Full Text CA-96-003
 
WOMEN AND MINORITY RECRUITMENT:  SMALL GRANT PROGRAM
 
NIH GUIDE, Volume 25, Number 1, January 26, 1996
 
RFA:  CA-96-003
 
P.T. 34, FF, II

Keywords: 
  Cancer/Carcinogenesis 
  Disease Prevention+ 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  February 20, 1996
Application Receipt Date:  April 18, 1996
 
PURPOSE
 
The Early Detection Branch (EDB), Division of Cancer Prevention and
Control (DCPC), National Cancer Institute (NCI) invites Small Grant
Program applications (RO3) to perform pilot studies, test new ideas,
or gather information that will lead to the development of effective
models and strategies to improve the participation of women and
minority groups as subjects in cancer prevention and screening phase
III research.  Populations of research interest are defined in the
NIH Guidelines on the Inclusion of Women and Minorities as Subjects
in Clinical Research and include women and U.S. minority
racial/ethnic groups (American Indian or Alaskan Native, Asian or
Pacific Islander, Black, and Hispanic) and their subpopulations (DHHS
1994).
 
HEALTHY PEOPLE 2000
 
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
(Women & Minority Recruitment: Small Grants Program) is related to
all of the special populations targets. 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, DC 20402-9325 (telephone 202-783-3238).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government. Eligible Principal
Investigators include new investigators, established researchers,
qualified staff of public health departments and collaborating
agencies, and predoctoral investigators currently enrolled in an
accredited doctoral degree program.  Racial/ethnic minority
individuals, women and persons with disabilities are encouraged to
apply as Principal Investigators.  Ineligible applicants include
individuals who are or were previously a Principal Investigator (PI)
on an NCI-funded cancer control grant or contract for more than two
years; previous NCI small grant recipients; and foreign institutions.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Cancer Institute (NCI) Small Grants
(R03) Program.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  Collaboration of investigators funded under this RFA is
planned, see SPECIAL REQUIREMENTS section below. The total project
period for an application submitted in response to this RFA may not
exceed two years. The anticipated award date is September 30, 1996.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of an award will
vary also. This RFA is a one-time solicitation.  Future unsolicited
competing continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.
 
FUNDS AVAILABLE
 
Approximately $400,000 in total costs per year for two years will be
committed to fund applications submitted in response to this RFA.  It
is anticipated that four to five applications will be funded.  Each
award will be limited to $50,000 in direct costs per year.  The total
project period of these awards may not exceed two years.  This level
of support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NCI, awards pursuant to
this RFA are contingent upon the availability of funds for this
purpose.
 
RESEARCH OBJECTIVES
 
Background
 
The NIH Revitalization Act of 1993 directed NIH to establish
guidelines for the inclusion of women and minorities in clinical
research.  The guidelines were to supersede and strengthen prior
policies regarding the participation of women and minorities as
subjects in clinical research, the manner in which clinical trials
are designed and carried out, and the operation of outreach programs
(DHHS 1994). The NIH published these guidelines in the Federal
Register on March 28, 1994.
 
The NIH guidelines are intended to ensure that all future NIH-
supported research is designed to elicit information on both genders
and diverse minority groups (DHHS 1994).  Under these guidelines, the
NIH will not award funds for projects which do not comply with the
new policy.  The level of participation of minorities and women as
subjects in NCI~s treatment trials is currently close to their
representation in populations at risk. This success is due in part to
two recent NCI programs, the Minority-Based Clinical Community
Oncology Program (MBCCOP) and the Increasing Minority Accrual to
Cooperative Clinical Trials program.
 
However, the numbers of women and minority groups participating in
NCI~s prevention and screening trials lag behind those enrolled in
its treatment trials.  Unlike treatment trials, cancer prevention and
screening trials focus on cancer-free populations.  These trials
generally require large numbers of subjects to participate over very
long periods of time.  Given that a significant proportion of many
minority groups carry a heavy burden of poverty, worries about daily
safety and well- being are likely to take precedence over concerns
for a disease they do not yet have (Lacey 1993).
 
The NCI is eager to gather information that will lead to the
development of effective strategies and models to increase the
participation of women and minority groups as subjects in cancer
prevention and screening trials.  Large gaps currently exist in our
understanding of important health and clinical trial-related
knowledge, attitudes, and behaviors for many women and minority
population groups (ORWH 1994).  This program is designed to help fill
these gaps and enable investigators to develop more effective
participation strategies.
 
Research Objectives and Scope
 
The objective of this RFA is to fund applications that will test new
ideas, gather information, or perform pilot studies that can lead to
the development of new, testable hypotheses and interventions to
improve the participation of women and minority groups as subjects in
cancer prevention and screening phase III research.
 
To address program objectives, investigators should consider surveys
of patient, provider, and/or public attitudes, knowledge, and
behaviors related to clinical trials; pilot studies; or collection of
baseline information.  New, as well as experienced investigators in
relevant fields and disciplines, are encouraged to submit
applications for exploratory studies that address research issues
within well-defined study populations, such as but not limited to the
following:
 
(1)  Examining knowledge, attitudes, and behaviors of physicians and
other health care providers, current and potential subjects, special
interest groups, or the public about health, cancer screening and
prevention, and clinical research.
 
(2)  Examining how population groups obtain information (the credible
sources) and how this information is translated into disease
prevention and health behavior activities.
 
(3)  Determining optimum ways to recruit subjects.
 
