HR 1715 · 111th Congress · Health

Protection for Participants in Research Act of 2009

Introduced 2009-03-25· Sponsored by Rep. DeGette, Diana [D-CO-1]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2009-03-26)

Plain Language Summary

[AI summary unavailable — showing source text] Protection for Participants in Research Act of 2009 - Amends the Public Health Service Act to require all human subject research conducted, supported, or otherwise subject to federal regulation, to be conducted in accordance with the Common Rule and the vulnerable-population rules, as set forth in the Code of Federal Regulations. Requires the Secretary of Health and Human Services to review and harmonize such regulations. Requires informed consent before an individual may be a subject of human research. Requires an Institutional Review Board to approve all human subject research proposals. Directs the Secretary to establish criteria for determining whether a human subject research project must be conducted in accordance with a data safety and monitoring plan. Prohibits grants or awards to a public entity or private academic institution that does not have a program to educate investigators and Board members on the protection of human research subjects. Prohibits the use of federal funds for classified human subject research if: (1) the Board has waived the informed consent requirement; or (2) the research is exempt from Board review. Establishes the Office of Human Research Protecti…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (2)

1 Democrat1 Republican