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Appendix B

Examples of State-Required Components of Informed Consent for Genetic Testing --- Selected States*

Massachusetts

  • A statement of the purpose of the test
  • A statement that before signing the consent form, the consenting person discussed with the medical practitioner ordering the test the reliability of positive or negative test results and the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease
  • A statement that the consenting person was informed about the availability and importance of genetic counseling and provided with written information identifying a genetic counselor or medical geneticist from whom the consenting person might obtain such counseling
  • A general description of each specific disease or condition tested for
  • The persons to whom the test results may be disclosed

Michigan§

  • The nature and purpose of the presymptomatic or predictive genetic test
  • The effectiveness and limitations of the presymptomatic or predictive genetic test
  • The implications of taking the presymptomatic or predictive genetic test, including, but not limited to, the medical risks and benefits
  • The future uses of the sample taken from the test participant to conduct the presymptomatic or predictive genetic test and the information obtained from the presymptomatic or predictive genetic test
  • The meaning of the presymptomatic or predictive genetic test results and the procedure for providing notice of the results to the test participant
  • Who will have access to the sample taken from the test participant to conduct the presymptomatic or predictive genetic test and the information obtained from the presymptomatic or predictive genetic test, and the test participant's right to confidential treatment of the sample and the information

Nebraska

  • The nature and purpose of the presymptomatic or predictive genetic test
  • The effectiveness and limitations of the presymptomatic or predictive genetic test
  • The implications of taking the presymptomatic or predictive genetic test, including the medical risks and benefits
  • The future uses of the sample taken to conduct the presymptomatic or predictive genetic test and the genetic information obtained from the presymptomatic or predictive genetic test
  • The meaning of the presymptomatic or predictive genetic test results and the procedure for providing notice of the results to the patient
  • Who will have access to the sample taken to conduct the presymptomatic or predictive genetic test and the genetic information obtained from the presymptomatic or predictive genetic test and the patient's right to confidential treatment of the sample and the genetic information

New York**

  • A general description of the test
  • A statement of the purpose of the test
  • A statement indicating that the person might consider obtaining professional genetic counseling before signing the informed consent
  • A statement that a positive test result is an indication that the person might be predisposed to or have the specific disease or condition being tested for and might consider additional independent testing, consult a personal physician, or pursue genetic counseling
  • A general description of each specific disease or condition being tested for
  • The level of certainty that a positive test result for the disease or condition serves as a predictor of such disease. (If no level of certainty has been established, this may be disregarded.)
  • The name of the person or categories of persons or organizations to whom the test results may be disclosed
  • A statement that no tests other than those authorized will be performed on the biological sample and that the sample will be destroyed at the end of the testing process or not more than 60 days after the sample was taken, unless a longer period of retention is expressly authorized in the consent
  • The signature of the person being tested or, if that person lacks the capacity to consent, the signature of the person authorized to consent for the person being tested

South Dakota††

  • The nature and purpose of the test
  • The effectiveness and limitations of the test
  • The implications of taking the test, including, the medical risks and benefits
  • The future uses of the sample taken from the person tested to conduct the test and the information obtained from the test
  • The meaning of the test results and the procedure for providing notice of the results to the person tested
  • A list of who will have access to the sample taken from the person tested and the information obtained from the test and the person's right to confidential treatment of the sample and the information

* The National Conference of State Legislatures provides a summary table of each state's genetic testing privacy statutes (available at http://www.ncsl.org/programs/health/genetics/prt.htm). As of June 2008, 12 states required informed consent for a third party to perform or request a genetic test; the five states included in this appendix (Massachusetts, Michigan, Nebraska, New York, and South Dakota) have specific informed consent components in the statutes.

State of Massachusetts. Chapter 111: §70G. Genetic information and reports protected as private information; prior written consent for genetic testing. Available at http://www.mass.gov/legis/laws/mgl/111-70g.htm.

§ State of Michigan. Public Health Code. Act 368 of 1978. §333.17520. Genetic test; informed consent. Available at http://www.legislature.mi.gov/(S(n1vwrs55k0f0v2zec544quuk))/mileg.aspx?page=getobject&objectName=mcl-333-17020.

State of Nebraska. Nebraska revised statues. §71-551. Physician; genetic tests; written informed consent; requirements; Department of Health and Human Services; duty. Available at http://uniweb.legislature.ne.gov/laws/statutes.php?statute=s7105051000.

** New York State. Civil Rights Law. §79-I: confidentiality of records of genetic tests; 2002. Available at http://www.wadsworth.org/labcert/regaffairs/clinical/79-l_1_2002.pdf.

†† State of South Dakota. South Dakota codified laws. Chapter 34-14-22; SL 2001, chapter 184, §2. Available at http://legis.state.sd.us/statutes/DisplayStatute.aspx?Statute=34-14-22&Type=Statute.

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Date last reviewed: 5/29/2009

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