Reconsidering research exclusion for serious mental illness: Ethical principles, current status, and recommendations

Reconsidering research exclusion for serious mental illness: Ethical principles, current status, and recommendations
Irene Harris, Devin Hanson, Jennie Leskela, John Billig, Viviana Padilla-Martinez, Jennifer Boyd, Tasha Nienow
Journal of Psychiatric Research, November 2021; 143 pp 138-143
Historically, individuals managing serious mental illness (SMI) have often been excluded from research, typically because of concern that these individuals may not be able to understand and provide truly informed consent. As treatment has improved, the assumption that individuals managing SMI may not be capable of consent needs to be re-examined. Systematic exclusion from research may limit empirically tested treatments available for people managing SMI, and may contribute to the health care disparities seen in this population.
This article examines this issue by documenting current rates of research exclusion for high disease burden conditions, based on empirical review of studies in
Research design
Current rates of exclusion from studies for psychiatric conditions were assessed through systematic review of relevant clinical trials on
Subjects in this inquiry are either articles accessed in the literature reviews, or descriptions of studies in public data on
The primary measure was a previously published coding system to document the extent and types of research exclusion related to psychiatric status.
Among studies of interventions for substance use disorders and chronic pain, individuals managing SMI were more likely to be excluded than those with other psychiatric disorders at statistically significant levels. This was not the case among studies of interventions for ischemic heart disease. In studies of substance use disorders, 9% explicitly excluded SMI and 83% could exclude people with SMI based on broader exclusion criteria. In studies of chronic pain these two categories of exclusion were 16% and 55%, and in studies of ischemic heart disease, these two categories of exclusion were 1% and 20%.
Evidence indicates that it is ethically and scientifically more appropriate to exclude based on capacity to consent than membership in the group of individuals managing SMI. The discussion outlines techniques researchers can use for more equitable and generalizable sampling.

‘Surrogate decision-making’ in India for women competent to consent and choose during childbirth

‘Surrogate decision-making’ in India for women competent to consent and choose during childbirth
Kaveri Mayra, Zoë Matthews, Jane Sandall
Agenda: Empowering women for gender equity, 1 September 2021
Open Access
    In a postcolonial, deeply patriarchal culture, decisions are often made for Indian women about every aspect of their life – beginning with whether they will be allowed to be born. This is followed by every life decision, including education and marriage. A ‘surrogate decision-maker’ is a guardian who decides for an adult incapable of making their own decisions due to a mental health condition, or as a substitute based on a patient’s stated or predicted wishes. However, the majority of Indian women are ‘controlled’ and ‘allowed’ or otherwise regarding everything. No choice in women’s life is women’s own, including decisions about deeply personal experiences such as giving birth.

­Our article is embedded in feminist epistemology and uses voice-centred relational analysis of interviews with four women from impoverished backgrounds in Bihar, India, to explore decision making around childbirth and throughout their lives. The surrogate decision-makers in the birth environment are: 1) healthcare and non-healthcare providers, and/or 2) family members (who play the dominant role in every other decision about women’s lives). They communicate amongst themselves about a woman’s active bodily experience. Through I-poems we present women’s varied levels of resistance and non-resistance to obstetric violence, which can be looked at as an extension of their response to violence in their routine lives. We find similarities in women’s conditioning to endure, and argue that women should be the key stakeholders of their decisions about themselves and their bodies, which includes decisions about birth.

Dental informed consent challenges and considerations for cognitively impaired patients

Dental informed consent challenges and considerations for cognitively impaired patients
Review Article
Ahmed Alsaleh, Anjuli Kapila, Iftee Shahriar, Yvonne L. Kapila,
Periodontology, 31 August 2021
Open Access
Because the US population is living to an older age, the number of individuals with cognitive impairment and periodontitis is increasing, as both conditions/diseases increase with age. Dental informed consent best practices for dental/periodontal treatment of individuals with cognitive impairment have not been explored, yet warrant consideration, because complex dental treatments to address periodontal needs/edentulism raise challenges for informed consent in the elderly with cognitive impairment. The purpose of this review is to help practitioners better understand this topic and develop best practices in dentistry for informed consent of patients with cognitive impairment that need extensive dental treatment, including surgical and implant therapy.

