1. Purpose
This SOP describes the process WVU OHRP follows to ensure uniformity in the review and approval of genetic research across all WVU sites.
2. Overview
Studies falling into this class of research must be approved by the IRB. Genetic research on human participants must have a legally enforceable informed consent including all federally required and additional elements, and additional requirements which may be imposed by the WVU OHRP for safety reasons. Genetics informed consent documents must include a statement concerning the ownership of any derived property as a result of research done on the genetic material. Transfer of ownership, by way of research, will generally go to West Virginia University and not the investigator/PI conducting the research. This may change through special dispensation by WVU and its officers. Studies concerning sensitive topics such as autism, race or ethnicity, and how genetics relates to everyday life may be a special concern to the IRB. To properly protect participants in the populations described above, the IRB may impose special guidelines, regulations, or requirements, as necessary.
3. Procedures
3.1. For informed consent to be legally enforceable, it must comply with
45 CFR 46.116. For additional information on informed consent, please see SOP 012:
Informed Consent Requirements and SOP 014: Documentation of Informed Consent Process.
3.2. The following are additional elements that must be included in the informed consent for genetic research:
- Statement about whether test results will be returned
- Whether mistaken paternity will be reported
- Whether adoption or undisclosed maternity will be reported
- Whether participants have the option to find out the results
- A list of sources of genetic material
- Statement that participant must be informed of their rights through Genetic Information
Nondiscrimination Act (GINA) - HIPAA Authorization if PHI will be attached to the genetic material
- Statement about what it means for participants to relinquish ownership of their genetic material (i.e., DNA)
- Multiple options for consenting (if applicable)
3.3. The following are additional elements that must be included in the informed consent for genetic research in which the genetic material will become part of a bank:
- Statement as to where DNA will be stored
- Statement of who will have access to the DNA
- Whether PHI will be attached to the DNA
- Whether the participant can opt out of banking and remain a part of the research
- Whether participants will be contacted later to consent to future studies
3.4. The following are additional elements that must be included in the informed consent for genetic research concerning ownership of the genetic material/DNA:
- Statement that the genetic material is a gift
- Non-exhaustive list of what the genetic material could be used for
- Statement that relinquishing property rights is permanent
- Statement that the genetic material provided and all research therefrom can be patented by the genetic material owner and/or research proprietor
3.5. WVU researchers must include a statement in the informed consent that tells the participant (if the participant agrees to genetic testing of their sample) the genetic material obtained will be owned by WVU and can be used for any purpose at the discretion of WVU officials.
3.6. During the approval process, the IRB will take into consideration any outcomes from the research that may have a net negative (greater risk than benefit) effect on society. In these instances, the IRB may use normal processes in attempts to remediate the effects during the course of the research.
4. References
WVU Policies:
SOP 012: Informed Consent Requirements
SOP 014: Documentation of Informed Consent Process
Federal Guidance:
Considerations for Design, Development, and Analytical Validation of Next Generation
Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis
of Suspected Germline Diseases, issued April 13, 2018.
AAHRP:
Element I.1.G