kristoff@GENBANK.BIO.NET (Dave Kristofferson) (05/31/91)
$$P5 BEGIN PA-91-63 ****************************************************
CUTANEOUS MANIFESTATIONS OF HIV INFECTION AND AIDS
PA: PA-91-63
P.T. 34; K.W. 0715120, 0715185
National Institute of Arthritis and Musculoskeletal and Skin Diseases
The Skin Diseases Program supports research on the structure, function,
and diseases of skin. This program announcement is to encourage
submission of research grant applications in the area of cutaneous
manifestations of human immunodeficiency virus (HIV) infection and
diseases, including AIDS, that are caused by HIV infection. Research
grant applications may be basic, clinical, or epidemiologic. Research
mechanisms to support these studies include investigator-initiated
research grants (R01), Clinical Investigator Awards (K08), First
Independent Research and Transition (FIRST) Awards (R29), and Individual
National Research Service Awards (F32).
The vast majority of patients with AIDS manifest cutaneous disease at
some time during their illness. Patients with HIV infection not meeting
the criteria for the diagnosis of AIDS also frequently manifest
cutaneous disease. In addition, an exanthem that is associated with
initial HIV infection in humans has been described; it precedes
seroconversion to HIV positivity by weeks to months. The skin diseases
seen in HIV infection encompass diseases for which the pathogenesis has
yet to be elucidated, including psoriasis and seborrheic dermatitis;
infectious diseases such as candidiasis and viral and bacterial
infections; and malignancies, particularly Kaposi's sarcoma.
A previous program announcement (NIH Guide for Grants and Contracts,
Vol. 17 No. 11, March 25, 1988) was published to stimulate research in
this area. This program announcement is designed to further encourage
research grant applications to investigate basic, clinical, and
epidemiologic aspects of these diverse cutaneous manifestations of HIV
infection. Projects may be oriented specifically towards the cutaneous
manifestations of HIV infection. They may also be oriented towards
utilizing the high incidence of skin disease in the HIV-infected and
AIDS populations to investigate the pathogenesis of the idiopathic skin
disease. Thus, we expect to obtain new information relevant to
idiopathic skin diseases as well as a better understanding of the
coexistence of AIDS and skin disease.
Among the broad spectrum of basic research projects encouraged are
studies of disease pathophysiology and genetics. Clinical studies may
include prevention of morbidity and mortality or amelioration of
cutaneous complications. Epidemiologic studies may focus on the
etiology, risk factors for disease development and severity, natural
history of disease, and prognosis for developing disease. This includes
descriptive studies of incidence, prevalence, morbidity, and mortality.
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.
Investigators are encouraged to work with existing, or proposed,
longitudinal data collection resources and cohorts of patients.
Populations that may be included are those at increased risk for HIV
infection, as well as HIV-positive cohorts who are clearly defined by
their source of exposure. Investigators are encouraged to work with
existing patient cohorts, such as the Multicenter AIDS Cohort Study
(MACS), The HIV Pulmonary Complication Study, and the AIDS Clinical
Trials Group.
ELIGIBILITY
Nonprofit organizations and institutions, governments and their
agencies, for-profit organizations, and individuals are eligible to
apply.
DEADLINE
Applications will be accepted in accordance with receipt dates for
unsolicitated AIDS R01 and R29 applications: January 2, May 1, and
September 1 of each year. AIDS investigator-initiated applications
received on these dates by the Division of Research Grants will be
subjected to expedited review. Applicants for F32 awards must submit
applications to meet the receipt dates listed in the instructions for
those mechanisms.
REVIEW PROCEDURES AND CRITERIA
All applications, except F32s, must be submitted on form PHS 398, rev.
10/88. Form PHS 416-1 must be used to submit F32 applications.
Application kits are available at the business or grants and contracts
office at most research and academic institutions. Additional
application kits may be obtained from the Office of Grants Inquiries,
Division of Research Grants, NIH, Westwood Building, Room 449, Bethesda,
MD 20892, telephone (301) 496-7441. The phrase, "Cutaneous
Manifestations of HIV Infection and AIDS, PA-91-63" must be typed at
item 2 of the first page of the application form 398 or item 3 of the
form 416-1. The original and 24 copies of an R01 or R29 application
submitted for expedited review, or the original and 2 copies of a
fellowship application must be sent to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications in response to this solicitation will be reviewed on a
nationwide basis in competition with other research grant applications
in accord with the expedited NIH peer review procedures for AIDS-related
research. In order to expedite the review, PHS human subject
certifications and animal welfare verifications must be submitted with
the applications. Applications will first be reviewed for technical
merit by initial review groups and then by the appropriate national
advisory council. The review criteria customarily employed by the NIH
for research grant applications will prevail.
