; (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. 3. Eliminating cost barriers Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct and complete a study on— (1) the need for review of human subject regulations specified in part 46 of title 45, Code of Federal Regulations (or successor regulations), and related guidance; (2) the modernization of such regulations and guidance to establish updated guidelines for reimbursement of out-of-pocket expenses of human subjects, compensation of human subjects for time spent participating in the clinical trial, and incentives for recruitment of human subjects