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
Abstract
Background
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.
Objectives
This article examines this issue by documenting current rates of research exclusion for high disease burden conditions, based on empirical review of studies in ClinicalTrials.gov.
Research design
Current rates of exclusion from studies for psychiatric conditions were assessed through systematic review of relevant clinical trials on ClinicalTrials.gov.
Subjects
Subjects in this inquiry are either articles accessed in the literature reviews, or descriptions of studies in public data on ClinicalTrials.gov.
Measures
The primary measure was a previously published coding system to document the extent and types of research exclusion related to psychiatric status.
Results
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%.
Conclusions
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
Kaveri Mayra, Zoë Matthews, Jane Sandall
Agenda: Empowering women for gender equity, 1 September 2021
Open Access
Abstract
    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
Review Article
Ahmed Alsaleh, Anjuli Kapila, Iftee Shahriar, Yvonne L. Kapila,
Periodontology, 31 August 2021
Open Access
Abstract
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.