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3 Overview of Programs of Research on Ethnic Minority and Medically Underserved Populations at the National Institutes of Health The National Institutes of Health (NIH) is responsible for a broad range of basic, biomedical, behavioral, epidemiologic, and clinical research that addresses America's health needs. Research on the prevention, detection, treatment, and control of cancer is the primary responsibility of the National Cancer Institute (NCI). The National Cancer Act of 1971 (P.L. 75-244) directs NCI to plan and develop a coordinated research program that encompasses all institutes, centers, and divisions (ICDs) of NIH, as well as other federal and nonfederal research organizations, and to develop a cancer control program that demonstrates effective practices in cancer prevention and management. NCI interprets its mission as follows: The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Specifically, the Institute: Supports and coordinates research projects conducted by universities, hospitals, research foundations, and businesses throughout this country and abroad through research grants and cooperative agreements. Conducts research in its own laboratories and clinics. Supports education and training in fundamental sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through career awards, training grants, and fellowships.
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Supports research projects in cancer control. Supports a national network of cancer centers. Collaborates with voluntary organizations and other national and foreign institutions engaged in cancer research and training activities. Encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular capability for programmatic research. Collects and disseminates information on cancer. Supports construction of laboratories, clinics, and related facilities necessary for cancer research through the award of construction grants (National Cancer Institute, 1998d). Although NCI directs a large and comprehensive program of cancer research within its portfolio and collaborates with other groups on research or cosponsors other cancer research at other ICDs, the committee finds that there is little evidence of a strategic plan for cancer research relevant to ethnic minority and medically underserved populations at NIH coordinated through NCI or any other central mechanism, as noted below. This section describes the range of ongoing cancer-related research and programs at NCI and other ICDs, summarizes cancer-related research programs at NCI and other ICDs that are relevant to ethnic minority and medically underserved populations, and reviews the funding for these programs. Particular emphasis is placed on the programs and functions of NCI, given its stated role in coordinating cancer-related research at NIH. Overview of NIH Appropriations and Funding for Cancer Research Over the past decade, NIH and NCI have enjoyed significant increases in congressional appropriations, from periods of little to no growth in the early 1980s to steady increases in the mid-1990s (Figure 3-1). NCI experienced a slight decline in its budget from 1980 ($1 billion) to 1983 ($987.6 million), but by 1986 the Institute's budget reached $1.26 billion, and it had reached nearly $1.6 billion by the end of the decade (National Cancer Institute, 1998e). Annually, nearly 80 percent of the institute's budget is dedicated to research, whereas approximately 10 percent of the budget is allocated toward both resource development and cancer prevention and control activities. In fiscal year (FY) 1997, $1.411 billion was allocated for research grants, including $577 million for investigator-initiated grants (R01 grants) and $132 million for cancer center grants. More than $412
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FIGURE 3-1 National Cancer Institute appropriations, 1983–1997. SOURCE: National Cancer Institute. million was reserved for intramural research and $231 million was allocated for cancer prevention and control. NCI has appeared to prioritize extramural spending on traditional R01 grants (increasing allocations for R01 grants from $356 million in FY 1986 to $377 million in FY 1989, even though the number of such grants declined from 2,508 to 2,239), outstanding investigator grants (increasing spending from $23.2 million in FY 1986 to nearly $53 million in FY 1989), cooperative agreements (doubling spending of $10 million in FY 1986 to $20 million by FY 1989), and intramural research (increasing spending from nearly $214 million in FY 1986 to $294 million by FY 1989; National Cancer Institute, 1998e). (See Box 3-1 for a description of common NIH research grant mechanisms.) By FY 1993, NCI's budget topped $2 billion for the first time, allowing the Institute to increase funding for R01 grants to $430 million (although the number of grants awarded decreased again to 1,955), increasing MERIT awards from $32 million in FY 1989 to $51.6 million in FY 1993, increasing spending on cancer control contracts from $33 million in FY 1989 to more than $52 million in FY 1993, and nearly doubling the cancer career grant program over FY 1989 levels to $14 million (National Cancer Institute, 1998e). Congressional appropriations for NCI topped $2.38 billion in FY 1997 and fueled increases in both funding and the number of R01 grants made by the institute (more than $577 million was applied to 2,194 awardees). The number and amount allocated for First Independent Research Support