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research. In such a case, a letter of agreement from the Program
Director of the GCRC must be included with the application material.
All PHS and NIH grant policies governing research project grants apply
to applications received in response to this program announcement.
Applications will be referred in accordance with normal procedures of
the NIH Division of Research and Grants.
For further information contact:
Dr. Alan N. Moshell
Director, Skin Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD 20892
Telephone: (30l) 496-7326
Reva C. Lawrence, M.P.H.
Epidemiology/Data Systems Program Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 31, Room 4C13
Bethesda, MD 20892
Telephone: (301) 496-0434
For fiscal and administrative matters, contact:
Diane M. Watson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 407-A
Bethesda, MD 20892
Telephone: (301) 496-7495
This program is described in the Catalog of Federal Domestic Assistance
No. 93.846, Arthritis, Musculoskeletal and Skin Diseases 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 grants policies and Federal Regulations 42
CFR Part 52 and 45 CFR Part 74. This program is not subject to
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
$$P5 END ***************************************************************
$$P6 BEGIN PA-91-64 ****************************************************
THE HEALTH AND EFFECTIVE FUNCTIONING OF OLDER RURAL POPULATIONS
PA: PA-91-64
P.T. 34, 44; K.W. 0710010, 0417000, 0408006, 0414000, 0413001, 0730000
National Institute on Aging
I. BACKGROUND
The National Institute on Aging (NIA) invites research and research
training grant applications on the social, economic, psychological,
environmental, and biomedical factors affecting the aging processes and
the health and effective functioning of older people in rural areas.
Recent governmental and non-governmental reports highlight the special
health-care and other services needs of rural people and especially
those who are old. People in rural areas are more likely than their
urban counterparts to be in fair or poor health, to suffer from chronic
or serious illness, to be without a regular source of health care and
health insurance. Moreover, a higher proportion of deaths occur among
the nonmetropolitan than the metropolitan population over 65 years of
age. The U.S. Congress has called for an increased research effort in
order to improve the knowledge base necessary for the promotion of
health and the prevention of disease among rural older people and for
developing and implementing effective, acceptable, and accessible health
care and other services.
II. SPECIFIC OBJECTIVES
A research agenda is needed for examining the life-long experience, the
current circumstances, and the special physical and social nature of
rural life as they affect the health, well-being, and functioning of
nonmetropolitan older people. Although many research topics are worthy
of consideration, NIA consultants and staff have identified five as
requiring special attention. Applications proposing activities relevant
to these broad topics are especially encouraged. (To obtain more
detailed information about these topics from NIA Staff, see Section
VII.)
A) The changing social, economic, demographic, and epidemiologic
characteristics of the older rural population
In 1980, 25.5 million Americans were 65 or older, and 25 percent of
these lived in rural areas. While older people comprised about 11
percent of both the urban and rural populations, several aspects of the
older rural population reflect its diversity and distinguish it from its
urban counterparts. These sources of diversity and distinctiveness need
to be considered in regard to their possible effects on aging and the
health and effective functioning of older rural residents.
B) The occupational and physiochemical environment
The exposure of older rural residents to particular physiochemical and
occupational environments reflects the wide diversity of aging processes
and health in rural areas and also distinguishes them from the
experiences of older urban residents. This exposure raises the general
question of whether or not the effects are cumulative and whether or not
it interacts with aging processes (e.g., accelerates aging).
C) The aging population of rural communities
Attention needs to be paid not only to the health and well-being of
older people, but also to the entire infrastructure of the communities
in which older people live. A thorough investigation of the health and
socioeconomic circumstances of older rural residents implies a need to
study older individuals in the context of their social environment.
Currently, many rural communities are undergoing massive changes. Some
of these changes are brought on by the significant increases in the
proportion of the population that is old--the "aging" of the rural
population is exacerbated by either the emigration of younger people or
the immigration of older people. As rural communities change, complex
interactions--among older people, their families, other individuals in
the community, and various community organizations, institutions, and
agencies--influence the health and psychological, social, and financial
well-being of older rural people. As people grow older and live longer,
changes may occur in their relationships with their families, their
churches, and their membership in informal social groups.
D) The availability, utilization, and quality of health-care and other
services
Research is needed on the origins and consequences for older rural
residents of the relative unavailability of health-care (including
disease-preventive services, e.g., for hypertension, smoking, and
injuries) and social services in rural communities.
E) Aging rural people as resources
Aspects of rural physical and social environments that may promote
health and effective functioning as people grow older deserve attention.
