I chair the Institutional Review Board that oversees all research on human patients at a local Seattle hospital. Our job it to protect the rights of patients. This is not to suggest any evil intent on the part of the doctors. The problem is that clinical research involves risks and rewards. The risks are not always obvious, like the side effects of a drug. Much of what we do is cancer studies. Frequently, part of these protocols is the establishment of central tissue repositories for future research. Okay, what does that mean? Let’s say Mr. X has lung cancer and is referred to Dr. Y, a cancer specialist, who happens to be part of a multicenter trial evaluating the effect of apple juice on lung tumors. During X’s evaluation, his lung is biopsied. Some of this specimen is examined microscopically to confirm the diagnosis but some is left over. Should this excess biopsy material be thrown in the trash or should it be stored in a tissue bank for future research?
If you were Mr. Smith, what would you do? If you’re like many people, you may think, “Sure, I’d allow that. After all, it may end up helping medical science.” But here’s the rub: A piece of tissue in isolation may not very useful. Its value often comes from the personal health information attached to it, such as the donor’s sex, age, diagnosis, smoking history, medications, etc. Would you be comfortable allowing this type of personal information to be released to someone you don’t know for undefined purposes?
And what if Dr. Xu holds several thousand shares of a company that uses the repository to develop a hugely successful monoclonal antibody treatment that earns him a large profit? Is this what you envisioned when you donated tissue? Perhaps it makes no difference. Perhaps it does.
And what if, two years from now, a marker for a fatal disease is identified and your material tests positive for it? Would you want to be notified? Is the researcher obligated to do so?
Ideally tissue repositories are set up so that specimens are “de-identified.” Meaning they cannot be linked back to any one person. However, our individual genetic code is as specific as fingerprints. Given enough genetic mapping, any specimen can eventually be traced back to the donor.
Along with medical advances come weighty ethical issues.