Multidimensional results reporting to participants in genomic studies: getting it right.
Recent surveys about participation in cohort studies reconfirm that participants value and desire the return of research results to a degree that is out of step with the restrictive recommendations of various ethics advisory groups, which have historically limited disclosure based on clinician value judgments and the severity and treatability of the disease in question, among other factors. Rather than framing the current inconclusive ethics discussion as a standstill among competing ethical principles and their potential applicability, we introduce a new element, communicability (that is, those properties of a message that will determine how likely it is that its informational intent will be grasped by the study participant), as the subject of empirical research to align participants' goals with beneficent and responsible results reporting. Structural changes in research design, combined with governance changes in assessing impact, allow us to move beyond a binary construction of report/do not report and to create a structure in which the communicability of the message and the participants' preferences are variables in a function that affects results reporting. Here we illustrate this structure and its principles.
Kohane
Isaac S
IS
Children's Hospital Informatics Program, Children's Hospital, Boston, MA 02115, USA.
Taylor
Patrick L
PL
D015331:Cohort Studies; D032984:Ethics, Research; D023281:Genomics / Q000941:ethics / Q000379:methods* / Q000592:standards; D006801:Humans; D033181:Information Dissemination / Q000941:ethics*; D010353:Patient Education as Topic / Q000941:ethics* / Q000592:standards*; D010358:Patient Participation; D015203:Reproducibility of Results