Elective Rotation: Informed Consent and Biobanking

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


NSGC "Prospectives in Genetic Counseling" newsletter

The National Society of Genetic Counselors (NSGC) Student/New Member SIG has put together the third edition of their "Prospectives in Genetic Counseling" newsletter, which is geared toward prospective and new genetic counseling students.  It includes articles by recent alum Sarah Chadwell and current student Stacey Aldrich.  Check it out here:

Prospectives in Genetic Counseling Newsletter


My Experience as a Second Year Genetic Counseling Student

One of the strengths that I have perceived within the Genetic Counseling Program at Cincinnati Children’s is the wealth of opportunities we have as students here. The first year of the training program is relatively academically heavy with significant coursework, group assignments, research experience, and clinical exposure. The second year of training offers more flexible time and an ability to truly tailor our learning experience. Over the last year, a variety of experiences and opportunities have shaped my professional and personal growth and I wanted to take some time to share that with all of you. Here is a short summary of some of the things I’ve done over the past year and a few pictures as well: https://jmshank.weebly.com

I had the privilege to be a LEND trainee in my second year. LEND stands for Leadership and Education in Neurodevelopmental and related Disabilities. It is a federally funded program which seeks to cultivate leadership skills within clinical and non-clinical members of the disability community. Through LEND I gained an understanding of my own leadership skills and abilities while exploring how those skills fit within the greater context of advocacy and disability policy. The LEND program at Cincinnati Children’s this past year consisted of 24 trainees from 13 different disciplines. Attending classes and working on projects with the other LEND trainees has given me a broad understanding of multiple disciplines and how genetic counseling fits in the greater medical field. LEND afforded me many opportunities to travel for conferences and service trips as well as setting a foundation for lifelong learning and growth through work within the disability community.

Throughout the year I also attended a variety of conferences and experiential learning events. Specific to genetic counseling, I attended the Ohio Genetic Counselor’s conference in Cleveland and the National Society of Genetic Counselor’s conference in Seattle. We also had the chance to attend a bereavement conference in Columbus with other genetic counseling program students from the Midwest area. Related to my work with LEND, I was able to spend a week in Nicaragua working with a developmental pediatrician and a speech team. Our LEND cohort also took a trip to Columbus, the Ohio state capitol, to meet with our legislators for Disability Awareness day. We discussed up and coming bills and developed our own ways to tell our stories and advocate for our patients and their needs.

I also had the opportunity for non-clinical training opportunities. I was able to rotate in our lab at Cincinnati Children’s to gain an understanding of genetic testing technologies and methodologies. I worked with genetic counselors writing reports and interpreting variants in both the molecular and cytogenetic labs. Additionally, I was able to visit Myriad Genetics the summer before my second year which gave me hands-on exposure to industry and oncology genetics.

I am so grateful for my time at Cincinnati Children’s and the experiences I can take with me in my career. You get out of life what you put into it, but it comes back so much fuller. My second year of training has given me confidence in my skills and broadened my perspectives towards genetic counseling and the healthcare field as a whole. With a foundation set in strong clinical, practical, and relational skills as well as the ability to facilitate my own lifelong learning I couldn’t be more excited for my future. 

--Jessica Shank, 2017 graduate