Relationships of health information orientation and cancer history on preferences for consent and control over biospecimens in a biobank: A race‐stratified analysis
Soo Jung Hong, Bettina Drake, Melody Goodman, Kimberly A. Kaphingst
Journal of Genetic Counselling, 28 January 2020
In this study, we investigated how patients’ self‐reported health information efficacy, relationship with health providers, and cancer history are associated with their preferences for informed consent and need for control over biobank biospecimens. We recruited 358 women aged 40 and older (56% African American; 44% European American) and analyzed the data using multivariable regression models. Results show that African American participants’ health information efficacy was significantly and negatively associated with their need for control over biospecimens and preference for a study‐specific model. European American participants’ dependency on doctors was a significant and negative predictor of their preference for a study‐specific model. Several significant interaction effects, which varied across races, were found with regard to health information efficacy, personal cancer history, need for control, and preference for a study‐specific model. The study findings suggest it is important to consider health information efficacy, relationship with providers, and need for control when developing large diverse biobanks.
Eliciting consent from patients with dementia in general X-ray departments: Law, ethics and interpretation of context [CONFERENCE PAPER]
Katie Kelly, Lisa Booth, Paul K. Miller
United Kingdom Imaging and Oncology Congress 2020: Pathways and Communication, 1-3 June 2020; ACC, Liverpool
While the numbers of individuals suffering from dementia syndromes in the UK steadily increase, many practitioners in the allied healthcare professions, and particularly junior staff, still feel ill-equipped for face-to-face communicative encounters with such individuals (Miller et al., 2019; Tullo et al., 2016). An elemental feature of effective communication in healthcare contexts is the seeking of proper consent to perform given procedures. The propositions above, however, raise questions regarding how ‘properly’ consent is being acquired when dementia is at stake. This paper, thus, reports findings from a qualitative study of general radiographers’ experiences of acquiring consent from patients with dementia, specifically exploring participants’ interpretations of correct legal and ethical practice therein.
With institutional ethical approval, N=6 general radiographers with less than ten years of clinical experience were recruited to sit for extended interviews. Verbatim transcripts were analysed using the domain-established techniques of Interpretative Phenomenological Analysis (Miller et al., 2017).
Four key areas of extremely variable interpretation and practice were identified. (1) How to assess capacity for informed consent; (2) How to effectively modify communication when gaining consent; (3) Managing carer involvement during consent-acquisition and; (4) Constituting the ‘best interest’ of the patient.
Participants’ own accounts often indicated that they were often not lawfully implementing the Mental Capacity Act (MCA) when acquiring consent. Moreover, as previously identified by Miller et al. (2019), the situational confusion did little for participants’ confidence, with prospectively damaging import for future encounters. Stronger training in practical application of the MCA is recommended.
Consent conundrums: patient consent in neuroscience nursing
British Journal of Neuroscience Nursing, 25 February 2020; 16(1)
In BJNN 15(4) and BJNN 15(5), John Finch looked in detail at the role of the Mental Capacity Act 2005 and its accompanying Code in the practice of neuroscience nurses. He concluded, as have others, that the guidance offered by the Act and the Code falls short of what neuroscience nurses need in their practice. In this article, he turns his attention to the treatment of patients who can and do consent to proposed treatment. The law relating to such patients in this matter offers neither an act nor a code. The law is to be found in court decisions. It might, at first sight, appear that a practice situation in which a patient with undoubted mental capacity or, at least, sufficient mental capacity to understand and accept what is proposed, presents no legal problem. But a closer examination of mental processes encountered in patients who may be in pain, distress and pressing need reveals that communication between the treater and the treated may be subtle and complex, and that the meeting of minds required in law to ensure that a patient has genuinely agreed to a detailed proposal is anything but simple.
