Second year students in the UC/CCHMC GCP who are on track to complete their clinical logbook requirements are given the option to develop their own elective rotation. Students choose these rotations based on their interests or skills they would like to obtain. Along with input from program faculty, they develop the learning objectives and outcomes for their rotation. Previous elective rotation posts were about the International Adoption Center, StarshineHospice, Psychiatry, and Bioethics.
How are biobanks regulated? What information are patients provided during the informed consent process for biobank research enrollment? What is discussed when reviewing biobanking research protocols at an IRB meeting?
I learned about biobanking through lectures in Human Genetics and Emerging Topics in Clinical Genomics during my first year of the program. Genetic counselors are often asked to facilitate consent for research protocols involving genomics, as well as for participation in biobanks. Biobanks offer opportunities for researchers to access many patient samples and clinical data to facilitate research into therapeutics, natural history of disease, how genetics may influence disease states, etc. Genetic information is often collected, de-identified, and stored as part of this process. However, there is ongoing debate as to if and how genetic variants found through biobanking should be communicated to study participants.
Through networking with faculty members at the University of Cincinnati and Cincinnati Children’s Hospital, I set up a rotation with Dr. Kelsey Dillehay McKillip, Director, and her team at the University of Cincinnati Biorepository, as well as Dr. Mike Linke, IRB Chair, with the University of Cincinnati Institutional Review Board (IRB). At this time, the UC Biorepository is mostly composed of blood, urine, tumor and paired normal tissue samples from patients with solid cancers. The UC IRB has 20+ members with various professional backgrounds including biobanking, medicine, sociology, etc. The UC IRB meets every week for about two hours. Each IRB meeting was composed of at least eight different IRB members.
During my rotation, I observed the biobanking process from start to finish including screening patients to determine who met eligibility criteria, talking with eligible patients during the informed consent process, collecting and processing blood or tissue samples, and dispensing samples to researchers who have IRB approval for research that utilizes UC Biorepository specimens. I also attended UC IRB meetings where investigator-initiated biobanking protocols were discussed. The UC Biorepository is a core facility that supports basic scientists at UC and CCHMC, however there are also separate investigator initiated research protocols that can involve biobanking as well. Finally, I revised and consolidated multiple informed consent documents for different sample types into a universal consent document. Currently, if patients have different types of cancers, they are asked for their consent to participate in biobanking research for each individual cancer during their clinic visits. Therefore, the ultimate goal was to create a clear and concise consent form that would allow patients to provide consent once and provide multiple sample types for biobanking research in the future. The use of a universal consent form not only facilitates research, but also increases efficiency during patient clinic visits if patients only have to talk with one member of the research team at one time point.
Related to my knowledge in genetics, I was specifically tasked with adding language to the consent about how participants’ genetic information may be handled, as well as specific laws that protect this information (such as GINA: Genetic Information Nondiscrimination Act). Further, I conducted a literature review about how changes in human subjects research policy impacts genetic information and the informed consent process. The majority of biobanks, including the UC Biorepository, do not report genetic research findings to participants. However, there is debate within the research community about the most ethical way to handle and store genetic information and whether it should be communicated to research participants.
My experience with the UC Biorepository team and the UC IRB will allow me to better explain the biobanking process to patients and anticipate questions an IRB may have about a research protocol that involves biospecimen collection. I thank Dr. Kelsey Dillehay and Dr. Mike Linke, as well as the UC Biorepository team members including Matt Koch, Farah Sagin, MS, and Karen Winstead for their time and supervision.
I am thankful that the UC graduate program encourages students to take responsibility for their education and seek opportunities that foster their personal and professional growth. Further, I thank my classmates and program faculty for facilitating my interests into action throughout my graduate career at UC.
--Kristen Fishler, Class of 2018