Genetic Counseling Practice in Next Generation Sequencing Research: Implications for the Ethical Oversight of the Informed Consent Process
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The potential for next generation sequencing research (NGS) to generate individual genetic results could have implications for the informed consent process and the provision of genetic counseling. We undertook a content analysis of informed consent templates and guidelines produced by Canadian institutional review boards, purposively sampling documents used by researchers to obtain consent from participants in genetics studies. Our goal was to examine the extent to which the informed consent documents addressed genetic counseling and the return of individual genetic results. Our analysis reveals that the majority of informed consent documents did not mention genetic counseling while several did not mention the return of results. We found differences in the ways in which documents addressed availability of counseling, eligibility criteria for referral to a genetic counselor, genetic counselor involvement, provision of services to family members of participants and incidental findings. From an ethical standpoint, consent documents should provide appropriate information so that participants may make an informed decision about their participation in research. The need to ensure adequate counseling for study populations in an NGS research context will necessarily involve adapting values that underlie care in genetic counseling practice. If the interests of research participants are to be truly promoted, the drafting and review of informed consent documents should give proper due to genetic counseling.
KeywordsGenetic counseling Next generation sequencing Informed consent Genetic research Return of results Incidental findings Consent forms Ethical issues
This research and the work presented in the manuscript have been supported by a Genome Quebec grant. For taking the time to review our manuscript, we thank Laurence Baret, genetic counselor. We also thank John Bisping for his linguistic revisions and helpful comments.
Conflict of Interest
Nathalie Egalite declares that she does not have any conflict of interest. Beatrice Godard declares that she does not have any conflict of interest. Iris Jaitovich Groisman serves as a member and consultant on ethics committees in the public and private sectors.
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