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Box 3-1 Common Research Grant Award Mechanisms at NIH F31 Predoctoral Individual National Research Service Award K01 Research Scientist Development Award—Research and Training K08 Clinical Investigator Award P20 Exploratory Grants R01 Traditional Research Project Award R03 Small Grant Award R13 Conference Grant Award R15 Academic Research Enhancement Awards R21 Exploratory/Developmental Grants R25 Education Projects R43 Small Business Innovation Research Grants—Phase I R55 James A. Shannon Director's Award S06 Minority Biomedical Research Support U01 Cooperative Agreement Research Support and Transition awards also increased ($47 million in awards to 446 grantees, an increase of more than $18 million from FY 1993 levels), as was the case for U01 cooperative agreements (more than $81 million in awards, up from $56 million in FY 1993) and the Clinical Cooperative Program (more than $86 million in awards, an increase of more than $12 million from FY 1993). Spending on cancer control grants and contracts more than doubled to more than $70 million and $110 million each, respectively (National Cancer Institute, 1998e). Cancer Research at Other ICDs Although the increases outlined above do not represent the sum of spending on all cancer-related research at NIH, NCI has traditionally allocated the largest amount of any of NIH's ICDs on cancer research. Over the past several years, NCI's share of this budget has hovered at slightly greater than 85 percent of the total amount of NIH money spent on cancer-related research (National Institutes of Health, 1998). Many cancer-related grant programs sponsored by ICDs other than NCI enjoy joint sponsorship with NCI. In FY 1997, NIH spent approximately $2.76 billion on cancer research, more than 86 percent of which was funded directly by NCI. It is expected that by FY 1999 overall spending by NIH on cancer-related
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research will exceed $3.23 billion, fueled in large part by the Clinton Administration's request for NCI appropriations of $2.77 billion. The National Institute of Environmental Health Sciences (NIEHS) holds the second largest portfolio of cancer-related research among the institutes at NIH, with allocations of $84.44 million in FY 1997, a figure that approached nearly $90 million in FY 1998. The National Heart, Lung, and Blood Institute (NHLBI) is third in cancer-related funding with funding, of $57.6 million in FY 1997, followed by the National Institute of Allergy and Infectious Diseases (NIAID) with funding of $43 million and the National Institute on Diabetes and Digestive and Kidney Diseases (NIDDKD) with funding of $33.4 million (see Table 3-1). Examined by spending on specific cancer sites, cancer types, diseases related to cancer, and types of research mechanisms, NIH reports spending the greatest amount of money on cancer clinical trials (more than $400 million in FY 1997, an increase of more than $150 million from FY 1990), followed by funding for breast cancer (more than $330 million in FY 1997, a fourfold increase over FY 1990 levels of $81 million), cancer prevention and control activities (nearly $240 million in FY 1997, up from $80.5 million in FY 1990), AIDS-related cancers ($224 million spend in FY 1997, up from $149 million in FY 1990), and lung cancer ($132 million in FY 1997, up from $65 million in FY 1990). Among cancers that disproportionately affect ethnic minority and medically underserved communities (in addition to the cancer types described above), NIH spent $74 million across ICDs on prostate cancer-related research in FY 1997 (up from $13.2 million in FY 1990), $54 million on cervical cancer (an increase of $30 million from FY 1990 levels), approximately $100 million on colorectal cancer (nearly doubling spending from $51.2 million in FY 1990), and $39 million on ovarian cancer (nearly four times the $10.5 million spent in FY 1990). In contrast, other cancers that disproportionately affect minority and medically underserved groups, such as liver cancer ($33 million in FY 1997) and uterine cancer ($8.6 million in FY 1997), have not received substantial increases in funding, with increases of only about $5 million and $2 million, respectively, since FY 1990. It must be noted, however, that funding for these disease areas can and often does overlap. Basic research and clinical research that benefits more than one type of cancer site are included in estimates of total funding for each cancer (see Table 3-2; National Institutes of Health, 1998). Office of Research on Minority Health The NIH Office of Research on Minority Health (ORMH) was established in 1990 by then-director of NIH William Raub and was authorized by the U.S. Congress in the 1993 National Institutes of Health Revitalization
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TABLE 3-1 National Institutes of Health Cancer Research Initiative Dollars (in thousands) Participating ICDS FY 1997 Actual FY 1998 Estimate FY 1999 Estimate % Change 1999/1998 NCI $2,389,041 $2,547,314 $2,776,267 $9.0 Cancer % to Total 86.50% 86.6% 85.9% NHLBI* 57,620 59,815 67,539 12.9 NIDR 16,448 17,313 19,811 14.4 NIDDK 33,430 36,450 39,350 8.0 NINDS 17,929 18,734 24,468 30.6 NIAID 43,085 44,377 47,927 8.0 NIGMS 22,574 24,421 30,421 24.6 NICHD 10,311 11,000 11,900 8.2 NEI 8,616 9,242 9,508 2.9 NIEHS 84,368 89,430 94,796 6.0 NIA 12,183 12,730 14,990 17.8 NIAMS 5,303 5,690 6,220 9.3 NIDCD 2,910 3,087 4,296 39.2 NIMH 4,287 3,823 4,116 7.7 NIAAA 2,700 2,000 2,500 25.0 NINR 3,570 4,250 4,570 7.5 NHGRI 17,084 22,158 30,151 36.1 NCRR 25,926 28,754 37,874 31.7 FIC 195 575 600 4.3 NLM 0 0 4,500 0.0 NIH 2,760,698 2,941,163 3,231,804 9.9 * All years adjusted to reflect Women's Health Initiative. SOURCE: National Institutes of Health. Act (P.L. 103–43). Its mission, as established by Congress, is to coordinate the development of NIH policies, goals, and objectives related to minority health research and research training programs and to expand the level of participation of minorities in all aspects of biomedical research (including training of minority scientists and participation of ethnic minority individuals in NIH-sponsored clinical trials). ORMH seeks to accomplish these goals largely by working in partnership with other NIH ICDs, as well as other governmental agencies. ORMH holds no independent grant-making authority; its primary function in addressing minority health research needs is to leverage research support by creating partnerships with other NIH institutes. In effect, ORMH collaborates with NIH institutes and centers (ICs) to support research and training projects. Administrative and professional support
