Home Medical Centers as Suppliers Ethical Issues

Should health care institutions consider ethical issues in collaborating with tissue repositories?

A number of ethical issues are involved in tissue collection for repositories. These include: procedures for obtaining informed consent from tissue donors, information about potential research and end-users for donated tissue, potential conflicts of interest between patient care and tissue collection, communicating research findings to donors, etc. But what group or individual at a medical center should deliberate on these and related ethical issues in repository collaborations?

Many medical centers direct ethical issues related to repository collaborations to their IRBs. IRBs are not mandated by any federal regulation to consider collection issues. IRBs are established to protect human subjects in research. However, tissue collection for repositories is not research. For this reason, some IRBs may refuse to consider collaboration proposals. Others may claim that some of the ethical issues in collection (e.g. informed consent, privacy of medical information, communicating research findings to donors) are issues that IRBs address only when considering specific research applications.

The issues related to protecting the rights and welfare of tissue donors are distinct from protecting the rights and welfare of research subjects. IRBs may quickly be perplexed when issues such a general consent (e.g. blanket consent) are reaided by repositories. IRBs may wonder exactly how to address these issues. For instance, general consent would not be appropriate in a typical research application for it would not meet the minimal conditions for informing potential research subjects. In addition, IRBs are skilled at evaluating risks/benefits to research subjects but what criteria should be used when evaluating risks/benefits of tissue donors whose bodies will not be directly involved in a research project? Also, there are ethical issues beyond the act of tissue donation that IRBs usually do not consider. One example is that of conflicts of interest related to tissue collection quotas and financial agreements between for-profit repositories and a medical center.

In short, tissue collection does not neatly fit the clinical trial paradigm fundamental to IRB review. Nonetheless, many medical centers lack a broader ethics committee that might be appropriate for these deliberations, such as a tissue banking steering committee. They direct ethical issues related to repository collection to their IRBs.