Assent and consent in adolescent research: teachers’ perspectives from a developing country
Research Article
Mahmoud A. Alomari, Nihaya A. Al-sheyab, Omar F. Khabour, Karem H. Alzoubi
Heliyon, January 2020; 6(1)
Open Access
Abstract
Teachers play a vital role in facilitating research in schools. However, teachers’ views of informed consent/assent for children participation in research in the Middle East have not been investigated. In this study, focus group interviews were conducted to understand high-school teachers’ perspectives toward adolescent assents and consents. The teachers indicated that parent consent is important and should be coupled with sufficient information about the research study. The teachers added that assent is most important for children above 13 years old. Conversely, the teachers believed that parent approval is only important for invasive (such as research involves blood withdrawal) but not simple procedures. Most importantly, for procedures that are considered simple, part of the teachers do not acknowledge the significance of parental approval, such as body weight, or beneficial, such as new treatment. The results indicate that some of the teachers’ views were consistent with proper conduction of pediatric research. However, other views were worrisome and might warrant further studies and actions. Risks related need to be assessed and policies needs to be developed in order to ensure the proper conduction of pediatric research.
Medical Informed Consent in India: Blind Leading the Blind
Medical Informed Consent in India: Blind Leading the Blind
Review article
Sareen R
Journal of Community Medicine and Health Research, 4 December 2019; 1(3)
Open Access
Abstract
This work is an endeavor to enable health care workers to understand the significance of ‘consent in medical treatment in India’. There have been increased litigations in recent years in health care therefore it is prudent to respect patient autonomy and refrain from too harsh medical paternalistic attitude. The Bolam test has been the yard stick for determining Medical negligence and it is also relevant in terms of consent for medical treatment. The landmark judgment by apex court in India emphasized on role of consent, absence of which shall be considered as deficiency of medical services actionable under tort. As the developed nations move towards ‘Informed consent’ we in India have a long way to go with rampant illiteracy, poor socioeconomic strata and limited resources it is like a dream. The review focuses on hurdles in the informed consenting process as well as the mandatory bare minimum requirements in Indian Law.
The Landscape of the Legal Aspects of Informed Consent for Medical Treatment in Papua New Guinea
The Landscape of the Legal Aspects of Informed Consent for Medical Treatment in Papua New Guinea
Alfred P. Minei, Rachelyn Ann S. Araña, Ronald R. Roldan Jr., Sam O. Kaipu
Journal of Health Science, 2019; 7
Open Access
Abstract
The major challenges militating against the proper practice of informed consent identified in our desk top review are related to cultural issues of the people. Many patients continue to value strongly their kinship ties with the past and believe in the traditional methods of healing sickness. The patients must be given some information about what the doctor proposes to do. The underlying spirit of informed consent is new in PNG, and it strives against the traditional attitudes of doctors that they know it best for the patients and the strong culture in customs and patients’ misconceptions that affect their perceptions in making important health care decisions. Majority of the patients have some notion of informed consent, however not many people understand what it is. They still hang onto their traditional customs, beliefs and opinions that affect their health care decisions; they often look to their village elders, family and parents for advice in times of sickness or death in the family but where the law implies consent it is not often obtained. Summarization of current laws, reports of legal cases, and personal experiences were examined. Special requirements must be prescribed when patients are subjected to medical treatment. Documentation of a well-defined process, not only on paper, may not only protect the medical doctor from exposure to liability but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment; and advances the interests of both patient and doctor. Lack of informed consent can reinforce a claim of medical malpractice, and could well undermine relevant health care policy to protect patient autonomy.
The Paradox of Consent for Capacity Assessments
The Paradox of Consent for Capacity Assessments
Research Article
Peter Koch
The Journal of Law, Medicine and Ethics, 19 January 2020
Abstract
The use of decision-making capacity assessments (DMCA) in clinical medicine is an underdeveloped yet quickly growing practice. Despite the ethical and clinical importance of these assessments as a means of protecting patient autonomy, clinicians, philosophers, and ethicists have identified a number of practical and theoretical hurdles which remain unresolved.2 One ethically important yet largely unaddressed issue is whether, and to what extent physicians ought to inform and obtain consent from patients prior to initiating a capacity assessment. In what follows, I address the following question: Must, or should, physicians obtain consent for capacity assessments? I argue that physicians have an ethical obligation to obtain express patient consent for capacity assessments, and in doing so, I challenge the predominant view which requires physicians to merely inform patients without obtaining consent. I then identify an underlying philosophical paradox that complicates the clinician’s duty to obtain consent: in short, consent is needed for an assessment of one’s ability to consent. Finally, I recommend a practical solution to this paradox of consent for capacity assessments by proposing a model of double consent from both the patient and health care representative.
Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
Review Article
Johanna Glaser, Sarah Nouri, Alicia Fernandez, Rebecca L. Sudore, Dean Schillinger, Michele Klein-Fedyshin, Yael Schenker
Medical Decision Making, 16 January 2020
Abstract
Background
Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension.
Purpose
An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent.
Data Sources
Systematic searches of MEDLINE and EMBASE (2008–2018).
Study Selection
We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent.
Data Extraction
Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus.
Data Synthesis
Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity.
Limitations
Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome.
Conclusions
Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.
