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) 710-0267, 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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