Subject: NIH Guide - Vol. 20, No. l7, April 26, l99l, Part l of 2
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 25 Apr 91 08:31 EST

Hi Paul,
   Please post this to the NIH Listserver as:
      NIHGUIDE.910426
Thanks.  Please notify me when completed.
                                         Dottie
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19910426 V20N17 P1O2 ************************************
X-comment: RFAs described: CA-91-15
 
NIH GUIDE - Vol. 20, No. 17, April 26, 1991
 
$$INDEX BEGIN **********************************************************
 
                                   NOTICES
 
$$INDEX N1 *************************************************************
 
SUPPORT OF SCIENTIFIC MEETINGS BY THE NATIONAL CANCER INSTITUTE
National Cancer Institute
Index:  CANCER

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$INDEX R1 *************************************************************
 
A RESEARCH RESOURCE OF BB/W RATS (RFP)
National Institute of Diabetes and Digestive and Kidney Diseases
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
 
$$INDEX R2 *************************************************************
 
CULTIVATION OF CYANOBACTERIA (BLUE-GREEN ALGAE) (RFP)
National Cancer Institute
Index:  CANCER
 
$$INDEX R3 08/28/91 ****************************************************
 
PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS (RFA CA-91-15)
National Cancer Institute
Index:  CANCER

                        ONGOING PROGRAM ANNOUNCEMENTS
 
$$INDEX P1 *************************************************************
 
RESEARCH ON THE ETIOLOGY AND PATHOPHYSIOLOGY, NATURAL HISTORY AND
OPTIMAL THERAPY OF ASYMPTOMATIC PRIMARY HYPERPARATHYROIDISM (PA-91-45)
National Institute of Diabetes and Digestive and Kidney Diseases
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
 
$$INDEX P2 *************************************************************
 
IMPLEMENTATION OF THE NATIONAL PLAN FOR RESEARCH ON CHILD AND
ADOLESCENT MENTAL DISORDERS (PA-91-46)
National Institute of Mental Health
Index:  MENTAL HEALTH
 
$$INDEX P3 *************************************************************
 
SPECIAL EMPHASIS RESEARCH CAREER AWARD:  THE DEMOGRAPHY AND
ECONOMICS OF AGING (PA-91-47)
National Institute on Aging
Index:  AGING
 
$$INDEX P4 *************************************************************
 
INDIVIDUAL POSTDOCTORAL NATIONAL RESEARCH SERVICE AWARD FELLOWSHIPS
IN RADIOLOGICAL SCIENCES RELATED TO CANCER (PA-91-48)
National Cancer Institute
Index:  CANCER
 
$$INDEX END ************************************************************
 
                                   NOTICES
 
$$N1 BEGIN *************************************************************
 
SUPPORT OF SCIENTIFIC MEETINGS BY THE NATIONAL CANCER INSTITUTE
 
P.T. 42; K.W. 1014006
 
National Cancer Institute
 
Prospective applicants interested in seeking support of scientific
meetings from the National Cancer Institute (NCI) are reminded that as
of October 1, 1989, all grant application submissions for support of
meetings must adhere to the Division of Research Grants (DRG) regular
receipt dates of February 1, June 1, and October 1.  These dates are
published by DRG in the information and instructions form of the PHS 398
(revised 10/88) application and the booklet on "Support of Scientific
Meetings," August 1988.
 
Applications received late will be returned or held for the next regular
review cycle if the proposed meeting date permits.  Waiver of the
receipt date(s) will be considered only for exceptional circumstances.
Requests must be submitted as instructed in the above referenced booklet
and may be obtained from the Office of Grants Inquiries, DRG, at the
address below.  Specific questions regarding the NCI conference grant
program should be directed to the NCI Conference Grant Coordinator at
(301) 496-7173.
 
Office of Grants Inquiries
Division of Research Grants
Westwood Building, Room 449
Bethesda, MD  20892
Telephone:  (301) 496-7441
 
$$N1 END ***************************************************************
 
                   NOTICES OF AVAILABILITY (RFPs AND RFAs)
 
$$R1 BEGIN NIH-NIDDK-91-4 **********************************************
 
A RESEARCH RESOURCE OF BB/W RATS
 
RFP AVAILABLE:  NIH-NIDDK-91-4
 
P.T. 34; K.W. 1002002, 0201016
 
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
continue a centralized and stable source of supply of
the BB/W diabetic rat model and to continue the
development of genetically homogeneous familial lines
with and without the diabetic defect.
 
This is a recompetition of contract no. NO1-DK-72287, currently
held by the University of Massachusetts.
 
The NIDDK expects to make one award from this solicitation.
 
This Request for Proposals (RFP) No. NIH-NIDDK-91-4, will
be issued on or about May 1, 1991, with a closing date of
July 1, 1991.  To receive a copy of this RFP, please
supply this office with two self-addressed mailing labels
and cite the RFP number referenced above.  Requests must be
in writing and addressed to:
 
Shirley A. Shores
Contracts Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 602
Bethesda, MD  20892
 
This advertisement does not commit the Government to make
an award.
 
$$R1 END ***************************************************************
 
$$R2 BEGIN NCI-CM-27715-72 *********************************************
 
CULTIVATION OF CYANOBACTERIA (BLUE-GREEN ALGAE)
 
RFP AVAILABLE:  NCI-CM-27715-72
 
P.T. 34; K.W. 0780005, 1002027
 
National Cancer Institute
 
The National Products Branch (NPB), Developmental
Therapeutics Program (DTP), Division of Cancer Treatment
(DCT), National Cancer Institute (NCI), has a requirement to
isolate and grow various species of cyanobacteria to provide
NCI with a repository of cell extracts for use in new screens
for antitumor/anti-AIDS activities.  It is anticipated that
one (1) cost-reimbursement type contract will be awarded for
a five-year, incrementally funded period of performance.  A
completion form of contract is planned.
 
