“Ethics Ready”? Governing Research Through Informed Consent Procedures
Florence Caeymaex, Carole Wenger, Felicien de Heusch, Jean-Michel Lafleur
International Journal of Qualitative Methods, 11 April 2023
Open Access
Abstract
Social Scientists using ethnographic methods are increasingly confronted with ethical clearance procedures imposed by universities, national authorities, professional organizations and funders. In this article, we focus on informed consent procedures in particular and discuss how they govern fieldwork interactions. To do so, we first show how ethical clearance procedures in Europe have been influenced by biomedical science, creating a risk of “governing the social science research in the name of ethics” (Haggerty, 2004) through “anticipatory regulatory regimes” (Murphy and Dingwall, 2007). We subsequently discuss the implementation of ethical procedures negotiated with an ethical review panel in the framework of an EU-funded project in migration studies. In doing so, we show how Research Ethics Committees (RECs) can incentivize researchers to comply with ethical guidelines and procedures in order to be considered as “ethics ready” by the funder. Providing examples of different ethnographic situations, we argue that —while informed consent procedures might reinforce participants’ vulnerabilities— they can also activate their desire to assert power. The article concludes with three recommendations that call for a redefinition of the relationships between institutions, researchers and participants through a co-construction of research ethics.
Month: May 2023
Privacy for IoT: Informed consent management in Smart Buildings
Privacy for IoT: Informed consent management in Smart Buildings
Chehara Pathmabandu, John Grundy, Mohan Baruwal Chhetri, Zubair Baig
Future Generation Computer Systems, August 2023; 145 pp 367-383
Abstract
Smart Buildings (SBs) employ the latest IoT technologies to automate building operations and services with the objective of increasing operational efficiency, maximising occupant comfort, and minimising environmental impact. However, these smart devices – mostly cloud-based – can capture and share a variety of sensitive and private data about the occupants, exposing them to various privacy threats. Given the non-intrusive nature of these devices, individuals typically have little or no awareness of the data being collected about them. Even if they do and claim to care about their privacy, they fail to take the necessary steps to safeguard it due to the convenience offered by the IoT devices. This discrepancy between user attitude and actual behaviour is known as the ‘privacy paradox’. To address this tension between data privacy, consent and convenience, this paper proposes a novel solution for informed consent management in shared smart spaces. Our proposed Informed Consent Management Engine (ICME) (a) increases user awareness about the data being collected by the IoT devices in the SB environment, (b) provides fine-grained visibility into privacy conformance and compliance by these devices, and (c) enables informed and confident privacy decision-making, through digital nudging. This study provides a reference architecture for ICME that can be used to implement diverse end-user consent management solutions for smart buildings. A proof-of-concept prototype is also implemented to demonstrate how ICME works in a shared smart workplace. Our proposed solution is validated by conducting expert interviews with 15 highly experienced industry professionals and academic researchers to understand the strengths, limitations, and potential improvements of the proposed system.
Assent and vulnerability in patients who lack capacity
Assent and vulnerability in patients who lack capacity
Commentary
Christopher A Riddle
Journal of Medical Ethics, 17 April 2023
Excerpt
Smajdor’s Reification and Assent in Research Involving Those Who lack Capacity claims, among other things, that ‘adults who cannot give informed consent may nevertheless have the ability to assent and dissent, and that these capacities are morally important in the context of research’. More pointedly, she suggests we can rely upon Gillick competence, or that ‘it is worth thinking about why the same trajectory [as children] has not been evident in the context of [adults with impairments of capacity to give informed consent (AWIC)]’. I argue that her likening assent in AWIC to assent in children is problematic for at least two related reasons. First, direct comparisons between AWIC and children run the risk of perpetuating or reinforcing infantilising stereotypes against people with disabilities. Second, I argue that people with disabilities are vulnerable in ways that most children are not, and thus, are dissimilar in a morally relevant manner…
Editor’s note: The article which is referenced in this commentary was featured in the February edition of this digest.
