Diversity goals for clinical trials funded by the National Institutes of Health

(a) Applications Beginning on the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (referred to in this section as the Secretary), shall require that a research organization or entity funded by the National Institutes of Health (referred to in this section as an NIH-funded research organization or entity) seeking to conduct a clinical trial investigating a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) or a biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))) that is funded by the National Institutes of Health or a behavioral intervention, the protocol for which is approved by the National Institutes of Health, submit an application (or renewal thereof) for such funding or approval that includes— (1) clear and measurable goals for the recruitment and retention of participants that reflect— (A) the race, ethnicity, age, and sex of patients with the disease or condition being investigated; or (B) as scientifically or ethically justified and appropriate, the race, ethnicity, age, and sex of the general population of the United States if the prevalence of the disease or condition is not known; (2) a rationale for the goals specified under paragraph (1) that specifies— (A) how investigators will determine the number of participants for each population category that reflect the population groups specified in paragraph (1); or (B) strategies that will be used to enroll and retain participants across the different race, ethnicity, age, and sex categories; (3) a detailed plan for how the clinical trial will achieve the goals specified under paragraph (1) that specifies— (A) the requirements for researchers, in conducting the trial, to analyze the population groups specified in paragraph (1) separately; and (B) how the trial will recruit a study population that is— (i) scientifically and ethically appropriate in terms of the scientific objectives and proposed study design; and (ii) in sufficient numbers to obtain clinically and statistically meaningful determinations of the safety and effectiveness of the drug, device, or behavioral intervention being studied in the respective race, ethnicity, age, and sex groups; and (4) the NIH-funded research organization or entity’s plan for implementing, or an explanation of why the NIH-funded research organization or entity cannot implement, alternative clinical trial follow-up requirements that are less burdensome for trial participants, such as— (A) requiring fewer follow-up visits; (B) allowing phone follow-up or home visits by appropriately qualified staff (in lieu of in-person visits by patients); (C) allowing for online follow-up options; (D) permitting the patient’s primary care provider to perform some of the follow-up visit requirements; (E) allowing for evening and weekend hours for required follow-up visits; (F) allowing virtual or telemedicine visits; (G) use of wearable technology to record key health parameters; and (H) use of alternate labs or imaging centers, which may be closer to the residence of the patients participating in the trial. (b) Terms (1) In general As a condition on the receipt of funding through the National Institutes of Health, as described in subsection (a), with respect to a clinical trial, the NIH-funded research organization or entity of the clinical trial shall agree to terms requiring that— (A) the aggregate demographic information of trial participants be shared on an annual basis with the Secretary while participant recruitment and data collection in such trial is ongoing, and that such information is provided with respect to— (i) underrepresented populations, including populations grouped by race, ethnicity, age, and sex; and (ii) such populations that reflect the prevalence of the disease or condition that is the subject of the clinical trial involved (as available and as appropriate to the scientific objective for the study, as determined by the Director of the National Institutes of Health); (B) the NIH-funded research organization or entity submits to the program officer and grants management specialist of the specific institute, center, or office of the National Institutes of Health, annually or as frequently as such officer or specialist determines necessary, the retention rate of participants in the clinical trial, disaggregated by race, ethnicity, age, and sex; (C) the clinical trial researchers complete education and training programs on diversity in clinical trials; and (D) at the conclusion of the trial, the sponsor submits to the Secretary the number of participants in the trial, disaggregated by race, ethnicity, age, and sex. (2) Privacy protections Any data shared under paragraph (1) may not include any individually identifiable information or protected health information with respect to clinical trial participants and shall only be disclosed to the extent allowed under Federal privacy laws and by National Institutes of Health policy. (c) Exception In lieu of submitting an application under subsection (a) and documentation of goals as required by paragraph (1) of such subsection, an applicant may provide reasoning for why the recruitment of each of the population groups specified in paragraph (1) of subsection (a) is not necessary and why such recruitment is not scientifically justified or possible.