‘Delusional’ consent in somatic treatment: the emblematic case of electroconvulsive therapy
Giuseppe Bersani, Francesca Pacitti, Angela Iannitelli
Journal of Medical Ethics, 13 February 2020
Even more than for other treatments, great importance must be given to informed consent in the case of electroconvulsive therapy (ECT). In a percentage of cases, the symbolic connotation of the treatment, even if mostly and intrinsically negative, may actually be a determining factor in the patient’s motives for giving consent. On an ethical and medicolegal level, the most critical point is that concerning consent to the treatment by a psychotic subject with a severely compromised ability to comprehend the nature and objective of the proposed therapy, but who nonetheless expresses his consent, for reasons derived from delusional thoughts. In fact, this situation necessarily brings to light the contradiction between an explicit expression of consent, a necessary formality for the commencement of therapy, and the validity of this consent, which may be severely compromised due to the patient’s inability to comprehend reality and therefore to accept the proposal of treatment, which is intrinsic to this reality. With the use of an electric current, the symbolic experience associated with anaesthesia, and the connection to convulsions, ECT enters the collective consciousness. In relation to this, ECT is symbolic of these three factors and hooks on to the thoughts, fears, feelings and expectations of delusional patients. These are often exemplified in the violent intervention of the persecutor in the patient with schizophrenia, the expected punishment for the ’error’ committed for which the depressed patient blames himself and the social repression of the maniacal patient’s affirmation of his inflated self-esteem.
A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research
Rajpal Nandra, Alan F. Brockie, Faisal Hussain
European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Open Reviews, 3 February 2020; 5(2)
- A vulnerable participant in research lacks capacity to consent or may be exposed to coercion to participate. Capacity may be temporarily impaired due to loss of consciousness, hypoxia, pain and the consumption of alcohol or elicit substances.
- To advance emergency care, providing life-threatening measures in life-threatening circumstances, vulnerable patients are recruited into research studies. The urgent need for time-critical treatment conflicts with routine informed consent procedures.
- This article reviews ethical considerations and moral obligations to safeguard these participants and preserve their autonomy.
- A particular focus is given to research methodology to waive consent, and the role of ethics committees, research audits, research nurses and community engagement.
- Research on the acutely unwell patient who lacks capacity is possible with well-designed research trials that are led by investigators who are sufficiently trained, engage the community, gain ethical approval to waive consent and continuously audit practice.
Editor’s note: EFORT Open Reviews publishes high-quality instructional review articles across the whole field of orthopaedics and traumatology. It is published by The British Editorial Society of Bone & Joint Surgery (BESBJS).
Consent for Research on Violence against Children: Dilemmas and Contradictions
Paula Cristina Martins, Ana Isabel Sani
Societies, 5 February 2020
The increasing visibility of violence involving children has led to a recognition of the need to research its underlying dynamics. As a result, we now have a better understanding of the complexities involved in this kind of research, associated with children’s developmental characteristics and social status, exposure to violence, and compromised parenting of caregivers. This paper discusses the issues raised by parental consent in research on violence against children, specifically the dilemma of children’s rights to participation and protection, and proposes changes in research practice in this domain.
Admission and discharge criteria for adolescents requiring inpatient or residential mental health care a scoping review
Nicola Evans, Deborah Edwards, Judith Carrier
JBI Evidence Synthesis, February 2020; 18(2) pp 275-308
This scoping review sought to locate and describe criteria relating to admission to and discharge from inpatient mental health care for adolescents aged 11 to 19 years in the literature.
In the United Kingdom (UK) and internationally, it is estimated that one in 10 children and adolescents has a diagnosable mental health problem. Children and adolescents with the highest levels of need are cared for in hospital, but there is a high demand for beds and a general lack of agreement regarding the criteria for admission to, and discharge from, such units.
We considered research studies that focused on criteria for admission to and discharge from inpatient mental healthcare units for adolescents aged 11 to 19 years. We included all quantitative and qualitative research designs and text and opinion papers.
We searched MEDLINE, Embase, PsycINFO, CINAHL, ERIC, British Nursing Index, Applied Social Sciences Index and Abstracts, ProQuest Dissertations and Theses, the Cochrane Central Register of Controlled Trials, OpenGrey, EThOS and websites of professional organizations for English language citations from 2009 to February 2018. Potentially relevant citations were retrieved in full and their citation details imported into the JBI System for the Unified Management, Assessment and Review of Information. Full texts of selected citations were assessed in detail against the inclusion criteria by two independent reviewers. Findings were extracted directly into tables accompanied by a narrative summary relating to the review objectives.
