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)
Open Access
Highlights

• 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).

An end to coercion: rights and decision-making in mental health care
Policy & Practice
Kanna Sugiura, Faraaz Mahomed, Shekhar Saxena, Vikram Patel
Bulletin of the World Health Organization, January 2020; 98(1)
Article
The United Nations Convention on the Rights of Persons with Disabilities requires a paradigm shift from a medical model of disability to a social model that emphasizes overcoming the barriers to equality created by attitudes, laws, government policies and the social, economic and political environment. The approach adopted by the social model recognizes that people with psychosocial disabilities have the same right to take decisions and make choices as other people, particularly regarding treatment, and have the right to equal recognition before the law. Consequently, direct or supported decision-making should be the norm and there should be no substitute decision-making. Although recent mental health laws in some countries have attempted to realize a rights-based approach to decision-making by reducing coercion, implementing the Convention on the Rights of Persons with Disabilities can be challenging because it requires continuous refinement and the development of alternatives to coercion. This article reviews the impact historical trends and current mental health frameworks have had on the rights affected by the practice of involuntary treatment and describes some legal and organizational initiatives that have been undertaken to promote noncoercive services and supported decision-making. The evidence and examples presented could provide the foundation for developing a context-appropriate approach to implementing supported decision-making in mental health care.

Conducting a Randomized Controlled Trial in Care Homes: The Challenges of Recruiting Residents Who Lack Capacity to Consent
Case
Victoria Shepherd, Jane Davies
SAGE Research Methods Cases: Medicine and Health, 2020
Abstract
Older people living in care homes (long-term care facilities) are at high risk of developing infections due to weakened immunity, close proximity living, and other multiple illnesses. As a result, care home residents are prescribed far more antibiotics than the general population. Probiotics are friendly live bacteria that may give health benefits by improving the immune system of care home residents and reducing the spread of harmful bacteria. We conducted a randomized controlled trial to investigate whether a probiotic supplement could reduce the number of infections in care home residents, reduce antibiotic use in this vulnerable group, and so help curb antibiotic resistance. Conducting clinical trials in care homes can be challenging, in part because a high proportion of residents have conditions such as dementia that may affect their ability to provide informed consent to take part. When someone lacks capacity to provide consent for themselves, alternative processes are followed to ensure that the research is conducted ethically. This case study provides an account of the challenges of conducting a randomized controlled trial in care homes, focusing on the recruitment of residents who lack capacity to consent, and strategies we employed to ensure their appropriate inclusion in the trial.

Informed Consent for the Human Research Subject with a Neurologic Disorder
Neil H. Vaishnav, Winston Chiong
Seminars in Neurology, 2018; 38 pp. 539-547
Open Access
Abstract
The doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts— from emergency epilepsy research to long-term dementia research—and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come.

What is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study [CONFERENCE PAPER]
Jennifer Lim, Rosa Almeida, Vjera Holthoff-Detto, Geke Ludden,  Kristina Niedderer
International MinD Conference 2019, 19-12 September 2019; Dresden, Germany
Open Access
Abstract
Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience in the MinD project, and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.

Neurological Deficits in Stroke Patients that May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials
Paula M.Janssen, VickyChalos, Sophie A.van den Berg, Erwin J.O.Kompanje, Paul J.Nederkoorn, Bart H.van der Worp, Wim H.van Zwam, Diederik W.J.Dippel
Journal of Stroke and Cerebrovascular Diseases, 14 October 2019
Abstract
Background
We assessed the occurrence of neurological deficits that may impede the capacity to provide consent for trial participation in patients with an acute stroke, who are eligible for endovascular treatment (EVT).
Methods
We used data from the Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective observational cohort study. We included 1526 patients with an anterior large vessel occlusion, undergoing EVT between March 2014 and June 2016. We based our assessment of decision-making capacity for trial participation on neurological symptoms influencing conditions concerning informed consent as stated in the declaration of Helsinki. We formulated a strict and a mild capacity assessment rule, using 2 different cut points in item scores on the National Institutes of Health Stroke Scale (NIHSS).
Results
Applying the strict and mild rule, respectively 1469 (96%) and 1220 (80%) patients deemed not capable of decision-making for trial participation on admission, and 1077 (79%) and 825 (60%) patients at 24-48 hours after admission. Highest frequencies of predefined scores suggesting incapacity based on the strict rule were on the NIHSS items “Level of Consciousness Questions” (59%), “Best Gaze” (68%), and “Best Language” (58%). Patients who were considered incapable were older (median 71 versus 66 years, P = .043), had higher NIHSS scores (median 16 versus 8, P < .001), and had more often left hemisphere strokes (55% versus 28%, P < .001) than patients who were presumably capable.
Conclusions
In the majority of patients with an anterior circulation stroke who are eligible for EVT, neurological deficits are present that may impede the capacity to provide informed consent for trial participation.

‘It’s a tough decision’: a qualitative study of proxy decision-making for research involving adults who lack capacity to consent in UK
Victoria Shepherd, Kerenza Hood, Mark Sheehan, Richard Griffith, Fiona Wood
Age and Ageing, 9 October 2019; 48(6) pp 903–909
Abstract
Background
Research into dementia and other conditions connected with cognitive impairments is essential but conducting research with populations who lack capacity to provide consent involves a number of ethical, legal and practical challenges. In England and Wales, family members can act as a consultee or legal representative on behalf of someone who lacks capacity. However, there is a paucity of research about how family members make decisions concerning research participation.
Objective
To explore family members’ experiences of proxy decision-making for research. Understanding how proxy decisions are made could lead to interventions to support greater inclusion of individuals in research who have impaired decision-making capacity.
Methods
Semi-structured interviews were conducted with a purposive sample of 17 family members who had experience as a proxy for making decisions about participation in research, including those who had agreed to participation and those who declined. Thematic analysis was used to examine experiences and generate findings for research practice and to develop future supportive interventions.
Results
Proxy decision-making is highly contextualised. Proxies balance a number of factors when deciding about research participation, including the person’s values and preferences, within the specific context of the study, and the practicalities of being involved. Proxies use these factors to construct a decision that is authentic to the person they care for.
Conclusions
Proxy decision-making for research is a complex process with inter-woven layers of decision-making. Decisions can be problematic for some proxies who may benefit from decision support to make an informed decision about research participation on behalf of a family member.

Informed consent and ethical reporting of research in clinical trials involving participants with psychotic disorders
Guy M.Weissinger, Connie M.Ulrich
Contemporary Clinical Trials, September 2019; 84
Abstract
Informed consent is critical for protecting vulnerable individuals interested in research participation, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). Individuals with psychotic disorders may have fluctuating capacity to consent and capacity assessment prior to research participation can help determine decisional status. However, there is little research on how, or if, these assessments are conducted in clinical research. A systematic review of randomized medication or device trials that specifically recruited individuals with psychotic disorders to understand the use and reporting of capacity assessment to consent was conducted. A total of 646 articles were reviewed using a developed questionnaire on ethical reporting of consent practices and capacity assessment. Less than 10% (n = 34; 5.3%) of the studies reported an assessment of capacity to provide informed consent and less than half of those used a standardized assessment. Sixty-four (9.9%) of the articles reported capacity to provide informed consent in the study’s inclusion and exclusion criteria. Additionally, 66 (10.2%) of the articles did not provide a statement about institutional review board (IRB) approval; and given the large number of medication and device trials, one out of five articles (n = 134; 20.7%) reported no statement about potential conflicts of interest. Future research should continue to examine these issues and to better understand the benefits and challenges of research participation with psychotic individuals and their decisional capacity in this context.