991. Additional
applications submitted in response to this RFA may be funded in Fiscal
Year 1992. The award of grants pursuant to this RFA is contingent on
receipt of applications of high scientific merit and the availability of
funds for this purpose.
Generally, future competing renewal applications will compete with all
investigator-initiated applications and be reviewed by the Division of
Research Grants (DRG). However, should the NIA determine that there is
a sufficient continuing program need, the RFA may be reissued. The
earliest feasible start date for the initial awards will be September
30, 1991.
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 Section 2, A-D of the Research
Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors 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.
IV. REVIEW PROCEDURES AND CRITERIA
Applications will be received by the NIH Division of Research Grants and
will be assigned to NIA. Responsive applications will be assigned to a
special review group convened by NIA for review. Proposals judged by
the NIA to be non-responsive (those not directed at the goals of this
RFA) will be administratively withdrawn and returned to the applicant
without review. Proposals may first receive a preliminary review by a
subcommittee of the review panel to establish those applications deemed
to be competitive. Those proposals judged noncompetitive will be so
designated, and an abbreviated summary statement noting the major areas
of concern will be sent to the Principal Investigator. Applications
judged to be competitive will be given full review. Following review by
the initial review group, the applications will be considered by the
National Advisory Council on Aging.
Listed below are the major review criteria to be used in the evaluation
of the applications received in response to this RFA:
o scientific merit of the research proposed;
o significance of the research project to the goals of the RFA;
o qualifications, experience, and commitment of the investigators, and
their ability to devote the required time and effort to the
project;
o appropriateness of the total budget and budgetary requests; and
o institutional commitment to the requirements of the project.
V. Method of Applying
A letter of intent to submit an application, while not required, is
requested. The letter should include a descriptive title, the name and
address of the principal investigator and other key investigators as
well as identifying any other participating institutions. This letter
must be addressed to the staff contact listed below (see VI below) by
March 15, 1991. Applications must be submitted on the standard PHS-398
application form (revised October 1988), available at most institutional
business offices or from the Division of Research Grants, NIH, telephone
(301) 496-7441. Institutions submitting multiple proposals must submit
each on a separate PHS-398 form. On item 2 of the face page of the
application, applicants must enter: NIA RFA-- STOP/IT Companion
Studies, AG-91-08. The RFA label available in the 10/88 revision of the
Application Form 398 must be affixed to the bottom of the face page and
placed on the top of the entire package. Failure to use this label
could result in delayed processing of the application and prevent it
from reaching the review committee in time for review.
The deadline for receipt of applications is April 29, 1991. The
completed application and four copies must be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
When the application is submitted to the Division of Research grants,
two copies of the application must be sent to:
Chief, Scientific Review Office
National Institute on Aging
Building 31, Room 5C12
9000 Rockville Pike
Bethesda, MD 20892
Failure of these copies to be received by the deadline may prevent the
application from being reviewed under this announcement in time to be
considered for an award.
VI. STAFF CONTACT
Potential applicants interested in obtaining further information may
write or call:
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Room 5C27, Building 31
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-6761
This program is described in the Catalog of Federal Domestic Assistance,
Number 93.866. Grants are awarded under the authority of the Public
Health Service Act (Section 301 42 USC 241) and administered under PHS
grant policies and Federal Regulations, most specifically at 42 CFR Part
52 and 45 CFR Part 74. This program is not subject to review by a
Health Systems Agency.
SITES TESTING OSTEOPOROSIS PREVENTION/INTERVENTION TREATMENTS
RFA AVAILABLE: AG-91-04
P.T. 34; K.W. 0705050, 0745027, 0755015, 0710010
National Institute on Aging
Letter of Intent Receipt Date: March 15, 1991
Application Receipt Date: April 29, 1991
The National Institute on Aging (NIA) invites applications for
cooperative agreements to develop and test interventions to
lessen, prevent, or reverse loss of bone strength in the hip
to reduce risk of hip fractures in older persons.
I. BACKGROUND
The enormous public health impact of osteoporosis continues
to grow. This burden is concentrated heavily among persons
65 years old and older. In particular, the vast majority of
hip fractures occur in this age range causing
hospitalization and temporary disability for more than
215,000 persons per year and long-term loss of independence
for a significant fraction of these.
Understanding of the causes of osteoporosis has progressed
significantly in recent years, and several clinical trials of
interventions have reported promising results. However, most
trials have included relatively few subjects over age 65, few
trials have studied effects on bone density in the hip, and
no trials have had adequate statistical power to determine
the effect of interventions on hip fractures in this
population. This Request for Applications (RFA) seeks to fill the
above gaps in
knowledge.
II. RESEARCH GOALS, SCOPE, AND ELIGIBILITY REQUIREMENTS
The RFA solicits projects that will test the efficacy of
interventions (or combinations of interventions) against
osteoporosis of the hip in persons aged 65 or older. All
proposed studies must measure effects in the hip but may
also include measures of effects at additional skeletal
sites. Studies may also measure effects of osteoporosis
treatment on fractures of the hip and other skeletal sites.
