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
