Informed consent, genomic research and mental health: A integrative review
Nina Kilkku, Arja Halkoaho
Nursing ethics, 4 February 2022
Open Access
Abstract
Background
Research on genomics has increased while the biobank activities are becoming more common in different countries. In the mental health field, the questions concerning the potential participants’ vulnerability as well as capacity to give the informed consent can cause reluctancy in recruiting persons with mental health problems, although the knowledge and understanding of mental health problems has remarkably changed, and practice is guided with inclusive approaches, such as recovery approach.
Aim
The aim of this study was to describe the current knowledge of informed consent practices in the context of genomic research on mental health from the nurses’ viewpoint.
Methods
An integrative review was conducted with search from seven international databases. Data consist 14 publications which were analyzed with thematic analysis.
Ethical considerations
Ethical requirements were respected in every phase of the research process.
Findings
Most of the papers were published in USA and between 2000-2010. Eight reports were categorized as discussion papers, four qualitative studies and one quantitative study. The thematic analysis provided information on five themes: complexity with the capacity to consent, mixed emotions towards participation, factors influencing the decision to participate, nurses’ informed consent process competence and variations between consent procedures.
Discussion
In the informed consent practices, there are various aspects which may affect both the willingness to participate in the study and the informed consent process itself. Implications for practice, education, research, and policies are discussed.
Conclusion
There is a need for more updated international research on the topic in the context of different international and national guidelines, legislation, and directives. This study provided a viewpoint to the more collaborative research activities with people with lived experiences also in this field of research following the ideas of recovery approach.
Month: March 2022
Informed consent practices for exome sequencing: An interview study with clinical geneticists in the Netherlands
Informed consent practices for exome sequencing: An interview study with clinical geneticists in the Netherlands
Original Article
Wendy Bos, Eline M. Bunnik
Molecular Genetics & Genomic Medicine, 14 January 2022
Open Access
Abstract
Background
Genomic sequencing is being used more frequently in the clinic, not only by clinical geneticists, but also by other specialists (“mainstreaming”). The use of genomic sequencing gives rise to challenges regarding informed consent, as it can yield more, and more complex results.
Methods
This study maps the informed consent process for exome sequencing in the Netherlands by means of semistructured interviews with 14 clinical geneticists. Interviewees were asked about their strategies for informing patients about exome sequencing and supporting patients in their decision making, about what they think of as essential information elements, about the challenges they experience, and about their preferences for future policy and practice.
Results
Clinical geneticists typically discuss the following topics: the nature and aim of the test, the possible results (including unsolicited or incidental findings and Variants of Uncertain Significance) of the test and the consequences of those results for the patient and their family members. Some clinical geneticists use a layered approach to informed consent, meaning that they give short and concise information at first, and provide more detailed information depending on the situation or the needs of the patient.
Conclusion
During pre-test counseling for genomic sequencing, clinical geneticists use various strategies to enhance patient understanding and personalization of the informed consent process. Going forward, layering information may be part of a solution to ethical challenges of informed consent, also in mainstream settings.
Toward an architecture to improve privacy and informational self-determination through informed consent
Toward an architecture to improve privacy and informational self-determination through informed consent
Mohamad Gharib
Information and Computer Security, 23 February 2022
Abstract
Purpose
Most developed countries have enacted privacy laws to govern the collection and use of personal information (PI) as a response to the increased misuse of PI. Yet, these laws rely heavily on the concept of informational self-determination through the “notice” and “consent” models, which is deeply flawed. This study aims at tackling these flaws achieve the full potential of these privacy laws.
Design/methodology/approach
The author critically reviews the concept of informational self-determination through the “notice” and “consent” model identifying its main flaws and how they can be tackled.
Findings
Existing approaches present interesting ideas and useful techniques that focus on tackling some specific problems of informational self-determination but fall short in proposing a comprehensive solution that tackles the essence of the overall problem.
Originality/value
This study introduces a model for informed consent, a proposed architecture that aims at empowering individuals (data subjects) to take an active role in the protection of their PI by simplifying the informed consent transaction without reducing its effectiveness, and an ontology that can partially realize the proposed architecture.
Sovereign Digital Consent through Privacy Impact Quantification and Dynamic Consent
Sovereign Digital Consent through Privacy Impact Quantification and Dynamic Consent
Article
Arno Appenzeller, Marina Hornung, Thomas Kadow, Erik Krempel, Jürgen Beyerer
Technologies, 21 February 2022; 10(35)
Open Access
Abstract
Digitization is becoming more and more important in the medical sector. Through electronic health records and the growing amount of digital data of patients available, big data research finds an increasing amount of use cases. The rising amount of data and the imposing privacy risks can be overwhelming for patients, so they can have the feeling of being out of control of their data. Several previous studies on digital consent have tried to solve this problem and empower the patient. However, there are no complete solution for the arising questions yet. This paper presents the concept of Sovereign Digital Consent by the combination of a consent privacy impact quantification and a technology for proactive sovereign consent. The privacy impact quantification supports the patient to comprehend the potential risk when sharing the data and considers the personal preferences regarding acceptance for a research project. The proactive dynamic consent implementation provides an implementation for fine granular digital consent, using medical data categorization terminology. This gives patients the ability to control their consent decisions dynamically and is research friendly through the automatic enforcement of the patients’ consent decision. Both technologies are evaluated and implemented in a prototypical application. With the combination of those technologies, a promising step towards patient empowerment through Sovereign Digital Consent can be made.
