RERC Reviewer Form

Genetic Consent Form

Required information for submitting an informed consent form/protocol submission.

Note: The following information is provided as a guide for investigators and is not all-inclusive. Please refer to the Genetic Informed Consent Form Template and Check List for Submission for a complete list of required information.

Initial Mandatory Requirement
- Is this statement true and verbatim?
Risk Section
- Does this section conform to the mandatory wording?
  - When there is a genetic component to the study, subjects must be informed about the nature of genetic information, and risks of inadvertent disclosure of genetic information.
    Note: the risk of individual harm from participating in genetic/pharmacogenetic/biomarker research is unclear. Inclusion of the following paragraph may offer some clarity, if it reflects what the investigator and sponsor intend to achieve. The paragraph may be modified as needed.
    - “There may be risks to your eligibility for employment, life insurance, mortgage insurance or
      private health insurance if the results of genetic testing were to be inadvertently disclosed to certain parties. Safeguards have been established to ensure that such disclosure will not occur. For example, a coded number will be used to identify your sample and your name will not be disclosed in association with the sample at any time. In addition, genetic testing results will not be placed in your medical record. Despite these efforts, we cannot guarantee that your genetic information could not be linked to you.”
Signature Page
- Does this section conform to the mandatory wording?
Document Footer
- Does this section contain the version date, page number(s) and space for patient initials?