scholarly journals Informed consent for return of incidental findings in genomic research

2013 ◽  
Vol 16 (5) ◽  
pp. 367-373 ◽  
Author(s):  
Paul S. Appelbaum ◽  
Cameron R. Waldman ◽  
Abby Fyer ◽  
Robert Klitzman ◽  
Erik Parens ◽  
...  
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Genomic Research

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

2019 ◽  
Vol 55 ◽  
pp. 29-35 ◽  
Author(s):  
Anna Sundby ◽  
Merete Watt Boolsen ◽  
Kristoffer Sølvsten Burgdorf ◽  
Henrik Ullum ◽  
Thomas Folkmann Hansen ◽  
...  
Keyword(s):  
Informed Consent ◽  
Incidental Findings ◽  
Genetic Research ◽  
Genomic Research ◽  
Research Subjects ◽  
Cross Sectional ◽  
Telephone Consultation ◽  
Active Involvement ◽  
Consent Procedure ◽  
To Receive

AbstractBackground: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.

Critical social theory approach to disclosure of genomic incidental findings

2012 ◽  
Vol 19 (6) ◽  
pp. 819-828 ◽  
Author(s):  
Jeffrey L Bevan ◽  
Julia N Senn-Reeves ◽  
Ben R Inventor ◽  
Shawna M Greiner ◽  
Karen M Mayer ◽  
...  
Keyword(s):  
Informed Consent ◽  
Social Theory ◽  
Incidental Findings ◽  
Critical Social Theory ◽  
Genomic Research ◽  
Theory Approach ◽  
Nursing Research ◽  
Related Information ◽  
Health Related ◽  
Critical Social

Technology has expanded genomic research and the complexity of extracted gene-related information. Health-related genomic incidental findings pose new dilemmas for nurse researchers regarding the ethical application of disclosure to participants. Consequently, informed consent specific to incidental findings is recommended. Critical Social Theory is used as a guide in recognition of the changing meaning of informed consent and to serve as a framework to inform nursing of the ethical application of disclosure consent in genomic nursing research practices.

scholarly journals Ethical issues in genomics research on neurodevelopmental disorders: a critical interpretive review

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
S. Mezinska ◽  
L. Gallagher ◽  
M. Verbrugge ◽  
E.M. Bunnik
Keyword(s):  
Informed Consent ◽  
Neurodevelopmental Disorders ◽  
Cognitive Abilities ◽  
Social Impact ◽  
Mental Health Problems ◽  
Ethical Issues ◽  
Family Members ◽  
Genetic Diagnosis ◽  
Research Participation ◽  
Genomic Research

Abstract Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

scholarly journals Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research

2016 ◽  
Vol 5 (1) ◽  
pp. 3 ◽  
Author(s):  
Emmanuelle Souzeau ◽  
Kathryn P. Burdon ◽  
David A. Mackey ◽  
Alex W. Hewitt ◽  
Ravi Savarirayan ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genomic Research ◽  
Ethical Considerations

scholarly journals Rapid Ethical Appraisal: A tool to design a contextualized consent process for a genetic study of podoconiosis in Ethiopia

2017 ◽  
Vol 2 ◽  
pp. 99 ◽  
Author(s):  
Tewodros Tariku Gebresilase ◽  
Zebene Deresse ◽  
Girmay Tsegay ◽  
Tesfaye Sisay Tessema ◽  
Abraham Aseffa ◽  
...  
Keyword(s):  
Informed Consent ◽  
Genetic Study ◽  
Research Process ◽  
Genomic Research ◽  
Community Members ◽  
Factors Affecting ◽  
Institutional Review ◽  
Field Workers ◽  
And Gender ◽  
Healthy Community

