Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study

Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study  Full Text
 

While international policies suggest that there may be an ethical duty of care to communicate individual genetic research results if certain conditions are met [8], there is a lack of agreement in guidance between countries [9], and the potential benefits or harm of sharing non-accredited research results requires further evaluation [10].

Background

There are numerous arguments in favor of individual genetic research results being communicated to study participants, including the right of the participants to receive potentially important research information about themselves and the possible benefit from clinically actionable findings to both participants and their families [1]. Indeed, research has shown that most research participants are interested in receiving their genomic research results [2] and that this interest extends to participants in different countries [3]. Arguments against communicating individual results include the fact that the significance of the genetic research results may be uncertain and that there may be a potential for participants to misinterpret their results or make ill-informed treatment decisions [4], unless they receive genetic counselling and their results are confirmed in clinically accredited laboratories. Many countries have ethics guidelines recognizing that exploratory genetic results may have limited clinical utility; while in some other countries regulation provides participants with the right to access their individual results [5]. In the United States, where there is no explicit legal requirement to return genetic research findings [6], the American College of Medical Genetics and Genomics suggested that pathogenic mutations in 56 specified genes should be returned to patients undergoing clinical exome and genome sequencing [7], a position that has further added to the debate on whether similar recommendations are required in the genetic research setting....

Conclusion

This study illustrates the importance of increasing the clarity and scope of informed consent and the need for patient engagement to ensure clinical trial participants can indicate their preference regarding receipt of potentially important individual pharmacogenetic results.

Trial registration

This study was registered in the NCT Clinical Trial Registry under NCT00866697 on March 19, 2009, following approval from participating ethics committees (Additional file 1).