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; 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 referred to as the Federal Anti-Kickback Statute (42 U.S.C. 1320a–7b)) with respect to the assistance provided under this section.