To be considered for this contract, offerors must show evidence
of capability to isolate and cultivate cyanobacteria as well as
possess the expertise to accomplish:  maintenance and preservation of
cultures, optimization and scale-up of production, extraction of
cells, and concentration of extracts.  The project will require that
approximately 300 different axenic cultures and 700 culture equivalents
be grown to obtain 1.5 to 5G cyanobacteria cell extracts.  The
contractor may be required by NCI to scale-up cultivation of
certain cultures to produce 20G to 40G of cell extracts.  This
may be subcontracted.  The Principal Investigator (PI)
should be trained in microbiology or phycology, preferrably
at the Ph.D. level or equivalent from an accredited school,
and have at least three to five years experience in the proposed
area.  The PI should have a broad knowledge of culture
cultivation, particularly in those areas related to
growing cyanobacteria, cyanobacteria taxonomy, sample
preparations, or related fields.  The PI should be
assigned to the project for a minimum of 50 percent of the time.
The level of training of the team members should reflect
their assigned duties, and they should have experience in
taxonomy, culture isolation and preservation, culturing
of cyanobacteria, and chemical extraction.
 
RFP No. NCI-CM-27715-72 may be requested from
Ms. Jacqueline Ballard, Contract Specialist, on or about
May 15, 1991, and proposals will be due on July 3, 1991.
 
The proposed contract project represents a recompetition
of contract no. N01 CM-67745, currently held by the
University of Hawaii at Manoa.
 
All written requests should be directed to:
 
Ms. Jacqueline Ballard
Contracting Officer's Representative
National Institutes of Health
National Cancer Institute
Research Contract Branch, TCS
Executive Plaza South, Room 603
9000 Rockville Pike
Bethesda, MD  20892
 
$$R2 END ***************************************************************
 
$$R3 BEGIN CA-91-15 FULL-TEXT ******************************************
 
PLANNING GRANTS FOR PROSPECTIVE CANCER CENTERS
 
RFA AVAILABLE:  CA-91-15
 
P.T. 04; K.W. 0715035, 0745027, 0795003, 0403004
 
National Cancer Institute
 
Letter of Intent Receipt Date:  July 15, 1991
Application Receipt Date:  August 28, 1991
 
I. INTRODUCTION
 
The Cancer Centers Branch (CCB) of the Division of Cancer Biology,
Diagnosis and Centers (DCBDC) of the National Cancer Institute (NCI)
announces the availability of planning and development grants for the
purpose of assisting eligible institutions develop the organizational
capability that will lead to the formation and/or development of cancer
research centers of excellence.  The goal of this Request for
Applications (RFA) initiative is to encourage the development of
clinical and consortium cancer research centers in geographic areas that
currently are not served by existing NCI-designated clinical or
comprehensive cancer centers.  In addition to basic cancer research,
these new centers should plan to emphasize clinical and
prevention/control research that will ultimately impact on the
populations in their regions.  It is anticipated that after completion
of these planning and development grants, recipient institutions will be
in a position to compete for Cancer Center Support Grants from the NCI.
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000", a
PHS-led national activity for setting priority areas.  This RFA is
related to the priority area of cancer.  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).
 
II.  ELIGIBILITY REQUIREMENTS
 
Applicant institutions must intend to develop clinical or consortium
cancer centers.  Eligible institutions must be in states that do not
currently have an NCI-designated Comprehensive, Clinical, or Consortium
Cancer Center, and must be located beyond a reasonable distance from an
existing Comprehensive, Clinical, or Consortium Cancer Center.  In
addition, eligible institutions must have three or more externally
funded, peer-reviewed, cancer research project grants or contracts
(e.g., R01, P01, N01, U01), or equivalent types of research projects.
At this time, the Cancer Centers Branch defines peer-reviewed cancer
research projects as NCI research grants and contracts, American Cancer
Society research project grants, and other NIH and the National Science
Foundation (NSF) research grants that meet the NCI referral guidelines
for cancer-related research.  Questions concerning the NCI referral
guidelines should be addressed to the individual noted in Section IV of
this announcement.
 
Eligible institutions should require approximately three
years of support under a planning and development grant to
develop the institutional capability to form and or develop
a cancer research center of excellence.  Institutions that
already have an established organizational capability as a
cancer center and a sufficient peer-reviewed cancer research
base are not eligible under this program.  Potential
applicants are strongly advised to contact NCI program staff
of the Cancer Centers Branch to discuss eligibility prior to
preparing an application (see section V below).
 
III. MECHANISM OF SUPPORT
 
Support of this program will be through the National
Institutes of Health (NIH) grant-in-aid.  The exploratory
grant mechanism, designated P20, will be used.  Applicants
will be responsible for the planning, direction, and
execution of the proposed project.  Except as otherwise
stated in the RFA, awards will be
administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement, DHHS Publication No.
(OASH 90-50,000, revised October 1,1990)
 
Approximately $750,000 in total costs per year will be
committed specifically to fund applications
submitted in response to this RFA.  It is anticipated that three
to five awards will be made.  This funding level is dependent
upon the receipt of a sufficient number of applications of
high merit.  The total project period for applications
submitted in response to the present RFA should not exceed three
years.  The earliest feasible start date for the initial
awards will be August 1, 1992.  Although this program is
provided for in the financial plans of the
NCI, the award of grants pursuant to this RFA is
also contingent upon the availability of funds for this
purpose.
 