Thirty-five citations were included: quantitative research studies (n = 18), qualitative research studies (n = 1), and textual and opinion publications (n = 16). Of the quantitative research studies, 16 used a retrospective cohort design using case note reviews and two were prospective cohort studies. The qualitative study used interviews. The research studies were conducted in nine countries: USA (n = 7), UK (n = 3), New Zealand (n = 2), Israel (n = 2), Canada (n = 1), Norway (n = 1), Ireland (n = 1), Greece (n = 1) and Turkey (n = 1). The 16 textual and opinion publications included book chapters (n = 3), reviews (n = 3), policy and guidance documents (n = 3), reports (n = 3) and service specifications (n = 4). The majority of these were published in the UK (n = 10), with the remainder published in Ireland (n = 2), Australia (n = 2), and USA (n = 2). Research was conducted across a variety of settings including child and adolescent mental health service inpatient and outpatient units, emergency departments and adult psychiatric units. Length of stay, where recorded, ranged from < 1 day to 351 days. Several categories emerged from the data: type of admission process, referral or point of access, reasons for admission to inpatient mental health care, assessment processes, criteria for discharge and reasons for non-admission.
There is little evidence identifying which behavioral or symptomatic indicators suggest that admission is required, beyond retrospective identification of diagnoses attributed to adolescents who become inpatients. The threshold of severity of risk or need is not currently articulated. No studies were identified that drew on the perspectives of adolescents and their families or carers regarding criteria warranting admission to inpatient mental health care, which indicates an important area for future investigation.
[An ethical evaluation of presumed consent for organ donation in Switzerland]
Revue médicale Suisse, 19 February 2020; 16(682) pp 370-373
Following a current trend in European countries, Switzerland is about to decide to adopt (or reject) a presumed consent legislation for organ donation. In such a system, every citizen is considered as a potential organ donor except in case of expressed refusal during lifetime. The presumed consent system raises ethical and practical issues that need to be carefully understood and weighed before deciding on its fate. This article reviews the most pressing ethical issues and provides the empirical data necessary for assessing the presumed consent legislation in Switzerland. At the end of the analysis, the reader will be able to form her own informed opinion on the issue.
Editor’s note: This is a French language publication.
GDPR: Is your consent valid?
Stephen Breen, Karim Ouazzane, Preeti Patel
Business Information Review, 17 February 2020
The General Data Protection Regulation (GDPR) 2018 imposes much greater demands on companies to address the rights of individuals who provide data, that is, Data Subjects. The new law requires a much more transparent approach to gaining consent to process personal data. However, few obvious changes to how consent is gained from Data Subjects to comply with this. Many companies are running the risk of non-compliance with the law if they fail to address how data are obtained and the lack of true consent which Data Subjects currently give to their data being processed. Consent is a complex philosophical principle which relies on the person giving the consent being in full possession of the facts, this article explores the philosophical background of consent and examines the circumstances which were the point of departure for the debate on consent and attempts to develop an understanding of it in the context of the growing influence of information systems and the data-driven economy. The GDPR has gone further than any other regulation or law to date in developing an understanding of consent to address personal data and privacy concerns.
Physician’s obligations to inform about complications based on a recent warning from drug authorities
Duttge G, Meyer T
Medizinische Klinik, Intensivmedizin und Notfallmedizin, 7 February 2020
Based on a recent warning from the drug authorities about increased suicidality among users of hormonal contraceptives, this article discusses the legal consequences of translating novel findings from clinical trials into altered contents of gaining informed consent during the medical consultation.
Methods and Results
Comprehensive information in accordance with 630e German Civil Code (BGB) requires that rare drug reactions be mentioned by the prescribing physician, when they are associated with serious sequelae. This act regulates the treating physician’s obligations to inform about complications for both preventive and curative treatment options. In this paper, we refer to the scientific evidence level of data from clinical trials as the key feature for implementing altered medical information in the proper conduct of acquiring the consent of the patient in line with 630e BGB. The article discusses how additions and amendments to the package leaflet and the expert information will impact on the obligations for the treating party to provide information for the patient in order to obtain informed consent. In particular, we focus on the relationship between the obligations for the physician prescribing oral contraceptives on an individual case and the generalized information conditions according to 11 and 11a German Medicinal Products Act.
Current warnings of the drug authorities in the form of red-hand letters do not necessarily have legal consequences for gaining informed consent during the medical consultation.
Editor’s note: This is a German language publication