Sec. 4. Public awareness and education campaign
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The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and the Commissioner of Food and Drugs (referred to in this section as the Secretary ) and in consultation with the stakeholders specified in subsection (e), shall carry out a national campaign to increase the awareness and knowledge of individuals in the United States, including healthcare professionals, patients, and others, with respect to the need for diverse clinical trials among the demographic groups identified pursuant to section 2(a)(1).
The national campaign conducted under this section shall include— the development and distribution of written educational materials; the development and placing of public service announcements that are intended to encourage individuals who are members of the demographic groups identified pursuant to section 2(b)(1)(A)(I) to seek to participate in clinical trials; and the development of curricula for health care professionals on— how to participate in clinical trials as an investigator; and how such professionals can enroll patients in trials; such efforts as are reasonable and necessary to ensure meaningful access by consumers with limited English proficiency; the development and distribution of best practices and training for recruiting underrepresented study populations, including a method for sharing such best practices among clinical trial sponsors, providers, community-based organizations who assist with recruitment, and with the public; and the conduct of focus groups to better understand the concerns and fears of certain underrepresented groups who may be reluctant to participate in clinical trials.
In developing the national campaign under subsection (a), the Secretary shall recognize and address— health inequities among individuals who are members of the population groups specified in section 2(b)(1)(A) with respect to access to care and participation in clinical trials; and any barriers in access to care and participation in clinical trials that are specific to individuals who are members of such groups. The Secretary shall establish a program to award grants to nonprofit private entities (including community based organizations and faith communities, institutions of higher education eligible to receive funds under section 371 of the Higher Education Act of 1965 ( 20 U.S.C. 1067q ), national organizations that serve underrepresented populations, and community pharmacies) to enable such entities— to test alternative outreach and education strategies to increase the awareness and knowledge of individuals in the United States, with respect to the need for diverse clinical trials that reflect the race, ethnicity, age, and sex of patients with the disease or condition being investigated; and to cover administrative costs of such entities in assisting in diversifying clinical trials subject to section 2.
The stakeholders specified in this subsection are the following: Representatives of the Health Resources Services Administration, the Office on Minority Health of the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the National Institutes of Health. Community-based resources and advocates. There is authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2025 through 2028.
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Sec. 4
Public awareness and education campaign
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