Background: Obtaining genuine informed consent from research participants in developing countries can be difficult, partly due to poor knowledge about research process and research ethics. The situation is complicated when conducting genomic research on a disease considered familial and a reason for stigmatisation. Methods: We used a Rapid Ethical Appraisal tool to assess local factors that were barriers to getting genuine informed consent prior to conducting a genetic study of podoconiosis (non-filarial elephantiasis) in two Zones of Ethiopia. The tool included in-depth interviews and focus group discussions with patients, healthy community members, field workers, researchers/Institutional Review Board (IRB) members, elders, religious leaders, and podoconiosis administrators who work closely with patients. Results: Most patients and healthy community members did not differentiate research from routine clinical diagnosis. Participants felt comfortable when approached in the presence of trusted community members. Field workers and podoconiosis administrators preferred verbal consent, whereas the majority of patients and healthy community members prefer both verbal and written consent. Participants better understood genetic susceptibility concepts when analogies drawn from their day-to-day experience were used. The type of biological sample sought and gender were the two most important factors affecting the recruitment process. Most researchers and IRB members indicated that reporting incidental findings to participants is not a priority in an Ethiopian context. Conclusions: Understanding the concerns of local people in areas where research is to be conducted facilitates the design of contextualized consent processes appropriate for all parties and will ultimately result in getting genuine consent.

scholarly journals Association of Researcher Characteristics with Views on Return of Incidental Findings from Genomic Research

2015 ◽  
Vol 24 (5) ◽  
pp. 833-841 ◽  
Author(s):  
Julia Wynn ◽  
Josue Martinez ◽  
Jimmy Duong ◽  
Yuan Zhang ◽  
Jo Phelan ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genomic Research

scholarly journals Researchers’ views on informed consent for return of secondary results in genomic research

2014 ◽  
Vol 17 (8) ◽  
pp. 644-650 ◽  
Author(s):  
Paul S. Appelbaum ◽  
Abby Fyer ◽  
Robert L. Klitzman ◽  
Josue Martinez ◽  
Erik Parens ◽  
...  
Keyword(s):  
Informed Consent ◽  
Genomic Research ◽  
Secondary Results

scholarly journals Raising Genomic Citizens: Adolescents and the Return of Secondary Genomic Findings

2016 ◽  
Vol 44 (2) ◽  
pp. 292-308 ◽  
Author(s):  
Maya Sabatello ◽  
Paul S. Appelbaum
Keyword(s):  
Exome Sequencing ◽  
Policy Development ◽  
Incidental Findings ◽  
Pediatric Research ◽  
Genomic Research ◽  
Whole Genome ◽  
Research With Children ◽  
Intense Debate

Whole genome and exome sequencing (WGS/WES) techniques raise hope for a new scale of diagnosis, prevention, and prediction of genetic conditions, and improved care for children. For these hopes to materialize, extensive genomic research with children will be needed. However, the use of WGS/WES in pediatric research settings raises considerable challenges for families, researchers, and policy development. In particular, the possibility that these techniques will generate genetic findings unrelated to the primary goal of sequencing has stirred intense debate about whether, which, how, and when these secondary or incidental findings (SFs) should be returned to parents and minors. The debate is even more pronounced when the subjects are adolescents, for whom decisions about return of SFs may have particular implications. In this paper, we consider the rise of “genomic citizenship” and the main challenges that arise for these stakeholders: adolescents' involvement in decisions relating to return of genomic SFs, the types of SFs that should be offered, privacy protections, and communication between researchers and adolescents about SFs. We argue that adolescents' involvement in genomic SF-related decisions acknowledges their status as valuable stakeholders without detracting from broader familial interests, and promotes more informed genomic citizens.

scholarly journals Informed consent for exome sequencing research in families with genetic disease: The emerging issue of incidental findings

2014 ◽  
Vol 164 (11) ◽  
pp. 2745-2752 ◽  
Author(s):  
Amanda L. Bergner ◽  
Juli Bollinger ◽  
Karen S. Raraigh ◽  
Crystal Tichnell ◽  
Brittney Murray ◽  
...  
Keyword(s):  
Informed Consent ◽  
Exome Sequencing ◽  
Genetic Disease ◽  
Incidental Findings
Sign in / Sign up

Export Citation Format

Share Document