Personalized Video Consent: A New Tool in the Preoperative Consent-Giving Process

Personalized Video Consent: A New Tool in the Preoperative Consent-Giving Process
Debraj Shome, Komal Doshi, Sapna Vadera, Vaibhav Kumar, Rinky Kapoor
Plastic and Reconstructive Surgery, October 2021; 148(4) pp 677e-679e
Open Access
    Medicolegal jurisprudence is ever increasing, and it is the right of each patient to have in-depth knowledge about their surgical procedure. Consent means voluntary and mutual agreement or permission. Preoperative informed consent should not only delineate the procedure, but also highlight the concerned risks.

However, written consent has certain drawbacks, including language, medical terms, understanding complications, expectations, and queries regarding surgery. An innovative approach to make informed consent simpler and more patient-friendly, such as video informed consent, may help in overcoming these barriers.

Video-augmentation of the Informed Consent Process in Mental Health Research: an Exploratory Study from India

Video-augmentation of the Informed Consent Process in Mental Health Research: an Exploratory Study from India
Abhijit Nadkarn, Sheena Wood, Ankur Garg, Danielle Fernandes, Ethel D’Souza, Urvita Bhatia
Asian Journal of Psychiatry, 23 September 2021
Only around 50-75% of individuals fully understand the various aspects of informed consent in research. The aim of our study was to examine whether supplementing the conventional paper-based informed consent process with an audiovisual aid improves participants’ understanding of the informed consent process and the information conveyed to them. Participants from two mental health/substance use intervention development studies were recruited for this study through consecutive sampling. They were then administered the traditional paper information and consenting process by itself or in combination with a video depicting the procedures of the study. Subsequently a bespoke questionnaire was administered to assess the participants’ understanding of the information conveyed to them about the parent study. The various domains of the questionnaire were compared between those who were administered the two different consenting processes using the chi square test. 27 (58.7%) participants were administered the traditional consenting process and 19 were administered the video-supplemented consenting process. The video-supplemented consenting process was not superior to the traditional paper-based informed consent process on any of the domains examined. In settings with participants having a limited education, and in research involving people with mental health or substance use problems, further research is necessary to identify of contextually relevant best practices for the informed consent process.

Evaluating the potential utility of three-dimensional printed models in preoperative planning and patient consent in gastrointestinal cancer surgery

Evaluating the potential utility of three-dimensional printed models in preoperative planning and patient consent in gastrointestinal cancer surgery
M Povey, S Powell, N Howes, D Vimalachandran, P Sutton
Annals: Royal College of Surgeons of England, September 2021; 103(8) pp 615-620
The Future of Surgery report from the Royal College of Surgeons of England acknowledges the important role that three-dimensional imaging will play in support of personalised surgical interventions. One component of this is preoperative planning. We investigated surgeons’ and patients’ perceptions of this evolving technology.
Materials and methods
Ethical approval was obtained. From a normal computed tomography scan, three-dimensional models of the stomach, pancreas and rectum were rendered and printed on an Ultimaker™ three-dimensional printer. Semi-structured interviews were performed with surgeons and patients to explore perceived model effectiveness and utility. Likert scales were used to grade responses (1 = strongly disagree; 10 = strongly agree) and qualitative responses recorded.
A total of 26 surgeons (9 rectal, 9 oesophagogastric, 8 pancreatic) and 30 patients (median age 62 years, interquartile range, IQR, 68–72 years; 57% male) were recruited. Median surgeon scores were effectiveness for preoperative planning, 6 (IQR 3–7), authenticity, 5 (IQR 3–6), likability, 6 (IQR 4–7), promoting learning, 7 (IQR 5–8), utility, 6 (IQR 5–7) and helping patients, 7 (IQR 5–8). Median patient scores were usefulness to the surgeon, 8 (IQR 7–9), authenticity, 8 (IQR 6–8), likability, 8 (IQR 7–8), helping understanding of condition, 8 (IQR 8–9), helping understanding of surgery, 8 (IQR 7–9) and feeling uncomfortable, 1 (IQR 1–4). Median overall decisional conflict score (0 = no; 100 = high) was 22 (IQR 19–28) and decision effectiveness was 25 (IQR 19–30).
Overall, patients and surgeons considered that three-dimensional printed models were effective and had potential utility in education and, to a lesser extent, preoperative planning. Patient decisional conflict and effectiveness scores were weighted towards certainty in decision making but had room for improvement, which three-dimensional models may help to facilitate.