Subjects for inclusion in proposed trials must be age 65 or
over.
To achieve the required number of subjects for a study,
applicants may require performance sites at more than one
institution. Applicants considering this approach should
contact program staff listed below regarding
administrative options.
Applicants are encouraged to consider designs that will
permit determination of intervention efficacy in different
age groups and sexes within the population over age 65, in
older subjects with low bone mass compared to the average for
their age, and in subjects whose rates of bone loss are
faster than the average for their age, or at high risk for
such accelerated loss. Such designs are, however, not
required.
A pilot phase for safety and feasibility testing and protocol
refinement may be proposed.
NIA anticipates that bone mass and/or bone density will be a
primary outcome variable in most, if not all, proposed
studies. However, because development of interventions that
will increase bone strength is the goal of this RFA,
applicants are encouraged also to include studies that will
provide information on the effects of their interventions on
bone strength.
Because comorbidity and use of multiple medications are
extremely common among persons over age 65, the ability to
screen, characterize, and monitor study subjects regarding
diseases and medications is essential in these studies.
Similarly, study designs should address potential confounding
issues posed by the presence of concurrent diseases and
medication use. Applicants may find it useful to include
staff with geriatric research expertise to address the above
considerations.
All proposed intervention studies should be blinded to the
maximum extent feasible.
The Principal Investigators and key staff of STOP/IT
(Sites Testing Osteoporosis Prevention/Intervention Treatments)
projects, under the terms of the awards, will meet with the
NIA Program Administrator every six months to review the
progress of their studies. Funds for such travel will be
included in awards.
A maximum of $550,000 first year total (direct plus indirect)
costs may be requested per application and a total of no more
than $3.1 million may be requested per application for the
entire project duration. This RFA is a one-time
solicitation. Up to $2.1 million (total cost) for first-year
expenses and additional approved expenses for up to five
years will be committed in Fiscal Year 1991 to fund
applications submitted in response to this RFA. It is
anticipated that up to four awards will be made in FY 1991.
This funding level is dependent on the receipt of a
sufficient number of applications of high scientific merit.
In addition to FY 1991 awards, other proposals responding to
this RFA may be funded in Fiscal Year 1992, depending on
quality of proposals and availability of funds. Issuance of
awards pursuant to this RFA is contingent on the availability
of funds for this purpose.
Generally, future competing continuation
applications will compete with all investigator-initiated
applications and be reviewed by the Division of Research
Grants (DRG). However, should the NIA determine that there
is a sufficient continuing program need, the RFA will be
reissued. The earliest feasible start date for the initial
awards will be September 30, 1991.
COMPANION STUDIES ON OSTEOPOROSIS IN ADVANCED AGE. Screening
and recruitment of subjects age 65 and older in these studies
will provide opportunities for studies on the pathophysiology
of osteoporosis in advanced age, and the mechanisms affecting
response to treatment in older persons. Hence, applicants are
encouraged to submit concurrent proposals on these topics in
response to NIA's accompanying RFA (AG-91-08) for companion
research project grants (R01s) on these topics. Such
proposed studies should in no way compromise the proposed
clinical trials.
III. MECHANISM OF SUPPORT
Support of this program will be through Cooperative
Agreements (UO1) between each awardee and NIA. Under the terms of
these cooperative agreements, the awardee defines the design
and details of the project under the terms of this RFA,
retains primary responsibility for performance of the
research and for analyzing and publishing results, and agrees
to accept assistance from the NIA Program Administrator in
the following:
o Participation in the monitoring of intervention study
issues relating to recruitment, treatment, follow-up,
quality control, and adherence to protocol.
o Consideration of refinements and adjustments of
intervention study designs and protocols.
o Assistance in analysis and reporting of intervention
study results.
The rationale for the above types of participation by the NIA
Program Administrator results from the fact that this RFA has
the objective of determining the efficacy of osteoporosis
interventions in older populations with a complex
variety of medical conditions and lifestyle factors that can
affect responses to treatment and compliance with protocols.
These interactions cannot always be foreseen before the start
of intervention studies. Even after scientific merit,
personnel, and resources of projects have been assessed by
peer review, needs for protocol modifications and additional
data analyses may arise during the course of the award.
There is need for the Program Administrator to work
cooperatively with awardees in considering these needs and
options for modifications and additions to ensure that they
permit achieving the goals of this RFA.
The NIA Program Administrator may provide advice on staffing,
statistical requirements, and implementation of intervention
studies, and will cooperate with awardees in considering
protocol adjustments. In instances where there has been
significant involvement in study design and analysis by
the NIA Program Administrator, he/she may cooperate with
awardees as co-authors in preparing manuscripts that report
results from these intervention studies.
Cooperative Agreements are subject to the same administrative
requirements as grants. Projects will be supported by the
Cooperative Agreement (U01) mechanism. The regulations (Code
of Federal Regulations, Title 42, Part 52 and Title 45, Part
74) and policies that govern the research grant programs of
the PHS will prevail. The awarding of funds pursuant to this
RFA is contingent on availability of funds. All pertinent
DHHS, PHS, and NIH grant regulations, policies, and procedures
are applicable. Business management aspects of the awards
will be administered in accordance with DHHS and PHS grant
administration requirements by the NIH, as stated in the
Public Health Service Grants policy statement, DHHS
Publication No. (OASH) 82-50,000, revised October 1, 1990.