Despite the popular stereotype that "old age means dependency," the
overwhelming majority of older people are never institutionalized and
lead productive and independent lives. Unfortunately, the substantial
societal resource that the growing numbers of older people represent is
usually overlooked. Research on aging rural people may be the place to
begin the process of recognizing older people as a resource.
III. DEFINITION OF RURAL
This program announcement follows the Bureau of the Census' definitions
of "rural vs. urban," "metropolitan vs. nonmetropolitan," and "farm vs.
nonfarm." It recognizes that "rural" or "nonmetropolitan" is not
synonymous with "agriculture" and/or that appropriate research
populations include people living in small towns engaged in
nonagricultural occupations.
IV. MECHANISMS OF SUPPORT AND REVIEW CRITERIA
Research project grant (R01) and First Independent Research Support and
Transition (FIRST) Award (R29) applications, fellowships (F32, F33),
research career development awards (K04) accepted in response to this
program announcement will be assigned to NIH/ADAMHA Institutes and an
Initial Review Group in accordance with standard Referral Guidelines.
Applications will be reviewed for scientific and technical merit by an
appropriate initial review group. Secondary review will be by the
appropriate National Advisory Council. Applications will compete on the
basis of scientific merit with all other applications.
V. ELIGIBILITY
Applications may be submitted by public or private, non-profit or
for-profit, organizations such as universities, colleges, hospitals,
research institutes and organizations, units of State and local
governments, and eligible agencies of the Federal government. Women and
minority investigators are encouraged to apply.
VI. INCLUSION OF WOMEN AND MINORITIES
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants 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, 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.
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 or 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
review will be deferred until the information is provided.
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.
VII. METHOD OF APPLYING
For further information, contact NIA staff in advance of submission.
Basic Aging Program
H. Warner
Telephone: (301) 496-6402
Behavioral and Social Research Program
R. P. Abeles
Telephone: (301) 496-3136
Geriatrics Program
S. Slater
Telephone: (301) 496-6761
Neuroscience and Neuropsychology of Aging Program
T. S. Radebaugh
Telephone: (301) 496-9350
Address financial management questions to:
J. Ellis
Grants and Contracts Management Office
National Institute on Aging
Building 31, Room 5C07
Bethesda, MD 20892
Telephone: (301) 496-1472
For information about the coordinated program of the National Center on
Nursing Research (NCNR), see "Rural Health Care Research: Impacting
Vulnerable Populations," NIH Guide to Grants and Contracts, Vol. 20, No.
6, February 8, 1991, and/or contact Dr. P. Moritz, NCNR, telephone (301)
496-0523.
Applicants must use the grant application form PHS 398 (rev. 10/88) and
fellowship application forms PHS 416-1 (rev. 7/88), which are available
at the applicant's institutional Application Control Office and from:
Office of Grants Inquiries
Division of Research Grants
National Institute of Health
Westwood Building, Room 449
Bethesda, MD 20892
Telephone: (301) 496-7441
Check the box on the application face sheet indicating that the
application is in response to this announcement and print on line 2 "HEF
of Older Rural Populations, PA-91-64." The standard receipt dates for
applications by the Division of Research Grants apply (for R01, R29,
P01, and K04: February 1, June 1, and October 1; for T32, F32, and F33:
January 10, May 10, and September 10 of each year). Mail the complete
original application and the appropriate number of copies to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
This program is described in the Catalog of Federal Domestic Assistance
No. 93.866. Agency 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 41 USC 289) and be subject to PHS
Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part
74. This program is not subject to Health Systems Agency review or
Executive Order 12372.
$$P6 END ***************************************************************
FULL TEXT OF RFAs FOR ONLINE ACCESS
$$XID RFA DKHD9113 DKHD-91-13 P1O1 *************************************
RESEARCH TRAINING AND CAREER DEVELOPMENT AWARDS IN NUTRITION
AND OBESITY
RFA: DKHD-91-13
P.T. 34, 44; K.W. 0710095, 0765020, 0715145, 072005
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
Application Receipt Date: September 18, 1991
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) and the National Institute of Child Health and Human Development
(NICHD) invite applications for research training and for career
development (T32, F32, K08, K11) for physicians and basic scientists in
the areas of nutrition and obesity-related research. The intent of this
Request for Applications (RFA) is to provide research training and
career development support to persons who have a commitment to and an
aptitude for research in nutrient metabolism, obesity, eating disorders,
and/or energy regulation, as well as maternal-fetal, infant, and
childhood nutrition.
