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Federal Legislation on Human Research Protections

Proposed Federal Legislation

• new H.R. 5578 Protection for Participants in Research Act of 2006. To amend the Public Health Service Act with respect to the protection of human subjects in research. (109th Congress / Second Session. DeGette. 2006-06-09.)

  • H.R. 5578 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d109:h.r.05578:

• S. 1956 Access Compassion, Care, and Ethics for Seriously Ill Patients Act. A bill to amend the Federal Food, Drug, and Cosmetic Act to create a new three-tiered approval system for drugs, biological products, and devices that is responsive to the needs of seriously ill patients, and for other purposes. (109th Congress / First Session. Brownback. 2005-11-03.)
  • S. 1956 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.01956:
  • Related: (External) Abigail Alliance for Better Access to Developmental Drugs
  • Related: Abigail Alliance for Better Access to Developmental Drugs and The Washington Legal Foundation v. Andrew von Eschenbach in His Official Capacity as Acting Commissioner, Food and Drug Administration, et al. No. 04-5350. United States Court of Appeals for the District of Columbia Circuit. 2006-05-02. Available from (External) http://pacer.cadc.uscourts.gov/docs/common/opinions/200605/04-5350a.pdf . Accessed 2006-05-03.

• H.R. 2124 Clinical Research Act of 2005. To amend the Public Health Service Act to provide for clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, and for other purposes. (109th Congress / First Session. Wheldon. 2005-05-05.)
  • H.R. 2124 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d109:h.r.02124:

• H.R. 5252 and S. 2933 The Fair Access to Clinical Trials Act. To amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to the availability to the public of information on clinical trials to determine the safety and effectiveness of drugs, biological products, and devices, and for other purposes. (108th Congress / Second Session. Markey and Waxman. 2004-10-07.)
  • H.R. 5252 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d108:h.r.05252:

• H.R. 4779 Clinical Research Act of 2004. To amend the Public Health Service Act to provide for clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research, and for other purposes. (108th Congress / Second Session. Weldon. 2004-07-08.)
  • H.R. 4779 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/D?d108:1:./temp/~bssGjoe::

Steps in the Right Direction

• H.R. 3594 Protection for Participants in Research Act of 2003. To amend the Public Health Service Act with respect to the protection of human subjects in research. (108th Congress / First Session. DeGette. 2003-11-23.)
  • H.R. 3594 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d108:h.r.03594:
  • Related: Summary and status of H.R. 3594. NIH Office of Legislative Policy and Analysis. Available from (External) http://olpa.od.nih.gov/legislation/108/pendinglegislation/humansub.asp

• H.R. 1585 To establish an office to oversee research compliance and assurance within the Veterans Health Administration of the Department of Veterans Affairs. (108th Congress First Session. Buyer. 2003-04-03.)
  • H.R. 1585 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d108:h.r.01585:

• H.R. 4697 Human Research Subject Protections Act of 2002. To amend the Public Health Service Act with respect to the protection of human subjects in research. (107th Congress / Second Session. DeGette and Greenwood. 2002-05-09.)
  • H.R. 4697 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d107:h.r.04697:

• S. 3060 Research Revitalization Act of 2002. A bill to amend the Public Health Service Act to provide protections for human participants in research. (107th Congress / Second Session. Kennedy and Frist. 2002-04-10.)
  • S. 3060 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/z?d107:s.03060:

• S. 193 Human Research Subject Protection Act of 1997. A bill to provide protections to individuals who are the human subject of research. (105th Congress / Second Session. Glenn. 1997-01-22.)
  • S. 193 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/D?d105:1:./temp/~bssyVIL::
  • Related: Senator John Glenn Jr. Statement on the Introduction of the S. 193 the Human Research Subject Protection Act of 1997. 1997-01-22. Available from (External) http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?position=all&page=S645&dbname=1997_record

The National Institutes of Health Office of Legislative Policy and Analysis maintains an excellent index of summaries of proposed legislation likely to affect NIH. Available from (External) http://olpa.od.nih.gov/legislation/

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Steps in the Wrong Direction

H.R. 2085 and S 1410 are the latest proposed bills in the perennial attempt to remove what little protection HHS and FDA afford human subjects and further restrict existing flimsy mechanisms for enforcing accountability in research. The bills are giant steps in the wrong direction.

A sensible overview of the issues: Mills C. Mainstreaming the Alternatives When Complementary and Alternative Medicines Become Westernized. 13 Alb. L.J. Sci. and Tech. 775.

• H.R. 2085 Access to Medical Treatment Act. To permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests, and for other purposes. (108th Congress / First Session. DiFazio and Burton. 2003-05-14.)
  • H.R. 2085 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/D?d108:1:./temp/~bss5AXF::

• S. 1410 Access to Medical Treatment Act. To permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests, and for other purposes. (108th Congress / Second Session. Harkin, Hatch, Inouye, Grassley, and Daschle. 2003-07-15.)
  • S. 1410 Bill Summary and Status. Available from (External) http://thomas.loc.gov/cgi-bin/bdquery/D?d108:2:./temp/~bss5AXF::

Voice Your Opinion

Let your elected representatives know the protection of humans in research is important to you and why. The web links below will take you to the online directories of the US Senate and the US House of Representatives respectively; the search boxes will locate your senator or congressional representative by zip code. This service is courtesy of (External) Capitol Advantage *

• (External) Write To Your Representative Find your congressional representative by zip code and get contact information (U.S. House of Representatives).

• (External) Find Your Senator and Contact Information (U.S. Senate.)

Get Involved

Use these resources to get involved and find more information about your elected representatives, track bills, and follow issues at the state and federal level.

• (External) Project Vote Smart Look up information about candidates and elected officials, bills, and issues.
• (External) Thomas / U.S. Congress on the Internet Track Bills and find pending legislation.
• (External) Find State Elected Officials and Representatives
• (External) State and Local Government on the Net
• (External) Office of Public Records Lobby Filing Disclosure Program Find out what organizations lobby and how much they spend.
• (External) Opensecrets.org Find out about federal political contributions: who gives, who gets, and how much.
• (External) Regulations.gov Comment on proposed federal regulations.

* CIRCARE is not affiliated with Capitol Advantage and our use of Capital Advantage's forms on this web page does not constitute advertising or endorsement. Capital Advantage makes valuable services available to the public and we're pleased to provide them to people visiting our web site.

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Last Updated: 2007-04-01

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