How cancer patients and oncologist assess data-sharing and the risk of re-identification in genomic research? Ethical implications for informed consent and governance.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e18186-e18186
Author(s):  
Eva Caroline Winkler ◽  
Sebastian Schleidgen ◽  
Christoph Schickhardt ◽  
Christof V. Kalle ◽  
Dominik Ose ◽  
...  
Keyword(s):  
Informed Consent ◽  
Cancer Patients ◽  
Data Sharing ◽  
Genomic Research ◽  
Ethical Implications

Ethics in Social Research

2018 ◽  
Author(s):  
Steve Bruce
Keyword(s):  
Informed Consent ◽  
Data Collection ◽  
Research Ethics ◽  
Social Research ◽  
Medical Interventions ◽  
Ethical Implications ◽  
Social Researcher ◽  
Naturally Occurring ◽  
The Social ◽  
Collection Phase

It is right that social researchers consider the ethical implications of their work, but discussion of research ethics has been distorted by the primacy of the ‘informed consent’ model for policing medical interventions. It is remarkably rare for the data collection phase of social research to be in any sense harmful, and in most cases seeking consent from, say, members of a church congregation would disrupt the naturally occurring phenomena we wish to study. More relevant is the way we report our research. It is in the disparity between how people would like to see themselves described and explained and how the social researcher describes and explains them that we find the greatest potential for ill-feeling, and even here it is slight.

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.

Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24121-e24121
Author(s):  
Celeste Cagnazzo ◽  
Veronica Franchina ◽  
Giuseppe Toscano ◽  
Franca Fagioli ◽  
Tindara Franchina ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Cancer Patients ◽  
Experimental Therapy ◽  
Average Score ◽  
Trial Participation ◽  
Primary Role ◽  
Fake News ◽  
Patient Awareness ◽  
The Impact

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.

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 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

Consent for Use of Genetic Data among US Hispanics/Latinos: Results from the Hispanic Community Health Study/ Study of Latinos

2021 ◽  
Vol 31 (4) ◽  
pp. 547-558
Author(s):  
Sara Gonzalez ◽  
Garrett Strizich ◽  
Carmen R. Isasi ◽  
Simin Hua ◽  
Betsy Comas ◽  
...  
Keyword(s):  
Community Health ◽  
Data Sharing ◽  
Genetic Data ◽  
Genomic Research ◽  
Health Study ◽  
Medicine Research ◽  
For Profit ◽  
Hispanic Community ◽  
Precision Medicine Research

Inclusion of historically underrepresented populations in biomedical research is critical for large precision medicine research initia­tives. Among 13,721 Hispanic Community Health Study/Study of Latinos (HCHS/SOL) enrollees, we used multivariable-adjusted prevalence ratios to describe characteristics associated with participants’ willingness to consent to different levels of biospecimen and genetic data analysis and sharing. At baseline (2008-2011), HCHS/SOL par­ticipants almost universally consented to the use of biospecimens and genetic data by study investigators and their collabora­tors (97.6%; 95%CI: 97.1, 98.0). Fewer consented to biospecimen and genetic data sharing with investigators not affiliated with the HCHS/SOL research team (81%, 95%CI: 80, 82) or any data sharing with commer­cial/for-profit entities (75%, 95%CI: 74, 76). Those refusing to share their data beyond the study investigators group were more often females, Spanish language-speakers and non-US born individuals. As expected, participants who were retained and recon­sented at the six-year follow up visit tended to embrace broader data sharing, although this varied by group. Over time, Puerto Ricans and Dominicans were more likely to convert to broader data sharing than individuals of a Mexican background. Our analysis suggests that acculturation and im­migration status of specific Hispanic/Latino communities may influence decisions about participation in genomic research projects and biobanks. Ethn Dis. 2021;31(4):547- 558; doi:10.18865/ed.31.4.547

Preimplantation Genetics

2021 ◽  
pp. 98-109
Author(s):  
Valerie Gutmann Koch
Keyword(s):  
Genetic Testing ◽  
Informed Consent ◽  
Genetic Disease ◽  
Chromosomal Abnormalities ◽  
Preimplantation Genetic Testing ◽  
Economic Implications ◽  
Genetic Traits ◽  
Ethical Implications ◽  
Wrongful Life ◽  
Wrongful Birth

This chapter highlights the uses and ethical implications of preimplantation genetic testing and addresses the topic of liability as it applies to use of this technology to screen and select embryos for chromosomal abnormalities and genetic traits prior to implantation. When errors or wrongs occur, there may be significant medical, psychological, and economic implications for those individuals who sought preimplantation testing to avoid a genetic disease or to improve the chance of achieving pregnancy. Informed consent, wrongful birth, and wrongful life claims may be available to those who are harmed due to these errors.

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.

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