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TABLE 3-2 Research Dollars (in millions) by Various Cancers 1990 Actual 1991 Actual 1992 Actual 1993 Actual 1994 Actual 1995 Actual 1996 Actual 1997 Actual President's Budget Total NCI* $1,644.3 $1,712.7 $1,947.6 $1,978.3 $2,076.2 $2,130.3 $2,254.9 $2,381.1 $2,441.7 AIDS $149.2 $160.9 $165.7 $173.0 $213.0 $217.4 $225.4 $224.7 $224.3 Brain and central nervous system 29.8 31.5 32.5 40.5 41.7 43.0 41.6 44.2 46.3 Breast cancer 81.0 92.7 145.0 211.5 267.6 308.7 317.5 332.9 338.9 Cancer prevention and control 80.5 90.8 114.9 112.6 153.9 205.0 22.0 248.7 251.0 Cervical cancer 21.9 22.3 30.7 42.2 42.3 45.5 51.6 54.0 56.0 Clinical trials 246.0 254.4 314.5 326.8 339.0 384.8 393.8 403.9 412.6 Colorectal cancer 51.2 56.5 69.2 74.2 83.1 96.5 98.0 99.0 100.0 Hodgkin's disease 7.5 7.8 6.7 6.8 6.7 7.8 8.0 8.4 8.8 Leukemia 50.4 60.1 64.6 74.2 77.7 77.5 79.3 83.0 86.0 Liver cancer 28.3 29.8 30.7 37.5 37.9 38.0 31.4 33.2 34.7 Lung cancer 65.1 68.7 76.3 92.9 106.4 113.9 119.4 123.3 128.2 Melanoma 21.2 26.2 24.8 29.8 33.4 31.8 36.0 37.3 38.3 Non Hodgkin's lymphoma* 33.4 40.1 38.7 39.7 49.9 51.5 52.7 Ovarian cancer 10.5 13.6 20.7 32.5 33.5 33.9 36.5 39.0 40.6 Prostate cancer 13.2 13.8 31.4 51.1 56.1 64.3 71.1 74.0 77.5 Uterine cancer 6.5 7.0 7.8 6.3 7.2 7.7 8.1 8.6 9.0 * Includes AIDS funding. SOURCE: National Institutes of Health.
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for these collaborations is conducted by IC staff following an interagency transfer of funds from ORMH to ICs. The ORMH priority-setting and funding processes appear to be driven by the professional judgment and research priorities of an ad hoc panel, as well as those of other ICs. In response to an inquiry from the study committee, ORMH writes: ORMH begins its funding process by asking the ICs, ''What is it that we should be doing that we are not doing?" In practice the ORMH sends out two communications to the ICs annually. The first call is for the confirmation of projects for which ORMH has committed out-year support. The second call is for the submission of new projects or programs that the ICs consider meritorious and which fill a gap in minority health research and/or research training. Because the level of support requested by the ICs usually exceed the budget for the Minority Health Initiative, an ad hoc review panel is convened to assist ORMH in prioritizing the projects to support (National Institutes of Health, Office of Research on Minority Health, 1998a). Research initiatives proposed by other ICs for ORMH co-funding are evaluated by the Center for Scientific Review and individual IC advisory councils for appropriateness. Proposals are then forwarded to ORMH for evaluation and prioritization. Although the ORMH proposal review process has been conducted by an ad hoc panel since the office's inception, as of recently the newly appointed Advisory Committee on Research on Minority Health will advise the ORMH director on prioritizing the projects that ORMH will support. This committee, which held its first meeting in April 1998, is composed of 12 individuals with expertise in minority health research or research training, or both. The committee will advise the ORMH director regarding appropriate research priorities and activities for the enhancement of minority health for the inclusion of minority groups as subjects in clinical research and for the enhancement of minority participation in research and training programs. The committee is expected to meet twice a year and to produce a biennial report summarizing its advice and recommendations regarding NIH programs. The establishment of the Advisory Committee appears to represent the first step toward a "formalized" process of internal review of ORMH activities (see Chapter 4 for a more detailed discussion of the ORMH priority-setting process). Specifically, at the first meeting of the committee, ORMH Director John Ruffin and NIH Director Harold Varmus asked for the committee's assistance in several areas, including reviewing the current portfolio of research co-funded by ORMH to identify potential gaps, assessing whether critical minority health research issues are being appropriately addressed through the Minority Health Initiative, and advising NIH regarding optimal
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approaches for recruiting and training minorities for health research. Ruffin specifically asked for assistance in responding to new challenges, including developments in human genome research and changes to federal affirmative action policies that may affect minority scientist recruitment and training. ORMH Research Funding Funding for ORMH has increased significantly since the office was created in 1991, but its overall funding remains minuscule in comparison to the $14 billion overall budget of NIH. In FY 1991 the office initiated activities with a budget of $1.5 million. In FY 1993 ORMH's budget allocation increased to $48.4 million, coinciding with passage of the Minority Health Improvement Act of 1993. In FY 1994 and FY 1995 ORMH funding increased to $62.7 million and $67.8 million, respectively, but it saw its first budget decline in FY 1997, when the ORMH allocation dropped to $70.1 million from a high of $71.1 million in FY 1996. In research relevant to the study of cancer among ethnic minority populations, ORMH reports that from 1992 to 1997, it provided nearly $20 million in funding to assist NCI minority initiatives. The bulk of this funding has been to support the Minority Adolescent HIV Prevention and Treatment Project (approximately $10 million from FY 1994 to FY 1997). Other significant expenditures include funding for grants to improve ethnic minority recruitment and retention in clinical trials, funds for training of minority investigators, and small research supplements. In FY 1997 ORMH allocated slightly less than $6 million to NCI (see Table 3-3), including $1.75 million to support the Minority Adolescent HIV Prevention and Treatment Project, $1 million to cancer centers to support minority recruitment to NCI-sponsored clinical trials, and