kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/13/91)
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. 6, February 8, 1991
NOTICES
NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN IN STUDY POPULATIONS ....... 1
National Institutes of Health (84/179)
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
ADAMHA/NIH POLICY CONCERNING INCLUSION OF MINORITIES IN STUDY POPULATIONS .. 2
Alcohol, Drug Abuse, and Mental Health Administration (182/265)
National Institutes of Health
Index: ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
NATIONAL INSTITUTES OF HEALTH
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH ......... 3
National Institutes of Health (268/296)
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CEREBRAL MAGNETIC RESONANCE IMAGING FOR EVALUATION OF STROKE RISK
FACTORS IN THE CARDIOVASCULAR HEALTH STUDY (RFP) ......(302/339)............ 3
National Heart, Lung, and Blood Institute
Index: HEART, LUNG, BLOOD
HUMAN LIVER CELL CULTURE FACILITY (RFP) ...............(342/379)............ 4
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
IMPROVED STRATEGIES FOR DIAGNOSIS OF LYME DISEASE (RFA AI-91-03) ........... 4
National Institute of Allergy and Infectious Diseases (382/490,2917/3339)
Index: ALLERGY, INFECTIOUS DISEASES
SMALL GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND
CLINICAL TRIALS IN RADIATION THERAPY (RFA CA-91-04) ........................ 6
National Cancer Institute (493/578, 1764/2215)
Index: CANCER
COOPERATIVE AGREEMENT RESEARCH PROGRAM: MAXIMIZING THE EFFICACY OF
PSYCHOTHERAPY AND DRUG ABUSE COUNSELING STRATEGIES IN THE TREATMENT
OF COCAINE ABUSERS (RFA DA-91-04) ................(581/708)................. 7
National Institute on Drug Abuse
Index: DRUG ABUSE
CHRONIC FATIGUE SYNDROME COOPERATIVE RESEARCH CENTERS (RFA AI-91-02) ....... 9
National Institute of Allergy and Infectious Diseases (721/833,2218/2914)
Index: ALLERGY, INFECTIOUS DISEASES
RESEARCH PLANNING GRANT: DIABETES IN MINORITY POPULATIONS
(RFA DK-NR-91-09) .............................(836/946, 3341/3778).........10
National Institute of Diabetes and Digestive and Kidney Diseases
National Center for Nursing Research
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES, NURSING RESEARCH
MINORITY DRUG ABUSE PREVENTION RESEARCH CENTERS (RFA DA-91-02) .............11
National Institute on Drug Abuse (949/1152)
Index: DRUG ABUSE
ONGOING PROGRAM ANNOUNCEMENTS
RURAL HEALTH CARE RESEARCH: IMPACTING VULNERABLE POPULATIONS (PA-91-23) ...14
National Center for Nursing Research (1158/1396)
Agency for Health Care Policy and Research
Index: NURSING RESEARCH, HEALTH CARE POLICY, HEALTH CARE RESEARCH
THE UROLOGICAL COMPLICATIONS OF DIABETES MELLITUS (PA-91-24) .(1399/1591)...17
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
NOTICE OF MEETING
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ....(1604/1696)........20
National Institutes of Health
Food And Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
NOTICES
NIH/ADAMHA POLICY CONCERNING INCLUSION OF WOMEN IN STUDY POPULATIONS
P.T. 34, II; K.W. 1014002, 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and
Mental Health Administration (ADAMHA) recognize that most researchers
adequately and appropriately consider gender representation in clinical
research design. Nevertheless, the following statement is published as a
reiteration and further interpretation of the existing NIH/ADAMHA policy
concerning inclusion of women in study populations. Clinical research
findings should be of benefit to all persons at risk of the disease,
regardless of gender. This policy was previously published in the NIH Guide
for Grants and Contracts on October 24, l986; January 23, l987; March 27,
l987; January l5, l988; and June l6, l989. For the purpose of this policy,
clinical research includes human studies of etiology, treatment, diagnosis,
prevention, and epidemiology of disease, including but not limited to clinical
trials. While this policy statement refers to inclusion of women, applicants
are strongly reminded that a similar policy exists regarding the inclusion of
minorities (NIH Guide for Grants and Contracts - September 25, l987; January
l5, l988; and June l6, l989). Both policies must be considered when preparing
clinical research applications/proposals for submission to the NIH/ADAMHA.
Public concern requires that clinical studies include both genders in such a
way that results are applicable to the general population; exceptions would be
those diseases or conditions that occur only in one gender. Therefore,
applications/proposals for NIH/ADAMHA support of clinical research should
employ a study design with gender representation appropriate to the known
incidence/prevalence of the disease or condition being studied. If inclusion
of women is impossible or inappropriate with respect to the purpose of the
research, the health of the subjects, or other reasons, or if in the only
study population available there is a disproportionate representation of one
gender, these reasons for excluding women or men must be well explained and
justified by the applicant. Similar justification is required if women will
not be included in numbers appropriate to the incidence/prevalence of the
disease.
In conducting peer review for scientific and technical merit, members of
Initial Review Groups (IRGs)/Technical Evaluation Groups (TEGs) will be
instructed to evaluate the proposed gender composition of the study
population.
1) If there is an inadequate number of women in a study design AND
this affects the potential to answer the scientific question(s)
addressed, that will be considered a weakness or deficiency in the
study design and should be reflected in the assigned score given to
the application/proposal, and in the summary statement of the
review.
2) If an applicant proposes that there is justification for conducting
a study in men only, or in a study population in which the
proportion of women does not reflect the gender prevalence of the
disease or condition under study, a strong scientific rationale, an
explanation of the need to protect the health of the subjects, or
other well-supported justification must be provided. The IRG/TEG
will be instructed to evaluate the merit of such justifications.
Appropriate justification will not adversely affect the assigned
score. The NIH/ADAMHA will not fund such applications/proposals
unless the justification provided is compelling.
3) If the gender composition of the study population is not described,
BUT the study otherwise has the potential to answer the scientific
question(s) posed and translate the findings to all persons at risk
of the disease, the omission will be documented by the Executive
Secretary of the IRG/TEG in an administrative note, and will not
adversely affect the scientific assessment and the assigned score.
If there is inadequate information on the study population to allow
evaluation of the scientific question(s), the review may be
deferred. The NIH/ADAMHA funding components will not fund/award
grants or contracts until the applicant provides sufficient
information on the study population to assure compliance with the
NIH/ADAMHA policy on inclusion of women in study populations.
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 1
Since the need to modify sample design could delay award and affect
the costs of the study, applicants are strongly advised to address
this issue in the initial submission. If costs or study designs
are significantly affected by such modification, submission of an
amended application/proposal for IRG/TEG review and/or
reconsideration by the appropriate National Advisory Council or
Board may be necessary.
