Clinical Trials Committee – Genetic Informed Consent Form Requirements

This is the required information for submitting an informed consent form/protocol submission.

 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 the Check Lists for Submission of a Research Study document for a list of required information.
 When submitting a revised informed consent form, please ensure the ICF document is in additions/deletions format and include continuous line numbers throughout the tracked document.

Initial Mandatory Requirement:

Is this statement included and verbatim?

Risks 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. Please note that the risk of individual harm arising from participating in genetic/pharmacogenetic/biomarker research is unclear. Inclusion of the following paragraph may offer some clarity but should only be inserted IF it reflects what you and sponsor are actually doing.  Otherwise, the paragraph could be modified, as needed, to reflect the reality.

“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, we have taken steps to ensure that a coded number, rather than your name, will be used to identify your sample and that your name will not be disclosed in association with the sample at any time.  In addition, the results of genetic testing will not be placed upon your medical record.  Despite these efforts, we cannot guarantee you with 100% certainty that your genetic information could never be linked to you.”

Signature Page:

Does this section conform to the mandatory wording?

Document Footer:

Does this section contain version date, page #s and space for patient initials?