The preferences of potential stakeholders in psychiatric genomic research regarding consent procedures and information delivery

Abstract

Background:Genomic sequencing plays an increasing role in genetic research, also in psychiatry. This raises challenges concerning the validity and type of the informed consent and the return of incidental findings. However, no solution currently exists on the best way to obtain the informed consent and deliver findings to research subjects.Aims:This study aims to explore the attitudes among potential stakeholders in psychiatric genomic research toward the consenting procedure and the delivery of incidental findings.Methods:We developed a cross-sectional web-based survey among five groups of stakeholders. A total of 2637 stakeholders responded: 241 persons with a mental disorder, 671 relatives, 1623 blood donors, 74 psychiatrists, and 28 clinical geneticists.Results:The stakeholders wanted active involvement as 92.7% preferred a specific consent and 85.1% wanted to receive information through a dynamic consent procedure. The majority of stakeholders preferred to receive genomic information related to serious or life-threatening health conditions through direct contact (69.5%) with a health professional, i.e. face-to-face consultation or telephone consultation (82.4%). Persons with mental disorders and relatives did not differ in their attitudes from the other stakeholder groups.Conclusion:The findings illustrate that the stakeholders want to be more actively involved and consider consent as a reciprocal transaction between the involved subjects and the researchers in the project. The results highlight the importance of collaboration between researchers and clinical geneticists as the latter are trained, through their education and clinical experience, to return and explain genomic data to patients, relatives, and research subjects.

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

“…Moreover, 3 mixed methods studies met 80% or more of the quality criteria [ 16 , 44 , 45 ], 6 studies met from 57% to 71% of the quality criteria [ 15 , 46 - 50 ], while 1 met only 43% of the quality criteria [ 51 ]. The only cohort study had a quality score of 7 [ 52 ], while the quality scores of cross-sectional studies were assessed to be 4 [ 53 - 56 ], 5 [ 57 - 61 ], and 6 [ 62 ].…”

Psychiatric genomics researchers’ perspectives on best practices for returning results to individual participants

“…The ethical arguments for RoR in the research setting, and many of the guidelines regarding which findings should be offered in both the clinical and research settings, have stressed the importance of medical actionability. 5,8,9,16,17,27 Some have argued for the return of non-medically actionable findings, though not as commonly as for returning medically actionable findings. 5,6 For example, Jarvik et al 6 reasoned that medically actionable findings generated in the course of research should be the "floor" or minimum information offered to participants, but that "researchers might be ethically and scientifically justified in returning all genomic information (the "ceiling") in some format and any level of information in between.…”

“…The practical challenges of instituting these dual roles in practice have likewise been noted in other areas of genetic research 43 but may be particularly acute when returning results to individuals at risk or diagnosed with a psychiatric disorder. 27,44 This is due to the potential need to identify participant characteristics (e.g., particular psychiatric states or acute episodes), in line with clinician recommendations, that may positively or negatively impact reception of results and thereby require special procedures. Over half of respondents reported concerns about available funding and noted the need for scalable strategies to meet these growing demands.…”

“…7,10 While these studies have opened a broader dialogue about whether results should be offered and why, only a few empirical studies to date have specifically addressed which results should be offered and how results should be returned in psychiatric genetics research. [19][20][21]27 No empirical study has examined these issue from the perspective of psychiatric genomics researchers who are key stakeholders in implementing plans for returning results.…”

A look into the future? Patients' and health care staff's perception and evaluation of genetic information and the right not to know

“…The empirical studies on the issue—which comprise predominantly smaller samples with qualitative interviews—show, that clients and patients are in general interested in predictive genetic information, but often have problems to adequately classify and interpret it for their own situation (see also section 4). However, there are at the present point of time only a few publications with detailed quantitative research in the field of neuropsychiatric diseases concerning the patients' perception and evaluation of the right not to know (e.g., Sundby et al, , ).…”