nearly $750,000 to support other efforts to increase minority participation in clinical trials. These expenditures for cancer-related projects were approximately 9 percent of ORMH's total budget in FY 1997. ORMH reports that NCI did not provide additional funds beyond initial funding (e.g., for overall cancer center or clinical trial operations) to support these projects. Estimated ORMH expenditures on cancer in FY 1998 reflect its two-fold mission. The office allocated $6.22 million to assist NCI projects on cancer among minorities in FY 1998. The three largest NCI projects supported by ORMH are the Minority Adolescent HIV Prevention and Treatment Project ($1.75 million), funds to encourage minority participation in NCI-sponsored trials ($1 million), and training supplements for under-represented minorities ($75,000; see Training of Minority Scientists below). Other expenditures include grants for regional workshops for minority
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TABLE 3-3 National Cancer Institute Minority Initiatives Supported by the NIH Office of Research on Minority Health (FY 1997) Projects ORMH Institute Minority Adolescent HIV and Treatment Project 1,750,000 0 Enrollment of Minorities in NCI Clinical Trials 59,535 0 Overcoming Impediments to Participation of Minorities and Special Populations in Clinical Trials 500,000 0 Minority Participation in NCI-Sponsored Clinical Trials 1,000,000 0 Barriers to Latino-American Participation in Cancer Clinical Trials 21,011 0 Procurement of Prostate Tumor Tissues from African-American Patients 52,326 0 Determination of Correlation Between Androgen Receptor CAG Trinucleotide Repeat Length and Prostate Cancer Risk 291,000 0 Small Grant for Women and Minority Recruitment 68,120 0 Cohort Study of African-American Men with Prostate Cancer 77,225 0 Caucus on Prostate Cancer and Minorities 45,528 0 Preventing Cancer in Hispanic Communities 249,954 0 Collaborative Clinical and Molecular Correlative Studies 350,000 0 Institute of Medicine Minority Cancer Study 600,000 0 Baylor College of Medicine—Biennial Symposium on Cancer and Minorities 30,000 0 NCI International Program Middle East Conference 250,000 0 Regional Grantsmanship Workshops for Minority Investigators 100,000 0 Minority Research Supplements 750,000 0 TOTAL 6,179,171 0 SOURCE: NIH Office of Research on Minority Health. investigators, for grants conferences to stimulate ethnic minority participation in clinical trials, supplemental funding for basic research related to prostate cancer and ethnic minorities, and small supplements for minority cancer control and prevention programs. ORMH's estimates of its expenditures on cancer-related research may overstate the amount of funding that directly addresses the cancer research needs of ethnic minority and medically underserved populations. As noted above, funding for the Minority Adolescent HIV and Treatment project represents a large proportion of ORMH's allocation for cancer research. The committee questions, however, the relevance of this project for cancer research. Although neoplasms are a significant health concern among patients suffering from AIDS and HIV-related complications, an overview of the Minority Adolescent HIV and Treatment Project supplied
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to the committee by ORMH does not mention the words "cancer," "neoplasms," or other related terms. Rather, this project's main focus appears to be the establishment of a community-based, comprehensive, and multidisciplinary health care center to monitor, treat, and enroll HIV-infected ethnic minority children and adolescents in HIV and AIDS Malignancy Branch clinical trials. It is unclear how many, if any, of the population enrolled in this program were treated for AIDS-related carcinomas. In addition, results of this research project may be limited; ORMH reports that the project was terminated in late FY 1998 "due to insurmountable contractual and legal issues" (National Institutes of Health, Office of Research on Minority Health, 1998a). Assessment of ORMH Activities ORMH serves as a focal point for the coordination of research on ethnic minority health at NIH. One of the office's major functions is to stimulate research on minority populations at relevant ICs of NIH by providing research supplements (including Minority Health Initiative funds) to "leverage" IC resources. ORMH has only recently, however, established a standing advisory panel to help guide the establishment of research priorities (this function had previously been assumed by an ad hoc panel) and does not participate in the Research Enhancement Awards Program with other specialty offices at NIH to coordinate funding proposals and priorities. Its criteria for program funding and research priorities have therefore been less open to public scrutiny. In addition, OMRH program funding appears to have supplanted, rather than leveraged, NCI resources for important research and program activities in many instances. The committee offers the following recommendation to strengthen ORMH's stated functions: Recommendation 3-1: The Office of Research on Minority Health should more actively serve a coordinating, planning, and facilitative function regarding research relevant to cancer among ethnic minority and medically underserved populations across relevant institutes and centers of NIH. To further this goal, the Office of Research on Minority Health should: make criteria for Minority Health Initiative project support explicit; coordinate with other specialty offices (e.g., the Office of Research on Women's Health) by participating in NIH-wide coordination efforts such as the Research Enhancement Awards Program; and
