Minority Inclusion in Clinical Trials Act of 2015

To improve minority inclusion in clinical trials. 1. Short title This Act may be cited as the Minority Inclusion in Clinical Trials Act of 2015 2. Sense of Congress on incentivizing inclusion of underrepresented communities in clinical trials It is the sense of Congress that the National Institute on Minority Health and Health Disparities (NIMHD) shall include within its strategic plan ways to increase representation of underrepresented communities in clinical trials. 3. Career development for scientists and researchers The Secretary of Health and Human Services (in this section referred to as the Secretary (1) expanding existing opportunities for scientists and researchers; and (2) promoting the inclusion of underrepresented minorities in the health professions. 4. Support for institutions committed to workforce development in underrepresented communities (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary (b) Eligibility To be eligible to receive a grant under subsection (a), an entity shall— (1) be an educational institution or entity that historically produces or trains meaningful numbers of underrepresented minority health professionals, including— (A) historically Black colleges and universities; (B) Hispanic-serving health professions schools; (C) Hispanic-serving institutions; (D) tribal colleges and universities; (E) Asian-American, Native American, and Pacific Islander-serving institutions; (F) institutions that have programs to recruit and retain underrepresented minority health professionals, in which a significant number of the enrolled participants are underrepresented minorities; (G) health professional associations, which may include underrepresented minority health professional associations; and (H) institutions— (i) located in communities with predominantly underrepresented minority populations; (ii) with whom partnerships have been formed for the purpose of increasing workforce diversity; and (iii) in which at least 20 percent of the enrolled participants are underrepresented minorities; and (2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. (c) Use of funds Amounts received under a grant under subsection (a) shall be used to expand existing workforce diversity programs, implement new workforce diversity programs, or evaluate existing or new workforce diversity programs, including with respect to mental health care professions. Such programs shall enhance diversity by considering minority status as part of an individualized consideration of qualifications. Possible activities may include— (1) educational outreach programs relating to opportunities in the health professions; (2) scholarship, fellowship, grant, loan repayment, and loan cancellation programs; (3) postbaccalaureate programs; (4) academic enrichment programs, particularly targeting those who would not be competitive for health professions schools; (5) kindergarten through 12th grade and other health pipeline programs; (6) mentoring programs; (7) internship or rotation programs involving hospitals, health systems, health plans, and other health entities; (8) community partnership development for purposes relating to workforce diversity; or (9) leadership training. (d) Reports Not later than 1 year after receiving a grant under this section, and annually for the term of the grant, a grantee shall submit to the Secretary a report that summarizes and evaluates all activities conducted under the grant. (e) Definition In this section, the term Asian-American, Native American, and Pacific Islander-serving institutions Asian American and Native American Pacific Islander-serving institution 20 U.S.C. 1067q(c) (f) Authorization of appropriations There is authorized to be appropriated to carry out this section, such sums as may be necessary for each of fiscal years 2015 through 2020. 5. Eliminating disparities in maternity health outcomes (a) In general The Secretary of Health and Human Services (in this section referred to as the Secretary (1) Conduct research into the determinants and the distribution of disparities in maternal care, health risks, and health outcomes, and improve the capacity of the performance measurement infrastructure to measure such disparities. (2) Expand access to services that have been demonstrated to improve the quality and outcomes of maternity care for vulnerable populations. (3) Establish a demonstration project to compare the effectiveness of interventions to reduce disparities in maternity services and outcomes, and implement and assess effective interventions. (b) Scope and selection of states for demonstration project The demonstration project under subsection (a)(3) shall be conducted in no more than 8 States, which shall be selected by the Secretary based on— (1) applications submitted by States, which specify which regions and populations the State involved will serve under the demonstration project; (2) criteria designed by the Secretary to ensure that, as a whole, the demonstration project is, to the greatest extent possible, representative of the demographic and geographic composition of communities most affected by disparities; (3) criteria designed by the Secretary to ensure that a variety of types of models are tested through the demonstration project and that such models include interventions that have an existing evidence base for effectiveness; and (4) criteria designed by the Secretary to assure that the demonstration projects and models will be carried out in consultation with local and regional provider organizations, such as community health centers, hospital systems, and medical societies