Autonomy of Individuals with Alcohol-Related Disorders: Informed Consent and Empowerment
Autonomy of Individuals with Alcohol-Related Disorders: Informed Consent and Empowerment
João Paulo Barbosa Azevedo
Journal of Addiction & Addictive Disorders, 12 April 2023
Abstract
Informed consent is a central concern in the care practice of individuals with alcohol- related disorders, with research and clinical practice indicating that they often refuse or abandon treatment early. In the relational care encounter it is important not only to recognize the patient as the subject of will and decision-making power, but also to pay attention to the experiences of vulnerability and the importance of promoting autonomy. These issues are particularly relevant when individuals with alcohol-use disorders come to treatment suffering from coercion or disturbed by anxiety and/or depression. A study on informed consent ethical practice was conducted on a sample of 85 professionals from the Addictive Behaviours and Dependencies network of the Regional Health Administration of the North, Portugal. A questionnaire was used to survey ethical attitudes. The results suggest the importance of reinforcing the practice of informed consent of individuals with alcohol-related disorders suffering from coercion, anxiety or depression as a place of a psychological empowerment process.
Informed consent with people judged incapable of legally consenting
Informed consent with people judged incapable of legally consenting
Amy Bittick, Ryan Holliman
Advances in Mental Health and Intellectual Disabilities, 6 April 2023
Abstract
Purpose
The purpose of this study is to consider informed consent with those who may be legally judged incapable of consent. Frequently individuals with traumatic brain injuries and intellectual disabilities may fall into this category. This paper seeks to consider aspects of guardianship, moral and legal implications and best practices for mental health professionals.
Design/methodology/approach
This practice piece reviews literature regarding informed consent, as well as pertinent issues in the professional literature regarding types of guardianship as well as the occurrence of “Lucid intervals.” Furthermore, literature from moral philosophy and current legal research was examined to fully provide readers with a grasp of the legal and ethical landscape of this issue.
Findings
The paper finds that treating consent as a one-time binary event is lacking in both practicality and nuance. Moral philosophy and issues regarding paternalism are raised, as well as practice approaches to assessment of capability and how to engage in therapy in meaningful ways.
Originality/value
This paper provides insight into providing dignity-affirming therapy with a population that is often not considered in the literature of mental health ethics. When it is considered, the suggestions are so vague as to be of limited use. This manuscript provides nuance and practical applications to be a therapist that promotes dignity in those who might have varying levels of capacity to consent.
The Role of Different Aspects of Communication Behavior in the Assessment of Capacity to Consent
The Role of Different Aspects of Communication Behavior in the Assessment of Capacity to Consent
Luise Badenhoop, Stefanie Baisch, Susanne Penger, Julia Haberstroh
Journal of Gerontopsychology and Geriatric Psychiatry, 5 April 2023
Open Access
Abstract
Any medical treatment that interferes with physical integrity requires the informed consent of a patient capable of such consent. For people with dementia, the capacity to consent is questioned even in the early course of the disease. Particularly diagnostic instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) often deny people with dementia the capacity to consent because of high confounding of the results with patients’ verbal abilities. To date, it remains unclear whether not only verbal but also nonverbal communication is associated with assessments of capacity to consent. The current study investigates associations between patients’ verbal and nonverbal communication behaviors as assessed by the measure for Communication Behavior in People with Dementia in Ambulant Settings (CODEMamb) and capacity to consent as assessed by the MacCAT-T. We expected the strongest positive associations for verbal communication behaviors compared to nonverbal communication behaviors. Data of N = 43 patients with dementia (n = 8 capable of consent) were collected at two different German psychiatric clinics. The results show small to moderate correlations between the overall scores of CODEMamb and MacCAT-T. As expected, correlations were strongest for the verbal CODEMamb subscale. The results support current findings on the dependency of the MacCAT-T on verbal communication. Based on the findings, the discussion addresses how people with dementia can be enabled to make self-determined medical treatment decisions.
Informed Consent, Assent, and Confidentiality
Informed Consent, Assent, and Confidentiality
Book Chapter
Eron Linver
Caring for the Hospitalized Child, May 2023 [American Academy of Pediatrics]
Excerpt
Informed consent is defined as the voluntary agreement of an individual or their authorized representative who has the legal authority to give such agreement. This consent must be exercised within the context of free choice, without any application of inducement or coercion. To give informed consent, an individual must have sufficient knowledge and understanding to be able to make a knowledgeable decision. Health care providers may have a different level of education and understanding than patients and their guardians. This knowledge gap can add complexity and potential misunderstandings to conversations surrounding informed consent…
Consent for the paediatric patient
Consent for the paediatric patient
Andrew Jones, James Hyde, Sharon Lee, Sondos Albadri, Laura Gartshore
Faculty Dental Journal, 1 April 2023; 14(2)
Abstract
Introduction
Obtaining valid consent is a fundamental process in dentistry. Written consent must be obtained where treatment involves conscious sedation or general anaesthesia. For children, consent may be provided by a person with parental responsibility (PR).