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status of the community members exposed to environmental hazards. Currently, 12 grants have been awarded across the United States. The majority of these grantees are located in lower-income communities confronting the redevelopment of brownfields. Minority Worker Training Program NIEHS, working in collaboration with the Environmental Protection Agency, has developed the Minority Worker Training Program as a series of national pilot programs designed to test strategies for the recruitment and training of young people for future environmental careers. The people selected live near hazardous waste sites or in communities at risk of exposure to contaminated properties. This program seeks to provide sustainable job development and training for young adults who live in areas with hazardous exposure potential, such as brownfields sites in urban communities. Community groups and HBCUs are involved in this partnership to teach math, science, and life skills to assist in reinforcing worker knowledge and positive behavior on the job. Environmental Health Science Centers: Agricultural Chemicals and Farm Workers The NIEHS Environmental Health Science Centers are academic institutions throughout the country that bring together individuals from many scientific disciplines to focus on particular environmental health problems. Three of these centers (those at the University of Iowa, University of California at Davis, and Oregon State University) focus on the health concerns of agricultural workers, many of whom are migrant workers or disadvantaged minorities. The results of this research will help define the true risks to this occupational group so that better prevention and intervention strategies can be developed to protect their health. Agricultural Health Study NIEHS is assisting NCI in a prospective study of cancer risk in a cohort of 75,000 pesticide applicators and their spouses. NIEHS manager and evaluates the part of the study devoted to noncancer endpoints and has assisted in recruiting African Americans into the study population. This study examines, in part, the unique risks to rural African Americans and other minority populations exposed to pesticides. Minority populations may have increased susceptibility to the effects of pesticides. For example, there is increasing evidence of racial differences in the prevalence of gene polymorphisms that affect the metabolism of chemicals including pesticides
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and the organic solvents in which they are mixed. In addition, such groups may have enhanced vulnerability to pesticides due to underlying nutritional deficiencies or concomitant health problems often associated with poverty. Brownfields National Partnership Action Agenda NIEHS is participating to help support the Brownfields National Partnership Action Agenda, a public, private, and community initiative to redevelop brownfields into safer living areas. Brownfields are abandoned, idled, or underused industrial and commercial facilities where expansion or redevelopment is complicated by environmental contamination. These areas are not as toxic as Superfund sites but still face immense barriers to their redevelopment. Although brownfields are typically found in urban areas, they are prominent in rural areas as well. A large proportion of medically underserved and economically disadvantaged citizens reside near brownfields. Mississippi Delta Project The Mississippi Delta Project is a collaborative effort of government, academia, grassroots organizations in communities, and local and state health agencies to address environmental contamination in the Mississippi Delta Region, one of the poorest regions in the country and a region that is greatly affected by environmental pollution. NIEHS works with other federal agencies to identify key environmental hazards, promote environmental quality, and reduce and, where possible, prevent these hazards from affecting the health and environment of residents. Working in collaboration with ORMH, NIEHS has initiated the Columbia Project, a community outreach program of the Mississippi Delta Project. This is a community-based effort to augment community participation and involvement in decisions concerning the environmental health of residents in the Delta Region. A Needs Assessment Workshop to identify demonstration projects in the Delta Region was held in February 1998 and included representatives from federal agencies, state and local health departments, HBCUs, grassroots organizations in communities, and health care professionals. Institutional Capacity Building NIEHS has supported several programs designed to enhance environmental health research and training capacity in underserved populations. NIEHS has initiated a series of planning activities organized through HBCUs
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and majority academic institutions to assess the needs and opportunities for building environmental health research and training capacity for underserved populations. In addition, a state-of-the-art Molecular Research and Training Center has been established at a local (Durham, North Carolina) high school that is attended by a large number of African-American students. Training and Education Workshop NIEHS sponsors several programs designed to increase the number of minority scientists involved in biomedical research, increase the levels of awareness and participation of minorities in NIEHS and NIH intramural and extramural activities, and facilitate cooperative research between minority and majority scientists on the health problems that may disproportionately affect minorities and lower-income populations. For example, the Minority Faculty Development program is designed to strengthen the ability of minority institutions to provide instruction of the environmental health discipline. National Institute of Allergy and Infectious Diseases NIAID supports a number of research projects relevant to cancer among minority and medically underserved populations. This research focuses largely on cancer associated with AIDS and neoplastic complications of HIV infection, notably Kaposi's sarcoma, but also includes basic studies of the abnormal proliferation of immune cells and immune responses to cell proliferation. Given that HIV infection disproportionately affects ethnic minority populations, particularly African-American and Hispanic communities, NIAID's portfolio of research in this area is highly relevant to the overall NIH effort to address cancer among minority and medically underserved populations. As noted above, NIAID supports the fourth-largest portfolio of cancer research among NIH ICDs, with $43 million in funding for 177 cancer-related research projects in FY 1997. Of these, NIAID reports that 63 projects, with funding totaling $4.49 million, are relevant to minority and medically underserved populations. Clinical Trials Through a range of intramural and extramural programs, NIAID directs a large national clinical trials network that tests and provides therapies for the treatment and prevention of HIV infection and its complications. These programs have enjoyed, on the whole, significant success in