The NIDDK and NICHD as part of the Public Health Service (PHS) are
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 is related to the priority area of
nutrition and obesity as targeted by that document. Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, D.C. 20402-9325 (telephone
202-783-3238).
BACKGROUND
The Nutritional Sciences Program of the Division of Digestive Diseases
and Nutrition (DDDN), NIDDK, supports research, research training, and
career development programs on nutrient metabolism, obesity, eating
disorders, and energy regulation. NICHD supports similar activities in
the nutrition of low-birth-weight infants, nutrient metabolism as
related to growth and development, nutritional antecedents of adult
disease, and dietary therapy of inborn errors of metabolism. Nutrition
and obesity-related research needs and opportunities in the early
decades of the next century will require an increased number of
physicians and basic scientists with nutrition sciences training that
can be related to clinical nutrition problems falling within the DDDN
and NICHD program areas. The number of awards for training support
aimed at supplying this cohort of qualified scientists has declined over
the past decade. In particular, the K award mechanism has been
under-utilized, and more applications from promising candidates for this
type of award are encouraged. This RFA is directed to strengthening the
national capacity for nutrition and obesity-related research.
OBJECTIVE AND SCOPE
The objective of this solicitation is to increase the number of
physicians and basic scientists who can conduct high quality research in
the area of nutrition and obesity, compete for NIH grant support, and
provide leadership in the areas of clinical nutrition/obesity research.
Of particular importance is an increase in the number of
underrepresented minority persons who are supported on NIH
nutrition/obesity research training and career development awards. The
award mechanisms offered to achieve this are:
1. The National Research Service Award Institutional Training Grant
(T32)
2. The National Research Service Award Individual Postdoctoral
Fellowship (F32)
3. The Physician Scientist Award (K11)
4. The Clinical Investigator Award (K08)
Potential applicants are encouraged to read the guidelines* for each
mechanism to identify the mechanism most appropriate to their needs.
In the case of the Institutional Training Grant, both new and competing
renewal applications are encouraged. Further, although predoctoral
traineeships may be sought in these applications, there is a particular
need for the research training of M.D.s and Ph.D.s. Thus, postdoctoral
traineeships are encouraged on Institutional Training Grant
applications.
ELIGIBILITY REQUIREMENTS
Physician Research Training and Career Development: Physicians
receiving support under any of the award mechanisms offered in this RFA
also may be enrolled in a medical or surgical subspecialty training
program that relates to the nutrition/obesity program of DDDN and NICHD.
However, a full-time commitment to research training is required: grant
funds are for research training and career development only, and may not
be used for the support of clinical training or clinical services. Such
clinical subspecialty activities must be supported from other funding
sources. The following requirements apply to physician research
training and career development and are in addition to the standard
eligibility criteria* for these PHS award mechanisms and apply to these
awards under this RFA. In addition, the following applies:
1. Institutional Training Grant (T32): The applicant organization must
be or must be associated with a major medical institution and must have
or be able to develop a potential basic science training staff who have
NIH or other competitively awarded research support. M.D. trainees must
have completed a residency in internal medicine, surgery, or pediatrics.
Ph.D. trainees are also eligible; consultation with DDDN staff is
important to the potential applicant.
* General guidelines and eligibility requirements: for the
Institutional Training Grant see the NIH Guide for Grants and Contracts,
Vol. 16, No. 20, June 12, 1987; for the Individual Postdoctoral
Fellowship see the NIH Guide for Grants and Contracts, Vol. 17, No. 3,
January 22, 1988, and "NIH National Research Service Awards", DRG, NIH,
November 1, 1988; for the Physician Scientist and Clinical Investigator
Awards see "The K Awards", Division of Research Grants, NIH, October 15,
1990. If not available at your institution, all of these documents are
available from the NIH Office of Grants Inquiries, Westwood Building,
Room 449, National Institutes of Health, Bethesda, MD 20892 (telephone
301-496-7441).
2. Physician Scientist Award (K11) and Clinical Investigator Award
(K08): The applicant must have completed, by the time an award would be
activated, a residency in internal medicine, surgery, or pediatrics.
3. Individual Postdoctoral Fellowship (F32): The applicant must have
received the Ph.D., M.D., or equivalent degree prior to the beginning
date of the appointment.
DURATION OF SUPPORT AND BUDGET
1. The National Research Service Award (NRSA) Institutional Training
Grant is a five-year renewable award providing trainee stipends, tuition
and fees (including medical insurance), travel allowances, and $2,500
per year per trainee for institutional costs. Trainees can be appointed
for up to three years, with waivers of this restriction considered for
persons needing four or five years of research training.