IV. REVIEW PROCEDURES AND CRITERIA
Applications will be received by the NIH Division of Research
Grants and will be assigned to the NIA. Responsive
applications will be assigned to a special review group
organized by NIA. Proposals judged by the NIA Program
Adminstrator to be non-responsive (those not directed at the
goals of this RFA) will be returned to the applicant without
review. Proposals may first receive a preliminary review
by a subcommittee of the NIA review panel to establish those
applications deemed to be competitive. Those proposals judged
non-competitive will be so designated, and an abbreviated
summary statement noting the major areas of concern will be
sent to the Principal Investigator. Applications judged to
be competitive will be given full review. Following review
by the initial review group, the applications will be
considered by the National Advisory Council on Aging.
Listed below are the major review criteria to be used in the
evaluation of the applications received in response to this
RFA:
o scientific merit of the research proposed.
o significance of the research project to the goals
of the RFA, i.e., the ability to obtain information
on the effects of the intervention(s) being tested
on bone loss in the hip in persons age 65 or older.
o qualifications, experience, and commitment of the
investigators (particularly regarding osteoporosis
research, clinical trials, and research involving
older persons), and their ability to devote the
required time and effort to the project.
o appropriateness of the total budget and budgetary
requests.
o institutional commitment to the requirements of the
project.
o plans for assurance and monitoring of safety of human
subjects.
o plans to implement special program requirements under
this RFA, including cooperation
with the Program Administrator concerning transmission
and review of data on recruitment, treatment, follow-up,
quality control, and adherence to protocol in the
proposed study.
o issues relating to inclusion of women and minorities
(see following special instructions).
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION
OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES
IN CLINICAL RESEARCH STUDY POPULATIONS:
NIH policy is that applicants and offerors for NIH grants,
cooperative agreements, and contracts 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 diseases, disorders, or conditions under study; special
emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders, and
conditions that disproportionately affect them. This policy
is intended to apply to males as well as females of all ages.
If women and minorities are excluded or inadequately
represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale for
exception to the policy should be provided.
The composition of the proposed study population must be
described in terms of gender and racial/ethnic groups,
together with a rationale for its choice. 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 Section 2, A-D of the
Research Plan AND summarized in Section 2, E, Human Subjects.
Applicant/offerors 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 populations should be provided. For the
purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, 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 definitions of minority differs in other
countries, the applicant must discuss the relevance of
research involving foreign population groups to the United
States' population, 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 is
inadequate to answer the scientific questions(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.
V. METHOD OF APPLYING
A letter of intent to submit an application, while not required, is
requested. This letter should be sent to the staff contact listed below
(see VI below) by March 15, 1991. The letter of intent should include a
descriptive title, the name and address of the principal investigator
and other key investigators as well as identification of any other
participating institutions. Applications should be submitted on the
standard PHS 398 application form (revised October 1988, reprinted
9/89), available at most institutional business offices and from the
Division of Research Grants, NIH, telephone (301) 496-7441. The
deadline for receipt of applications is April 29, 1991. On item 2 of
the face page of the application, applicants should enter: NIA
RFA--Sites Testing Osteoporosis Prevention/Intervention Treatments
(STOP/IT), AG-91-04. The RFA label available in the 10/88 revision of
the Application Form PHS 398 must be affixed to the bottom of the face
page and placed on the top of the entire package. Failure to use this
label could result in delayed processing of the application and prevent
it from reaching the review committee in time for review.
The completed application and four copies must be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
When the application is submitted to the Division
of Research grants, two
copies of the application should be sent to:
Chief, Scientific Review Office
National Institute on Aging
Building 31, Room 5C12
9000 Rockville Pike
Bethesda, MD 20892
Failure of these copies to be received by the deadline may
prevent the application from being reviewed under this
announcement in time to be considered for an award.
VI. STAFF CONTACT
Potential applicants interested in obtaining further
information may write or call:
Stanley L. Slater, M.D.
Geriatrics Program
National Institute on Aging
Room 5C27, Building 31
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-6761
This program is described in the Catalog of Federal
Domestic Assistance, Number 93.866. Awards are made
under the authority of the Public Health Service Act,
Section 301 (42 USC 241) and administered under PHS
grant policies and Federal Regulations, most
specifically at 42 CFR Part 52 and 45 CFR Part 74.
Special Terms of Awards applying to projects funded in
response to this RFA are in addition to, and not in lieu
of, otherwise applicable OMB administrative guidelines,
HHS grant administrative regulations at 45 CFR Part 74,
and other HHS, PHS, and NIH grant administration
policies. Awardees will maintain custody of and primary
rights to their data developed under their awards,
subject to Government rights of access, consistent with
current HHS, PHS, and NIH policies. This program is not
subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.