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the recruitment of minority candidates into clinical trials. NIAID works with these networks to identify and help develop culturally sensitive educational materials and to identify and overcome barriers to recruitment and retention of minority patients. Among the patients enrolled in the Adult AIDS Clinical Trials Group in 1996, for example, 35 percent were African American and 25 percent were Hispanic. Three institutions serving predominantly minority communities were originally funded in 1993 to assist in minority accrual to these trials. Similarly, the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) enrolled 31 percent African-American patients and 12 percent Hispanic patients among new enrollees in 1996. CPCRA is a community-based trials network located in community settings such as health care clinics and centers, making these trials much more accessible to women and ethnic minorities. NIAID supports epidemiologic research, clinical research, and research on the natural history and transmission of HIV infection in a variety of populations. Urban women and children are the focus of the Women and Infants Transmission Study, which evaluates issues of perinatal HIV transmission and disease progression in women and children. In 1996, 86 percent of the women enrolled in this program were ethnic minorities. Similarly, the Women's Interagency HIV Study examines the spectrum and clinical course of HIV infection in women and has enrolled 56 percent African-American and 24 percent Hispanic women. In contrast, NIAID's Multicenter AIDS Cohort Study, which examines the mechanisms by which HIV damages the immune system and how the immune system combats HIV infection among homosexual and bisexual men, has enrolled only 15 percent ethnic minority participants. Training and Infrastructure Development NIAID has provided support for a number of programs designed to increase the numbers of minority biomedical researchers and support the development of the biomedical research infrastructure at minority-serving institutions. The Research Supplements for Underrepresented Minorities program served to increase the number of minorities in biomedical research by providing supplemental training funds for research grants currently being funded by NIH. In 1996, NIAID funded 40 such supplements at $3.6 million for minority investigators at the junior faculty, postdoctoral, predoctoral, undergraduate, and high school levels. Similarly, the Research Centers in Minority Institutions (RCMI) program assists predominantly minority institutions that offer doctoral degrees via grant support for laboratory and infrastructure development, faculty expansion, and other areas to assist these institutions in becoming more competitive in seeking research
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funding. NIAID co-funds the AIDS Infrastructure Initiative of RCMI and supported 15 RCMI projects at eight institutions in FY 1996. To further enhance these efforts, NIAID offered its own AIDS Infrastructure for Minority Institutions RFA in FY 1990 and FY 1993 to provide funding for RCMI projects at three additional institutions. NIAID has also collaborated with the National Institute of Mental Health to support an initiative pairing NIAID's 12 Centers for AIDS Research investigators with RCMI investigators to increase collaborations between ethnic minority and majority institutions. Eleven projects at seven schools were ultimately funded. In 1995, NIAID established its own Enhancement Awards for Underrepresented Minority Researchers to enable these individuals to establish clinical or basic AIDS research programs. Nine individuals were funded. Furthermore, NIAID's Office of Research on Minority and Women's Health has developed a number of outreach programs, including one for Washington, D.C., area high school science students and teachers, and other collaborations with the Interamerican College of Physicians and Scientists to increase awareness of NIAID programs and resources among Hispanic investigators. Ethnic Minority Issues at NIAID In 1994, the NIAID director established the Minority Scientists Advisory Committee (MINSAC) as a standing committee to advise the director on issues and concerns of the minority scientific community and provide suggestions on ways that the Institute can attract highly qualified minority scientists to its intramural and extramural programs. In particular, MINSAC has conveyed concerns regarding the underrepresentation of minorities in tenure, tenure-track, and postdoctoral positions within NIAID's intramural research program, resulting in the creation of additional lines to attract minority scientists. In addition, MINSAC has initiated the development of a minority constituency catalog, including minority scientists, institutions, and organizations, to assist in the identification of qualified minorities to participate in the NIH peer-review system. National Institute of Diabetes and Digestive and Kidney Diseases NIDDKD directs approximately 70 percent of its budget to investigator-initiated grants. These awards are largely focused on basic research to understand underlying mechanisms of disease and pathogenesis. Like other ICDs, NIDDKD uses RFAs or program announcements sparingly and largely in response to congressional directives or the need to stimulate research in small program areas.
