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:
- "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.
- "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."
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.)
- NYS Law requires the following information be included in the consent:
- PURPOSE (Why are we doing this research)
- Include –
- A simple
explanation of the general description of each specific disease or condition
- A statement that tests conducted under this research study may
reveal genetic information.
- GENETIC COUNSELING INFORMATION:
- A statement that the individual may
wish to obtain professional genetic counseling prior to signing the informed
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.
- 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
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
- 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.
- 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
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).
- 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
- Whether or not participants will be informed of
the results of genetic tests, and if so, whether and how counseling will be
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.
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.
- 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.
Revised 1.02, 1.07, 1.09