The development of high-throughput techniques has permitted the accumulation of enormous amounts of genomic information. As increasing numbers of studies aim to utilize individual genomic information for diagnostic, preventive, or therapeutic purposes, Institutional Review Boards (IRBs) have a greater opportunity to review such types of study protocols. An article published in the Journal of Personalized Medicine titled, "Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience" identified the common concerns of IRBs in the process of reviewing such studies, and some concerns included the readability of informed consent materials, potential risks to participants, information sharing with family members, options for withdrawal or receiving limited results, and provisions to clear participant questions. Since there is an increase in the number of genomic medicine implementation studies worldwide, the insights provided by this study would assist future researchers in protocol preparation as well as aid project review by IRB members.
Keywords: biobank; bioethics; electronic health record; electronic medical record; genetic testing; next-generation sequencing; personalized medicine; precision medicine; research ethics; return of results.