How Informed is Consent? A Field Experiment
How Informed is Consent? A Field Experiment
Discussion Paper
Alexandra Avdeenko, Matthias Stelter
Centre for Economic Policy Research, 1 February 2022
Abstract
In an increasingly data-driven world, data protection and the requirement of obtaining informed consent rapidly gain relevance. The intention is to protect data holders. Yet, is consent provided by data holders truly informed? In the context of empirical research, the requirement for informed consent can affect external validity and data quality of the evidence generated. Conducting a survey with 7,752 potential participants in rural Pakistan, we find that respondents are insufficiently informed about important aspects related to their consent. Experimentally changing the consent process, we find that showing an animated video has a negative impact on respondent’s understanding, but additionally engaging them in an interactive dialogue about the informational text significantly improves understanding. Even though we find effects on levels of understanding, we do not find meaningful changes in consent rates and non-response behavior indicating no adverse effects on the quality of the survey.
Editor’s note: The Centre for Economic Policy Research’s network of Research Fellows and Affiliates includes economists conducting research on issues affecting the European economy.
Factorial Structure of Nursing Practices Related to Support for Decision-Making Regarding Consent for Surgery in Elderly Patients with Dementia
Factorial Structure of Nursing Practices Related to Support for Decision-Making Regarding Consent for Surgery in Elderly Patients with Dementia
Original Research
Sachiko Matsui, Miwa Yamamoto
Yonago Acta Medica, 22 February 2022; 65(1) pp 70–81
Open Access
Abstract
Background
When elderly patients with dementia require highly invasive treatment or surgery for lifethreatening conditions, decisions regarding consent for surgery are made based on informed consent provided by the family, which excludes the patient whose decision-making ability is deemed impaired due to the dementia. This study aimed to clarify the factorial structure of nursing practices related to support for decision-making regarding consent for surgery in elderly patients with dementia.
Methods
An anonymous self-administered questionnaire survey was completed by nurses with three or more years of experience working in orthopedic surgery wards at secondary emergency hospitals in the Kinki area. The survey collected data on participant attributes and nursing practices related to decision-making support. Data were analyzed by exploratory factor analysis (promax rotation) using nursing practice items related to decision-making support as variables. Internal consistency was examined.
Results
Participants were 112 nurses including 108 women (96.4%) and four men (3.6%), with a mean age of 38.3 (±SD 9.8) years. Exploratory factor analysis of the nursing practice items related to decision-making support demonstrated the validity of the observed 24 variables, with a Kaiser-Meyer-Olkin value of 0.858 and a significant Bartlett’s test of sphericity (P < 0.001). Five components with eigenvalues of 1 or more were extracted, including “achieving advocacy for elderly patients with dementia through cooperation among medical professionals,” “advice considering the lifestyles and values of patients and their families,” “support with a deeper understanding of elderly patients with dementia,” “support that helps elderly patients with dementia to express their intentions,” and “nurses’ attendance in IC sessions for elderly patients with dementia.” The Cronbach’s α coefficient for the 24 nursing practice items related to decision-making support was high, at 0.926.
Conclusion
The factorial structure of nursing practice related to support for decision-making regarding consent for surgery in elderly patients with dementia included five factors and 24 items. The reliability and construct validity of the factorial structure were also confirmed.
Editor’s note: Yonago Acta Medica (YAM) is a peer-reviewed journal, specializing in medical sciences, published by Tottori University Medical Press, Japan.
Consent and parental responsibility – the past, the present and the future
Consent and parental responsibility – the past, the present and the future
Asma Keshtgar, Mohamed Hania, Mohammad O. Sharif
British Dental Journal, 28 January 2022; 232 pp 115 – 119
Open Access
Abstract
Introduction
Informed consent is the ‘permission or agreement’ given by the patient for a proposed action. This paper explores the clinician’s role in obtaining informed consent, provides an overview of consent and parental responsibility in the UK, and presents practical adjuncts to aid dental professionals in ascertaining who has parental responsibility to delineate persons capable of providing assent on behalf of an underage patient.
Consent and parental responsibility
While the principles of consent have largely stayed constant with time, subtleties in parental responsibility legislation exist in different regions of the UK. An audit exploring consent and parental responsibility knowledge among clinicians within the orthodontic department at the UCLH Eastman Dental Hospital demonstrated that none of the respondents met the gold standard (100%). The results ranged from 59-89% with a mean score of 74%. The majority of questions answered incorrectly related to knowledge of parental responsibility.