2. The NRSA Individual Postdoctoral Fellowship permits initial requests
for up to three years of support, with waivers of this limit possible
for persons who find that a total of four or five years of research
training support is needed. The award provides a stipend plus an
institutional allowance of up to $3,000.
3. The Physician Scientist Award and the Clinical Investigator Award
each provides five years of research career development support. These
awards provide salary support of up to $50,000 per year, fringe benefit
costs, and allowances specific to each of the two award mechanisms.
TERMS OF THE AWARDS AND AVAILABILITY OF FUNDS
Physician trainees supported by the Institutional Training Grant are
expected to pursue a minimum of three continuous years of research
training, at least one of which is supported on the Institutional
Training Grant. The grantee institution must have a commitment to each
trainee for the support necessary to complete research training if
resources other than the Institutional Training Grant are to be used.
Preferably, physician trainees will be engaged in a Ph.D. or equivalent
program.
Basic scientist postdoctoral trainees are expected to complete at least
one year of research training supported by the Institutional Training
Grant.
Under this RFA, depending on the availability of funds and the receipt
of meritorious applications:
1) the NIDDK plans to award at least: one Institutional Training Grant
(the actual number depending upon the pool of competing renewal
applications), two Physician Scientist and/or Clinical Investigator
Awards, and four Individual Postdoctoral Fellowship Awards;
2) the NICHD plans to award at least two Physician Scientist and/or
Clinical Investigator Awards.
The earliest possible award date is January 1, 1992 for the Individual
Postdoctoral Fellowship applications and April 1, 1992 for the
Institututional Training Grant, Physician Scientist Award, and Clinical
Investigator Award applications.
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.
APPLICATION PROCEDURE
Use the Public Health Service Grant/Award application kits (PHS 398,
rev. 10/88 for Institutional Training Grant, Physician Scientist Award,
and Clinical Investigator Award applications. Use the PHS Individual
National Research Service Award application kit PHS 416-1, rev. 7/88,
for the Individual Postdoctoral Fellowship). Write "NIDDK-NICHD
Nutrition RFA DKHD-91-13" on line 2 of the PHS 398 form, and on line 3
of the PHS 416-1 form. One copy of the RFA label available in the PHS
398 application kit must be stapled to bottom of the face page of the
original application. Failure to use these identifying labels could
result in delayed processing of your application such that it may not
reach the review committee in time for review.
Applicants for the Institutional Training Grant should follow special
guidelines, "NIDDK Suggestions to National Research Service Award
Institutional Training Grant Applicants," available from the Research
Training and Career Development Program, DDDN, NIDDK, see below.
The original and six copies (if using the PHS 398) or two copies (if
using the PHS 416-1) must be submitted to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
REVIEW PROCEDURES
Upon receipt, applications will be examined by the NIH Division of
Research Grants for completeness. Incomplete applications will be
returned to the applicant without further consideration. Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA will be performed by NIDDK and NICHD staff. Applications that are
judged nonresponsive will be returned to the applicant without further
review. Such applications may be submitted as investigator-initiated
applications at the next appropriate receipt date.
Initial review for scientific and technical merit is conducted by a
group of predominantly non-Federal scientists convened by the NIDDK. A
second level review is conducted by the National Advisory Diabetes and
Digestive and Kidney Diseases Council or the National Advisory Child
Health and Human Development Council, or, in the case of the Individual
Postdoctoral Fellowship, by an NIDDK inhouse committee.
TIMETABLE
Application receipt date: September 18, 1991
Initial review date: January 1992
Advisory Council review date: May 1992
Anticipated award date: July 1, 1992
(F32s: May 1, 1992)
INQUIRIES
For further information please contact:
Judith M. Podskalny, Ph.D.
Director, Research Training and Career Development Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A15
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-7455
or
Ephraim Y. Levin, M.D.
Medical Officer
National Institute of Child Health and Human Development
Executive Plaza North, Room 637
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-5593
For information on fiscal matters and payback requirements contact:
Mrs. Nancy Dixon
Supervising Grants Management Specialist
DDN/KUH Team Leader
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 649
Bethesda, MD 20892
Telephone: (301) 496-7467
This program is described in the Catalog of Federal Domestic Assistance
No. 93.848. Awards will be made under the authority of the Public
Health Service Act, Section 301 (Public Law 78-410, as amended 42 USC
241) and administered under PHS grants policies and Federal regulations,
most specifically 42 CFR Part 52 and 45 CFR Part 74. This program is
not subject to the intergovernmental review requirements of Executive
Order 12372 or to Health Systems Agency review.