1. If a blood draw is included in a protocol for the purposes of extracting DNA or doing genetic research, is that stated in the consent document? Are the physical risks of the blood draw (e.g., pain, bleeding, bruising, lightheadedness/fainting) stated in the consent?
2. Are the social, psychological and legal risks of the research (parentage issues, knowledge of previously unknown condition, possible loss of insurability, etc.) disclosed in the informed consent document? Is the possible discovery of other unanticipated findings, such as the diagnosis or risk of conditions unrelated to the research study considered? For any of these possible findings is a plan for disclosure or purposeful non-disclosure explained to the subject in the consent?
3. Does the investigator explain in the informed consent document if the DNA sample or genetic information will be shared with other collaborators inside or outside of U of M, and if so how the privacy and the confidentiality of the subject will be protected?
4. What consent provisions will pertain to current and future specimen use? The following is a list of the types of levels of consent that can be considered for the use of tissue/DNA. It is suggested that an investigator decide what level is necessary to achieve the goals of his research, and then specify that level accordingly in the consent document (with a place for the subject to check and initial that choice). More than one option for levels of access is allowed, but too many would be confusing to the subject.
- No research use permitted
- Only anonymous research use for initial project
- Project specific use, secondary use anonymously only
- Project specific use, no further contact
- Project specific use, contact for future use
- Project specific and related project use
- Project specific and other study use (should this be allowable?)0 Commercial use
Please note: New studies not covered under the original IRB protocol and consent will need to be submitted to the IRB for approval, even if the consent under which the tissue was originally collected allows for future use of the sample in one of the above ways. It is possible that the IRB may determine that the risk/benefit ratio is such that it will not allow the new “secondary use” research to use the samples previously collected without recontacting the subject for new project specific consent or de-identifying the samples in some way.
5. How long will the sample be stored? What will happen to the DNA sample and genetic information at the time the study ends or the PI leaves the institution? Most investigators will want to state that the study information and DNA will move with them (with approval from the University) if they relocate so their research in this area could continue and if the study ends they should dispose of the DNA samples or anonymize the DNA (destroying all links to the subject). Note: the University is the owner of any tissue, DNA or information collected in research done at the University. The University controls if an investigator can take specimens or data with them when leaving the institution. Are these pertinent points explained in the informed consent document?
6. Does the consent tell the subject when or how they can withdraw from the study? With DNA studies, there may be a point in time after which withdrawal is no longer possible, but disposal of the stored DNA sample is possible. If there is a point after which withdrawal of the data is no longer possible, that should be stated in the consent and a contact person should be provided for withdrawal notifications. Any time limits for withdrawal must be specified in the consent when this is applicable.
7. Are their any costs associated with participation in the research for the subject or family? This could include costs associated with genetic testing or analysis where results are disclosed at the subject’s request, genetic counseling associated with result disclosure or costs to send blood samples to the lab for analysis. All possible costs to the subject should be explained in the consent document.
8. Are subjects enrolling in clinical research trials that include donation of tissue or DNA samples for research purposes given the option to withhold consent for tissue or DNA sample donation, but still allowed to participate in the clinical research trial? Is there a specific place for the subject to opt out of donation in the informed consent document?