Full Text CA-96-015
 
REGIONAL CONFERENCES ON RECRUITMENT AND RETENTION OF MINORITY
PARTICIPANTS IN CLINICAL CANCER RESEARCH
 
NIH GUIDE, Volume 25, Number 17, May 24, 1996
 
RFA:  CA-96-015
 
P.T. 42

Keywords: 
  Cancer/Carcinogenesis 
  Clinical Medicine, General 

 
National Cancer Institute
 
Application Receipt Date:  July 30, 1996
 
PURPOSE
 
The objective of this Request for Applications (RFA) is to provide
support for regional conferences to share current information and
strategies that will aid cancer clinical investigators in recruiting
and retaining minority participants in clinical cancer research and
to stimulate local/regional adaptations of these strategies.  Another
objective of the conferences would be to define additional research
needs and to promote collaborations among cancer clinical
investigators and the community that will further the representation
of minorities in their studies.  For the purpose of this RFA,
minorities are populations that include African Americans, Hispanic
Americans, American Indians, Alaskan Natives, and Native Pacific
Islanders.
 
These conferences follow a National Conference on the Recruitment and
Retention of Minority Participants in Clinical Cancer Research held
in Washington, DC on January 26-27, 1996 and co-sponsored by the
National Cancer Advisory Board, the National Cancer Institute (NCI),
the American Cancer Society, the Oncology Nursing Society, the
National Institutes of Health (NIH) Office of Research on Minority
Health, and the NIH Office of Research on Women's Health.  The
regional conferences will build on the national meeting by focusing
on adaptations of what is known about recruitment and retention of
minorities to local/regional conditions and populations, with
emphasis in the regional conferences placed on minority accrual into
cancer prevention and control cancer trials.  Increased minority
accrual into cancer treatment trials will also be addressed.
Expected outcomes will include the publication of the proceedings of
each of the regional conferences, and clinical research programs that
will be increasingly successful in designing and conducting research
that meets statutory and regulatory minority inclusion requirements
for NIH funded clinical research.
 
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,
Regional Conferences On Recruitment and Retention of Minorities in
Clinical Cancer Research, 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 Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
This RFA is primarily intended for domestic for-profit and non-profit
(1) universities, (2) community organizations recognized nationally
and by NIH including local and national coalitions, (3) Clinical
Cooperative Groups (CCOGs), (4) NCI Cancer Centers, (5) university
hospitals, (6) private and institutional health care providers, and
(7) patient advocacy groups. All institutions, organizations,
coalitions and advocacy groups are expected to have access to
substantial numbers of underrepresented minorities. Racial/ethnic
minority individuals, women, and persons with disabilities are
encouraged to apply as principal investigators.
 
MECHANISM OF SUPPORT
 
This is a one time-solicitation.  Awards in response to this RFA will
use the conference grant award (R13).  Planning, direction and
execution of the proposed project will be the responsibilities of the
applicant.  The total project period for an application submitted in
response to this RFA may not exceed one year.  The anticipated award
date is September 30, 1996.  Each award is non-renewable and
non-transferable from one awardee to another awardee.
 
Awards will be administered under PHS grants policy as stated in the
Public Health Services Grants Policy Statement DHHS, Publication
No.(OASH) 94-50,000, revised 4-1-94.
 
FUNDS AVAILABLE
 
The estimated total costs available for the support of the program is
$350,000. There will be approximately seven to eight new awards made
at a maximum direct cost level of $50,000 each.
 
Funding in response to this RFA is dependent on receipt of a
sufficient number of applications of high scientific merit. Although
this program is provided for in the financial plans of NCI, the award
of grants pursuant to this RFA is contingent upon the anticipated
availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Background
 
Substantial national and local efforts have been made and are
continuing to be made to reduce cancer morbidity and mortality in the
general population.  However, in spite of these efforts, projections
made for 1995 were 1.25 million newly diagnosed cancer cases and
547,000 cancer deaths (American Cancer Society, 1995).  Past patterns
of cancer incidence and mortality predict that a disproportionate
share of this cancer burden will be borne by minorities.  As an
example, past and current SEER data show Hispanics residing in New
Mexico and Arizona to have excess cancer incidences of the cervix,
stomach and gallbladder.  American Indians from New Mexico and
Arizona show the highest incidence rate for gallbladder cancer of any
racial group, and during the 1975-1984 period showed the poorest
survival rates of any racial group for eight evaluated cancer sites.
Alaska Natives have the highest cancer incidence rates among any
racial group for cancer of the oral cavity and pharynx, colon and
rectum, cervix uteri, and kidney and pelvis.  Finally, cancer
mortality rates for all sites for Blacks are almost 2.5-times greater
than for Whites.
 
