Should Results from Genetic Research Be Returned to Research Subjects and Their Biological Relatives?

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1. Introduction

Medical research focusing on genetic disorders and changes will occasionally generate knowledge about a research subject's possible carrier status and his or her current or future disease. Furthermore, the knowledge gained often pertains not only to the subjects but also to their biological relatives. In this paper, I address the question of how to treat personal information about disease and hereditary dispositions, resulting from research, including information that not only affects individuals, but can also be of interest to their biological relatives.

First, I ask whether results should be returned at all. Perhaps the best way to keep difficulties at bay would be to avoid the issue. Second, if a case can be made for the desirability of returning information to the individual, I will ask whether this individual's biological relatives have a right or duty to know about familial information that may greatly affect their lives. How do we weigh the arguments? As Crouch and Elliott point out (1999:275), when it comes to "moral decisions about the family, the tools of moral philosophy and the law have not always served us well, particularly when the question involves exposing one family member to risks for the sake of the other." I discuss how family ethics and a certain conception of autonomy challenge the often-undisputed notion of nondirectiveness. In this paper, I map the ethical terrain and provide reminders about important features, both moral and factual, that should guide any assessment of policymaking in this area. I do not try to propose what any individual should do in any particular situation. We need to remember that no ethical deliberation of the kind offered here can replace the subject's responsibility for his or her own actions. Facing up to responsibility and interacting with family members are identity-shaping actions and are thus closely connected to a person's innermost being. In Margaret Walker's words, in doing such things a person exercises "strong moral self-definition" (Walker 1987).

2. Should research results be returned to subjects?

Those who answer this question in the negative do so on principle or because of misgivings concerning the results' usefulness. The first type of objection asserts that it is never necessary to return results to subjects, as this should not be the investigators' first priority. This argument merits discussion, and I will return to it below.

Discussions of usefulness point to the quality of results. There is a concern that different types of errors could have crucial consequences, as individuals may change their entire lives because of a test result. With genetic information, an error may also greatly affect family (see, e.g. Fost and Farrell 1989). In the case of predictive information, it may be a long time before an error or a misinterpretation is recognized. One must be aware of the risk of errors due to situations such as misidentification or contamination of samples, incorrect testing procedures or transcription errors. A research laboratory seldom meets the same expectations regarding quality control as would a diagnostic laboratory. Therefore, strong requirements must be placed on the quality of results. This serves the initial purpose of limiting the results that may be considered for a return.

Results from research are often very uncertain, difficult to interpret, or even not applicable to the individual. These shortcomings pertain to screening tests in general (Sasse 2002), not least since genetic prognostications apply mostly to the aggregate rather than individuals (Finkler et al. 2003:404). Hence, it can be said that information to be considered for disclosure must be such that is applicable to an individual, reasonably legible, and reliable--that it springs from a relatively certain research result (i.e., its sensitivity and specificity). To be a basis for information to be shared, knowledge should furthermore indicate that harm is foreseeable (the subject is at risk), that it is likely (e. …