(4)  Examining ways to reduce barriers to subject participation and
to enhance those factors that help motivate and facilitate
participation.
 
(5)  Determining optimum ways to assure subject compliance with
clinical trial protocols.
 
(6)  Determining optimum ways to retain subjects throughout the
duration of a clinical trial.
 
(7)  Determining factors that influence a health care professional~s
decision to refer patients to clinical trials.
 
(8)  Defining issues that should be addressed in the recruitment and
informed consent process for subjects and their health care
providers.
 
(9)  Defining the impact of participation in clinical trials on the
subsequent behavior of subjects and their interactions with health
professionals.
 
(10)  Identifying optimal referral sources and networks for potential
clinical trial subjects.
 
(11)  Examining the role of economic barriers to subject
participation in clinical trials including issues surrounding
reimbursement of patient care costs.
 
(12)  Examining the role of partnerships between research
institutions and communities on the participation of subjects and
health care providers in clinical trials.
 
(13)  Examining ways to ensure the protection of ~vulnerable~
populations from research abuse (e.g., avoiding coercion or undue
influence to participate or remain in a study).
 
SPECIAL REQUIREMENTS
 
This RFA is not intended to support or supplement new clinical
trials. If the application calls for use of secondary data or primary
data collected by someone else, the source (owner) of the data must
be clearly indicated and written permission to use the data must be
submitted with this application.  The letter must state that the
application and research plan were reviewed and approved by the
source (owner) of the data.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the ~NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research,~ which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy or additional
relevant information from the program staff listed under INQUIRIES.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by February 20, 1996 a
letter of intent that includes a descriptive title of the proposed
research, the name, address, telephone and FAX numbers of the
Principal Investigator, the identities of other key personnel and
participating institutions, and the number and title of the RFA in
response to which the application may be submitted.  Although a
letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it
contains allows NCI staff to estimate the potential review workload
and avoid conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Nancy K. Simpson, Sc.M.
Early Detection Branch
National Cancer Institute
Executive Plaza North, Room 305
6130 Executive Boulevard, MSC 7342
Bethesda, MD  20892-7342
Rockville, MD  20894 (courier express)
Telephone: (301) 496-3893
FAX:  (301) 496-8667
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone 301/435-0714, email: girg@drgpo.drg.nih.gov; and from the
NCI Information Office listed under INQUIRIES.
 
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier express)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Suite 636
6130 Executive Boulevard - MSC 7405
Bethesda, MD  20892-7405
Bethesda, MD  20852 (courier express)
 
Applications must be received by April 18, 1996.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application. The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by the
DRG and for responsiveness by the NCI.  Incomplete applications will
be returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NIH staff may contact the
applicant to determine whether it should be returned or submitted for
review in competition with unsolicited applications at the next
review cycle.  Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit, and for
adequacy and plans for addressing special considerations by an
appropriate peer review group convened by the NCI in accordance with
the review criteria stated below.
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with NIH peer review procedures.
As part of the initial merit review, all applications will receive a
written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally
the top half of applications under review, will be discussed,
assigned a priority score, and receive a second level review by the
National Cancer Advisory Board.
 
Review Criteria
 
o  applications will be judged on evidence of an in-depth
understanding of the target population; the ability to access and
obtain the participation of target population members; and the
innovativeness of proposed strategies.
 
o  scientific, technical, or medical significance and originality of
proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
AWARD CRITERIA
 
The anticipated date of award is September 30, 1996.  Applicants will
compete for funding based on the quality and merit of the proposed
research as determined by peer review, availability of funds, and
programmatic priorities.  It is the intent of this program to fund a
portfolio of research projects that will target a variety of
population groups, and, therefore, geographic and racial/ethnic
variation will be considered in making funding decisions.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Direct inquiries regarding programmatic
issues to:
 
Nancy K. Simpson, Sc.M.
Early Detection Branch
National Cancer Institute
Executive Plaza North, Room 305
6130 Executive Boulevard, MSC 7342
Bethesda, MD  20892-7342
Rockville, MD  20894 (courier express)
Telephone:  (301) 496-3893
FAX:  (301) 496-8667
Email:  SIMPSONN@DCPCEPN.NCI.NIH.GOV
 
Direct inquiries regarding fiscal issues to:
 
Robert Hawkins
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard, MSC 7150
Bethesda, MD  20892-7150
Rockville, MD  20852 (courier express)
Telephone:  (301) 496-7800  Ext. 213
FAX:  (301) 496-8601
Email:  HAWKINSR@GAB.NCI.NIH.GOV
 
AUTHORITY AND REGULATION
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control Science Program.  Awards are
made under the 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 part 52 and 45 CFR part 74 and 92.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro- Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
References
 
Department of Health and Human Services (DHHS).  NIH guidelines on
the inclusion of women and minorities as subjects in clinical
research.  Federal Register 59(50):14508-14513, 1994.
 
Lacey L.  Cancer prevention and early detection strategies for
reaching underserved urban, low-income black women: Barriers and
objectives.  Cancer Supplement 4(4):312-320, 1994
 
National Cancer Institute (NCI).  Small Grants Program: 1984-1990
status report, cancer prevention and control research.  NIH
Publication No. 91-3233, Sept. 1991.
 
Office of Research on Women~s Health (ORWH).  Recruitment and
retention of women in clinical studies: a Report of the task force on
the recruitment and retention of women in clinical studies.  NIH,
Washington, D.C., August 1994.
 
.

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