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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

• Regulations

  • Protection of Human Subjects [hhs.gov]
    Code of Federal Regulations, Title 45, Part 46.
    
    

• Guidelines

  • Belmont Report: Ethical Principals and Guidelines for the Protection of Human Research Subjects [ohsr.od.nih.gov]
    April 1979
    
    
  • National Bioethics Advisory Committee (NBAC) [bioethics.gov]
    
    
  • Protecting Human Research Subjects
    1993 OPRR IRB Guidebook Chapter on Human Genetic Research
    
    
  • Department of Health and Human Services Office for Human Research Protections Home Page [hhs.gov]
    
    

• NHGRI Guidelines

  • NHGRI-DOE Guidance on Human Subjects Issues in Large-scale DNA Sequencing
    August 17, 1996
    
    
  • Update to the NHGRI-DOE Guidance on the Use of Human Subjects in Large-Scale DNA Sequencing
    April 27, 1998
    
    
  • July 16, 1997 Revised Criteria/Process for Obtaining NHGRI Approval for DNA Libraries

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
  • Sponsor: Rep Diana DeGette
  • Summary and Bill Status [thomas.loc.gov]
    
    
• H.R.4531 IH: Ronald Reagan Memorial Stem Cell Research Act of 2004
  • Sponsor:Rep. Gary L. Ackerman
  • Summary and Bill Status [thomas.loc.gov]
    
    
• S.2083 IS (Introduced in Senate): Bipartisan Patient Protection Act of 2004
  
  • Sponsor: Sen. Barbara Boxer
  • Summary and Bill Status [thomas.loc.gov]
    
    
• S.1945 IS (Introduced in Senate): Bipartisan Patient Protection Act
  • Sponsor: Sen. John McCain
  • Bill Summary and Status [thomas.loc.gov]

Informed Consent Federal Legislation Archive

• 107th Congress (2001-2002)
• 106th Congress (1999-2000)
• 105th Congress (1997-1998)

Reports

• Informed Consent for Genetics Research Using Stored Tissue Samples
  1994 Workshop Report from the Centers for Disease Control and NHGRI.
  
  
• Protecting Human Research Subjects
  1993 Institutional Review Board Guidebook from the National Institutes of Health.

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Last Reviewed: February 28, 2012