Treatment Decisions for a Future Self: Ethical Obligations to Guide Truly Informed Choices
Treatment Decisions for a Future Self: Ethical Obligations to Guide Truly Informed Choices
Viewpoint
Claire J. Creutzfeldt, Robert G. Holloway
JAMA, 2 January 2020; 323(2) pp 115-116
Excerpt
It is estimated that every 3 minutes in the United States, a person dies after sustaining a severe acute brain injury, such as an ischemic stroke, intracranial hemorrhage, traumatic brain injury, or cardiac arrest.1 Almost half of deaths after severe acute brain injury, 100 000 per year, occur during the acute hospitalization, and approximately 90% of patients die after a decision to limit the intensity of treatment rather than from the direct effects of the brain injury.1,2
The decision to continue or withdraw life-sustaining treatment usually involves asking a surrogate decision maker to balance the uncertain possibility that a patient will return to some minimally acceptable quality of life against the burden of a prolonged hospital and rehabilitation course, which are options that are difficult to predict and difficult to fathom…
Supporting informed decision-making about vaccination: an analysis of two official websites
Supporting informed decision-making about vaccination: an analysis of two official websites
Original Research
Vivion, C. Hennequin, P. Verger, E. Dubé
Public Health, January 2020; 178 pp 112-119
Abstract
Objective
To analyze the content of two official French-speaking websites that are used to inform the general public about recommended vaccines in France and Quebec.
Study design
Qualitative content analysis.
Methods
All pages that inform and educate parents regarding childhood vaccination were downloaded and analyzed according to evidence-informed risk communication metrics.
Results
A total of 32 webpages, 14 videos, and two infographics were included in the analysis. The following were the most frequent risk communication approaches: ‘debunking common misconceptions about vaccination’ or ‘answering common questions about vaccines.’ Harm and benefit information focused primarily on the risks of vaccine-preventable diseases and the risks of adverse events after immunization. Most materials used qualitative terminology to describe the risk (e.g., vaccines are among the safest tools, adverse events are rare). Very few materials provided numeric likelihood of harms and benefits. When numeric information was stated, they were only presenting the risks of the diseases or number of cases in an outbreak. The approaches used to debunk misconceptions generally focused on the myth itself rather than the correct information. Few materials used visual aids (e.g., graphics, pictures, icons arrays, etc.) to convey important information.
Conclusions
It is often assumed that misinformation and rumors about vaccination found online is a leading cause of the increase in vaccine hesitancy. Existing communication materials could be improved to better align with best practices in risk communication. Given the availability of confusing and conflicting vaccine narratives, it is crucial that authoritative communication materials aim to build trust and support informed choices about vaccination.
Consent for newborn screening: screening professionals’ and parents’ views
Consent for newborn screening: screening professionals’ and parents’ views
Original Research
Ulph, N. Dharni, R. Bennett, T. Lavender
Public Health, January 2020; 178 pp 151-158
Abstract
Objectives
Expansion of newborn bloodspot screening (NBS) within England, which practices an informed consent model, justified examining acceptability and effectiveness of alternative consent models.
Study design
Qualitative focus groups.
Methods
Forty-five parents and 37 screening professionals (SPs) participated. Data were analysed using thematic analysis.
Results
Parents and SPs initially appeared to have differing views about appropriate consent models. Most parents accepted assumed consent, if adequately informed; however, once aware of bloodspot storage, informed consent was wanted. SPs valued informed consent, but acknowledged it was difficult to obtain. Both samples wanted parents to be informed but were unclear how this could be achieved. Most parents felt NBS was not presented as optional.
Conclusion
The simultaneous exploration of parents and SPs views, in real time is original. This rigour avoided the reliance on retrospective accounts which make it difficult to establish how decisions were made at the time. It is also unique in providing pre-interview consent models to drive the depth of data. It was rigorous in member checking. Findings suggested a preference for full disclosure of all information with some parents valuing this more than choice. Both samples queried whether current consent was sufficiently informed and voluntary. Results suggest differing tolerances of consent type if screening is solely for diagnostic purposes vs bloodspot storage. Results highlight the need for caution when examining consent model preferences without also checking knowledge, as opinions may be based on incomplete knowledge. Future research is needed to examine efficacy of proposed changes.
Procedural Informed Consent to Psychoanalysis: the Challenge from Transformative Experience
Procedural Informed Consent to Psychoanalysis: the Challenge from Transformative Experience
Christopher Poppe
Journal of Ethics in Mental Health Open, 2019; 10 pp 1-11
Abstract
Any valid informed consent to medical treatment needs the personal weighing of consequences of different treatment choices. In psychoanalysis, personal consequences are often unknown and, more importantly, cannot be reasonably weighed up before the start of analysis, as psychoanalysis constitutes a transformative experience in the sense of L.A. Paul (2014). The transformative potential hence complicates informed consent to psychoanalysis. In light of this, some authors have recommended to adopt a procedural approach to informed consent, where informed consent is repeatedly obtained throughout the process of psychoanalysis. However, this procedural informed consent, as I argue in this paper, does not constitute a valid form of informed consent due to the irreversibility of the psychoanalytic experience.
Researcher Views and Practices around Informing, Getting Consent, and Sharing Research Outputs with Social Media Users When Using Their Public Data
Researcher Views and Practices around Informing, Getting Consent, and Sharing Research Outputs with Social Media Users When Using Their Public Data
Nicholas Proferes, Shawn Walker
Proceedings of the 53rd Hawaii International Conference on System Sciences, 2020
Open Access
Abstract
Publicly accessible social media data is frequently used for scientific research. However, numerous questions remain regarding what ethical obligations researchers have in regard to using such content. We report on researchers’ own views and practices regarding informing, getting consent from, and sharing research outputs with users when using publicly accessible social media data. Findings reveal both diverging current practices and views on what researchers ought to do in the future. Some researchers view the ethics of public data use as merely requiring compliance with the requirements of their ethics board, while others’ ethical practices go beyond what is minimally required. Some researchers worry about the effects of contacting users to inform, seek consent, or share outputs with users. Yet others note that they want to build bridges with online communities through these mechanisms, but struggle with a lack of precedent and tools to do so at scale.