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Priority setting at NIDDKD is determined by a planning process that establishes a framework for program activities. This program plan is submitted to the NIDDKD Advisory Council for discussion. Of the six sections in the current program plan, one references ''minority activities" and highlights minority initiatives, research projects, center activities, and training and career development programs. NIDDKD's cancer-related research is coordinated with NCI via a formalized memorandum of understanding that establishes NCI's primary responsibility for research on carcinoma of the prostate and NIDDKD's primary responsibility for research on noncancerous conditions, including research on the growth, development, and maturation of the prostate. NIDDKD reports that it allocated a total of $33.4 million for research related to cancer among minority and medically underserved groups. This funding supports 142 programs or research grants. Nearly $1.5 million of this funding was allocated to the minority emphasis within the NIDDKD clinical trial on Medical Treatment of Prostatic Symptoms (MTOPS); this money represents 20 percent of the total funding for MTOPS. NIDDKD supported a workshop to identify barriers to the successful recruitment and retention of minority participants in this study and provided funding for 11 of 17 participating clinical centers to develop minority recruitment plans specific to their locales. In collaboration with NCI and NIAID, NIDDKD has sought to stimulate research on Helicobacter pylori and its relationship to digestive diseases and cancer, particularly in minority populations, by establishing an RFA in January 1997. The RFA calls for studies on the epidemiology of Helicobacter in minority populations, genetic susceptibility to Helicobacter infection, and the clinical course of infection. The RFA notes that 10 to 12 awards are anticipated, with $2.5 million in funding available for awards. Before FY 1997, NIDDKD offered RFAs for studies of the regulation of prostate growth, the molecular epidemiology of prostate carcinogenesis, clinical trials of medical therapy in benign prostatis hyperplasia, hormonal regulation of breast-specific growth factors, and other studies of cancers that disproportionately affect ethnic minority populations. National Heart, Lung, and Blood Institute NHLBI reported a dramatic increase in cancer-related research expenditures from FY 1985 to FY 1997. In 1985, NHLBI allocated $3.87 million to cancer-related research; this figure increased to $50.7 million in FY 1993 and $57.6 million in FY 1997, spurred in large part by the cancer portion of the Women's Health Initiative (WHI; see below), of which $16.7 million is included in the FY 1993 total and $19.5 million is included in
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the FY 1997 total. The bulk of NHLBI's cancer-related research funding is for basic scientific projects that are not targeted to specific populations. NHLBI reports that before FY 1997 it did not support any cancer research relevant to minority and medically underserved populations. According to NHLBI Director Claude Lenfant, "The NHLBI does not have any processes for establishing priorities for cancer-related research among minority and medically underserved populations. Research on cancer and research on cancer in minorities are not part of the mission of the NHLBI, except for the WHI which NHLBI administers as part of a NIH consortium with the National Cancer Institute (NCI), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and the National Institute on Aging (NIA)" (Lenfant, 1998, p. 1). In FY 1997, NHLBI supported aspects of WHI that included research on cancer (approximately 40 percent of the total WHI contract). NHLBI estimates that the minority population of these study trials is approximately 20 percent. WHI is a cross-institute collaboration that examines the effects of promising interventions, such as hormone replacement therapy and dietary modification, in preventing a number of common diseases among women, including coronary heart disease, osteoporosis, and cancer (specifically, breast and colorectal cancers). In addition, WHI attempts to identify risk factors for these diseases and assess the feasibility of various community-based programs of preventive care. National Human Genome Research Institute The National Human Genome Research Institute (NHGRI) was established in 1989 first as a center, then as an Institute in 1997 to lead NIH's efforts in the Human Genome Project, including chromosome mapping, DNA sequencing, DNA-based diagnostics and gene therapy development, database development, technology development for genome research, and studies of the ethical, legal, and social implications of genetics research. Cancer-related research represents a significant proportion of NHGRI's portfolio, including work conducted in the Laboratory of Cancer Genetics, where researchers are seeking to understand genetic changes in somatic cells that lead to cancer, inherited mutations that predispose individuals to cancer, and genes involved in the development of malignant characteristics in cancer cells, such as drug resistance and metastasis. Of note in NHGRI's cancer research portfolio is a collaborative effort between NHGRI and NIH's ORMH to establish an intramural research project, the Center for Collaborative Research on Genomic Analyses of Diseases that Disproportionately Affect African Americans, at Howard University in Washington, D.C., an historically black university. NHGRI and ORMH have identified four principal objectives of this collaboration:
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to increase the competitiveness of minority researchers and minority institutions by developing a center that will become a self-sustaining entity through competitive grants and contracts; to promote collaborative research between majority and minority institutions (NHGRI and Howard University scientists will be involved in an exchange between the two campuses to foster cross-fertilization and training); to increase the inclusion of minorities in study populations; and to promote the study of diseases that disproportionately affect African Americans, such as diabetes and hereditary prostate cancer, which will be a focus of the Center. In a summary of this initiative, NHGRI notes that there is a paucity of standardized, population-based data on the genetic and epidemiologic factors underlying the diseases that disproportionately affect African Americans. To address this need, the help of African-American physicians, research scientists, and institutions is needed to increase the participation of African Americans in research. The Center's initial objectives include the recruitment of African-American families for genomic research; the development of standardized protocols for the collection of genetic, clinical, and epidemiologic data; and the establishment of core facilities for the isolation, characterization, and storage of cells and DNA for study. Specific projects emerging from this collaboration include a study of sibling pairs with non-insulin-dependent diabetes mellitus in West Africa, genetic linkage studies of hereditary prostate cancer among African Americans (which has also received research support from NCI), and studies of the ethical, social, and legal aspects of genetic research and testing, such as the informed-consent process and the psychosocial impact of a genetic diagnosis on African-American patients and their families. The training and education of young African-American scientists is also a major goal of the collaboration with Howard University. With funding from ORMH, several African Americans at the doctorate level have been recruited for these projects, and additional training for pre- and postdoctoral scientists will occur at NHGRI's laboratories in the Division of Intramural Research. NHGRI proposes that the Center be supported for 5 years, with assistance from ORMH. Summary and Recommendations NIH, and particularly NCI, has funded an impressive array of research projects and training initiatives that may have a demonstrable impact in
