This page provides a checklist for the additional details necessary in the protocol application when a proposed study includes a component that involves genetic testing.
In order for the ED/SBS IRB to review an application involving genetic testing, the following must be documented in the application and/or documents:
□ The proposed study is largely an education or behavioral study, that happens to include a genetic testing component.□ Sample collection is a non-invasive procedure or a simple blood draw.
□ Genetic testing is not being done for clinical or diagnostic purposes, but rather to study a known condition or behavior.
□ If genetic testing is being done to confirm a diagnosis, details must be provided as to what the investigator will do if the testing does not confirm the diagnosis. If subject's eligibility for a study hinges on the results of genetic testing, in most cases, the researcher should provide a plan for informing the potential subject that s/he is not eligible, without directly or indirectly disclosing the results of the genetic testing.
□ Results of the testing cannot be shared with participants and no genetic counseling will occur.
□ Test results will not become part of a medical record.
□ Genetic samples, if they will be banked for unspecified future use, will be de-identified (or a justification provided in the file as to why retention of identifier(s) is appropriate).
□ Details as to where the samples will be stored, who will have access to the samples, who/how it is decided when samples can be used.
The confidentiality section of the application should specifically include details addressing:
□ Will data and samples be coded?
□ Timetable for de-identification of samples OR justification for why they will not be de-identified.
□ Method of de-identification of samples.
□ Secure method for storage of samples, data and master lists of coded data.
□ Specific confidentiality protections for any banked samples.
The consent form must specifically include the following details:
□ That genetic testing will take place and the specific reason for the genetic testing.
□ Whether or not the genetic samples will be identifiable.
□ If samples will be identifiable, when and how samples will be de-identified.
□ How the samples will be used and, if the samples will not be consumed in the testing, what will happen to the excess genetic material.
□ Who will have access to the genetic samples.
□ How long the samples will be stored, whether the samples will be shared with collaborators, and whether or not shared samples will be identifiable.
□ Whether samples will be banked for future research and, if so, what type of future research.
□ When samples will be banked, what information about subjects will accompany the samples, how that information will be protected, and who will have access to it.
□ The risks of genetic testing, particularly if there is a breach of confidentiality.
□ Text explaining the limitations of Genetic Information Nondiscrimination Act (GINA):
GINA makes it illegal for health insurers and employers to discriminate against you based on your genetic information. But you should know that there are limitations to this law. For example, it does not apply to businesses that employ fewer than 15 people, or life, disability or long-term care insurance. An abnormal genetic test could result in denial or much higher rates for life insurance, disability or long term care insurance if your genetic test results were to become known.
□ Whether subjects may request to withdraw their sample and, if so, procedures to do so.
If the application involves genetic testing of samples from a vulnerable population (such as children) then the application must include details as to why it is appropriate to include vulnerable subjects in the sample population.