With next-generation sequencing on the rise, researchers and clinicians have the predicament of presenting –or not presenting- study participants with large amounts of data. Guidelines for presenting clinical genomic test results are present for clinicians, but there is much more gray area in presenting results to research participants. In October 2013, CSER Consortium and eMERGE Network came together to formulate four consensus recommendations regarding research participants and their genomic results.
When discovered, researchers are obligated to offer medically important and actionable genomic research results to study participants. However, researchers hold no duty to search for genomic variants outside of those specified in their research.
Study participants merit the right to refuse research genomic test results related, and unrelated to the study, as long as the study purpose is not aimed at the return of data. The consent process and form should be clear and should discuss withdraw opportunities and future circumstances. After considering the child’s best interests and health significance, parents of minors participating in genomic research should have the right to refuse results.
Situations where researchers are scientifically and ethically justified to return all or some genomic information are possible. Therefore, studies examining the return of genomic information should measure benefits and harms in order to determine which return method is most beneficial in these cases.
With the growing use of genomic sequencing in clinical research, additional studies on return methods and the benefits and harm of receiving genomic test results are needed.
Read the full published article here.