The ethical considerations for emergency care research in low- and middle-income countries: A scoping review of the published literature

Abstract

Introduction Research studies on emergency care in low- and middle-income countries (LMICs) face many ethical considerations, including obtaining valid informed consent from vulnerable patients. This study aims to describe the body of literature related to the ethical considerations associated with emergency care research in low- and middle-income settings. Methods A scoping review was conducted to identify literature published between 2000 and 2020 related to ethical considerations associated with emergency care research in the LMIC setting. Titles and abstracts were screened in duplicate, and full texts were reviewed and extracted by the principal author. Results In total, 1087 articles were identified and 17 articles were included. Major themes identified in the literature included risk versus benefit assessments, patient vulnerabilities, consent, community engagement, clinical roles, ancillary care provision, and regulation of research. Alternative models of consent are often used in emergency care research, including surrogate consent, community consent, and waiver of consent. Challenges and best practices with these alternative models of consent in LMICs are discussed. Discussion Gaps remain in the literature describing the ethics of emergency care research in LMICs, including clear guidelines for protecting vulnerable patients and designing ethical consent processes. Best practices identified include community engagement for designing research studies, identifying acceptable risk profiles, and allocating benefits. Continuous and rigorous assessment of the quality of consent is also needed.

Practices of Informed Consent for Emergency Procedures at a Tertiary Care Hospital in Lahore, Pakistan

“…Informed consent refers to the voluntary agreement of a competent individual to the nature, potential risks, benefits, and alternative options related to an intervention [ 9 ]. Consent is an exigent ethical issue in emergency care in LMICs [ 5 ]. It is a well-established concept that when human subjects are invited to participate in both clinical and research settings, it necessitates the requirement of informed consent [ 3 ].…”

“…This overwhelming amount of information might be difficult for a patient to comprehend in this limited time [ 6 ]. As the patient becomes emotionally and psychologically dependent on the healthcare provider, the urgency to make a quick decision can threaten the validity of informed consent [ 5 ].…”

“…The majority of the documents (93.5%) were signed by a relative of the patient, while only 1.6% were signed by the patient, in contrast to another study conducted at private hospitals in Pakistan in which 42% of the consents were signed by the patients [ 4 ]. In LMICs, surrogate consent is taken predominantly as compared to waived consent [ 5 ]. In Pakistan, families seem to have a more influential role in decision-making along with patients during treatment, and the participation decision is usually influenced by factors such as poverty, illiteracy, and an oppressive mindset [ 3 , 7 ].…”

“…Appropriate consent solidifies the patient-clinician relationship of trust, provides the patient with a sense of autonomy and shared decision-making, and ensures the protection of the physician and his institute against possible legal implications [ 3 ]. Ways to obtain consent may vary due to cultural ramifications in low- and middle-income countries (LMICs) that may include surrogate consent, community consent, and waived consent [ 5 ]. A surrogate is a patient’s legally accepted representative, while community consent allows community leaders to make decisions [ 5 ].…”

“…Ways to obtain consent may vary due to cultural ramifications in low- and middle-income countries (LMICs) that may include surrogate consent, community consent, and waived consent [ 5 ]. A surrogate is a patient’s legally accepted representative, while community consent allows community leaders to make decisions [ 5 ].…”