Share and Share Alike?
Jim is a graduate student in the department of genetics. For his
thesis research, he is mapping a gene involved in blood sugar
homeostasis. His work is part of a larger multi-center study of the
genetics of obesity. The larger study involves several thousand
patients and includes information such as socioeconomic class,
self-identified ethnicity, activity level, weight and other medical
data. Blood and DNA samples are maintained in Jim's lab along with
a database that links unique identifiers ' but not patient names '
with the data. The study coordinator at each site has access to the
encryption key; however, the students and other researchers working
on the project do not. Researchers may use the database to retrieve
and enter data pertaining to the samples, but they cannot learn the
identity of the individuals in the study.
The subjects/patients involved in the study were recruited at
various study sites. On first contact with a potential participant,
a genetic counselor explains the study and arranges for a meeting
to begin the informed consent process. During this meeting,
participants learn about the aims of the project, their role as
subjects, and the risks and benefits involved in participation. The
consent forms state that blood and DNA samples and the resulting
data will be anonymized, that subjects may withdraw at any time and
that samples will be used exclusively for this study. If their
samples are to be used in unrelated research, the individual
participants must be recontacted and go through a second consent
process, specific to the new study.
Jim's project involves a subset of several hundred samples from
the obesity study. One day, Renee, one of the other graduate
students in the lab, approaches Jim and starts asking questions
about the samples he's working with. She explains that for her work
on sickle cell anemia and mutations in a hemoglobin gene in African
Americans, she needs 50 ethnicity-matched control samples. Since
Jim has access to such a large collection of samples, Renee asks if
she can take small aliquots of some of his samples from the obesity
study. She tells Jim that she will not be looking at disease in
these patients, or really doing a "study" on them; she just needs
them as controls, and she doesn't even need that much DNA. "Which
box are they in?" Renee asks, as she heads for the freezer.
Renee was standing at the freezer with the door open when Jim
said, "I'd be happy to tell you more about our samples, Renee, but
you had better talk to Jane, the study coordinator, about getting
consent from the obesity study participants if you really want to
use them for your study. Another option," he suggested, "which
might be faster, is to just order a set of anonymous samples from a
commercial DNA bank. It would really be a pain to recontact all of
those people just for a set of controls."
Discussion Questions
- As Renee said, she does not intend to really "study" the
obesity samples; she just needs ethnicity-matched anonymous
controls for her work. Should the aim of her study affect Jim's
response?
- Does the fact that she and Jim are in the same lab make a
difference?
- If the consent forms were not explicit regarding the use of
samples, would that change Jim's responsibilities?
- If you were the study coordinator, and Renee approached you
about using these samples, what would you do?
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Participant Commentary: Share and Share Alike?
Participant's commentary on issues of research subjects' informed and voluntary consent, specifically whether participants must be recontacted and provide a second consent specific to the new study or whether the case author simply assumes that is an implication of the previously stated elements of the agreement.
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Commentary: Share and Share Alike
Commentary on issues of research subjects' informed and voluntary consent, specifically whether participants must be recontacted and provide a second consent specific to the new study or whether the case author simply assumes that is an implication of the previously stated elements of the agreement.