Use of next generation sequencing technologies in research and beyond: Are participants with mental health disorders fully protected?

BMC Medical Ethics (Impact Factor: 1.5). 12/2012; 13(1):36. DOI: 10.1186/1472-6939-13-36
Source: PubMed


Next Generation Sequencing (NGS) is expected to help find the elusive, causative genetic defects associated with Bipolar Disorder (BD). This article identifies the importance of NGS and further analyses the social and ethical implications of this approach when used in research projects studying BD, as well as other psychiatric ailments, with a view to ensuring the protection of research participants.

We performed a systematic review of studies through PubMed, followed by a manual search through the titles and abstracts of original articles, including the reviews, commentaries and letters published in the last five years and dealing with the ethical and social issues raised by NGS technologies and genomics studies of mental disorders, especially BD. A total of 217 studies contributed to identify the themes discussed herein.

The amount of information generated by NGS renders individuals suffering from BD particularly vulnerable, and increases the need for educational support throughout the consent process, and, subsequently, of genetic counselling, when communicating individual research results and incidental findings to them. Our results highlight the importance and difficulty of respecting participants’ autonomy while avoiding any therapeutic misconception. We also analysed the need for specific regulations on the use and communication of incidental findings, as well as the increasing influence of NGS in health care.

Shared efforts on the part of researchers and their institutions, Research Ethics Boards as well as participants’ representatives are needed to delineate a tailored consent process so as to better protect research participants. However, health care professionals involved in BD care and treatment need to first determine the scientific validity and clinical utility of NGS-generated findings, and thereafter their prevention and treatment significance.

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Available from: Iris Jaitovich Groisman, Aug 27, 2014
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    • "A coding scheme was developed based on these themes. Identification of codes was also informed by results of our earlier studies on ethical issues related to the consent process as it applied to the implementation of genomic technologies (Groisman et al. 2012; Mathieu et al. 2013). 1 During a second stage, analysis was expanded to the corresponding institutional IRB guidelines for every case in which thematic data were not coded. The two coders each read and coded 18 IRB guidelines using the same analytical framework. "
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    ABSTRACT: 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.
    Full-text · Article · Mar 2014 · Journal of Genetic Counseling
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    • "Researchers in psychiatric genetics research using NGS are facing rapid developments in the understanding of mechanisms mediating brain disorders (Zoghbi and Warren, 2010) and this may challenge participants' expectations – like getting confirmation that they have or do not have a genetic predisposition to a psychiatric disorder. The benefits of rapidly sequencing multiple genes at once are clear and the use of NGS has enormous ethical and social implications, for both psychiatric research participants and patients (Groisman et al., 2012), since this technology can reveal important information about their genome (Raffan and Semple, 2011), 'once in a lifetime' (Kamb, 2011, p. 1165). "
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    ABSTRACT: The use of next generation sequencing (NGS) technologies in psychiatric genetics research and its potential to generate individual research results will likely have far reaching implications for predictive and diagnostic practices. The extent of this impact may not be easily understood by psychiatric research participants during the consent process. The traditional consent process for studies involving human subjects does not address critical issues specific to NGS research, such as the return of results. We examined which type of research findings should be communicated, how this information should be conveyed during the consent process and what guidance is required by researchers and IRBs to help psychiatric research participants understand the peculiarities, the limits and the impact of NGS. Strong standards are needed to ensure appropriate use of data generated by NGS, to meet participants' expectations and needs, and to clarify researchers' duties regarding the disclosure of data and their subsequent management. In the short term, researchers and IRBs need to be proactive in revising current consent processes that deal with the disclosure of research findings.
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