[bionet.sci-resources] NIH Guide, vol. 20, no. 20, pt. 2, 24 May 1991

kristoff@GENBANK.BIO.NET (Dave Kristofferson) (05/29/91)

$$P3 BEGIN PA-91-56 ****************************************************

CLINICAL INVESTIGATOR AWARD - NURSING

PA:  PA-91-56

P.T. 34; K.W. 0785130, 0785035, 0710030

National Center for Nursing Research

PURPOSE

The Clinical Investigator Award (CIA) (KO8) is designed to be a
mid-career development award.  The candidate is expected to conduct a
research project in an area related to nursing systems, the promotion of
health, prevention of disease, and mitigation of acute and chronic
illnesses or disabilities.

OBJECTIVES AND ELIGIBILITY CRITERIA

The objective of this program is to enhance the development of
clinically trained individuals into independent clinical investigators.
The program enables candidates to investigate a well-defined problem
under a sponsor competent to provide guidance in the chosen area of
research at an NIH-supported center program, such as the specialized
centers supported by the National Center for Nursing Research, the
National Cancer Institute, the National Heart, Lung, and Blood
Institute, the National Institute of Arthritis and Musculoskeletal and
Skin Diseases, the National Institute of Diabetes and Digestive and
Kidney Diseases, or one of the General Clinical Research Centers
supported by the National Center for Research Resources.

The candidate must:

  o  Be a U.S. citizen, a noncitizen national of the U.S., or have been
     lawfully admitted to the U.S. for permanent residence.

  o  Be a registered nurse.

  o  Hold a doctorate or equivalent degree.

  o  Show evidence of scholarly achievements (e.g., articles and books).

  o  Have sufficient research experience and background (generally 4-8
     years beyond the doctorate) so that time devoted to research would
     ensure the development of a highly qualified nurse investigator.
     The candidate may not be a current Principal Investigator of a
     research grant (RO1, R29, R15) nor have been a Principal
     Investigator in the past.

  o  Describe in detail the clinically oriented research project that is
     to be conducted under this support.  Identify plans for a research
     development program designed to enhance the candidate's research
     skills (e.g., course work; clinical, laboratory, and statistical
     techniques; and application and usage of equipment).  Clinically
     oriented research projects focusing on basic, biological, and/or
     behavioral research topics are appropriate and encouraged.

  o  Describe in detail the training component of the application.
     Provide a clear discussion of how the training component
     complements the research project to be conducted.

  o  Identify a sponsor (and a cosponsor if desired) who is working at
     an NIH-supported research center or a General Clinical Research
     Center.  The sponsor (and cosponsor) must be recognized as an
     accomplished investigator in the research area proposed, have
     experience in training independent investigators, and be willing to
     provide the guidance for the awardee's development and research
     plan.  The sponsor or the cosponsor must be committed to continue
     this involvement through the individual's total period of
     development under this award.

  o  Have the approval and a letter of support from the Center Director
     to allow him/her to pursue the research and share in the center's
     resources, if neither the sponsor nor the cosponsor is the director
     of the center where the candidate desires to conduct the research.

  o  Provide in the application letters of support from the sponsor and
     the cosponsor delineating the match with the applicant's research
     plans and their willingness to provide the necessary assistance for
     the candidate.  Letters of support from the sponsor and the
     cosponsor must list the research fellows they have and will be
     monitoring during the period of this application.

  o  Provide a letter with strong justification for describing why the
     sponsor and the cosponsor were selected.  The letters must detail
     the expertise of the sponsor and the cosponsor, the environment and
     resources, and level of commitment available to the candidate from
     the sponsor and the cosponsor, and the benefits the candidate will
     gain from the experience.

  o  Commit 75-100 percent effort to the proposed research and
     research-related activities.

  o  Document that the grantee institution is a domestic university,
     nursing school, or comparable institution with strong,
     well-established research and training programs in the chosen area
     and/or strong ties to the institution housing the Research Center
     Program that is to support the CIA candidate.  The Center Director
     must have the interest, capability, and commitment to provide the
     environment to support clinically trained individuals in the
     development of independent research.

