Patients' views on identifiability of samples and informed consent for genetic research

Abstract

It is unclear whether the regulatory distinction between non-identifiable and identifiable information--information used to determine informed consent practices for the use of clinically derived samples for genetic research--is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario (i.e., following the regulatory distinction). Curiosity-based reasons were the most common (37%) among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission (versus notification) in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples.

Figure 1

Reasons why respondents wanted to be told about research being done with leftover samples. *All respondents in this group were first asked about the anonymous scenario and responded that they did not need to know what was done with their sample in that case. Their desire to know was triggered by the fact their sample now had an identification attached. This group most closely aligns with the current regulations.