The cancer statistics for minorities could be improved through
minority participation in NCI cancer clinical treatment and
prevention trials.  These trials provide individuals access to
state-of-the-art treatment and prevention protocols. However, data
from the NCI Minority Based and Community Clinical Oncology Programs
(MBCCOP, CCOP, respectively) show that, at least for individuals 55
years or older, minorities have not been adequately represented in
specific cancer treatment trials relative to their proportions in
incident cancer cases, and in cancer prevention and control trials
relative to their proportions in the U.S. population.  Specifically,
data from the NCI Minority Based and Community Clinical Oncology
Programs (MBCCOP, CCOP, respectively) for clinical treatment trial
participants 55 years or older show for the period 1991-1993 only 5.7
percent non-Hispanic Blacks and 3.6 percent Hispanics.  However,
estimates from SEER cancer incidence rates show that 8.7 to 8.9
percent of incident cancer cases in individuals ages 55 years or
older between 1991 and 1993 were among non-Hispanic Blacks and 5.5 to
5.6 percent were among Hispanics ( U.S. estimated from incident cases
among New Mexico Hispanics).  Similarly, for MBCCOP and CCOP cancer
prevention and control trials during 1991-1993 and for participants
55 years or older, only 6.4 percent were non-Hispanic Blacks and only
2.3 percent were Hispanic.  This compares with 8.6 percent of the
1990 55 year and older U.S. census population being non-Hispanic
Blacks, and 4.3 percent Hispanic (U.S. Census, 1992).  Additionally,
insufficient numbers of minorities are accrued into trials to permit
valid analysis of outcomes for the component minority subpopulations.
 
Current NIH policy regarding inclusion of minorities in clinical
trials has been stated in the NIH Guide for Grants and Contracts of
March 18, 1994 (Volume 23, Number 11) as follows:
 
o  All NIH-supported biomedical and behavioral research involving
human subjects must ensure that women and members of minority groups
and their subpopulations are included;
 
o  In the case of any clinical trial in which women or members of
minority groups will be included as subjects, the trial must be
designed and carried out in a manner sufficient to provide for valid
analysis of whether the variables being studied in the trial affect
women or members of minority groups, as the case may be, differently
than the other subjects in the trial.
 
Barriers to achieving these objectives, and possible strategies for
addressing these barriers, have been described and recently
summarized in review articles (see REFERENCES) and at the National
Conference on the Recruitment and Retention of Minority Participants
in Clinical Cancer Research held in Washington, DC on January 26-27,
1996.  Some of the more important patient barriers that have been
identified include geographic inaccessibility to the treatment site,
lack of treatment protocols for the disease and stage at
presentation, comorbid conditions, lack of insurance coverage and
cost, managed health care, travel and waiting time, and fear and
distrust of the U.S. health care system.  Physicians perceptions of
the time required of themselves and their patients, their perceived
interference of clinical trials with the normal physician/patient
relationship, concerns about a placebo arm, difficulty in explaining
randomization, and the conflict between the roles of a physician as
caregiver and researcher are some of the more frequently cited
barriers to enrollment of patients into clinical trials by their
physicians.
 
Community involvement in all stages of a trial has been cited as a
key factor in overcoming barriers to participation in clinical
trials.  This involvement includes going out into the community to
recruit trial subjects, convincing the community that cancer is a
community problem rather than just an individual problem, having
members of the community as part of the research team; and most
importantly, giving something back to the community for their
involvement in the clinical trial.  Cultural differences between the
members of a minority group regarding attitudes towards signing an
informed consent form as opposed to simply taking their word,
preferred modes of receiving a message (media versus personal
messenger), and perceptions of styles of non-verbal communication,
must all be factored up front into the recruitment strategy design.
Finally, physician barriers, as well as patient barriers, must be
addressed.
 
SPECIAL REQUIREMENTS
 
Each regional conference must be convened within one year of an
award.
 
The major focus of each regional conference should be identification
of recruitment strategies that will include the largest proportions
of all the minority subpopulations contained within the germane
geographic region.  Possible recruitment strategies may include but
not be limited to appropriate combinations of the successful
strategies described in individual published papers or review
articles, and/or strategies described in the National Conference on
the Recruitment and Retention of Minority Participants in Clinical
Cancer Research.  These strategies should address the barriers to
participation in cancer clinical trials by the populations within the
geographic region circumscribed by the regional conference.
 