CONDITIONS OF THE AWARD

  o  Awards may be made for a period of 3 years and are not renewable.

  o  Allowable direct costs will not exceed $70,000 a year.  The salary
     requested must be consistent with the established salary structure
     of the grantee institution for persons of equivalent
     qualifications, experience, and rank up to a maximum of $50,000 per
     year plus related fringe benefits.  Supplementation of salary from
     non-Federal sources is allowable.  Requested effort must be at
     least 75 percent, but may range up to 100 percent for research and
     research-related activities.  Salary and fringe benefits will be
     awarded accordingly (i.e., 75 percent of the candidate's full-time
     base salary up to a maximum of $50,000 plus associated fringe
     benefits for a guaranteed protection of 75 percent effort committed
     to research and research-related activities).  In addition, Other
     Research Support costs (personnel other than the awardee,
     equipment, supplies, and travel) may be requested up to $20,000.
     In no case, however, will the total direct costs exceed $70,000.

  o  Indirect costs will not exceed 8 percent of the direct costs,
     exclusive of tuition and fees and equipment expenditures.

  o  The release or retention of salary and fringe benefit grant funds
     for the awardee on other PHS-supported research grants will be
     reviewed on a case-by-case basis.  For example, such funds may be
     approved for retention if the effort is justified as above and
     beyond the total commitment to research funded in the NCNR CIA.
     Funds budgeted in a PHS-supported research or training grant for an
     individual's salary and applicable fringe benefits, but freed as a
     result of funding a career award for that individual, may not be
     used for any other purpose except when the individual no longer
     participates in the grant-supported activity and another individual
     replaces him or her and requires comparable remuneration.

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.

REVIEW CRITERIA

The following characteristics will be considered:

  o  Background and high potential of the candidate for a research
     career as a clinical investigator.

  o  Sponsor and cosponsor must have an active and productive program of
     research in the area of the candidate's research interests.

  o  Appropriate consultants for the concepts and methods used with the
     research proposal (e.g., theorists, methodologists, and
     statisticians).

  o  The scientific merit of the research project.  The soundness of the
     plan for research development and training.

  o  The plan detailing the protection of the 75-100 percent of the
     candidate's time to be spent in research and research-related
     activities.

  o  Appropriateness of the availability of the environment and
     resources necessary to implement the proposal's program of research
     and development.

  o  Plan of the Center's support of the candidate during the period of
     the award.

REVIEW PROCESS AND METHOD OF APPLYING

Applications will receive initial scientific and technical review by the
Nursing Science Review Committee (NRRC).  Second level review will be by
the National Advisory Council on Nursing Research.

Applications will be reviewed three times a year according to the
following schedule:

Applications   NRRC         Council Review       Earliest Starting
Received by                                        Date

October 1      Feb/March    May/June             July 1
February 1     June/July    September/October    Dec 1
June 1         Oct/Nov      Jan/Feb              April 1

Applications must be submitted on the research grant application form
PHS 398 (rev.  10/88).  If not available at the institution's office of
sponsored programs, it may be requested from:

Office of Grants Inquiries
Division of Research Grants
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7441

Completion of the application includes following the general
instructions from the PHS 398 application form and incorporating the
following additional information:

  o  Complete item 2 on the face page by typing in "NCNR K08 Clinical
     Investigator Award, PA-91-56."

  o  Utilize the Research Career Development Award (RCDA) Table of
     Contents, but relabel the page "Clinical Investigator Award."

  o  Complete a biographical sketch for the candidate, the sponsor, and
     the cosponsor.

  o  Provide information on "Other Support" and plans for the candidate,
     the sponsor, and the cosponsor.

  o  Utilize the Research Career Development Award Reference Guidelines,
     but relabel the page "Clinical Investigator Award Reference
     Guidelines."  Submit four letters of reference documenting the
     candidate's research skills and experience.