IV. LETTER OF INTENT
 
Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent
application, it is requested in order to provide an indication of
the number and scope of applications to be reviewed.
Prospective applicants are
requested to submit, by July 15, 1991, a letter of intent
that includes a descriptive title of the proposed cancer
center, the name, address, and telephone/fax number of the
planning director (Principal Investigator), the names of
other key personnel, the participating institutions, and the
number and title of this RFA.
 
Prospective applicants are strongly encouraged to contact the NCI
staff listed below before the submission of a letter of intent
and/or an application.  Such contact is advantageous to the
prospective applicant because it will start a dialogue with the
NCI staff where issues such as eligibility requirements and
application procedures may be discussed.
The letter of intent is to
be sent to:
 
Dr. Alan A. Schreier
Program Director
Cancer Centers Branch
Division of Cancer Biology, Diagnosis and Centers
National Cancer Institute
Executive Plaza North, Room 308
Bethesda, MD  20892
Telephone:  (301) 496-8531
 
V. INQUIRIES
 
The complete text of the RFA, containing the application
procedures that must be used and the review criteria, may
be obtained from the Cancer Centers Branch, NCI, at the
above address.  It may also be obtained through the NIH
Guide to Grants and Contracts (computer version).  Written
and telephone inquiries concerning the objectives, scope,
application procedures, and allowable budget items for this
RFA or inquiries about whether specific proposals would be
responsive are encouraged and should be directed to the
Cancer Centers Branch, NCI, program officer listed above.
The Branch staff welcomes the opportunity to clarify any
issues or questions from potential applicants.
In addition,
questions of a more administrative nature not directly
related to the programmatic aspects of this RFA may be
directed to the Grants Administration Branch official listed
below.
 
Ms. Francis Cohen
Grants Specialist
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 42
 
$$R3 END ***************************************************************
 
                        ONGOING PROGRAM ANNOUNCEMENTS
 
$$P1 BEGIN *************************************************************
 
RESEARCH ON THE ETIOLOGY AND PATHOPHYSIOLOGY, NATURAL
HISTORY AND OPTIMAL THERAPY OF ASYMPTOMATIC PRIMARY
HYPERPARATHYROIDISM
 
PA:  PA-91-45
 
P.T. 34; K.W. 0705030, 0755030, 0765033, 0765035
 
National Institute of Diabetes and Digestive and Kidney Diseases
 
PURPOSE
 
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites investigator-initiated research grant applications to
develop information on asymptomatic hyperparathyroidism (HPT).  Research
is solicited on the pathogenesis of this condition, its effects at the
cellular and molecular levels, and its effects on the skeletal,
neuromuscular, renal, cardiovascular, gastrointestinal and central
nervous systems.  Of particular interest are studies to compare the
long-term consequences of asymptomatic HPT with and without surgical
treatment and/or to identify predictive factors to distinguish patients
who will ultimately develop complications from this disorder.
 
DISCIPLINES AND EXPERTISE
 
Interdisciplinary approaches may be needed for these studies
with expertise required in several of the following areas:
molecular and cellular biology, endocrinology, gerontology,
nephrology, gastroenterology, neurology, psychiatry,
radiology, epidemiology, and biostatistics.
 
BACKGROUND
 
Widespread use of multiphasic screening tests has resulted
in increased detection of hypercalcemia and subsequent
diagnosis of HPT.  This has now been recognized as a
relatively common disorder, with approximately 100,000 new
cases per year in the United States, primarily among
women.  Screening has revealed a significant new population
of patients in whom symptoms and signs are subtle or
absent.  Although surgery is clearly indicated for patients
with overt manifestation of HPT, optimal management of the
asymptomatic form of HPT is uncertain.  Information is now
becoming available on the natural history of asymptomatic
HPT.  This information was evaluated at a recent Consensus
Development Conference on Diagnosis and Management of
Asymptomatic Primary Hyperparathyroidism held at the NIH
(October 29-31, 1990).  In addition to developing guidelines
for diagnosis and management of this condition based on
currently available information, the Consensus Development
panel identified a number of areas in which additional
research is needed.
 
OBJECTIVES
 
This solicitation is intended to stimulate research that
will result in new understandings of the etiology and
pathogenesis of asymptomatic HPT and its pathophysiology,
and the complications associated with chronic elevation of
parathyroid hormone levels.  Ultimately a multicenter,
randomized controlled trial of sufficient size and duration
to assess and compare the long-term outcomes of medical
followup and surgical therapy of asymptomatic HPT will be
needed to establish the optimal management of this
condition.  Research is sought to establish feasibility of
and to develop strategies for such full-scale clinical trials
of the management of asymptomatic HPT.
 