The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation [BOOK]

The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation [BOOK]
Fiona Mayne, Christine Howitt
Routledge, 16 November 2021
    The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation is a practical guide for researchers who want to engage young children in rights-based, participatory research. This book presents the Narrative Approach, an original and innovative method to help children understand their participation in research. This approach moves away from traditional paper-based consent to tailor the informed consent process to the specific needs of young children. Through the Informing Story, which employs a combination of interaction, information and narrative, this method enables children to comprehend concepts through storytelling. Researchers are stepped through the development of an Informing Story so that they can deliver accurate information to young children about what their participation in research is likely to involve. To further inform practice, the book documents the implementation of the Narrative Approach in four case studies demonstrating the variety of settings in which the method can be applied.

The Narrative Approach to Informed Consent addresses the rights of young children to be properly researched, expands opportunities for their active and engaged research participation, and creates a unique conceptual ethical space within which meaningful informed consent can occur. This book will be an invaluable tool for novice and experienced researchers and is applicable to a wide range of education and non-education contexts.

Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician’s duties of disclosure

Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician’s duties of disclosure
Robert MacDougall
Kennedy Institute of Ethics Journal, September 2021; 31(3) pp 247-270
    Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient’s consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.

What could morally justify the physician’s special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians’ special duties from an argument in Kant’s political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as “consent” in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.

Challenges of the informed consent in some countries of the MENA region: A Literature Review

Challenges of the informed consent in some countries of the MENA region: A Literature Review
T. Habiba, K. Richaa, F. Abou-Mrad
Ethics, Medicine and Public Health, December 2021; 19
The world of medicine has seen a shift from a paternalistic to a patient-centred approach along with a surge in medical research in the MENA region. This medical revolution is accompanied by ethical challenges, most importantly concerning the informed consent. Countries in the MENA region have become aware of this, as several studies aim to study these challenges, their cause, and their solution. This article summarizes all the major findings of these studies.
A total of 36 articles were reviewed in order to form a proper idea about the importance of informed consent and its applicability in some countries of the MENA region. Literature review included the following countries: Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Syria, Tunisia, UAE, and Yemen. Excluding criteria were studies conducted in a country not considered to be part of the MENA region and articles not relevant to our objectives.
Challenges of the informed consent in the MENA region are the result of several interrelated factors unique to this region including cultural, religious, and legislative factors.
Efforts have been made to improve the ethical behaviour of physicians in the MENA region, however we are still far behind as several undeniable factors play a significant role, thus forcing an adapted informed consent form and procedure to every country and every population.

OP23 Parental consent for time-critical neonatal trials in low and middle-income countries: is it truly informed?

OP23 Parental consent for time-critical neonatal trials in low and middle-income countries: is it truly informed?
Stuti Pant, Maya Annie Elias, Kerry Woolfall, Sudhin Thayyil
Journal of Epidemiology & Community Health, 15 September 2021; SSM Annual Scientific Meeting Oral presentations, Obesity Diabetes & Global Health
Parental consent rates for neonatal interventional trials are significantly higher in Low and middle-income countries (LMIC) than in high-income countries, raising concerns about the credibility of the consent processes (Patterson et al PLOS One 2021). We conducted a mixed-methods study to understand the informed consent process in a neonatal cooling trial [Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial] conducted in India, Sri Lanka and Bangladesh.
Term infants with neonatal encephalopathy, aged less than six hours were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed the A-V records of the consent process using a 5-point Likert scale on three parameters – Empathy, Information, Autonomy. Additionally, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 health care professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.
In HELIX trial, a total of 475 parents were approached, of which 408 (86%) consented. Of these, 294 A-V records were analysed. Median (Interquartile range) score for empathy, information, autonomy was 5 (0), 5 (1) and 5 (1) respectively. However, thematic analysis suggested that the parental decision to participate was based on a unreserved trust in the treating doctors, therapeutic misconception, and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial, nor the nature of the intervention. Lower levels of parental education and misinformation further convoluted the voluntary informed consent process. Parents were visibly incapacitated, and many told the doctor to do whatever is best for the baby. Clinicians lacked equipoise and were biased towards cooling therapy as it was already a standard of care in high-income countries, and this influenced parental decision making. However, the HELIX trial results subsequently showed cooling was harmful and increased mortality in these settings.
Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context appropriate strategies to ensure truly informed trial participation.