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Informed Consent
Informed consent is an important aspect of any genetic test or research study.
The NHGRI has participated in policy development in the area of informed consent
as it relates to genetic/genomic studies. Because of the often profound impact
of genetic testing, patients should be adequately counseled about the specifics
of that test.
Before an individual agrees to participate in a clinical trial,
research project or undergo a genetic test, he or she must be informed of the
test's purpose, medical implications, alternatives, and possible risks and benefits.
Patients should additionally be made aware of their privacy rights, including
where their DNA will be stored and who will have access to their personal information.
An informed consent document, requiring the patient's signature, should articulate
all of these details. Even after signing, the patient may still opt out of the
test or study; the informed consent document is not a contract.
Federal Policy
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Regulations
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Guidelines
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NHGRI Guidelines
Federal Legislation
Below is a list of bills that were introduced or passed in the 108th Congress
(2003 -2004) regarding informed consent. Many bills contain language that addresses
both discrimination and privacy and therefore will be listed in multiple categories.
108th Congress
- H.R.3594 IH (Introduced in House): Protection for Participants in Research
Act of 2003
- H.R.4531 IH: Ronald Reagan Memorial Stem Cell Research Act of 2004
- S.2083 IS (Introduced in Senate): Bipartisan Patient Protection Act of
2004
- S.1945 IS (Introduced in Senate): Bipartisan Patient Protection Act
Informed Consent Federal Legislation Archive
Reports
Last Reviewed: January 8, 2009
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