Whenever there are scientific reasons to anticipate differences between men
and women with regard to the hypothesis under investigation, applicants should
consider the inclusion of an evaluation of gender differences in the proposed
study. However, if men and women are enrolled in numbers that reflect the
gender proportion of the disease under study, it is not an automatic
requirement for the study design to include statistical power for men and
women separately.
It is important to note that regardless of the program relevance of the
proposed research, the NIH/ADAMHA funding components will not fund/award
grants or contracts that do not comply with this policy.
ADAMHA/NIH POLICY CONCERNING INCLUSION OF MINORITIES IN STUDY POPULATIONS
P.T. 34, FF; K.W. 1014002, 1014006
Alcohol, Drug Abuse, and Mental Health Administration
National Institutes of Health
There are clear scientific and public health reasons for specifically
including members of minority groups in study populations. Accordingly, the
Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) and the
National Institutes of Health (NIH) require that applications/proposals for
clinical research must give appropriate attention to inclusion of minorities
in study populations, unless compelling scientific or other justification for
not including minorities is provided. For the purpose of this policy,
minorities include U.S. racial/ethnic minority populations (specifically:
American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and
Hispanics), and clinical research includes human studies of etiology,
treatment, diagnosis, prevention, and epidemiology of diseases, disorders and
conditions, including but not limited to clinical trials and research on
health service and its impact on disease. Grants, cooperative agreements, and
contracts are covered by this policy.
This statement is published as a reiteration and further interpretation of the
existing ADAMHA/NIH policy concerning inclusion of minorities in study
populations. This policy was previously published in the NIH Guide for Grants
and Contracts on September 25, 1987, Vol. 16, No. 32; January 15, 1988, Vol.
17, No. 2; and June 16, 1989, Vol. 18, No. 21. While the focus of this policy
is on inclusion of minorities in general population studies, ADAMHA and NIH
also encourage attention to gaps in knowledge about specific U.S.
racial/ethnic minorities and health problems that significantly affect them.
Examples of these problems include but are not limited to: cancer, substance
abuse, heart disease and stroke, homicide and accidents, diabetes, infant
mortality, and acquired immunodeficiency syndrome (AIDS). Addressing these
gaps may be appropriate justification for focusing a particular study on a
single racial/ethnic group.
While this policy statement refers to inclusion of minorities, applicants are
strongly reminded that a similar policy exists regarding women (NIH Guide for
Grants and Contracts - October 24, 1986, Vol. 15, No. 22; January 23, 1987,
Vol. 16, No. 3; January 15, 1988, Vol. 17, No. 2; June 16, 1989, Vol. 18, No.
21; and August 24, 1990, Vol. 19, No. 31). Both policies must be considered
when preparing research applicants/proposals for submission to ADAMHA/NIH.
Applicants for grants/cooperative agreements and offerors for contracts should
be aware that in attempting to include minority groups in a particular study,
attention must be paid to research design and sample size issues. ADAMHA and
NIH recognize that it may not be feasible or appropriate in all research
projects to include representation of the full array of U.S. racial/ethnic
minority populations. However, applicants/offerors are urged to assess
carefully the feasibility of including the broadest possible representation of
minority groups.
In all applications or proposals for clinical research, applicants must
describe the anticipated race/ethnic composition of the study population. In
conducting peer review for scientific and technical merit, members of Initial
Review Groups (IRGs)/Technical Review Groups (TEGs) will be instructed to
evaluate the appropriateness of the proposed minority composition:
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 2
1) If there is insufficient attention to inclusion of minorities in a
study design AND this affects the potential to answer the
scientific question(s) addressed, that will be considered a
weakness or deficiency and must be reflected in the assigned score
given to the application/proposal, and in the summary statement of
the review.
2) However, if an applicant proposes that there is justification for
conducting a study where there will be limited minority
participation or inclusion of only one racial/ethnic group, a
strong scientific rationale or other well-supported justification
must be provided. The IRG/TEG will be instructed to evaluate the
merit of such justifications. Appropriate justification will not
adversely affect the assigned score. The ADAMHA/NIH will not
fund/award such applications unless the justification is
compelling.
3) For grant and cooperative agreement applications, if there is
inadequate information on the study population to allow evaluation
of the scientific question(s), the review will be deferred or the
application returned.
It is important to note that the ADAMHA/NIH funding components will not
fund/award grants, cooperative agreement, or contracts that do not comply with
this policy.
CONFERENCE: FOSTERING SCIENTIFIC INTEGRITY IN BIOMEDICAL RESEARCH
P.T. 42; K.W. 1014004, 1014006
National Institutes of Health
The National Institutes of Health (NIH), the Association of American Medical
Colleges, and Washington University School of Medicine are co-sponsoring an
interactive conference for biomedical investigators, research administrators,
and university attorneys with an interest in fostering the integrity of
scientists. The goals of the workshop are to discuss the scope of the problem
of scientific misconduct; to identify perceived or real factors contributing
to misconduct; to discuss the roles of Congress, NIH, and institutions in
managing allegations of scientific misconduct; to examine how well specific
institutions have dealt with allegations of fraud, plagiarism or other
unacceptable scientific practices; to discuss any special ethical
considerations associated with Industry/University ties; and to discuss the
responsibilities of authors and collaborators in maintaining scientific
integrity in research. Several break-out sessions will address focussed
topics of particular concern.
This conference is approved for credit in AMA Category 1.
DATES: April 25-26, 1990
SITE: The Adams Mark Hotel, St. Louis, MO
PROGRAM AND REGISTRATION INFORMATION: Telephone: (800) 325-9862, interstate
(314) 362-6893, in Missouri
NOTICES OF AVAILABILITY (RFPs AND RFAs)
CEREBRAL MAGNETIC RESONANCE IMAGING FOR EVALUATION OF STROKE RISK FACTORS IN
THE CARDIOVASCULAR HEALTH STUDY
RFP AVAILABLE: NIH-NHLBI-HC-91-06
P.T. 34; K.W. 0706030, 0715200, 0715042, 0411005
National Heart, Lung, and Blood Institute
The National Heart, Lung, and Blood Institute (NHLBI) requires a reading
center for cerebral magnetic resonance imaging (MRI) to be performed on
approximately 4,000 participants in the multicenter longitudinal study of risk
factors for heart disease and stroke in the elderly entitled, "The
Cardiovascular Health Study" (CHS). The MRI Reading Center will assist in
protocol development for the performance of cerebral MRI in the four CHS Field
Centers and will perform measurements and interpretations of these images in a
standardized and reproducible manner. The period of performance is
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 3
anticipated to be September 1991 through June 1995. The NHLBI plans to make
one award from this solicitation.
This is an announcement for a Request for Proposals (RFP). RFP NHLBI-HC-91-06
will be available on or about February 15, 1991. Responses will be due by
close of business on April 5, 1991. One (1) award is anticipated to be made
during September 1991. All requests should be submitted in writing and
include three (3) mailing labels, self-addressed, and must cite RFP No.
NHLBI-HC-91-06.
Requests for copies of the RFP should be sent to the following address:
Donna J. Neal
Contracts Specialist
ECA Section, Contracts Operations Branch, DEA
National Heart, Lung, and Blood Institute
Federal Building, Room 3C16
National Institutes of Health
Bethesda, MD 20892
HUMAN LIVER CELL CULTURE FACILITY
RFP AVAILABLE: NIH-NIDDK-91-3
P.T. 34; K.W. 0780015, 0780005, 0755050
National Institute of Diabetes and Digestive and Kidney Diseases
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
is seeking an organization to provide a facility where: (1) the science of
culturing human primary hepatocytes in long-term culture would be highly
developed; (2) such cells would be available for use by other investigators in
the culture facility; (3) such cultures would be shipped to investigators in
the United States; and (4) cryopreserved hepatocytes from which cultures could
be developed would be shipped to investigators in the United States.
Stringent characterization and quality control of the cultures would be
required. Requests for cells would be reviewed and prioritized by a committee
advisory to the contractor.
The NIDDK expects to make one award from this solicitation.
This Request for Proposals (RFP), RFP No. NIH-NIDDK-91-3, will be available on
or about February 18, 1991, with a closing date set for April 8, 1991. To
receive a copy of the RFP, please supply this office with two (2)
self-addressed mailing labels. Since a limited number of copies will be
printed, requests shall be filled on a first come, first served basis until
the supply is exhausted. Requests for the RFP should be sent to the following
address:
Patrick M. Sullivan, Chief
Contracts Management Branch
National Institute of Diabetes, and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 602
5333 Westbard Avenue
Bethesda, MD 20892
This advertisement does not commit the Government to award a contract.
IMPROVED STRATEGIES FOR DIAGNOSIS OF LYME DISEASE
RFA AVAILABLE: AI-91-03
P.T. 34; K.W. 0745020, 0715125, 0710070, 0785035, 0710030, 0755010
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: March 15, 1991
Application Receipt Date: May 3, 1991
The National Institute of Allergy and Infectious Diseases (NIAID) invites
grant applications for research that applies an understanding of the biology
of Borrelia burgdorferi and host responses to infection by this organism to
studies that will lead to the development of reliable and sensitive diagnostic
tests for the detection of Lyme disease.
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 4
RESEARCH GOALS AND SCOPE
The goal of this Request for Applications (RFA) is to stimulate programs of
multidisciplinary basic and clinical research focused upon determining the
most effective approach(es) for diagnosis of Lyme disease. Applications
submitted in response to this RFA are expected to focus upon developing and
testing new diagnostic strategies that should result in a more reliable and
sensitive approach to the detection of Lyme disease in patients.
Applications should include innovative approaches to the following:
o Identification and characterization of antigens, antibodies, and
DNA sequences that are good candidates as reagents, probes, or
targets for use as a basis for a Lyme disease diagnostic test.
o Identification and recruitment of three patient populations
(patients that have a firm diagnosis of Lyme disease, patients that
have no history or signs of Lyme disease, and patients that have
symptoms of Lyme disease but test negative using a defined set of
diagnostic tests currently available.
o Evaluation of the sensitivity and specificity of candidate
diagnostic assays relative to one another and to selected
commercially available diagnostic kits using a standard panel of
clinical specimens from each of the individuals in the recruited
patient populations described above.
However, alternative approaches or additional components may be included in
applications providing they are directly related to the overall objective of
this RFA which is the development of improved strategies for the diagnosis of
Lyme disease.
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.
MECHANISM OF SUPPORT
The support mechanism for this program will be the traditional individual
research grant (R01). Responsibility for planning, direction, and execution
of the proposed project will be solely that of the applicant.
This is a one-time solicitation. NIAID anticipates making two awards as a
result of this request. However, the number of awards to be made is dependent
upon receipt of a sufficient number of applications of high scientific merit
and upon the availability of funds. If appropriate, collaboration with other
investigators or institutions is encouraged. NIAID staff anticipates that
each application would be a comprehensive single project (i.e., not a
multiproject application). It is expected that the initial year's awards for
successful applications will average $500,000 in total (direct plus indirect)
costs for each award, although individual awards may be slightly higher or
lower. Awards will be made for a project period of up to five years. (Awards
to applicant institutions outside the United States will be limited to three
years). The earliest possible award date is September 30, 1991. NIAID has no
plans to reissue this announcement. At the end of the award period, awardees
may apply for continuation through the usual competing renewal process for R01
grants. Universities, medical colleges, hospitals, and laboratories or other
public, private, or for-profit institutions are eligible.
INQUIRIES
Investigators seeking information relevant to this RFA should contact Dr.
Robert L. Quackenbush at the address below.
Dr. Robert L. Quackenbush
Chief, Bacteriology and Mycology Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 738
Bethesda, MD 20892
Telephone: (301) 496-7728
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 5
Questions regarding review procedures should be addressed to Dr. Preble at the
address below.
Dr. Olivia Preble
Chief, Microbiology and Immunology Review Section
Program and Project Review Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health Westwood Building, Room 3A10
Bethesda, MD 20892
Telephone: (301) 496-8208
SMALL GRANTS TO STIMULATE CORRELATIVE LABORATORY STUDIES AND CLINICAL TRIALS
IN RADIATION THERAPY
RFA AVAILABLE: CA-91-04
P.T. 34; K.W. 0745062, 0715035, 0755015
National Cancer Institute
Letter of Intent Receipt Date: March 4, 1991 Application Receipt Date: May
22, 1991
Introduction
The Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI)
announces the availability of a Request for Applications (RFA) for tightly
focused, basic science laboratory studies that interface with radiation
therapy clinical trials or for radiation therapy clinical trials that attempt
to correlate new and/or unique developments in the laboratory.
Background Information
Using the small grants (R03) mechanism, the NCI hopes to stimulate the
communication of promising and potentially relevant new developments between
the basic science laboratory and the clinical setting. The R03 mechanism
provides complementary research support for short-term, pilot, radiation
therapy clinical trials that test and verify basic laboratory findings.
Research Goals and Scope
The aims of this RFA are two-fold: (1) to provide a mechanism for accelerated
funding of correlative studies relevant to radiation therapy clinical trials
and (2) to stimulate pilot clinical studies with or without relevant
laboratory correlations so as to foster the development of interactions
between basic science laboratories and clinicians performing radiotherapy
clinical trials. Laboratory correlates should be designed to ultimately lead
to improved radiation therapy.
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
This small grant (R03) RFA is a non-renewable, one-time solicitation. The NCI
plans to make multiple awards for project periods up to two years. All awards
will be limited to a $50,000 direct-cost ceiling for a period of up to two (2)
years. The total project period for applications submitted in response to the
present RFA should not exceed two (2) years. The earliest feasible start date
for the initial awards will be December 2, 1991.