SCOPE
 
Some examples of research topics which would be considered
responsive to this solicitation include the following:
 
  o  basic studies on the molecular and cellular pathophysiology of HPT
 
  o  etiology of HPT and pathogenesis of parathyroid adenomas and
     hyperplasia
 
  o  the role of the multiple endocrine neoplasia (MEN) Type I gene in
     abnormal parathyroid function in MEN and sporadic HPT
 
  o  identification of predictive factors to distinguish subpopulations
     of patients who will develop adverse effects of mild HPT
 
  o  multisystem effects of HPT, particularly effects on neuromuscular,
     psychological, cardiovascular and gastrointestinal parameters, and
     the reversibility of these complications with surgery.  [A possible
     approach would be case control studies before and after surgery in
     patients with HPT and carefully matched controls undergoing other
     elective surgical procedures such as thyroidectomy]
 
  o  the effects of asymptomatic HPT on bone mass and structure and
     correlation of these effects with changes in bone strength and
     susceptibility to fracture
 
  o  optimal methodology for monitoring changes in bone mass in patients
     with asymptomatic HPT
 
  o  epidemiologic studies to identify conditions associated with HPT
 
  o  development of potential animal models for study of pathogenesis
     and therapy of asymptomatic HPT
 
  o  development and study of pharmacologic agents potentially useful in
     HPT, such as antagonists of PTH synthesis, secretion and end organ
     effects, as well as effects of estrogen in HPT
 
  o  other studies to provide guidance in designing and establishing the
     feasibility of a large randomized multicenter clinical trial
     comparing surgery and medical management of asymptomatic HPT
 
  o  clinical trials comparing bone mass outcomes and biochemical
     measures of bone turnover in postmenopausal women with HPT randomly
     assigned to estrogen plus surgery versus estrogen alone
 
These areas of interest are not listed in any order or
priority.  They are only suggested examples of areas of
research.  Applicants are encouraged to propose other areas
which are related to the objectives and scope described
above.
 
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.
 
MECHANISM OF SUPPORT
 
The mechanism of support for this program will be the grant-
in-aid via the research project grant (RO1).  The regulations
(Code of Federal Regulations, Title 42, Part 52 and, as
applicable to the State and local governments, Title 45,
Part 74) and policies which govern the research grant
programs of the National Institutes of Health will
prevail.  Support for this solicitation is contingent upon
receipt of appropriated funds.  Since a variety of
approaches would represent valid responses to this
solicitation, it is anticipated that there will be a range
of costs among individual grants awarded.  With respect to
post-award administration, the current policies and
requirements that govern the regular research grant programs
of the NIH will prevail.
 
ELIGIBILITY
 
All domestic public or private, for-profit or non-profit institutions or
organizations are eligible to apply in response to this program
announcement.  Awards in connection with this announcement will be made
to foreign institutions only for research of very unusual merit, need,
and promise, and in accordance with Public Health Service policy
governing such awards.
 
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 either the GCRC program director or Principal
Investigator may be included with the application.
 
REVIEW PROCEDURES AND CRITERIA
 
Assignment of applications
 
Applications will be received by the NIH, Division of
Research Grants (DRG), referred to an appropriate Initial
Review Group (IRG) for scientific merit review, and assigned
to individual Institutes for possible funding.  Referral
decisions will be governed by normal programmatic
considerations as specified in the Referral Guidelines of
the NIH, DRG.  Some applications may receive dual
assignment.
 
Review procedures
 
Applications in response to this solicitation will be
reviewed on a nationwide basis in accord with the usual NIH
peer review procedures.  Applications will be reviewed first
for scientific and technical merit by an IRG composed
primarily of non-Federal scientific consultants, and then by
the National Advisory Council of the appropriate
Institute(s).  The review criteria customarily employed by
the NIH for regular grant applications will prevail.
 
Review criteria
 
The factors to be considered in the evaluation of scientific
merit of each application will be those used in the review
of traditional research project grant applications,
including the novelty, originality, and feasibility of the
approach; the training, experience, and research competence
of the investigator(s); the adequacy of the experimental
design; the suitability of the facilities; and the
appropriateness of the requested budget to the work
proposed.
 
METHOD OF APPLYING
 
Format for applications
 
Applications must be submitted on form PHS 398 (rev.  10/88), which is
available from an applicant institution's Office of Sponsored Research
or from the NIH DRG.  Use the conventional format for research project
grant applications and ensure that the points identified in this PA in
the section on "Review Procedures and Criteria" are fulfilled.  To
identify the application as a response to this PA, check "yes" on item
two of page one of the application and enter the title "Asymptomatic
Primary Hyperparathyroidism" and the PA number PA-91-45.
 
Deadline
 
Applications will be accepted in accordance with the
announced receipt dates for new applications -
February 1, June 1, and October 1.
 
Application procedure
 
The original and six copies of the application should be
sent or delivered to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Inquiries
 
For further information, investigators are encouraged to
contact the following program official:
 
Ronald N. Margolis, Ph.D.
Director, Endocrinology Research Program
Division of Diabetes, Endocrinology and Metabolic Diseases
NIDDK/NIH
Westwood Bldg, Room 605
Bethesda, MD  20892
Telephone:  (301) 496-7504
 
For fiscal and administrative matters, contact:
 
Mr. Bruce Butrum
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 647-D
Bethesda, MD  20892
Telephone:  (301) 496- 7467
 
This program is described in the Catalog of Federal Domestic
Assistance 93.847, Diabetes, Endocrinology, and Metabolic
Diseases.  Awards will be made under the authority of the
Public Health Service Act, Title III, Section 301 (Public
Law 78-410, as amended; 42 USC 241) and administered under
PHS grant policies and Federal Regulation 42 CFR Part 52 and
45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order
12372 or Health Systems Agency Review.
 