representing providers of maternity services. (c) Duration of demonstration project The demonstration project under subsection (a)(3) shall begin on January 1, 2015, and end on December 31, 2019. (d) Grants for evaluation and monitoring The Secretary may make grants to States and health care providers participating in the demonstration project under subsection (a)(3) for the purpose of collecting data necessary for the evaluation and monitoring of such project. (e) Reports (1) State reports Each State that participates in the demonstration project under subsection (a)(3) shall report to the Secretary, in a time, form, and manner specified by the Secretary, the data necessary to— (A) monitor the— (i) outcomes of the project; (ii) costs of the project; and (iii) quality of maternity care provided under the project; and (B) evaluate the rationale for the selection of the items and services included in any bundled payment made by the State under the project. (2) Final report Not later than December 31, 2020, the Secretary shall submit to Congress a report on the results of the demonstration project under subsection (a)(3). 6. Health disparities education program (a) Establishment The Secretary, acting through the National Institute on Minority Health and Health Disparities and in collaboration with the Office of Minority Health, the Office for Civil Rights, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Health Resources and Services Administration, and other appropriate public and private entities, shall establish and coordinate a health and health care disparities education program to support, develop, and implement educational initiatives and outreach strategies that inform health care professionals and the public about the existence of and methods to reduce racial and ethnic disparities in health and health care. (b) Activities The Secretary, through the education program established under subsection (a), shall, through the use of public awareness and outreach campaigns targeting the general public and the medical community at large— (1) disseminate scientific evidence for the existence and extent of racial and ethnic disparities in health care, including disparities that are not otherwise attributable to known factors such as access to care, patient preferences, or appropriateness of intervention, as described in the 2002 Institute of Medicine Report entitled Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (2) disseminate new research findings to health care providers and patients to assist them in understanding, reducing, and eliminating health and health care disparities; (3) disseminate information about the impact of linguistic and cultural barriers on health care quality and the obligation of health providers who receive Federal financial assistance to ensure that people with limited-English proficiency have access to language access services; (4) disseminate information about the importance and legality of racial, ethnic, disability status, socioeconomic status, sex, gender identity, and sexual orientation, and primary language data collection, analysis, and reporting; (5) design and implement specific educational initiatives to health care providers relating to health and health care disparities; and (6) assess the impact of the programs established under this section in raising awareness of health and health care disparities and providing information on available resources. (c) Authorization of appropriations There is authorized to be appropriated to carry out this section such sums as may be necessary for each of fiscal years 2015 through 2020.

Summary: Minority Inclusion in Clinical Trials Act of 2015 This bill expresses the sense of Congress that the National Institute on Minority Health and Health Disparities shall include within its strategic plan ways to increase representation of underrepresented communities in clinical trials. The bill directs the Department of Health and Human Services (HHS) to award grants for expanding existing opportunities for scientists and researchers, and for promoting the inclusion of underrepresented minorities in the health professions, to eligible entities that demonstrate a commitment to health workforce development in underrepresented communities. To be eligible to receive a grant, an entity must be an educational institution or entity that historically produces or trains meaningful numbers of underrepresented minority health professionals. Grants shall be used to implement, expand, or evaluate workforce diversity programs that shall enhance diversity by considering minority status as part of an individualized consideration of qualifications. HHS must carry out the following activities to eliminate disparities in maternal health outcomes: conduct research into the determinants and the distribution of disparities in maternal care, health risks, and health outcomes and improve the capacity of the performance measurement infrastructure to measure such disparities; expand access to services that have been demonstrated to improve the quality and outcomes of maternity care for vulnerable populations; and establish a demonstration project in up to eight states to compare the effectiveness of interventions to reduce disparities in maternity services and outcomes and implement and assess effective interventions. HHS must establish and coordinate a health and health care disparities education program to support, develop, and implement educational initiatives and outreach strategies that inform health care professionals and the public about the existence of, and methods to reduce, racial and ethnic disparities in health and health care.