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 firstname.lastname@example.org.