$$P1 END ***************************************************************
 
$$P2 BEGIN *************************************************************
 
IMPLEMENTATION OF THE NATIONAL PLAN FOR RESEARCH ON
CHILD AND ADOLESCENT MENTAL DISORDERS
 
PA:  PA-91-46
 
P.T. 34, AA; K.W. 0715129, 0403001, 0404020
 
National Institute of Mental Health
 
BACKGROUND
 
At least 7.5 million children and adolescents in the
United States suffer from some sort of mental disorder
(about 12 percent of the Nation's youth).  Although
children under age 18 comprise about one-quarter of the
Nation's population, the knowledge base required to
successfully treat or prevent mental disorders in
children has been slow to develop.  In part, these
difficulties may stem from the lack of awareness of the
public and the scientific community of the research
needs in this area, the shortage of qualified
investigators, and the lack of a coherent national
strategy to address the critical research problems.  As
a result, progress in mental health research on child
and adolescent disorders has not kept pace with related
research in adults.
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000", a
PHS-led national activity for setting priority areas.  This program
announcement, "Implementation of the National Plan for Research on Child
and Adolescent Mental Disorders" is related to the priority area of
mental health in children and adolescents.  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).
 
Meeting these challenges requires a two-pronged
approach that both addresses critical research needs
and builds the Nation's research capacity.  Under this
program announcement, the National Institute of Mental
Health (NIMH) seeks to expand the full spectrum of
research related to child and adolescent mental
disorders, with special focus in the following areas:
 
  o  the epidemiology of child and adolescent mental disorders and other
     associated mental health problems;
 
  o  the determination of optimal approaches for defining, assessing,
     and diagnosing mental disorders and related conditions in children
     and adolescents;
 
  o  basic neuroscience and behavioral research that clarifies the
     developmental origins, dynamics, and characteristics of mental
     disorders and suggests new avenues for overcoming them;
 
  o  the determination of effective treatment techniques and preventive
     interventions for mental disorders;
 
  o  clinical services research and service systems research to evaluate
     and improve the efficacy, organization, delivery, and accessibility
     of treatment and prevention services to young people with mental
     disorders; and
 
  o  research with special applicability to children, including the
     impact of developmental factors on mental disorders in children,
     the joint effects of environment and biology in modulating
     children's behavior, and comorbidity.
 
Four types of applications focusing on research on
child and adolescent mental disorders are encouraged:
 
o    regular research grants (RO1);
o    small grants (RO3);
o    program project grants (PO1); and
o    FIRST awards (First Independent Research Support
and Transition award - R29).
 
Capacity Building:  In addition to encouraging
increased research, NIMH seeks to expand the Nation's
scientific capacity to conduct research in child and
adolescent mental disorders by enlarging the supply of
well-trained investigators and by fostering the
evolution of multidisciplinary research centers.  These
capacity-building strategies are essential in order to
sustain and accelerate the scientific progress that is
urgently needed.
 
Six types of applications focused specifically on child
and adolescent mental disorders are encouraged:
 
o    centers (P50);
o    institutional research training grants (T32);
o    individual fellowships (F30, F31, F32);
o    research career awards (KO2, KO5, K20, K21);
o    academic awards (KO7); and
o    training and career development grants for
minority students and faculty (T34, F34).
 
Although these specific mechanisms should greatly
enhance the Nation's child and adolescent mental health
research capacity, these mechanisms alone may not be
sufficient to ensure a vibrant and growing research
infrastructure.  Therefore, NIMH encourages experienced
researchers who apply for research funding (small
grants, regular research grants, program projects, and
centers) to involve persons with less research
experience (e.g., predoctoral and medical students and
experienced clinicians) at appropriate points within
their research applications.  Systematic efforts in
this regard may attract individuals into research at an
early point in their careers.  Likewise, as experienced
researchers form research collaborations with
experienced clinicians, better access to populations of
interest, increased relevance of research to pressing
clinical questions, and increased appreciation by
clinicians of the importance of research should result.
 
DEVELOPMENTAL CONSIDERATIONS
 
A keen appreciation of developmental factors is key to
an adequate understanding of the evolution of behavior,
cognition, mental health, and mental disorders in
children and adolescents.  Although the entire human
lifespan is shaped by the interplay between change and
constancy, the theme of the progressive unfolding of
human potential is the leitmotif from infancy through
adolescence.  These young age periods are characterized
by rapid qualitative and quantitative shifts in neural,
behavioral, and emotional organization in some areas,
while at the same time other developmental domains
remain relatively constant.  This developmental
framework is a hallmark of state-of-the-art basic,
applied, and clinical research in child and adolescent
populations, and provides the essential context for
understanding child and adolescent mental health and
disorder at molecular, molar, intrapsychic,
interpersonal, and social organizational levels.  Thus,
the ultimate goals of neuroscientists, behavioral
scientists, and applied and clinical scientists are
complementary; these goals culminate in the
clarification of the origins of child and adolescent
mental disorders, and the development of new avenues
for overcoming these disorders across the developmental
epochs of infancy, childhood, and adolescence.
 
ELIGIBILITY
 
Applications may be submitted by public or private
nonprofit or for-profit 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.
 
APPLICATION CHARACTERISTICS
 
All applicants should take into account certain
methodologic considerations:
 
Definition and Assessment.  Most studies of child and
adolescent psychopathology have used different terms
and definitions.  Validity and reliability of
instruments are issues that deserve continued careful
study.  Mindful attention should be given to the
instrumentation and methodologies used in assessing and
classifying child and adolescent psychopathology and
related conditions.
 