Eligibility Requirements
Only domestic non-profit and for-profit organizations, institutions,
governments and their agencies are eligible to apply. Although NCI-funded
Cooperative Groups are ineligible to apply, individual institutions or
consortia of the Cooperative Groups may apply through their own institutions.
Awards will be made only to institutions with either a funded clinical or
laboratory component of the proposed study. These awards are to complement a
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 6
previously existing source of support. These pre-existing resources need not
be at a single institution but may exist within a consortium.
Inquiries
Written or telephone inquiries concerning the objectives and scope of this
RFA, or inquiries about whether or not specific proposed research would be
responsive, are encouraged and should be directed to the program director at
the address given below. The program director welcomes the opportunity to
clarify any issues or questions from potential applicants.
Thomas A. Strike, Ph.D.
Radiation Research Program
Division of Cancer Treatment
National Cancer Institute
6130 Executive Boulevard, Suite 800
Rockville, MD 20852
Telephone: (301) 496-9360
COOPERATIVE AGREEMENT RESEARCH PROGRAM: MAXIMIZING THE EFFICACY OF
PSYCHOTHERAPY AND DRUG ABUSE COUNSELING STRATEGIES IN THE TREATMENT OF COCAINE
ABUSERS
RFA AVAILABLE: DA-91-04
P.T. 34; K.W. 0404009, 0745060
National Institute on Drug Abuse
Application Receipt Date: April 24, 1991
PURPOSE: The purpose of this announcement is to support collaborative
multi-site research on the comparative efficacy of psychodynamic
psychotherapy, cognitive-behavioral therapy, and drug counseling in the
treatment of cocaine abusers in outpatient drug-free settings. The
interaction of patient characteristics with type of treatment will also be
investigated. Collaborators from a Coordinating Center, a Collaborative
Treatment Site (CTS), and the National Institute on Drug Abuse (NIDA) are
currently developing the protocol and piloting subjects for this study. Funds
will be available under this announcement for supporting additional CTSs to
collaboratively finalize and carry out this protocol. Applicants for
additional CTSs must agree to abide by this protocol. Applicants must also
propose sub-studies to be carried out within this protocol. Final protocols
for sub-studies will be collaboratively developed by a Steering Committee (SC)
after awards are made.
RESEARCH OBJECTIVES: One research objective is to conduct a comparative
pyschotherapy/drug counseling treatment efficacy study, using a common
protocol at multiple CTSs, in order to compare the efficacy of different
therapy approaches. An equally important goal is to specify the nature of any
interactions between patient characteristics (e.g., sociopathy) and therapy
type as reflected in treatment outcome.
MECHANISM OF SUPPORT: The mechanism to support these clinial trials will be a
Cooperative Agreement (CA) between the awardees and NIDA. Researchers agree
to accept close coordination and guidance by the SC in all aspects of the
scientific and technical management of the common project, and retain primary
responsibility for performance of the research, in accordance with terms
formally negotiated and mutually agreed on prior to the award. CAs are
subject to the same administrative requirements as grants. All pertinent
DHHS, PHS, and ADAMHA grant regulations, policies, and procedures are
applicable. Business management aspects of these awards will be administered
in accordance with DHHS and PHS grant administrative requirements.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF ADAMHA POLICIES
CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
Applications/proposals for Alcohol, Drug Abuse, and Mental Health
Administration (ADAMHA) grants and cooperative agreements are required to
include both women and minorities in study populations for clinical research,
unless compelling scientific or other justification for not including either
women or minorities is provided. This requirement is intended to ensure that
research findings will be of benefit to all persons at risk of the disease,
disorder, or condition under study. For the purpose of these policies,
clinical research involves human studies of etiology, treatment, diagnosis,
prevention, or epidemiology of diseases, disorders or conditions, including
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 7
but not limited to clinical trials; and minorities include U.S. racial/ethnic
minority populations (specifically: American Indians or Alaskan Natives,
Asian/Pacific Islanders, Blacks, and Hispanics).
ADAMHA recognizes that it may not be feasible or appropriate in all clinical
research projects to include representation of the full array of U.S.
racial/ethnic minority populations. However, applicants are urged to assess
carefully the feasibility of including the broadest possible representation of
minority groups.
Applications should include a description of the composition of the proposed
study population by gender and racial/ethnic group and the rationale for the
numbers and kinds of people selected to participate. 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.
Applications should incorporate in their study design gender and/or minority
representation appropriate to the scientific objectives of the work proposed.
If representation of women or minorities in sufficient numbers to permit
assessment of differential effects is not feasible or is not appropriate, the
reasons for this must be explained and justified. The rationale may relate to
the purpose of the research, the health of the subjects, or other compelling
circumstances (e.g., if in the only study population available, there is a
disproportionate representation in terms of age distribution, risk factors,
incidence/prevalence of one gender or minority/majority group).
If the required information is not contained within the application, the
applications will be returned to the applicant. Peer reviewers will address
specifically whether the research plan in the application conforms to these
policies. If gender and/or minority representation/justification are judged
to be inadequate, reviewers will consider this as a deficiency in assigning
the priority score to the application.
All applications/proposals for clinical research submitted to ADAMHA are
required to address these policies. ADAMHA funding components will not award
grants that do not comply with these policies.
REVIEW PROCEDURES: The Division of Research Grants, NIH, serves as a central
point for receipt of applications. Applications received under this
announcement will be assigned to a Special Review Committee (SRC) within the
NIDA. The SRC will review the applications for scientific and technical merit
during the summer of 1991. Notification of the review recommendations will be
sent to the applicant after this initial review. Applications will receive a
second-level review by the National Advisory Council on Drug Abuse in
September 1991. Only applications recommended for approval by the Council may
be considered for funding.
Applications submitted in response to this announcement are not subject to the
intergovernmental review requirements of Executive Order 12372, as implemented
throught Department of Health and Human Service regulations at 45 CFR Part 100
and are not subject to Health Systems Agency review.
APPLICATION PROCEDURES: Applicants must use the research grant application
form, PHS 398 (last revised 10/88). Application kits with the necessary forms
and instructions (PHS 398) may be obtained from institutional business offices
or offices of sponsored research at most universities, colleges and medical
schools, and other major research facilities. Applications may also be
obtained from: The National Institute on Drug Abuse (NIDA), Grants Management
Branch, Room 8A-54, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
(301-443-6710).
INQUIRES: Further information can be obtained from:
Dr. J. Boren
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-30
Rockville, MD 20857
Telephone: (301) 443-1263
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 8
CHRONIC FATIGUE SYNDROME COOPERATIVE RESEARCH CENTERS
RFA AVAILABLE: AI-91-02
P.T. 04; K.W. 0715043, 0715026, 0715125, 0715150, 0710070, 1002045
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: March 1, 1991
Application Receipt Date: April 1, 1991
The National Institute of Allergy and Infectious Diseases (NIAID) invites
applications for the establishment of Chronic Fatigue Syndrome Cooperative
Research Centers (CFS CRCs) to augment the existing grant program for CFS
research. The CRCs are intended to provide a sustained multidisciplinary
approach to CFS research that will advance the field by bridging the basic
science and clinical research arenas and facilitating confirmatory testing and
follow-up of new hypotheses and observations.