Methods
A retrospective evaluation was completed of 160 children over 2 UK hospital sites with paediatric services. Cases involving conscious sedation or general anaesthesia for dental treatment were selected. Data were obtained to establish whether it was documented that the correct person had provided consent for a child and whether all possible individuals with PR for the child were identified at the initial visit. UK national legislation and guidance was reviewed, from which a PR form (to determine PR status for a child) was created and implemented. A second evaluation was subsequently completed, again with 160 children.
Results
Combined data from both sites confirmed documentation of an appropriate person providing consent in 127 cases (79%) in the first evaluation. This improved to 155 cases (97%) following implementation of the PR form. All possible individuals who had PR for the child were identified at the initial visit in 35 cases (22%). This improved to 139 cases (87%) following the introduction of the PR form.
Conclusions
Use of a PR form improved documentation regarding valid consent for children.
Editor’s note: This is a publication from the Royals College of Surgeons England.
Informed Consent: How much information is enough? In a Obstetrics and Gynaecology Department in Tertiary Care Hospital – An Interventional Study
Informed Consent: How much information is enough? In a Obstetrics and Gynaecology Department in Tertiary Care Hospital – An Interventional Study
Indian Journal of Forensic Medicine & Toxicology, 17(2), April-June 2023
Open Access
Abstract
Permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits. A process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This paper was an interventional study it was conducted in the Department of Forensic Medicine and Toxicology, Sri Manakula Vinayaga Medical College and Hospital, Madagadipet, Puducherry to audit and to improve it was conducted in the Department of Obstetrics and Gynaecology. The deficiencies were identified and it was analysed. The results of both pre-interventional and post-interventional were recorded, which showed the significant improvement in the consent form of the major and minor procedures. It is essential that this information be discussed in simple terminology that can be easily readily understood and help the patient to give proper consent for the procedures.
Traditional Health Care Practitioners’ Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study
Traditional Health Care Practitioners’ Perspectives on Applying Informed Consent During African Traditional Medical Practice in Akwa Ibom State, Nigeria: A Cross-Sectional Qualitative Study
Francis Akpa-Inyang, Sylvester C. Chima
Journal of Integrative and Complementary Medicine, 17 April 2023
Abstract
Introduction
This study explored the perspectives of traditional health care practitioners (THPs) practicing in the areas of herbalism, bone setting, and traditional birth attendance, from Akwa Ibom state, Nigeria, on the possibility and implications of applying informed consent (IC) during African traditional medicine (ATM) practice.
Methods
Semistructured interviews were conducted with 11 THPs, consisting of 5 herbalists, 3 traditional bone setters (TBS), and 3 traditional birth attendants (TBAs), who represented the diverse groups that the study intended to cover. In-depth interviews were conducted using a semistructured guide and were recorded, transcribed, and analyzed using thematic analysis with the assistance of NVivo® qualitative analysis software.
Results
Participants were seven males (64%) and four females (36%), 35–67 years of age, with 5–25 years of experience as THPs. Forty-six percent of participants were herbalists (27%), TBS, and TBAs (27%). Most participants (82%) were Annang, and (18%) were Ibibio first-language speakers. Three major themes emerged from the data analysis: (i) Existing ethical framework related to IC, (ii) knowledge of consent, and (iii) application of IC during traditional medical practice. These themes and relevant subthemes were explored. All (100%) THPs agreed that it was essential to communicate risks and benefits while allowing patients to ask questions before treatment. All participants (100%) stated that risk communication is essential in ATM, whereas 36% said they communicated all therapy benefits to their patients. Respondents believed patients could make an informed choice if they had complete information disclosure. However, THPs in this study had limited knowledge of formal IC rules and regulations.
Conclusions
This study revealed that THPs in this setting disclose a diagnosis, risks, some benefits, and treatment options to patients. Consent/agreement was obtained verbally and voluntarily during ATM practice, consistent with IC doctrine. THPs had limited knowledge of the critical elements of IC. However, they suggested that a form of IC that does not conflict with traditional African norms could be applicable in ATM. IC could facilitate documentation and help reduce risks in ATM practice.
Center for Informed Consent Integrity 