Wherever possible, standardized diagnostic and
assessment methods should be used.  These methods may
include dimensional or categorical approaches.
Commonly, a combination of these methods may be
necessary.  Obtaining assessment and/or diagnostic
information from multiple informants and/or settings
may be required.  Careful attention must be paid to
issues of handling different sources and types of
information.  It is important for applicants to address
the issues of adequate diagnostic coverage by the
instrument(s), as well as interrater reliability and,
to the extent possible, validity.  The instrument(s)
should make diagnoses according to recognized clinical
criteria and should also permit the assessment of
subclinical or variant conditions, such as subclinical
depression.
 
Risk Factor Definition.  The identification and
operational definition of potential risk factors and
correlates need to proceed with as much care as case
definition.  It is as important to attend to the
reliability and validity of risk factor assessment as
it is to the reliability and validity of case
assessment.  The unreliability of retrospective data on
risk factors, which are often subject to poor recall
and selective nonreporting, must also be addressed and
steps taken to minimize bias.
 
Sampling.  Special attention must be paid to the
representativeness of subjects selected for study and
to the selection and representativeness of appropriate
control or comparison groups.  It is important to know
whether the groups being studied are representative of
the universe of persons with the selected
characteristics.  Careful consideration of the
relationship between subjects' gender and developmental
stage, as these factors relate to the dependent and
independent variables, is critical.  Where appropriate,
applicants must demonstrate that potential sources of
selection bias, such as Berkson's bias, are not likely
to occur in the proposed studies.  In addition,
applications must address questions of power and sample
size, e.g., how many cases and controls are needed to
establish statistically significant findings.  Clear
explanation and detailed descriptions of anticipated
data analyses are required.
 
Basic Science.  Wherever feasible, applicants should
consider employment of basic science techniques and
relevant animal models to clinical and epidemiologic
research, e.g., screening for restriction fragment
length polymorphisms (RFLP's) in pedigrees with heavy
loading on suicidal behavior.
 
Treatment Studies.  Applicants proposing studies of
psychosocial treatment or pharmacotherapy should attend
to additional methodologic considerations.
Psychosocial treatment studies should have therapists
with standardized training.  Attention should be given
to measures of adherence to the prescribed treatment.
Pharmacotherapy studies should use standard research
designs with randomized, double-blind, placebo-
controlled conditions when possible.  Attention should
be focused on the choice of control groups (i.e.,
matching for relevant variables, use of multiple
control groups).  Pilot data assessing feasibility are
encouraged.
 
Preventive or Promotive Interventions.   Applicants
proposing preventive or promotive intervention studies
should also attend to additional methodologic concerns.
Intervention studies should include a clearly
articulated, empirically based, theoretical model that
reflects putative processes underlying the
psychopathology conditions, as well as a conceptual
link among the chosen target group, intervention, and
outcome measures.  Research designs and procedures must
be appropriate to the developmental and socio-
demographic characteristics of the target group.  In
addition, follow-up of sufficient duration (e.g., two or
more years) to determine the differential onset of the
psychopathologic condition between the intervention
groups(s) and the control group(s) is desirable.  The
proposal should include an assessment of the
limitations, duration, and safety of the proposed
intervention and must provide clear indication that the
applicant organization has access to and experience in
working with the proposed target population.
 
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
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 review will be deferred until it is
provided.  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.
 
APPLICATION PROCEDURES
 
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.  In
addition, prospective applicants are strongly
encouraged to contact one of the NIMH staff listed at
the end of this announcement.
 
REVIEW
 
The Division of Research Grants, NIH, serves as a central point for
receipt of applications for most discretionary PHS grant programs.  Some
of the areas outlined in this announcement are also of interest to the
National Institute of Neurological Disorders and Stroke.  In these areas
of overlap, the standing referral guidelines will determine the
appropriate research component within the NIH/ADAMHA system.  Further,
the applications will be referred to the appropriate study
section/review committee for scientific and technical review, and
assigned according to the established review referral guidelines.  The
IRGs, 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 appropriate National Advisory Council, whose
review may be based on policy considerations as well as scientific
merit.  Only applications recommended for approval by Council may be
considered for funding.
 
APPLICATION RECEIPT AND REVIEW SCHEDULE
 
Grant applications will be accepted in accordance with the
usual receipt dates for applications.  Applications
received after the receipt dates below are subject to
assignment to the next review cycle or may be returned
to the applicant:
 
Receipt Dates    Initial   Advisory Council    Earliest
New/Renewal      Review       Review          Start Date
 
June 1/July 1*  Oct./Nov.     Jan./Feb.         Apr. 1
Oct. 1/Nov. 1*  Feb./Mar.     May/June          July 1
Feb. 1/Mar. 1*  May/June      Sept./Oct.        Dec. 1
 
*Amended applications (new or renewal) are to be
submitted on the latter dates.  NRSA institutional and
individual applications, AIDS applications, and Centers
have differing receipt dates.  For further information
about these receipt dates, applicants should refer to
the relevant announcements or contact an appropriate
staff person listed at the end of this announcement.
 
TERMS AND CONDITIONS OF SUPPORT
 
Grant funds may be used only for expenses clearly
related and necessary to conduct research projects,
including both direct costs that can be
identified specifically with the project and allowable indirect
costs of the institution (except research training
grants, which are limited to a maximum of eight percent).
All costs must be justified in terms of research
objectives, methods, and designs which promise to yield
generalizable knowledge and/or make a significant
contribution to theoretical concepts.  In fiscal year
1990, NIMH supported a total of $106.1 million of
research in direct and related areas of child and
adolescent mental disorders.
 
AWARD CRITERIA
 
Applications recommended for approval by Council will
be considered for funding on the basis of overall
scientific and technical merit of the research as
determined by peer review, program needs and balance,
and availability of funds.
 
