Part of the advances in medical science has been the development of
biobanks, or collections of human tissue researchers can use to develop drugs
and diagnostic tests to treat certain illnesses. According to Jennifer A. Girod, J.D.,
Ph.D., an associate in the Health and Life
Sciences Practice Group of Taft Stettinius
& Hollister LLP in Indianapolis, more and
more community hospitals are finding
there are multiple benefits to collaborating
with national and international biobanks.
Smart Business spoke with Girod about
biobanks, how to reap their benefits and
also how to mitigate the potential risk in
being involved with them.
Why is the existence of biobanks important
for the development of new drugs and treatments?
Biobanks are collections of human tissue, including blood, saliva, excised
tumors and healthy biopsied tissues from
the breast. The donors of those tissues also
provide the biobank with personal health
information about themselves, such as
whether and when they’ve been sick in the
past, their family medical history and medications they take. Some biobanks continue to collect that information by contacting
donors at specified intervals and asking
them a series of questions. By using sophisticated information technology tools,
researchers can use these tissues and related information to develop drugs and diagnostic tests that can be targeted to people
most likely to benefit from them and least
likely to suffer serious side effects.
Are there any opportunities in biobanking for
community hospitals and physicians?
There are tremendous opportunities for
biobanking in community hospital settings.
Community hospitals can collaborate with
national and international biobanks, which
can raise the quality of research and clinical care at those hospitals, reflect positively on those hospitals’ reputations and
attract clinicians who have an interest in
continuing research in a community setting. Because community physicians are
less likely than academic physicians to have salary support for the time-consuming task of collecting and preparing samples, it may be in a community hospital’s
best interest to underwrite some of the
costs of developing and maintaining
biobanks.
What are some business challenges facing
biobanks?
There is a great deal of initial work
involved in developing standard operating
procedures and receiving the institutional
approvals necessary to begin to collect tissues. Institutional review boards (IRBs)
must approve the informed consent forms
used, and researchers should expect this
process to take a while as IRBs get up to
speed on the ethical and legal issues and
their potential solutions. In addition, it’s
expected to take time for biobanks to
make the money necessary to maintain
themselves. Although the tissues stored in
biobanks are considered to be extremely
valuable, it’s not yet clear how biobanks
will recoup their costs of operation.
Therefore, biobanks may have to initially
rely on volunteer efforts and public and private grant funds to get up and running,
but they should also work on developing
business plans that can offer investors a
clear vision for how they will achieve a
return on their investments. Biobanks
may, for instance, commercialize products
developed from intellectual property or
charge an access fee for those who use the
contents of the bank.
What are the legal risks associated with creating and maintaining a biobank?
Some of the controlling federal regulations regarding biobanks are ambiguous,
and some even conflict with each other.
The FDA, for instance, does not allow
researchers to ask tissue donors to waive
any legal rights, including property rights,
to their tissues. This leaves open the possibility that there may be lawsuits over the
ownership of those tissues and any products developed from them. There is also
the risk that biobanks will enter into contracts with researchers to supply tissues to
them, and that some unforeseen event will
damage or destroy the tissues that have
been promised. There is also a possibility
a donor will confuse his or her donation of
tissue and interaction with the researcher
as a clinical health care relationship,
which could result in a medical malpractice claim against the researcher if the
donor gets sick.
How can institutions and researchers minimize their legal and financial risks?
It’s important to think ahead about the
bank’s potential liabilities and to make sure
the bank and its researchers are adequately protected against malpractice claims, as
well as other risks of lawsuits and property loss. While there is no specific insurance
product created for biobanks, insurance
companies can work with biobanks to figure out the risks they face and the cost to
insure against them.
JENNIFER A. GIROD, J.D., Ph.D., is an associate in the Health and Life Sciences Practice Group of Taft Stettinius & Hollister LLP in
Indianapolis. Reach her at (317) 713-3500 or [email protected].
