There have been many advances in recent years in the human genome project, which studies the gene sequence of humans. For the most part, these advances have great promise for humankind, especially in the early detection and curing of diseases. The tools for genetic research are becoming more and more sophisticated; genome sequencing is becoming less expensive and more available. Further, researchers examining the DNA of cells are able to find things that they had not expected to find things for which they were not even looking. But a problem has arisen. Donors and research organizations sign legal documents that stipulate that the donors are to remain anonymous and are not to be contacted for any reason. This has resulted in an interesting ethical dilemma for the researchers. Here are two examples.
At the Center for Translational Pathology at the University of Michigan, a researcher found something unexpected. He noticed that a man with cancer, a subject in one of his studies, had the genes of the virus that causes AIDS. Only further testing could tell if the man actually had AIDS. But there was a problem: the man had donated his cells on condition that he remain anonymous and that he not be contacted by the Center no matter what. Because of the non-disclosure agreement signed by both the subject and the Center, neither the researcher nor anyone else at the Center could contact the man and inform him of what had been discovered and advise him to seek appropriate treatment.
Another case is fraught with even more serious consequences. A young woman, in whose family there was a strong history of breast cancer, signed up for a study being conducted by the National Institutes of Health that was trying to find cancer genes that, when mutated, greatly increased the risk of breast cancer. The woman, who was aware of her family history and fearful of her risk of contracting breast cancer, had, previous to donating her cells for this research project, decided to undergo surgery to have her breasts removed prophylactically. When she consented to donate cells for the study, she clearly indicated that she did not want to be contacted by the researchers, whom she had told of her plan for the surgery during her initial screening process for donors. The research ultimately showed that the woman did not have her family’s breast cancer gene, but the researchers were legally barred from informing her of the discovery and thus preventing her from proceeding with the now completely unnecessary double mastectomy.
Dr. Francis Collins, Director of NIH, has said: “We are living in an awkward interval where our ability to capture information often exceeds our ability to know what to do with it.”
Here are some thoughts on this issue.
- The NIH and similar medical research organizations are in the business of improving the standards of health and physical well-being of the general public. Their findings are used to develop and advance our knowledge of those procedures and practices and products that can ensure the health of the people. Even though these organizations are not in the business of treating people for medical conditions, the results of their work directly affect treatment.
- The consciences of the researchers ought not to be weighed down by their discoveries when, as the above situations indicate, the donor really needs to be informed of these discoveries in order to make a more informed decision about obtaining medical attention or reviewing a medical decision than he/she might have without that information. In other words, the burden of the decision for medical treatment or not ought to rest with the donor. It is unfair to force the researcher in a situation where he/she would violate legal documents and agreements when the health and/or life of a donor is potentially at stake.
- It would seem a commonplace to assert that the privacy right of a donor discovered to have a condition or disease that is a potential general health threat (bubonic plague, for example) ought to be informed of this in spite of the privacy right because that right should not be held higher than the right of the general public to a healthy environment and information about potentially harmful and/or lethal situations. That donor must seek medical treatment whether voluntarily or not, and the general public needs to be informed in general terms about the threat. Privacy rights, then, clearly have limits within the context of the commonweal.
- While someone who voluntarily participates in such research programs as conducted by the NIH and other organizations does indeed have a right to privacy and anonymity, and certainly these research organizations ought to respect that right of the person as an individual. However this standard operating procedure only to the extent that the welfare of the general public is not jeopardized. Further these organizations might have other obligations to the donor who is not only an individual but also a member of the general public which these organizations are established to serve. Thus the NIH and other organizations need to create documents for their donors that will enable the organization to inform a donor of any medical information that is learned about that donor during the time of the research that pertains to the donor’s individual health. Then it would be up to the donor to determine what course of action to take: ignore the information, act on it, wait it out.
- If whatever is discovered has ramifications for the health of the general public, the research organization, in addition to contacting the donor, ought to inform the appropriate government agencies about the threat posed by the situation. Any individual who does not wish to abide by the stipulations in these documents ought not to be accepted as a donor for research purposes.
What do you think? How would you advise the NIH and other research organizations on this issue?