INCLUSION OF WOMEN, MINORITIES AND PERSONS WITH DISABILITIES IN NIH
SPONSORED AND/OR SUPPORTED INTRAMURAL AND EXTRAMURAL SCIENTIFIC
MEETINGS AND CONFERENCES
 
It is the policy of NIH that organizers of scientific meetings, and
organizers who name NIH as a sponsor or use NIH facilities, should
make a concerted effort to achieve appropriate representation of
women, racial/ethnic minorities and persons with disabilities, and
other individuals who have been traditionally underrepresented in
science, in all NIH sponsored and/or supported scientific meetings.
The plans to seek appropriate representation should be specified
during selection of organizing committees, speakers, and other
invited participants.  Efforts should also be made to encourage
attendance by women, minorities and persons with disabilities.
 
All applicants should read the NIH Guidelines on Inclusion of Women,
Minorities and persons With Disabilities in NIH Sponsored and/or
Supported Intramural and Extramural Scientific Meetings and
Conferences published in the NIH Guide for Grants and Contracts of
April 28, 1995(Volume 24, Number 15).
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  The booklet "Support of Scientific
Meetings" should be referred to in the preparation of the
application.  These forms and booklet are available at most
institutional offices of sponsored research and may be obtained from
the Office of Extramural Outreach & Information Resources, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)
435-0714, email: asknih@odrockm1.od.nih.gov; and from the program
administrator 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 2 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 service)
 
At time of submission, send two additional copies of the application
to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636A
6130 Executive Boulevard MSC 7405
Bethesda, MD 20892-7405
 
Applications must be received by July 30, 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 also 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.
 
Information To Be Included In The Application
 
Complete biosketches of the Principal Investigator and all major
co-investigators must be provided.  Sufficient information must be
provided to enable the Special Review Group (SRG) to determine
whether the principal investigator and co-investigators have
sufficient experience to successfully organize and conduct the
regional conference.
 
The populations that will be targeted by the developed recruitment
strategies must be clearly delineated.  Previously identified
barriers to recruitment of these populations into cancer clinical
trials, and strategies that have been attempted to accrue these
populations into cancer clinical trials, should be described.  The
applicant should clearly show how these barriers and previous
recruitment strategies, as well as the barriers and strategies
summarily described in this RFA and discussed in detail in the
National Conference on the Recruitment and Retention of Minority
Participants in Clinical Cancer Research, will be integrated into the
agenda of the regional conference.
 
The geographic location of the regional conference should be
identified and justified.  The justification provided should include,
but not be limited to, the issue of accessibility to conference
participants with access to the populations targeted by the
conference.
 
The objectives of the regional conference must be stated.  The format
of the conference that will be selected to achieve the conference
objective(s) should be described.
 
A draft agenda for the conference should be provided.  This draft
should show the names of invited speakers and topics of each planned
presentation.  The agenda should include plans for summarization of
the conference, including the preparation and publication of the
conference proceedings.
 
A listing of representatives of all institutions, organizations,
CCOGs, health care providers, community organizations and patient
advocacy groups that will be invited to participate in the conference
should be provided.  Justification for selection of each of the
invited conference participants must be provided.  This justification
should include, but is not limited to, access to sufficient numbers
of the target populations and largest coverage of all target
populations within the domain of the regional conference, prior
experience in accessing the target populations, and previous
experience in recruitment for clinical trials.
 
Where supplemental funding will be needed to conduct the conference,
the applicant must describe how and from what sources these funds
will be solicited.
 
Finally, the applicant should provide detailed plans for an
evaluation of the conference.
 
Budget
 
Expenses allowed for conference support follow the guidelines
described in the PHS 398 form Application for a Public Health Service
Grant.  Applicants should also refer to the booklet Support for
Meetings.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the National Cancer Institute program staff.
Incomplete applications will be returned to the applicant without
further consideration.  If the application is not responsive to the
RFA, DRG staff may contact the applicant to determine whether to
return the application to the applicant or submit it 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 by an appropriate peer
review group with the review criteria stated below.  As part of the
initial merit review, all applications will receive a written
critique and may undergo a process in which only those applications
deemed to have the highest scientific merit will be discussed,
assigned a priority score, and may receive a second level review by
the appropriate national advisory council or board.
 
Review Criteria
 
o  The technical merit of the proposed conferences, as demonstrated
by:
 
The organization and agenda of each conference, including proposed
panel members.
 
Plans for assisting conference participants in the identification and
establishment of the partnerships needed to successfully implement
the recommendations of the conferences.
 
The proposed evaluation of the conference.
 
Plans for summarization of the conference proceedings.
 
The qualifications and experience of the Principal Investigator and
staff in the organization and running of conferences.
 
