A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research

Abstract

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. Cite this article: EFORT Open Rev 2020;5:73-79. DOI: 10.1302/2058-5241.5.180051

Observing resuscitative practice. A novice researcher’s experience of obtaining ethics approval

“…41 Researchers and ethics committees have much to do in advocating for the health needs of rural communities. Nandra 12 highlights that research involving acutely and/or critically unwell patients can be achieved with a waiver of consent if the researcher engages community and continuously audits practice. When defining the issues affecting their members, communities are frequently their own best spokespersons, so it makes sense that when researchers involve communities, the relevance of the research can be improved 43 Rural communities voices should be championed when decisions about rural for rural are made by having rural representation at the table either literally or symbolically.…”

“… 11 , 33 , 38 Due to a potential lack of capacity to make informed decisions and the risk for coercion, vulnerable participants' involvements in studies are thoroughly examined during the ethical review process. 12 In theory, to ensure that patients are protected from the potential risks of their involvement, informed consent should be obtained. However, challenges occur when a person’s capacity to consent is affected.…”

“…10,11 In particular, addressing consent issues within a research design when a participant lacks the capacity to provide informed consent. 12 The ethnographic research study that will be addressed in this paper, aimed to explore the resuscitative experiences and practices of rural nurses. The study involved immersion in fieldwork at rural hospitals to document nurses' behaviours and interactions up close, using observation and interviews.…”

“…10 , 11 In particular, addressing consent issues within a research design when a participant lacks the capacity to provide informed consent. 12 …”

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

“…[21,22] Overviewing biobanking evolution and operational systems, consent modifications over the years have created six different models of consent types that are currently applicable to biobanks. [23] Each of the following consent types described below set and retrieve specific rights to donors and biobanks, respectively, upon biosample and related data, and actually predetermine the future utilization of both [24][25][26][27][28] :…”