By Cansu Canca
A recent New York Times article drew attention to an issue with increasing importance as technology develops. Gene samples collected under conditions of anonymity reveal more and more information that may be of crucial importance for the subjects or their relatives. Researchers feel a moral obligation to disclose these important findings, which may even be life-saving, to the subjects. Yet, the anonymity clause in the consent forms prevents them from doing so.
Whether or not researchers can or must disclose the information in spite of the anonymity clause mainly turns on two issues: the scope of the informed consent and the reach of the obligation for beneficence.
Distrust in informed consent
If we assume that the anonymity clause reflects the subject’s decision well, then the issue does not arise unless some sort of paternalism comes into play. The consent form expresses the subject’s wish not to be contacted in relation to the research findings. Doing otherwise would violate the agreement as well as the subject’s autonomy. However, the researcher’s dilemma of disclosure may arise if there is a doubt about the comprehensiveness of the informed consent. Did the subjects really understand the scope and importance of information that may be found? Would they still prefer not to know even if the information could save their or their children’s lives? Were they given a real choice when entering the contract, in particular an option of under which circumstances they would like to be contacted? And with all these questions unanswered, is the researcher justifiably bound by the consent form in the face of a live-saving or life changing information about the subject?
Moral duty to tell
Faced with life-saving or greatly beneficial information about the subject, researchers feel a moral obligation to notify them. Such a moral obligation can be justified in a variety of ways – none of which providing an absolute duty to track these subjects down.
One might argue for a Kantian duty of beneficence. Assuming the subjects do not want to suffer and die, by disclosing life-saving or greatly beneficial information, the researcher helps the subjects pursue their ends. Therefore, once the researcher identifies such information, she is obligated to act on it. A principlist take on the duty of beneficence might sustain a similar argument: since researchers are obligated to do good taking into account both the society and the individual, they cannot simply ignore the effects of such crucial information on the individual’s well-being and go on with their research. In the absence of the anonymity clause, these arguments might have been sufficient to conclude that disclosing the information to the subjects would be the right action. However, the anonymity clause in the informed consent also puts another duty on the researchers: the duty to respect the subject’s autonomy. Which one prevails would seem to depend on the scope of the clause, as discussed above.
A utilitarian approach to the issue would have to take into account not only the lives that will be saved or improved with a particular bit of information but also the negative effects of allowing the researchers to track down the subjects or subjects’ families. Such an allowance would cause distress on subjects who did not want to be contacted under any circumstances; and it may even lead to a more wide-spread distrust in the system of anonymity. From the researchers’ and the research institutions’ perspective, such an allowance (or maybe requirement) would also result in possibly significant amounts of resources to be directed to the purpose of handing in the information to the subjects or their families. Going forward, subjects might be more reluctant to participate in studies if they did indeed intend to prevent any contact, and additional costs of tracking down subjects might weigh down research budgets.
The NYT article reports that the federal government is actively developing policy options. Clearly there is something disturbing about letting a subject die or remain ignorant about treatment options while the researcher could come to the rescue by simply revealing her information. On the other hand, an obligation to disclose despite of the anonymity clause might violate privacy and autonomy and significantly burden researchers and research institutions that would have to track the subjects and maybe even their families.
What can be done? For cases involving existing samples, a solution must be found to reconcile the benefits of disclosing crucial information with the harms of violating the agreements and autonomy. One partial solution could be to allow subjects to make changes in their privacy settings retrospectively. Advertising this option to all subjects should neither violate anybody’s privacy nor get anyone worried that they in particular are likely to have some threatening condition. However, it would not help the families of subjects who have already died (especially considering that the family may not even know about the subject’s participation in research). Also, simple inertia might prevent most people from changing their privacy settings regardless of their substantive preferences.
For prospective research, the informed consent form must be drafted in such a way that it provides more confidence to the researcher about the subject’s wishes. More fine-grained options in the consent form would provide the researcher with not only more clarity about the subject’s wishes, but also more confidence that the subject actually gave some thought to her wishes.