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addressing the disproportionate burden of cancer incidence and mortality among minority and medically underserved populations. The committee finds, however, that no "blueprint" or strategic plan exists to direct or coordinate this research activity (see discussion of priority setting in Chapter 4). As a result, model programs in one or more institutes are not replicated by other ICDs where indicated, some areas of research emphasis receive greater attention than others, and overall funding to address the needs of minority and medically underserved populations is inadequate. Several recommendations are therefore indicated: Recommendation 3-1: The Office of Research on Minority Health should more actively serve a coordinating, planning, and facilitative function regarding research relevant to cancer among ethnic minority and medically underserved populations across relevant institutes and centers of NIH. To further this goal, the Office of Research on Minority Health should: make criteria for Minority Health Initiative project support explicit; coordinate with other specialty offices (e.g., the Office of Research on Women's Health) by participating in NIH-wide coordination efforts such as the Research Enhancement Awards Program; and ensure that Minority Health Initiative funding does not supplant funding from institutes and centers for research and programs relevant to ethnic minority and medically underserved populations. Recommendation 3-2: Research and research funding relevant to cancer among ethnic minority and medically underserved populations should be more adequately assessed (as per Recommendation 3-3) and should be increased. Recommendation 3-3: NIH should improve the accuracy of its assessment of research that is relevant to ethnic minority and medically underserved groups by replacing the current "percent relevancy" accounting method with one that identifies studies whose purpose is to address a priori research questions uniquely affecting ethnic minority and medically underserved groups. Although the committee found evidence that NCI sponsors significant behavioral and social science research aimed at examining the range of behavioral, psychosocial, dietary, and other factors that enhance the risk for cancer or poor cancer outcomes among ethnic minority and medically
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underserved groups, behavioral and social science research should be expanded, particularly with respect to prevention and outreach efforts. Lerman et al., (1997) note that approximately 65 percent of cancer deaths are attributable to behaviors such as smoking, sexual risk behavior, and to factors such as diet. For example, over the past half-century, more than 300,000 women have died from cervical cancer, including a disproportionate number of women from ethnic minority and medically underserved backgrounds, even though the technological tools have been available since the 1940s to vastly decrease mortality due to cervical cancer. Similarly, greater research is needed to illuminate barriers to cancer care (Chapter 5) and strategies to overcome them. Although the committee does not seek to imply that NCI's research resources should be allocated entirely on the basis of likely etiologic factors, it is noteworthy that the NCI division with primary responsibility for funding behavioral and population-based research, DCCPS, allocated approximately $21 million to "minority health and assistance programs" in FY 1997 (as noted above, this figure is based on a percent relevancy calculation, which suggests that many projects were not specifically targeted to ethnic minority and medically underserved populations). This figure represents approximately 17 percent of the total NCI funding for MHAPs and is likely an inflated estimate of funding for behavioral and social science research, given that a large percentage of DCCPS's resources are allocated to important programs such as the SEER program and other nonbehavioral research. The agenda for such research should be based on an analysis of the prevalence of particular cancers in these population and their preventability (Chen, 1994). Particularly for ethnic minority populations, this research should include investigations of ethnically appropriate interventions, including culturally competent and linguistically appropriate approaches. In addition, more research is needed on barriers to cancer care among these populations, and strategies to overcome them. Recommendation 3-4: The newly established program of behavioral and social science research at NCI addresses an area of research that has been neglected in the past. The committee urges that this program of research identify as one of its highest priorities a focus on the cancer prevention, control, and treatment needs of ethnic minority and medically underserved groups. Such focused research will require collaboration and coordination between DCCPS and the NCI Divisions of Cancer Prevention and Cancer Treatment. As will be discussed in Chapter 4, coordination of this research
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activity is appropriately led by OSPR, provided that sufficient resources and authority are granted to OSPR to carry out this agenda. The NHGRI-Howard University collaboration stands as an outstanding, but unfortunately rare, example of a partnership between the federal scientific research infrastructure and an historically black institution that meets multiple goals. Not only will this partnership result in improved recruitment of ethnic minority patients as research subjects but it will also improve opportunities for the training of minority scientists and allow focused investigation of genetic risk as it applies to some segments of the African-American population. Recommendation 3-5: Collaborations between NIH and research and medical institutions that serve ethnic minority and medically underserved populations should be increased to improve the study of cancers that affect these groups and to increase the involvement of such entities and populations in scientific research. Although the committee found evidence that NCI sponsors a significant portfolio of training programs designed to increase the numbers of ethnic minority investigators in cancer-related research fields, there is little evidence that NCI or NIH has undertaken a thorough assessment of training programs to determine whether these programs are producing adequate numbers of ethnic minority researchers in all appropriate cancer research fields (e.g., behavioral and social sciences, epidemiology, genetics, and cell biology) and to determine whether training programs have resulted in the increased representation of ethnic minorities in cancer research fields. Furthermore, there is little evidence that guidelines or other training criteria have been established by NCI or NIH to ensure that all trainees can receive high-quality instruction and mentoring. Such efforts would improve the planning and implementation of future training programs. Recommendation 3-6: NIH should increase its efforts to expand the number of ethnic minority investigators in the broad spectrum of cancer research to improve minority health research. These efforts should (1) assess relevant areas of research needs and ensure that trainees are representative of these disciplines and areas of inquiry, (2) determine guidelines for the quality and expected outcomes of training experiences, and (3) maintain funding for a sufficient period of time to assess the impact of training programs on the goal of increasing minority representation in cancer research fields.
Representative terms from entire chapter: