APPENDIX ‘A’
Sample Template Including Instructions for Genetic Research

HELP TEXT: If genetic testing will NOT be performed under this study, DELETE this heading and all related genetic research paragraphs.

NY State Law and CCI/IRB definition of Genetic Test: New York Civil Rights Law Section 79-1 defines a genetic test as:

  1. "Any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the presence of a genetic variation linked to a predisposition to a genetic disease or disability in the individual or individual's offspring; such term shall also include DNA profile analysis. ‘Genetic test’ shall not be deemed to include any test of blood or other medically prescribed test in routine use that has been or may be hereafter found to be associated with a genetic variation, unless conducted purposely to identify such genetic variation. The CCI/IRB also includes any measurement of certain metabolites associated with heritable diseases as a genetic test.
  2. "Genetic Predisposition shall mean the presence of a variation in the composition of the genes of an individual or an individual’s family member which is scientifically or medically identifiable and which is determined to be associated with an increased statistical risk of being expressed as either a physical or mental disease or disability in the individual or having offspring with a genetically influenced disease, but which has not resulted in any symptoms of such disease or disorder."

CONSENT REQUIREMENTS:

  1. NYS Law requires the following information be included in the consent:
    1. PURPOSE (Why are we doing this research)
      1. Include –
        1. A simple explanation of the general description of each specific disease or condition tested for.
        2. A statement that tests conducted under this research study may reveal genetic information.
    2. GENETIC COUNSELING INFORMATION:
      1. A statement that the individual may wish to obtain professional genetic counseling prior to signing the informed consent.
        SAMPLE: You may wish to obtain professional genetic counseling prior to signing the informed consent. A genetic counselor is a person qualified to provide information about what the results of this type of test may mean to you and your family. You or your insurance company will be responsible for the cost of these services.
      2. The level of certainty that a positive test result for that disease or condition serves as a predictor of such disease. If no level of certainty has been established, this subparagraph may be disregarded.
        SAMPLE WHEN TEST SERVES AS A PREDICTOR:
        If the test is positive, it means that there is a ____% chance you might have ….. you may wish to talk with your doctor, go for another blood test or speak to a genetic counselor. If no level of certainty has been established, this subparagraph may be disregarded.
    3. PROCEDURES (How will the test be done?)
      Provide detailed information specific to your study.
      SAMPLE:
      We will obtain 10 ml of blood from your arm by a needle stick when you come to ……. This will only be done one time.
    4. ADDITIONAL TESTS ON YOUR SAMPLE
      Include a statement that no tests other than those authorized shall be performed on the biological sample and that the sample shall be destroyed at the end of the testing process or not more than sixty days after the sample was taken, unless a longer period of retention is expressly authorized in the consent.
      SAMPLE:
      No other tests other than those explained under this study will be done on your sample. The sample will be destroyed at the end of the research study.  Alternatively, include the CCI Future Use consent language. See Appendix B (identified) or Appendix C (de-identified).
    5. WHO CAN CONSENT
      The individual subject of the test or, if that individual lacks the capacity to consent, the signature of the person authorized to consent for such individual must sign. An authorized person is a health care proxy legal guardian.
  2. CCI/IRB Policy requires the following information be included in the consent: (CCI/IRB policy requirements and are in addition to the NYS Law requirement.)
    1. Whether or not participants will be informed of the results of genetic tests, and if so, whether and how counseling will be performed.
      SAMPLE:
      Since the significance of these tests are not known for you, we will not disclose the results of the genetic testing. No formal counseling will be provided under the research study. If you request, you will be referred to a genetic counselor. You or your insurance carrier will be responsible for the genetic counselor’s fee.
      OR
      You will be told the results of the genetic tests and formal counseling will be provided under the research study at no cost to you.
    2. If genetic tests may reveal other information unrelated to the study. For example, in cases where parents and children are both tested, the test may disclose the possibility that the father is not the biological parent. Although these types of information will not be disclosed, the participant must be informed about the potential findings.
      SAMPLE:
      Genetic tests may reveal medical information that is not related to this research study. For example, in cases where parents and children are both tested, the test may disclose the possibility that the father is not the biological parent. This information will not be revealed to you and will remain confidential.

Dated: 6.01
Revised 1.02, 1.07, 1.09