BACKGROUND
CFS is a multisystem syndrome thought to be triggered by viral infection and
is characterized by months of debilitating fatigue frequently associated with
sore throat, low grade fever, myalgia, headache, gastrointestinal symptoms,
and tender lymph nodes. Cognitive deficits, symptoms of depression and sleep
disorders have been reported and abnormal brain images derived by different
techniques have been described. CFS patients are reported to have
neuroendocrine response patterns that differ from those of controls. CFS is
diagnosed more frequently in women than in men. There have been numerous
reports of specific immune dysfunctions, but no single impairment has
regularly been associated with the syndrome. Similarly, viruses from several
taxonomic groups have been reported to be involved, but none as yet has been
confirmed to be consistently associated with disease onset or progression.
Patients have a high prevalence of allergies and recent reports indicate that
a state of chronic immune activation may exist in a significant fraction of
patients.
There have been many formidable obstacles to the effective study of this
syndrome, the most serious of which has been the lack of objective diagnostic
criteria. Progress has been made in case definition and a number of testable
hypotheses recently have been proposed.
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.
RESEARCH OBJECTIVES AND SCOPE
The purpose of this RFA is to stimulate the establishment of centers of CFS
research excellence in which coordinated projects in the fields of immunology,
virology, medicine, and clinical epidemiology are pursued in order to further
our understanding of CFS leading to improved diagnosis and treatment. It is
not expected that expertise in all these areas be available at a single
institution. CRCs with well-designed research projects with adequate sample
sizes are sought to confirm and extend preliminary findings and to test
biologically rational hypotheses concerning the etiology or pathogenesis of
CFS.
CLINICAL FACILITIES: CFS CRCs should be based at universities or at
university-affiliated medical facilities that have a strong clinical facility
with accessible well-defined CFS patient populations.
MECHANISM OF SUPPORT
Awards will be made as cooperative agreements. This mechanism is used when an
interactive assistance relationship exists between NIAID staff and the
investigative team as outlined in the RFA under "TERMS OF AWARD: AWARDEE
RIGHTS AND RESPONSIBILITIES; NATURE OF PARTICIPATION OF NIAID STAFF." Input
from the NIAID Scientific Coordinator is intended to facilitate technology
transfer, assist in the identification of expert consultants, collaborators
and resources, enhance communication between awardees, and help to ensure that
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 9
new studies will complement and not unnecessarily duplicate existing or
planned CFS research endeavors.
NIAID has set aside a total of $488,000 (direct plus indirect costs) per year
to support this RFA and anticipates making at least one (1) award in FY 1991,
the final number being dependent upon the number, cost, and scientific merit
of proposals received and the availability of funds. Awards will be made for
a project period of up to four years. The earliest possible award date is
September 30, 1991. NIAID intends to accept competitive renewal multi-project
applications contingent upon the continued availability of funds for this
purpose.
APPLICATION PROCEDURE
Investigators are urged to contact the NIAID staff listed below early in the
development of the application. Additionally, before preparing an
application, the applicant should carefully read the information brochure,
"Program Project and Center Grants, NIAID." A letter of intent is requested
by March 1, 1991. The deadline for receipt of applications is April 1, 1991.
INQUIRIES
Investigators seeking copies of the RFA and information relevant to this RFA
should contact:
Ann Schluederberg, Sc.D.
Chief, Virology Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 736
Bethesda, MD 20892
Telephone: (301) 496-7453
FAX: (301) 402-0804
RESEARCH PLANNING GRANT: DIABETES IN MINORITY POPULATIONS
RFA AVAILABLE: DK-NR-91-09
P.T. 34, FF; K.W. 0715075, 0755030, 0765033, 0745020, 0745027, 0745070
National Institute of Diabetes and Digestive and Kidney Diseases
National Center for Nursing Research
Letter of Intent Receipt Date: May 16, 1991
Application Receipt Date: July 16, 1991
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
and the National Center for Nursing Research (NCNR) have initiated a program
for Research Planning Grants to support the development of plans for research
projects that address critical questions related to the etiology,
pathogenesis, diagnosis, treatment, cure, and prevention of diabetes mellitus
and its complications in minority populations, including Blacks, Native
Hawaiians, Hispanics, Pacific Islanders, and Asian Americans. American
Indians and Alaskan Natives are not included in this Request for Applications
(RFA), since a similar initiative limited to these populations was announced
in Vol. 19, No. 40, November 9, 1990 issue of the NIH Guide for Grants and
Contracts.
Research proposed in response to this RFA may involve basic, clinical,
behavioral, or epidemiologic studies. Basic research may be designed to
elucidate biochemical alterations responsible for increased suceptibility to
diabetes mellitus or to the complications of diabetes. Clinical research may
be oriented to the cellular, organ, or human level and may include metabolic
studies and comparisons. Behavioral studies, particularly those focused on
prevention of diabetes through weight control programs, are encouraged.
Epidemiologic designs that might be considered include observational and
natural history studies, case-control studies of racial/ethnic differences,
studies of migrant populations in the U.S. versus in their country of origin,
urban/rural comparisons, acculturation of the minorities to the U.S. lifestyle
and environment, and longitudinal studies. Issues of obesity, aging, chronic
disease, and multiple chronic diseases (such as diabetes and hypertension) are
particularly encouraged. Research directed toward improving methodologies for
population-based studies of minority ethnic/racial groups is also encouraged.
Innovative approaches that involve new inter-disciplinary collaborations are
particularly desirable. Whenever possible, applicants are urged to make
cost-efficient use of current or recently terminated studies that contain
large components of populations that are minorities in the U.S. Many of the
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 10
studies extant may have been conceived for reasons other than for research on
U.S. minorities or for studies on diabetes mellitus.
This RFA is a one-time solicitation by NIDDK and NCNR for applications for
Research Planning Grants (R21) to help support the unique short-term needs of
investigators planning research studies related to diabetes in minority
populations. It is anticipated that the award of these Research Planning
Grants will be followed within approximately one year by an RFA for
investigator-initiated research project grant applications (RO1) related to
this same program area.
Applicants are encouraged to submit and describe their own ideas on how best
to meet the objectives of this RFA. Applications will be judged primarily on
(1) the likelihood that the new knowledge that may be gained will subsequently
help to reduce the burden of diabetes and its complications on the health
status of minority populations; (2) the potential scientific and technical
merit of the proposed project, including the significance of the scientific
question(s), rationale, appropriateness of the proposed planning process,
consideration of appropriate ethical issues, and availability of preliminary
data; (3) the potential to establish collaborations with groups and other
agencies involved in health care of the selected populations; and (4) the
qualifications and experience of the proposed investigators.
