published under paragraph (2), shall, not later than 
90 days after such date as may be agreed upon by 
the sponsor of the trial and the appropriate program 
officer and grants management specialist of the Na-
tional Institutes of Health, implement the strategic 
plan. 
(4) TECHNICAL
ASSISTANCE.—The Secretary 
may provide technical assistance to a sponsor of a 
clinical trial, as necessary for the sponsor to meet 
the requirements of paragraph (3). 
(f) WAIVER FOR CERTAIN CLINICAL TRIALS.— 
(1) IN GENERAL.—In the case of a clinical trial 
that received funding through the National Insti-
tutes of Health and is ongoing as of the date of the 
enactment of this Act, the sponsor of such clinical 
trial is exempt from the requirements of (and associ-
ated penalties imposed by) this Act. 
(2) REPORT.—The Secretary shall include in 
the triennial report required to be submitted under 
section 403 of the Public Health Service Act (42 
U.S.C. 283), a list of all clinical trials receiving 
funding through the National Institutes of Health 
that requested and received waivers under this sec-
tion. 
(g) STUDY.— 
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(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study that— 
(A) examines which actions Federal agen-
cies have taken to address barriers to participa-
tion in federally funded clinical trials by the de-
mographic groups specified in subsection (a)(1); 
and 
(B) identifies challenges, if any, in imple-
menting such actions. 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
General of the United States shall submit to Con-
gress a report on the findings of the study con-
ducted under paragraph (1). 
(h) NONDISCRIMINATION.—Section 1557 of the Pa-
tient Protection and Affordable Care Act (42 U.S.C. 
18116) shall apply with respect to a clinical trial subject 
to subsection (a). 
SEC. 3. ELIMINATING COST BARRIERS. 
Not later than 2 years after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services, acting through the Director of the National In-
stitutes of Health (referred to in this section as the ‘‘Sec-
retary’’), shall conduct and complete a study on— 
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(1) the need for review of human subject regu-
lations specified in part 46 of title 45, Code of Fed-
eral Regulations (or successor regulations), and re-
lated guidance; 
(2) the modernization of such regulations and 
guidance to establish updated guidelines for reim-
bursement of out-of-pocket expenses of human sub-
jects, compensation of human subjects for time 
spent participating in the clinical trial, and incen-
tives for recruitment of human subjects; and 
(3) the need for updated safe harbor rules 
under section 1001.952 of title 42, Code of Federal 
Regulations (or successor regulations) and section 
1128B of the Social Security Act (commonly re-
ferred to as the Federal Anti-Kickback Statute (42 
U.S.C. 1320a–7b)) with respect to the assistance 
provided under this section. 
SEC. 4. PUBLIC AWARENESS AND EDUCATION CAMPAIGN. 
(a) NATIONAL CAMPAIGN.—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 ‘‘Sec-
retary’’) and in consultation with the stakeholders speci-
fied in subsection (e), shall carry out a national campaign 
to increase the awareness and knowledge of individuals in 
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the United States, including healthcare professionals, pa-
tients, and others, with respect to the need for diverse clin-
ical trials among the demographic groups identified pursu-
ant to section 2(a)(1). 
(b) REQUIREMENTS.—The national campaign con-
ducted under this section shall include— 
(1)(A) the development and distribution of writ-
ten educational materials; 
(B) the development and placing of public serv-
ice 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 
(C) the development of curricula for health care 
professionals on— 
(i) how to participate in clinical trials as 
an investigator; and 
(ii) how such professionals can enroll pa-
tients in trials; 
(2) such efforts as are reasonable and necessary 
to ensure meaningful access by consumers with lim-
ited English proficiency; 
(3) the development and distribution of best 
practices and training for recruiting underrep-
resented study populations, including a method for 
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sharing such best practices among clinical trial spon-
sors, providers, community-based organizations who 
assist with recruitment, and with the public; and 
(4) the conduct of focus groups to better under-
stand the concerns and fears of certain underrep-
resented groups who may be reluctant to participate 
in clinical trials. 
(c) HEALTH INEQUITIES.—In developing the national 
campaign under subsection (a), the Secretary shall recog-
nize and address— 
(1) health inequities among individuals who are 
members of the population groups specified in sec-
tion 2(b)(1)(A) with respect to access to care and 
participation in clinical trials; and 
(2) any barriers in access to care and participa-
tion in clinical trials that are specific to individuals 
who are members of such groups. 
(d) GRANTS.—The Secretary shall establish a pro-
gram to award grants to nonprofit private entities (includ-
ing community based organizations and faith commu-
nities, 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 phar-
macies) to enable such entities— 
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(1) 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 dis-
ease or condition being investigated; and 
(2) to cover administrative costs of such entities 
in assisting in diversifying clinical trials subject to 
section 2. 
(e) STAKEHOLDERS SPECIFIED.—The stakeholders 
specified in this subsection are the following: 
(1) 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 Pre-
vention, and the National Institutes of Health. 
(2) Community-based resources and advocates. 
(f) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated to carry out this section 
$10,000,000 for each of fiscal years 2023 through 2026. 
SEC. 5. DEFINITIONS. 
In this Act: 
(1) CLINICAL TRIAL.—The term ‘‘clinical trial’’ 
means a research study in which one or more human 
subjects are prospectively assigned to one or more 
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interventions (which may include placebo or other 
control) to evaluate the effects of those interventions 
on health-related biomedical or behavioral outcomes. 
(2) SPONSOR.—The term ‘‘sponsor’’ has the 
meaning given such term in section 50.3 of title 21, 
Code of Federal Regulations (or successor regula-
tions). 
Æ 
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