Conclusion
It is the responsibility of clinicians providing any care within the UK to stay up to date with legislation and regulations regarding consent and parental responsibility. Knowledge-based questionnaires can highlight areas of knowledge deficit which can be addressed through continuous professional development. This paper provides a flowchart summarising parental responsibility and a prefilled parental responsibility questionnaire as adjuncts to simplify the process of dental professionals ascertaining parental responsibility.
Health care providers’ ethical perspectives on waiver of final consent for Medical Assistance in Dying (MAiD): a qualitative study
Health care providers’ ethical perspectives on waiver of final consent for Medical Assistance in Dying (MAiD): a qualitative study
Research
Caroline Variath, Elizabeth Peter, Lisa Cranley, Dianne Godkin
BMC Medical Ethics, 30 January 2022; 23(8)
Open Access
Abstract
Background
With the enactment of Bill C-7 in Canada in March 2021, people who are eligible for medical assistance in dying (MAiD), whose death is reasonably foreseeable and are at risk of losing decision-making capacity, may enter into a written agreement with their healthcare provider to waive the final consent requirement at the time of provision. This study explored healthcare providers’ perspectives on honouring eligible patients’ request for MAiD in the absence of a contemporaneous consent following their loss of decision-making capacity.
Method
A critical qualitative methodology, using a feminist ethics theoretical lens with its focus on power and relationality, was used to examine how socio-political and environmental contexts influenced healthcare providers’ moral agency and perspectives. Semi-structured interviews were conducted with 30 healthcare providers (13 physicians, six nurse practitioners, nine nurses and two social workers) from across Canada who provide MAiD-related care.
Results
Themes identified include; (1) balancing personal values and professional responsibilities, (2) anticipating strengths and limitations of the proposed waiver of final consent amendment, (3) experiencing ethical influences on decisions to enter into written agreements with eligible patients, (4) recognizing barriers to the enactment of MAiD in the absence of a contemporaneous consent and (5) navigating the potential for increased risks and burden.
Discussion
To our knowledge, this is the first study in Canada to explore healthcare providers’ perspectives on waiving the final consent for MAiD using a written agreement. Most participants supported expanding eligible people’s access to MAiD following loss of capacity, as they believed it would improve the patients’ comfort and minimize suffering. However, the lack of patients’ input at the time of provision and related ethical and legal challenges may impact healthcare providers’ moral agency and reduce some patients’ access to MAiD. Providers indicated they would enter into written agreements to waive final consent for MAiD on a case-by-case basis. This study highlights the importance of organizational, legal and professional support, adequate resources, clear policies and guidelines for the safety and wellbeing of healthcare providers and to ensure equitable access to MAiD.
Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study
Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study
Research Article
Zhanqing Hu, Chenxi Ouyang, Jessica Hahne, Kaveh Khoshnood, Jinqiang Zhang, Xiyu Liu, Ying Wu, Xiaomin Wang
Journal of Empirical Research on Human Research Ethics, 28 January 2022
Abstract
This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants’ knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.
The Analysis Causes of Informed Consent in Supporting the Quality of Medical Record In Graha Hospital Medika Banyuwangi
The Analysis Causes of Informed Consent in Supporting the Quality of Medical Record In Graha Hospital Medika Banyuwangi
Rizqi Aji Aprilia, Erma Sulistyaningsih, Leersia Yusi Rat
International Journal of Innovative Science and Research Technology, December 2021; 6(12)
Abstract
Backgrounds
Informed consent is an agreement given by the patient or family after receiving a clear explanation of the patient’s medical or dental action to be carried out. The standard of completeness of the Informed Consent is based on the Hospital Minimum Service Standard No. 290 of 2008 and the hospital quality standard is 100%. The number of incomplete informed consent at Graha Medika Hospital in the third quarter of 2020 was 11.14%, 26.90%, and 41%, which means that the standard for completeness of informed consent has not been achieved. The purpose of the study was to analyze the factors causing incomplete informed consent.
Methods
The research design used a quantitative approach with a cross-sectional research design. The population and sample were 258 informed consent forms. The unit of analysis was 30 medical doctors who filled out the informed consent. Data analysis used univariate, bivariate with Spearman Rank, and multivariate with Partial Least Square.
Results
The bivariate analysis results showed that the resource indicator had a relationship with the completeness of Informed Consent with a value of 0.005. A multivariate analysis that organizational factors had a relationship with the completeness of Informed Consent with a value of 0.001.
Conclusion
Strengthening the resource sector with a solid organizational commitment will increase the completeness of informed consent, which is inseparable from the quality of the organization’s management function. A good management function will run in harmony with the level of compliance of good service personnel.
Editor’s note: The International Journal of Innovative Science and Research Technology is an open access peer-reviewed international forum for scientists and engineers published in India.
Center for Informed Consent Integrity 