NCNR CONTACTS FOR SPECIFIC RESEARCH AREAS OF EMPHASIS

Acute and Chronic Illness - Dr. Mary Lucas, Dr. Laura James
Health Promotion and Disease Prevention - Dr. Sharlene Weiss,
  Dr. June Lunney
Nursing Systems - Dr. Patricia Moritz, Dr. Barbara Pillar

National Center for Nursing Research
Building 31, Room 5B03
Bethesda, MD  20892
Telephone:  (301) 496-0523

NCNR CONTACT FOR BUDGET AND ADMINISTRATIVE MATTERS

Ms. Sally Nichols
Grants Management Office
National Center for Nursing Research
Building 31, Room 5B06
Bethesda, MD  20892
Telephone:  (301) 496-0237

This program is described in the Catalog of Federal Domestic Assistance
No. 93.336, Nursing Research, and No. 93.866.  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 grants policies and Federal Regulations 42 CFR 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, April 6, 1988.

$$P3 END ***************************************************************

$$P4 BEGIN PA-91-57 ****************************************************

ACADEMIC INVESTIGATOR AWARD - NURSING

PA:  PA-91-57

P.T. 34; K.W. 0785130, 0710030

National Center for Nursing Research

PURPOSE

The Academic Investigator Award (KO7) is designed to be a mid-career
development award.  The candidate is expected to conduct a research
project in an area related to nursing systems, the promotion of health,
prevention of disease, and mitigation of acute and chronic illnesses or
disabilities.

OBJECTIVES AND ELIGIBILITY CRITERIA

The objectives of this program are to enhance the development of
research faculty in, and the research activities related to, nursing
science, thus strengthening the research capabilities of individuals
under the mentorship of their sponsors.  The goal of this grant
mechanism is to strengthen faculty expertise by enhancing knowledge and
skills in a specialized focus area of nursing science.

The candidate must:

  o  Be a U.S. citizen, a noncitizen national of the U.S., or have been
     lawfully admitted to the U.S. for permanent residence.

  o  Be a registered nurse.

  o  Hold a doctorate or equivalent degree.

  o  Have an academic appointment at the sponsoring institution.

  o  Show evidence of scholarly achievements (e.g., articles and books).

  o  Have sufficient research experience and background (usually four to
     eight years beyond the doctorate) so that time released from
     teaching and administrative duties and devoted to research would
     ensure the development of a highly qualified nurse investigator.
     The candidate may be a current Principal Investigator on a research
     grant (RO1, R15) or have been a Principal Investigator in the past
     (RO1, R29, R15).

  o  Describe in detail the research project to be conducted under this
     support.  Identify plans for a research development program
     designed to enhance the candidate's research skills (e.g., course
     work; clinical, laboratory, and statistical techniques; application
     and use of equipment).

  o  Describe in detail the career development plan of the application.
     Provide a clear discussion of how the career development plan
     complements the research project to be conducted.

  o  Identify a sponsor (and a cosponsor if desired) who is recognized
     as an accomplished investigator in the research area proposed, who
     has experience in training independent investigators and who will
     provide the guidance for the awardee's development and research
     plan.  The sponsor or the cosponsor is not required to be a faculty
     member of the candidate's sponsoring institution, but must be
     committed to continue this involvement through the individual's
     total period of development under this award.  If the sponsor or
     the cosponsor is geographically distant from the candidate,
     detailed rationale must be provided to document the
     sponsor-candidate relationship and level of commitment for the
     successful implementation and completion of the research proposed
     (e.g., travel plans, telephone conferences, and computer linkages).
     Letters of support from the sponsor and the cosponsor delineating
     the match with the applicant's research plans and willingness to
     provide the necessary assistance must be included in the
     application.  Letters of support from the sponsor and the cosponsor
     must list the research fellows they have and will be monitoring
     during the period of this award.

  o  Provide a letter with strong justification for why the sponsor and
     the cosponsor were selected.  The letter must detail the expertise
     of the sponsor and the cosponsor, the environment and resources,
     the level of commitment available to the candidate from the sponsor
     and the cosponsor, and the benefits the candidate will gain from
     the experience.

  o  Commit 75-100 percent effort to the proposed research and
     research-related activities.

  The dean of the school must:

  o  Present in writing a detailed plan to protect 75-100 percent of the
     candidate's time to be spent in research and research-related
     activities.

  o  Identify and demonstrate availability of the environment and
     resources (populations of patients, manpower, materials, equipment,
     laboratory facilities of the sponsor and cosponsor) necessary to
     implement the proposed program of research and development.