Plans to seek appropriate representation of women, minorities and
individuals with disabilities.
 
o  Plans for additional financial support from outside sources, if
needed, to fully meet conference expenses.
 
o  The adequacy and justification of the proposed budget.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions: Quality of the proposed project as determined by peer
review, geographic distribution of the applications, availability of
funds, and program priority.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Dr. Lester S. Gorelic
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 620
6130 Executive Boulevard MSC 7405
Bethesda, MD  20892-7405
Telephone:  (301) 496-7344
FAX:  (301) 402-4551
Email:  gorelicl@dea.nci.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Mrs. Joan Metcalfe
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard MSC 7150
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800 ext 228
FAX:  (301) 496-8601
Email:  metcalfj@gab.nci.nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the catalog of Federal Domestic
Assistance No. 93.395, Cancer Treatment Research and No. 93.399,
Cancer Control.  Awards are made 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.
 
The PHS strongly encourages all grant 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
 
American Cancer Society, 1995.  Cancer Facts and Figures-1995.
American Cancer Society, Inc.  Atlanta, GA.
 
Benson, Al., 1996.  Institutional Perspectives on Minority Population
Recruitment to Cancer Clinical Trials. Proceedings of The Conference
on Recruitment and Retention of Minority Participants in Clinical
Cancer Research. Washington, D.C. January 26-27, 1996.
 
Brawley O.W., Hunter C.P., Johnson K.A., Ford L.G., Kramer B.S.,
1993.  The Recruitment of Minority Patients to Cancer Clinical
Trials. Proc. Annu. Meet. Am. Soc. Clin. Oncol. 12:A363.
 
Burhannstipanov, L. and Dresser, C.M., 1993.  Native American
Monograph No. 1: Documentation of the Cancer Research Needs of
American Indians and Alaska Natives.  National Cancer Institute. NIH
Publication No. 93-3603.
 
Chase E.M., Modiano M., Brooks R., Schwartz J., Miller T.P., 1991.
Minorities Participation in Cancer Cooperative Clinical Trials:
Preliminary Arizona Cancer Center (ACC) Experience (Meeting
Abstract).   North American Conference on Cancer in Hispanics,
September 12-14, 1991, Tucson, Az, Arizona Cancer Center, The
University of Arizona, College of Medicine. 1991:A30.
 
Hussain, M., Wozniak, A., Valdevieso, M., Golden B., Baker, L., 1992.
Cancer Clinical Trials:  Reasons for Poor Patient Accrual Proc. Ann.
Meet. Am. Soc. Clin. Oncol 11:A1428.
 
Kaluzny, A., Brawley, O., Garson-Angert, D., Shaw, J., Godley, P.,
Warnecke, R., Ford, L., 1993. Assuring Access to State-of-the-Art
Care for U.S. Minority Populations: the First 2 Years of the
Minority-Based Community Clinical Oncology Program. JNCI 23:
1945-1950.
 
Kerner, J., 1996. Health Care System and Patient Perspective.
Proceedings of The Conference on Recruitment and Retention of
Minority Participants in Clinical Cancer Research. Washington, D.C.
January 26-27, 1996.
 
McCabe, M.S., Varrichio, C.G., Padberg R.M., 1994.  Efforts to
Recruit The Economically Disadvantaged to National Clinical Trials.
Sem. Oncol. Nursing 10:123-129.
 
Miller B.A., Ries L.A.G., Koasry C.L., Harras A., Devesa S.S.,
Edwards B.K. eds., 1993.  SEER Cancer Statistics Review; 1973- 1990,
National Cancer Institute. NIH Pub. No. 93-2789. Table II- 1: All
Sites Invasive).  Trends in SEER Incidence and U.S. Mortality, By
Race and Sex.
 
Modiano M., Villar-Werstler P., Lash S., Meister J., Zapien J.,
Buller D., Alberts D., 1992.  Increasing Enrollment of Minorities
Into Clinical Trials Through Community Involvement.  Proc. Ann. Meet.
Am. Soc. Clin. Oncol 11:A409.
 
Outreach Notebook For The NIH Guidelines On Inclusion Of Women And
Minorities As Subjects In Clinical Research. National Institutes of
Health, August 1994.
 
Russo J., 1994. Conducting Cancer Research Among Minority Populations
in the United States.  Proc Amer. Assoc. Cancer 35:664.
 
Swanson, G.M. and Ward, A.J., 1995.  Recruiting Minorities Into
Clinical trials: Towards a Participant-Friendly System.  JNCI
87:1747-1759.
 
U.S. Bureau of the Census. Census of Population, 1990.  General
Population Characteristics United States. 1990 CP-1-1. Table 16: "Age
and Sex by Race and Hispanic Origin: 1990"
 
Young, R., 1996. The Changing Health Care System and Its Threat to
Minority Access to Clinical Trails. Proceedings of The Conference on
Recruitment and Retention of Minority Participants in Clinical Cancer
Research. Washington, D.C. January 26-27, 1996.
 
.

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