STAFF CONSULTATION
 
Thomas Lalley, M.A.
Chief, Services Research Branch
Room 18C-14
Telephone:  (301) 443-3364
 
Susan Solomon, Ph.D.
Chief, Violence and Traumatic Stress Research Branch
Room 18-105
Telephone:  (301) 443-3728
 
Leonard Mitnick, Ph.D.
Chief, Basic Prevention and Behavioral Medicine Research Branch
Room 11C-06
Telephone:  (301) 443-4337
 
Mary Ellen Oliveri, Ph.D.
Acting Chief, Personality and Social Processes Research Branch
Room 11C-10
Telephone:  (301) 443-3566
 
Rodney Cocking, Ph.D.
Basic Behavioral and Cognitive Sciences Research Branch
Room 11C-10
Telephone:  (301) 443-3942
 
Peter S. Jensen, M.D.
Chief, Child and Adolescent Disorders Research Branch
Room 10-104
Telephone:  (301) 443-5944
 
Karen Bourdon, M.A.
Epidemiology and Psychopathology Research Branch
Room 10C-05
Telephone:  (301) 443-3774
 
Doreen Koretz, Ph.D.
Acting Chief, Prevention Research Branch
Room 14C-03
Telephone:  (301) 443-4283
 
To address correspondence to any of the above persons,
use the following address:
 
Name
Room Number (noted above after each name)
Branch or Office Name (noted above in each program
area)
National Institute of Mental Health
Parklawn Building
5600 Fishers Lane
Rockville, MD  20857
 
Grants Management questions should be directed to:
 
Mr. Stephen Hudak
Chief, Grants Management Section
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 7C-26
Rockville, MD 20857
Telephone:  (301) 443-4456
 
$$P2 END ***************************************************************
 
$$P3 BEGIN *************************************************************
 
SPECIAL EMPHASIS RESEARCH CAREER AWARD:
THE DEMOGRAPHY AND ECONOMICS OF AGING
 
PA:  PA-91-47
 
P.T. 34, CC; K.W. 0710010, 0413001, 0408006, 0417000
 
National Institute on Aging
 
The National Institute on Aging (NIA) solicits applications
for SPECIAL EMPHASIS RESEARCH CAREER AWARDS (SERCA) from
eligible institutions for interdisciplinary training and
research support of demographers and economists seeking
research careers in the demography or economics of aging.
This SERCA is intended to foster the career development of
junior and mid-level investigators with expertise in
economics or demography who seek additional research skills
and experience in the demography and/or economics of aging.
 
I.  BACKGROUND
 
The aging of the population in the U.S., and in nations
throughout the world, has raised many issues regarding the
social and economic consequences of aging societies.  The
phenomena of aging populations is unprecedented; never before
have improvements in mortality at the older ages been
accompanied by sustained low fertility.  As a consequence,
research on the demography and economics of aging has
recently gained much interest.
 
The demography of aging emphasizes research on the changing
social and demographic structure of society as a whole.  The
aging of the population and, in particular, the rapid
emergence of a large number of oldest-old persons, raises a
complex set of questions about the future size, composition,
and characteristics of the older population.  Of special
interest are the dynamics of various social phenomena of the
elderly, including migration, intergenerational exchanges,
living arrangements, and labor force participation.  Also of
interest is research designed to identify the health
trajectories associated with changes in age-related
disability and disease.
 
The economics of aging focuses on the economic consequences
of population aging--for both older persons and for society
at large.  Of particular interest are the areas of health and
retirement economics.  At the individual level, research
focuses on health services consumption, including nursing
home and other long-term care service use, and on the
financial status of older persons, measured in terms of
productivity, savings, consumption, and retirement income.
At the societal level, issues of public and private pension
funding and health care financing emerge.
 
Research in the demography or economics of aging often lends
itself to an interdisciplinary approach.  Economists or
demographers may need to acquire a thorough knowledge of, for
example, the acute or long-term care health system, pension
systems, epidemiology, biological and clinical aspects of
aging, dynamics of family systems, etc.  Assessments of the
economic effects of an older population must be based not
only on forecasts of sheer numbers of elderly, but on
insights into the dynamics of population aging; similarly,
demographic analyses might be made within economic and policy
contexts.
 
The recruitment of qualified investigators and faculty is
critical to an expansion of research in the area of
demography and/or economics of aging.  Research and training
institutions also need to develop critical masses of
qualified investigators in these areas.
 
II. PURPOSE OF THE AWARD
 
The NIA SERCA offers
an opportunity for social scientists to acquire supplementary
research skills and experience in order to pursue or enhance
a research career in the demography and/or economics of
aging.  This SERCA is intended to foster the career
development of researchers who are already well qualified in
the areas of demography and/or economics by encouraging such
individuals to acquire additional in-depth experience and
skills needed for a career focused on the demography and/or
economics of aging.
 
The award aims at a close and extended working relationship
between a demographer or economist (the awardee) and one or
more highly qualified investigators who have experience in
aging research, who will serve as sponsor (and) advisor.  The
relationship should optimize the opportunity for interdis-
ciplinary communication and collaboration in research on the
demography and/or economics of aging.  For the candidate, the
relationship should develop the capacity to apply the
knowledge and research methods of demography and/or economics
to issues in aging.  For the sponsoring institution, the
relationship should stimulate awareness of the importance of
demographic and/or economic tools for research on aging.
 
The NIA anticipates that this SERCA program will play a
significant role in the development of researchers needed to
assess the complex social and economic issues arising from
the aging of the population.  The SERCA program should also
lead to an increase in the critical mass of these researchers
within programs or departments of economics or demography.
 