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 are not included in these study populations, a specific
justification for this exclusion must be provided. Applications without such
documentation will not be accepted for review.
Prospective applicants are requested to submit a letter of intent by May 16,
1991, that includes a descriptive title of the proposed research; the name,
telephone number and mailing address of the Principal Investigator; the names
of other key personnel; the name of the applicant institution and other
collaborating entities; and the number and title of this RFA.
This letter of intent should be sent to:
Dr. Robert D. Hammond
Chief, Review Branch Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 406
Bethesda, MD 20892
Requests for the full text of this RFA and inquiries should be directed to the
following NIDDK or NCNR program staff:
NIDDK
Dr. Lois F. Lipsett
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
Westwood Building, Room 620
Bethesda, MD 20892
Telephone: (301) 496-7433
NCNR
Dr. Mary Lucas
National Center for Nursing Research
National Institutes of Health
Building, 31, Room 5B03
Bethesda, MD 20892
Telephone: (301) 496-0523
MINORITY DRUG ABUSE PREVENTION RESEARCH CENTERS
RFA AVAILABLE: DA-91-02
P.T. 04; K.W. 0404009, 0710030, 0755030, 0411005, 0745027, 0404000
National Institute on Drug Abuse
Application Receipt Date: April 24, 1991
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 11
PURPOSE: The purpose of this announcement is to encourage the development of
multidisciplinary research centers that will improve our ability to prevent
drug abuse among minority populations. Minority populations include American
Indian/Alaskan Natives, Asian Americans, Blacks, Hispanics, and/or Native
Hawaiians/Pacific Islanders. The proposed Centers are designed to: 1)
improve our understanding of etiologic factors that predispose individuals
from minority communities to initiate drug use; 2) identify factors involved
in the progression from initial drug use to drug dependence; 3) develop
criteria and early identification methodologies for use with children and
adolescents at high risk for drug abuse; 4) design and test preventive
interventions at the individual and small group level through controlled
randomized studies; 5) assess the progression of drug use through prospective
longitudinal studies of high-risk populations; 6) develop a series of
conferences and workshops addressing prevention research issues of specific
relevance to understanding etiologic factors and intervention strategies among
minority populations; 7) train minority investigators to conduct drug abuse
prevention research; and 8) involve the minority community in the development
and implementation of a research program.
RESEARCH OBJECTIVES: Prevention and intervention strategies demonstrate
differential effects within various ethnic groups and socioeconomic
populations. Multiple intervention strategies are needed within any
geographic location to block and delay the initiation of drug use behavior and
to impede progression to drug dependency and associated social, psychological,
and physiological sequelae.
Etiological studies designed to specify deferential causes for initiating,
continuing, and discontinuing drug abuse within and among ethnic groups in
urban, suburban, and rural geographic areas are needed. For example, are
there selective factors associated with blacks who remain in school longer
than other blacks and/or graduate? Are there factors that "protect" the
students from drug abuse? What is the role of the educational system in
reducing, delaying, or eliminating drug use? Furthermore, given the same
environment and equivalent level of being "vulnerable" to drug abuse, what
family, social, environmental protectors exist to prevent the use of drugs.
As our surveys of minorities rarely have included high-risk groups such as
school dropouts, runaways, and prisoners, the current estimates of drug abuse
in minority populations may underestimate the problem. Current research
indicates that dropouts have higher rates of illicit drug use than minority
youth in school. Such data suggest the need for community-wide drug abuse
education, prevention, and intervention programs in addition to the
school-based programs. More research is needed to explore the relationship
between poor school performance and acculturation-related stress with drug
abuse among minority youth. Areas related to the putative crime/drug
connection among blacks needs further examination to more fully understand the
causes and extent of the relationship within minority populations.
Applications for Minority Drug Abuse Prevention Research Centers are
encouraged but not restricted to any of the four content areas among minority
groups: Families and Multi-Generational Factors; Environmental and Cultural
Factors; High-Risk Children, Adolescents, and Young Adults; and Women and
Drugs.
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF ADAMHA POLICIES
CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY
POPULATIONS
Applications/proposals for ADAMHA grants and cooperative agreements are
required to include both women and minorities in study populations for
clinical research, unless compelling scientific or other justification for not
including either women or minorities is provided. This requirement is
intended to ensure that research findings will be of benefit to all persons at
risk of the disease, disorder, or condition under study. For the purpose of
these policies, clinical research involves human studies of etiology,
treatment, diagnosis, prevention, or epidemiology of diseases, disorders or
conditions, including but not limited to clinical trials; and minorities
include U.S. racial/ethnic minority populations (specifically: American
Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics).
ADAMHA recognizes that it may not be feasible or appropriate in all clinical
research projects to include representation of the full array of U.S.
racial/ethnic minority populations. However, applicants are urged to assess
carefully the feasibility of including the broadest possible representation of
minority groups.
Applications should include a description of the composition of the proposed
study population by gender and racial/ethnic group, and the rationale for the
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 12
numbers and kinds of people selected to participate. 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.
Applications should incorporate in their study design gender and/or minority
representation appropriate to the scientific objectives of the work proposed.
If representation of women or minorities in sufficient numbers to permit
assessment of differential effects is not feasible or is not appropriate, the
reasons for this must be explained and justified. The rationale may relate to
the purpose of the research, the health of the subjects, or other compelling
circumstances (e.g., if in the only study population available there is a
disproportionate representation in terms of age distribution, risk factors,
incidence/prevalence, etc., of one gender or minority/majority group).
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
gender and/or minority representation/justification are judged to be
inadequate, reviewers will consider this as a deficiency in assigning the
priority score to the application.
All applications/proposals for clinical research submitted to ADAMHA are
required to address these policies. ADAMHA funding components will not award
grants that do not comply with these policies.
MECHANISM OF SUPPORT: P50
ELIGIBILITY
Applications may be submitted by public or private nonprofit or profit-
making organizations such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible agencies
of the Federal government. Women and minority investigators are
encouraged to apply.
REVIEW PROCEDURES: The Division of Research Grants, NIH, serves as a central
point for receipt of applications for most discretionary PHS grant programs.
Applications received under this announcement will be assigned to an initial
review group (IRG) within the National Institute on Drug Abuse. The IRG,
consisting primarily of non-federal scientific and technical experts, will
review the applications for scientific and technical merit. Notification of
the review recommendations will be sent to the applicant after the initial
review. Applications will receive a second-level review by the National
Advisory Council on Drug Abuse whose review may be based on policy as well as
scientific merit considerations. Only applications recommended for approval
by the Council may be considered for funding.