CONDITIONS OF THE AWARD

  o  Awards may be made for a period of three years and are not
     renewable.

  o  Allowable direct costs may not exceed $70,000 a year.  The salary
     requested must be consistent with the established salary structure
     of the grantee institution for persons of equivalent
     qualifications, experience, and rank up to a maximum of $50,000 per
     year plus related fringe benefits.  Supplementation of salary from
     non-Federal sources is allowable.  Requested effort must be at
     least 75 percent, but may range up to 100 percent for research and
     research-related activities.  Salary and fringe benefits will be
     awarded accordingly (i.e., 75 percent of the candidate's full-time
     base salary up to a maximum of $50,000 plus associated fringe
     benefits for a guaranteed protection of 75 percent effort committed
     to research and research-related activities).  In addition, Other
     Research Support costs (personnel other than the awardee,
     equipment, supplies, and travel) may be requested up to $20,000.
     In no case, however, will the total direct costs exceed $70,000.

  o  Indirect costs will not exceed 8 percent of the direct costs,
     exclusive of tuition and fees and equipment expenditures.

  o  The release or retention of salary and fringe benefit grant funds
     for the awardee on other PHS-supported research grants will be
     reviewed on a case-by-case basis.  For example, such funds may be
     approved for retention if the effort is justified as above and
     beyond the total commitment to research funded in the NCNR Academic
     Investigator Award.  Funds budgeted in a PHS-supported research or
     training grant for an individual's salary and applicable fringe
     benefits, but freed as a result of funding a career award for that
     individual, may not be used for any other purpose.  However, if the
     KO7 awardee no longer participates in the grant-supported activity
     and another individual replaces him or her and requires comparable
     remuneration, the salary and fringe benefit funds may be used for
     the replacement.

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.

REVIEW CRITERIA

The following characteristics will be considered:

  o  Background and high potential of the candidate for a research
     career as an academic investigator.

  o  Sponsor and cosponsor must have an active and productive program of
     research in the area of the candidate's research interests.

  o  Appropriate consultants for the concepts and methods used with the
     research proposal (e.g., theorists, methodologists, and
     statisticians).

  o  The scientific merit of the research project.  The soundness of the
     plan for research development and training.

  o  The plan detailing the protection of the 75-100 percent of the
     candidate's time to be spent in research and research-related
     activities.

  o  Appropriateness of the availability of the environment and
     resources necessary to implement the proposal's program of research
     and development.

REVIEW PROCESS AND METHOD OF APPLYING

Applications will receive initial scientific and technical review by the
Nursing Science Review Committee (NRRC).  Second level review will be by
the National Advisory Council for Nursing Research.

Applications will be reviewed three times a year according to the
following schedule:

Applications     NRRC       Council Review       Earliest Starting
Received by                                      Date

October 1      Feb/Mar      May/June             July 1
February 1     June/July    Sep/Oct              Dec 1
June 1         Oct/Nov      Jan/Feb              April 1

  Applications must be submitted on the research grant application form
     PHS 398 (rev.  10/88).  If not available at the institution's
     office of sponsored programs, it may be requested from:

Office of Grants Inquiries
Division of Research Grants
Westwood Building, Room 449
5333 Westbard Avenue
Bethesda, MD  20892
Telephone:  (301) 496-7441

Completion of the application includes following the general
instructions from the PHS 398 application form and incorporating the
following additional information:

  o  Complete item 2 on the face page by typing in "NCNR K07 Academic
     Investigator Award, PA-91-57."

  o  Utilize the Research Career Development Award (RCDA) Table of
     Contents, but relabel the page "Academic Investigator Award."

  o  Complete a biographical sketch for the candidate, the sponsor, and
     the cosponsor.

  o  Provide information on "Other Support" and plans for the candidate,
     the sponsor, and the cosponsor.

  o  Utilize the Research Career Development Award Reference Guidelines,
     but relabel the page "Academic Investigator Award Reference
     Guidelines."  Submit four letters of reference documenting the
     candidate's research skills and experience.