III.  PROVISIONS OF THE AWARD
 
This non-renewable award provides support for up to five
years of full-time research and related activities.
 
A.  PROGRAM
 
i.  Developmental Phase:  During the first year or two the
awardee is expected to develop capabilities for conducting
interdisciplinary research on the demography and/or economics
of aging.  The awardee's activities may include participation
in any of the following:  formal courses, ongoing research,
workshops, symposia, and scientific and professional
meetings.
 
ii. Project Phase:  Beginning as early as possible, the
awardee is expected to engage in a research project designed
as a basis for more extended research.  One hundred percent
effort is expected on this award; at least 75 percent of an
awardee's time must be spent in the actual conduct of
research.  Up to 25 percent of time may be spent on teaching and
advising on research.
 
B.  SALARY
 
The SERCA award is made to the applicant institution and
provides up to $50,000 per year for full-time salary support
plus fringe benefits.  Supplementation of awardee's salary
from non-Federal sources is allowable.
 
C.  RESEARCH SUPPORT
 
In addition to the awardee's salary, up to a maximum of
$10,000 in each of the first three years and up to a maximum
of $20,000 in each of the subsequent two years may be requested
for research expenses; e.g., instrument development, data
collection, analysis costs, technical assistance, consultant
costs, domestic travel, publication costs, and other
appropriate expenses that are essential to the proposed
program.
 
D.  TUITION
 
If essential to the awardee's individual development program,
funds for tuition for training courses may be requested.
 
E.  SPONSORING INSTITUTION
 
The sponsoring institution must be a domestic university, or
comparable research institution with strong, well-established
research programs in demography and/or economics.  Already
established programs in the demography and/or economics of
aging are not required but will be considered advantageous.
Existence of training programs in those areas will also be
considered to be a positive factor.  The sponsoring
institution is expected to facilitate the program by
providing space, resources and other support insofar as
feasible.  While the program should be situated primarily at
a single institution, travel to, and stays at, other
institutions for relevant experiences are permissible.
 
F.  SPONSOR/ADVISOR
 
Throughout the grant period, the sponsoring institution is
expected to arrange significant working relationships with
the awardee through an advisor who will sponsor and oversee
the proposed program, and who will make sure that the awardee
will receive the proper experience for a future career in
demography and/or economics of aging.
 
The advisor must be a social scientist with extensive
research experience and must have a background in either the
demography or economics of aging.  The advisor should serve
as a consultant or preferably as a collaborator.
 
Up to five percent of the primary advisor's salary will be
allowed for the first two years.
 
IV.  CRITERIA FOR ELIGIBILITY
 
A.  THE CANDIDATE
 
1.  The candidate must hold a Ph.D. or equivalent
professional degree in a social, statistical, or mathematical
science (e.g., economics, sociology, demography,
epidemiology), and show clear evidence of expertise in
demography or economics (e.g., by scholarly publications, or
faculty or research appointments in these areas).
 
2.  By the beginning date of the award, the candidate should
have a minimum of two years post-doctoral research
experience.  Any deviation from this requirement must be
clearly justified, e.g. by demonstrating evidence of
exceptionally strong peer-reviewed publications (M.D./Ph.D.
candidates are assumed to meet the two-year minimum
requirement).  This experience should include evidence of (a)
clear intention to pursue research in demography and/or
economics, and (b) an interest in either the demography or
economics of aging.  Successful candidates will have
conducted high-quality research in their own discipline and
have published in peer-reviewed journals.  Previous pre- or
postdoctoral fellowship experience in the demography or
economics of aging is permissible.
 
3.  The candidate agrees to inform the NIA for a period of
five years subsequent to completion of the award regarding
research activities, publications, grants or contracts, and
academic status; and must agree to attend any scheduled
meetings of awardees at NIA during the period of the award.
 
4.  The candidate must be a citizen or noncitizen national of
the United States or its possessions and territories or must
hold a permanent residence visa at the time of application.
 
5.  Applications from women and minority candidates are
especially solicited.
 
6.  SERCA applications may not be submitted concurrently with
other PHS research career development applications (including
any of the other K series), which would duplicate the provisions of
the SERCA.  This does not preclude the concurrent submission
of a regular research project grant application.
 
B.  THE SPONSORING INSTITUTION
 
1.  The sponsoring institution must nominate the candidate on
the basis of qualifications, interests, accomplishments,
motivation, and potential for a research career in demography
and/or economics of aging.
 
2.  Evidence of the commitment of the institution to the
candidate's research development must be provided (covering
the advisor, space, resources, etc.)  The sponsoring
institution may or may not be the applicant's current
employer.  It is not essential for the sponsoring institution
to commit itself to eventual placement of the candidate on
its permanent faculty.
 
3.  The background, qualifications, and commitment of the
primary advisor must be described.
 
C.  THE PROGRAM OF ACTIVITY
 
1.  The candidate's proposal for training and research in the
demography and/or economics of aging must be described in
detail and fully justified.
 
2.  For the research project, the general area must be
defined and the research plan described in the grant
application, e.g., identification and justification of the
research problem; indication of possible study population(s),
hypotheses, and variables; and strategies for analysis.  It
is anticipated that full details will be formulated (or re-
formulated--see Supplementary Guidelines) during the first
two years of the grant period.
 
V. INCLUSION OF MINORITIES AND WOMEN
 
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,
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 in-
clude 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), diag-
nosis, 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 in-
clude 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