APPLICATION PROCEDURES: An application for a Minority Drug Abuse Prevention
Research Center grant must provide the following information within the
general proposal: research plan to include specific information on the
Center's research theme, goals, and objectives; detailed descriptions of the
specific research projects and their relationship to the core program;
identification of key scientists and their roles and responsibilities on
specific projects and research teams; and discussion of the management
structure to be employed to organize and coordinate multidisciplinary
scientific research initiatives; the research program plan must be organized
around a central research theme and address the research and administrative
requirements established by this announcement. Furthermore, the proposal must
include a description of training of research personnel; evidence of a strong
community relationship with demonstrated experience of working in the target
community; and descriptions of conferences, publications, and other methods
for the dissemination of research findings.
Applicants must use the research grant application form PHS 398 (rev. 10/88).
The RFA number DA-91-02 and the title of this announcement, "Minority Drug
Abuse Prevention Research Research", should be typed in item number 2 on the
face page of the PHS 398 application form.
When using the PHS 398 application form to respond to an RFA, applicants must
affix the RFA label available in the 398 to the bottom of the face page.
Failure to use this label may result in delayed processing of the application
such that it may not reach the review committee in time for review.
Application kits containing the necessary forms and instructions may be
obtained from business offices or offices of sponsored research at most
universities, colleges, medical schools, and other major research facilities.
If such a source is not available, the following office may be contacted for
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 13
the necessary application material: Division of Research Grants, NIH Westwood
Building, Room 240, 5333 Westbard Avenue, Bethesda, MD 20892 (301) 496-9797.
The complete announcement may be obtained from:
Grants Management Branch
National Institute on Drug Abuse
Room 8A54, 5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-6710
The signed original and six (6) permanent legible copies of the completed
application should be sent to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
INQUIRIES
Further information and consultation on program requirements relevant to
prevention research can be obtained from:
Dr. Zili Amsel
Acting Director
Division of Epidemiology and Prevention Research
National Institute on Drug Abuse
Rockwall II Building, Suite 620
c/o 5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-1514
ONGOING PROGRAM ANNOUNCEMENTS
RURAL HEALTH CARE RESEARCH: IMPACTING VULNERABLE POPULATIONS
PA: PA-91-23
P.T. 34; K.W. 0730050, 0730000, 0785055, 0785035, 0403004
National Center for Nursing Research
Agency for Health Care Policy and Research
PURPOSE
The National Center for Nursing Research (NCNR) and the Center for General
Health Services Extramural Research, Agency for Health Care Policy and
Research (AHCPR), invite applications for research grants to study ways of
improving the health and well being of vulnerable populations living in rural
areas. These vulnerable populations include: those who have a chronic
disease or who are in jeopardy of becoming chronically ill; those who may
become disabled due to health threatening behaviors; childbearing women;
infants; children; adolescents; and persons over 65 years of age. Of
particular importance are epidemiologic studies and clinical studies that
focus on the health needs of residents of rural areas. It is anticipated that
the clinical studies will focus on the development and validation of nursing
interventions as well as the development and evaluation of innovative practice
models aimed at facilitating improvements in the health and well being of
vulnerable populations who reside in rural communities.
This new rural health care research program builds on a previous NCNR
initiative focused on Community-Based Rural Health Care Models for Minority
Populations, co-sponsored by AHCPR and the Division of Nursing, HRSA, and
published in the NIH Guide for Grants and Contracts, Vol. 19, No. 10, March 9,
1990. The rural health research program of AHCPR is based on a research
agenda published in Health Services Research, Vol. 23, No. 6, February, 1989.
SCIENTIFIC BACKGROUND
The rural population in the U.S. has been growing proportionately smaller, but
at the same time their vulnerability to illness, disability, and poor
pregnancy outcomes has increased. As of 1988, about 23 percent of the U.S.
population lived in counties defined as nonmetropolitan and about 27 percent
lived in rural areas defined by the Census Bureau as places where there are
2,500 or fewer residents. For the purposes of this research program either
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 14
definition of rural may be used. Rural residents are characterized as having
higher rates of chronic illness, disability, and infant mortality, and their
care has been characterized as representing a mixture of formal and informal
approaches with variablity in the quality of short- and long-term outcomes.
With the changing availability of health care and long geographic distances
between residents and health care services in most rural settings, rural
residents are increasingly at risk for health problems that could be
alleviated through scientifically based intervention strategies and health
care models targeted to specific vulnerable rural populations.
Individuals residing in rural areas frequently live a considerable distance
from health services. It is not unusual for families to care for those with
chronic illness and disability at home with or without the advice and guidance
of a health care practitioner. Older people, 25 percent of the overall rural
population, have less education, a higher proportion of chronic illness, and
higher mortality rates in comparison to urban residents. Most older persons
live in the community and are not in need of institutional care, such as
nursing homes; however, the longer a person survives, the more likely there
will be a need for such care. Children comprise 33 percent of the total rural
population. The health status of rural children has been difficult to
determine, and to some extent it appears that nonrural child health data have
been applied to rural populations. A high proportion of women who receive
inadequate prenatal care reside in rural communities, and they are more likely
to be minorities, teenagers, and single parents.
SCOPE
It is intended that the science that develops as an outcome of this
announcement will build on existing epidemiological and clinical knowledge.
In addition, it is anticipated that the theoretical and empirical base will be
developed for understanding the health problems and health care requirements
of vulnerable rural populations and for determining the most effective
intervention strategies for improved patient outcomes. It should be noted
that studies supported under this program need to show evidence of an
interdisciplinary approach to the science and, when appropiate, the research
team should be interdisciplinary in background. Applications from all regions
of the nation and from investigators in rural areas are encouraged.
Some examples of important research topics for consideration might include,
but should not be limited to:
o Examination of factors related to health seeking, health promoting,
or health threatening behaviors, including those that influence
accessing health care resources;
o Investigation of strategies for the prevention, intervention, and
control of chronic disease and disability among vulnerable rural
populations;
o Evaluation of methods of primary care practice and the effect of
primary care approaches and intervention strategies, and other
community/public health-based care, on the health and outcomes of
the health problems of vulnerable rural populations;
o Investigation of the processes and outcomes of providing health
care in the home to vulnerable populations;
o Analysis of the continuity of care approaches used to support the
transition of rural residents as they move among the various levels
of health care services, particularly between acute care hospitals
or nursing homes and the home;
o Investigation of empirically derived nursing practice models
targeted to one or more of the vulnerable populations residing in
rural areas for the provision of community-based primary care or
institutionally-based acute or long-term patient care.
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
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 15
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 are urged to assess carefully the feasibility of including the
broadest possible representation of minority groups. However, NIH recognize
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 disease, 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.
MECHANISMS OF SUPPORT
All policies and requirements that normally govern the research grant programs
of the Public Health Service apply. The particular research grant mechanisms
for this announcement are the traditional research grant award (R01) and the
First Independent Research Support and Transition (FIRST) award (R29).
Applications for research training are encouraged and should be submitted
under the usual requirements and receipt dates for the NIH Individual National
Research Service Awards (F31, F32, & F33).
APPLICATION PROCEDURES AND REVIEW CRITERIA
Applications should be submitted on the standard PHS Form 398 (rev. 10/88).