NCNR CONTACTS FOR SPECIFIC RESEARCH AREAS OF EMPHASIS

Acute and Chronic Illness - Dr. Mary Lucas, Dr. Laura James
Health Promotion and Disease Prevention - Dr. Sharlene Weiss,
  Dr. June Lunney
Nursing Systems - Dr. Patricia Moritz, Dr. Barbara Pillar

National Center for Nursing Research
Building 31, Room 5B03
Bethesda, MD  20892
Telephone:  (301) 496-0523

NCNR CONTACT FOR BUDGETARY AND ADMINISTRATIVE MATTERS

Ms. Sally Nichols
National Center for Nursing Research
Grants Management Officer
Building 31, Room 5B06
Bethesda, MD  20892
Telephone:  (301) 496-0237

This program is described in the Catalog of Federal Domestic Assistance
No. 93.336, Nursing Research, and No. 93.866.  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 grants policies and Federal Regulations 42 CFR 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, April 6, 1988.

$$P4 END ***************************************************************

$$P5 BEGIN PA-91-58 ****************************************************

RESEARCH ON HOSPITALIZATION OF ADOLESCENTS FOR MENTAL DISORDERS

PA:  PA-91-58

P.T. 34; K.W. 0715129, 0770015, 0403001, 0745020

National Institute of Mental Health

PURPOSE

The National Institute of Mental Health (NIMH) seeks applications for
the support of research on adolescents with mental disorders in both
inpatient and residential treatment settings.  This announcement will
also support objective 6.3 of "Healthy People 2000:  National Health
Promotion and Disease Prevention Objectives."  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).

RESEARCH OBJECTIVES

Research issues of interest include:  severity of illness, diagnoses,
and characteristics of hospitalized adolescents; the types, intensities,
and/or duration of treatment received by adolescents across treatment
settings; development and testing of improved assessment criteria for
hospitalization of adolescents; assessment of quality of care provided
to adolescents in the inpatient setting; behavioral and social outcomes
of inpatient treatment for adolescents with mental disorders; effects of
payment mechanisms on access to hospital treatment, quality, and
availability of treatment services and length of stay for various
adolescent populations; role of juvenile justice system, social service
system, and/or school system and their interface with hospitalized
adolescents; alternate forms of treatment for adolescents with mental
disorders; and effectiveness of hospital treatment for adolescents with
mental disorders and co-occurring alcohol and/or drug abuse.

ELIGIBILITY

Applications may be submitted by any nonprofit or for-profit
organization, including units of State and local governments.

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.

SUPPORT MECHANISMS

Research support may be requested through applications for an individual
research grant (R01), the First Independent Research and Transition
(FIRST) award (R29), and a small grant (R03).

PERIOD OF SUPPORT

Applicants may request support for up to five years for research
projects.  Small grants are limited to two years and may not be renewed.
FIRST awards may be made for up to five years and are not renewable.
Annual awards will be made, subject to continued availability of funds
and progress achieved.  During Fiscal Year 1990 the Services Research
Branch of the NIMH Division of Applied and Services Research funded
approximately $5 million in child and adolescent research.

APPLICATION PROCEDURES

Applicants must use the form PHS 398 (revised 10/88).  The program
announcement number and the short version of the title for this program
announcement must be typed in item number 2 on the face page of the
application form; also check "yes" on item 2.

The signed original and six legible copies of the completed application
must be sent to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

REVIEW PROCEDURES

Applications will be reviewed in accordance with the regular PHS review
schedule:

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.

FURTHER INFORMATION

For further programmatic information, prospective applicants should
contact:

Ann Hohmann, Ph.D., M.P.H. or Junius Gonzales, M.D.
Services Research Branch
Division of Applied and Services Research
National Institute of Mental Health
Room 18C-14
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-3364

For further information of a grants management nature, prospective
applicants should contact:

Stephen J. Hudak, Chief
Grants Management Section
National Institute of Mental Health
Room 7C-23
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4456

This program is described in the Catalog of Federal Domestic Assistance,
Nos. 93.242, 93.281, and 93.282).  Under the authority of the Public
Health Service Act, Title IV, Section 301 (Public Law 78-410, as
amended; 42 USC 241) and administered under PHS grants policies and
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 and 92, the
National Institute of Mental Health will accept applications in response
to this announcement.

$$P5 END ***************************************************************

**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


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