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The progress in mapping the human genome and unlocking the
secrets of genetically-linked diseases has raised hope, but
it also raises new ethical issues.
If you suffered from cancer or some other devastating disease
you might be willing to donate extra tissue removed from your
body during surgery or biopsy, that would otherwise be discarded,
to advance genetics research towards a cure. But would you
also be willing to have your medical and family history travel
with the tissue to unknown scientists?
Human tissue needed for medical research must be held under
specialized conditions to preserve its research quality; but
to be useful, it also needs to be linked –anonymously through
coding systems– to clinical information about the patient.
Researchers running genetic experiments on tissue samples
need to know the subject's disease, treatment, and outcomes
in order to understand the development of the disease and
the genetic processes that differentiate normal from diseased
tissue.
Some hospitals have taken on the challenge of banking research
tissue to increase the quantity available to researchers,
but handling and tracking tissue is an expensive and demanding
undertaking. As a result, commercial tissue banks have emerged
to meet the need. These companies, backed by investors, seek
to collaborate with hospitals in obtaining tissue and related
clinical information that can be distributed to researchers
and pharmaceutical companies for fees.
For hospitals and for tissue banks, ethical issues must be
resolved before donations proceed. Hospitals, universities
and other research institutions have in-house Institutional
Review Board (IRB) programs that oversee research and guarantee
adequate protection of human subjects, but the guidelines
used by IRBs may not extend to all the issues in genetic research
and to commercial tissue banks.
Philosophy professor Julien Murphy, who has specialized in
bioethical issues since coming to USM in 1984, is principle
investigator on a grant project that will meet the need for
a guide to these ethical issues. The project grew out of her
experience as a member of the Subcommittee on Genetics for
the IRB at Maine Medical Center that was formed in 2000 to
examine the ethical issues posed by a proposal to collaborate
with Ardais, Inc., one of the new commercial research tissue
banks. After months of research and discussion, the Ardais
collaboration was approved, and the subcommittee went on to
develop a consent form to use with tissue donors.
Murphy is director of USM's Bioethics Project, established
in 2000 within USM's Research Institutes as a central place
for research on bioethics to serve the various biotech/clinical
research organizations in southern Maine.
Even though genetic research on tissue doesn't pose the kinds
of risk to subjects that clinical trials might, tissue donors
need to be informed. "Informed consent takes on new meaning,"
Murphy said, "when donors cannot know anything about the kind
or number of experiments that will be done on their tissue,
nor the names or location of the researchers."
When their work was presented at the New England Regional
Genetics Group, there was a lot of interest from others confronting
the same issues, she said, who asked for copies of the consent
form the subcommittee had developed. "I realized that our
work locally would be of value nationally," Murphy said. Their
experience pointed to a strong need for "an educational guide
that would explore the institutional issues."
Murphy wrote a grant with Karen Rasmussen, Ph.D., a geneticist
at the Maine Center for Cancer Medicine in Scarborough, that
has been funded by the Greenwall Foundation, the largest funder
of bioethics research, for $121,146 to develop a means for
institutions to assess collaborative agreements in a way that
would "balance patients' rights and the advancement of medical
research." Her grant proposes an interactive, on-line guide
that can be used by institutions as they consider whether
to enter collaborations. It will help them develop their own
policies on agreements and donor consent forms, tailored to
the local situation and needs. The grant proposal states the
guide will include "an enhanced patient informed consent mechanism
that takes into account the specific challenges, risks and
benefits of donating to a repository as opposed to participating
in a particular clinical trial." It will address such issues
as confidentiality, conflicts of interest, and allocation
of scarce resources.
The guide also will be helpful, Murphy hopes, to IRBs, policy
makers, and patient advocacy groups. It will be based on data
about ethical questions –such as procedures to protect confidentiality,
information provided to researchers, methods for recontacting
donors, opting out mechanisms, incentives and conflicts of
interest– gathered through site visits to four commercial
tissue repositories and four hospitals that will indicate
the needs of hospitals that have not yet entered collaborative
agreements. The guide will further discussion on how to handle
these issues and offer suggestions, Murphy said. She was motivated
to pursue these issues, she said, by a desire "to eliminate
barriers to treatment research by making tissue available
without violating patient rights and public trust."
In addition to MMC's IRB Subcommittee on Genetics, Murphy
also serves as a member of the Clinical Ethics Committee for
Maine Medical Center and on the Board of Directors of the
Maine Bioethics Network. As a member of the MMC/Ardais Steering
Committee, she continues to oversee the ethical issues arising
from the collaboration.
Her research interests have included political philosophy,
research ethics, and feminist theory. Over the last 10 years,
she has published articles on AIDS; on medical ethics from
a feminist perspective, including reproductive rights, sustaining
pregnancies in brain-dead women, and assisted reproduction
and biotech babies; physician-assisted suicide; and the ethics
of genetics and cloning. She is the author of the 1995 book,
"The Constructed Body: AIDS, Reproductive Technology and Ethics,"
editor of "Feminist Interpretations of Jean-Paul Sartre" (1999)
and co-editor of "Gender Struggles: Practical Approaches to
Contemporary Feminism" (2002).
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