Application forms are available at most institutional business offices and
from the Division of Research Grants, NIH, telephone (301) 496-7441. In order
to expedite the application routing within NIH, please (1) check the box #2 on
the face page indicating that your application is in response to this
announcement and (2) print (next to the checked box) "Rural Health Care:
Vulnerable Populations, PA-91-23." Mail the completed application and six
copies to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Receipt dates for applications are February 1, June 1, and October 1.
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 16
Applications will be reviewed for scientific and technical merit by an
appropriate study section in the Division of Research Grants. Second level
review will be conducted by an appropriate National Advisory Council.
Applications compete on the basis of scientific merit with all other
applications. Researchers considering an application in response to this
announcement are encouraged to discuss their project, and the range of the
grant mechanisms available, with NCNR staff in advance of formal submission.
Correspondence and inquires should be directed to:
Dr. Patricia Moritz, or Jean Carmody
Dr. Maureen Knippen Center for General Health
Nursing Systems Branch Services Research, AHCPR
National Center for Nursing Research Maxima Building, Room 678
Building 31, Room 5B09 Rockville, MD 20852-4993
Bethesda, MD 20892 Telephone: (301) 443-2080
Telephone: (301) 496-0523
Another NIH component that has research programs on rural health separate from
this announcement that potential applicants may wish to contact is the
National Institute of Aging, Social and Behavioral Science Program, Dr. Ronald
Ables, (301) 496-3136. In addition, the National Institute of Mental Health
supports projects to study mental health issues in rural areas. This program
was described in the NIMH Program Announcement, Research on Mental Disorders
in Rural Populations, NIH Guide for Grants and Contracts, Vol. 19, No. 1,
April 27, 1990. Contact Dr. Charles Windle, Services Research Branch, NIMH,
(301) 443-4233, for information.
The research program of NCNR is described in the Catalog of Federal Domestic
Assistance, No. 93-361, Nursing Research. Awards are under authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended
by Public Law 99-158, 42 USC 241 and 285; and administered under PHS grant
policies and Federal Regulations 42 CRF Part 52 and 45 CRF Part 74. This
program is not subject to the intergovernmental review requirements of
Executive Order 12372, or to Health Systems Agency review, April 6, 1988.
THE UROLOGICAL COMPLICATIONS OF DIABETES MELLITUS
PA: PA-91-24
P.T. 34; K.W. 0715075, 0785220, 0715125
National Institute of Diabetes and Digestive and Kidney Diseases
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
Division of Kidney, Urologic and Hematologic Diseases (DKUHD), and Division of
Diabetes, Endocrinology, and Metabolic Diseases (DDEMD), announce interest in
developing a research grants program in the urological disorders associated
with diabetes mellitus (UDDM). Areas of research interest within this area
include, but are not limited to, basic and clinical studies of diabetes
related disorders of bladder function, including urinary retention and
incontinence; male sexual function, especially erectile function; infections
of the urinary tract including the kidneys; and the effect of diabetes
mellitus, in general, on the innervation and musculature of the urinary tract.
INTRODUCTION
Diabetes mellitus produces significant deleterious effects on the lower
urinary tract. Urinary bladder dysfunction, urinary tract infections and
erectile impotence occur in a significant percentage of both insulin dependent
and non-insulin dependent diabetics. These complications are rarely mentioned
in studies of the disease and have been less frequently investigated. The
morbidity and health care expenditures for these urologic disorders are
extensive. If left untreated or undetected, these urological disorders can
lead to progressive renal failure, urinary incontinence, urinary retention,
drug-resistant urinary tract infections, and abscesses of the kidneys.
OBJECTIVES AND SCOPE
The objective of this announcement is to increase multidisciplinary research
into the urological complications that result from both insulin dependent
(IDDM) and non-insulin dependent (NIDDM) diabetes mellitus. Basic and
clinical research studies utilizing both human and animal and cell culture
models are encouraged. The comparison of the pathobiology of urological
disorders with other known disorders of diabetes mellitus, to gain insight
into the pathogenesis of urological disorders, is encouraged. Areas of
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 17
research that are applicable to this announcement include, but are not limited
to:
o the epidemiology of UDDM
o diagnostic strategies for the early detection of clinical changes
associated with UDDM
o effect of IDDM and NIDDM on penile erectile tissue
o effect of IDDM and NIDDM on the urinary bladder musculature,
urothelium, and nervous innervation
o genetic, molecular, cellular, and immunological abnormalities
associated with diabetes mellitus as expressed in urological
tissues
o diabetes mellitus and urinary tract infections
o sexual differences in the effect of diabetes mellitus on the
bladder, including the role of hormones in these differences
o racial differences in UDDM
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
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 18
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.
MECHANISMS OF SUPPORT
Applications in any of the NIDDK mechanisms of support are accepted.
Especially encouraged are the Research Project Grant (R01), First Independent
Research Support and Transition Award (R29), National Research Service Award
(NRSA) (F32), and Clinical Investigator Award (K08).
APPLICATION PROCEDURES
Applicants must use the standard research grant application form PHS 398
(revised 10/88) or the appropriate fellowship application forms PHS 416-1
(revised 7/88 or 4/89). These forms are available from the Office of
Sponsored Research at most institutions and from the Division of Research
Grants, National Institutes of Healthi, Westwood Building, Room 449, Bethesda,
MD 2082.
Receipt dates for the applications are listed on the forms. For new research
projects (R01 and R29) the dates are February 1, June 1, and October 1 and for
Clinical Investigator Award applications. Receipt dates for NRSA fellowship
applications are January 10, May 10, and September 10.
To identify responses to this announcement, check "yes" and list the title and
number of this announcement in item number 2 on the face page of the
application form. Use the mailing label provided in the application kit and
mail the signed original and six copies to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications will be reviewed for scientific and technical merit by
appropriate study sections comprised primarily of non-federal experts.
Secondary review will be performed by the appropriate National Advisory
Council.
Potential applicants are strongly advised to call or write for further
information:
Ralph L. Bain, Ph.D.
Acting Director, Urology Program
DKUHD/NIDDK
National Institutes of Health
Federal Building, Room 102
Bethesda, MD 20892
Telephone: (301) 496-8248
or
Joan T. Harmon, Ph.D.
Executive Director, Diabetes Research Program, DPB
DDEMD, NIDDK
National Institutes of Health
Westwood Building, Room 622
Bethesda, MD 20892
Telephone: (301) 496-7731
These programs are described in the Catalog of Federal Domestic Assistance
Nos. 93.849, 93.847. Awards will be made under the authority of the Public
Health Service Act, Section 301 (42 USC 241) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This
program is not subject to Health Systems Agency review.
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 19
NOTICE OF MEETING
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. 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"
II. 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
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 20
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
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816
NIH GUIDE - Vol. 20, No. 6, February 8, 1991 - Page 21