H.R. 965 — Introduced in House

I 114th CONGRESS 1st Session H. R. 965 IN THE HOUSE OF REPRESENTATIVES February 13, 2015 Mr. Pascrell (for himself and Mr. Boustany) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the issuance of guidance on the application of the Federal policy for the protection of human subjects with respect to clinical data registries. 1. Short title This Act may be cited as the Facilitating Participation in Clinical Data Registries Act of 2015. 2. Guidance on application of Common Rule to clinical data registries Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, through the Office for Human Research Protections of the Department of Health and Human Services, shall issue guidance on the application with respect to clinical data registries of the provisions of subpart A of part 46 of title 45, Code of Federal Regulations, or equivalent Federal regulations for the protection of human subjects in research.