A Formative Qualitative Study on the Acceptability of Deferred Consent in Adult Emergency Care Research in Malawi

Abstract

Research in emergency medical care is challenging due to a limited therapeutic window for intervention, which may compromise informed consent. "Deferred consent" allows initiation of study procedures before full consent is recorded. We conducted a formative qualitative study exploring perspectives on deferred consent in Malawi among research ethics committee members, health care professionals, and lay representatives. Participants identified several advantages of deferred consent including scientific value and potential health benefits to the study subjects and wider population. Participants also had concerns, including regulatory barriers and the risk of abuse and malpractice. Conditions affecting acceptability are related to the role of proxies, the nature of the research, the availability of robust regulatory oversight, and the need for community engagement. Our findings show deferred consent would be acceptable in Malawi, provided that a clear case can be made to advance medical knowledge and that adequate regulatory and ethical protections are in place.

Barriers and Enablers to Pulmonary Rehabilitation in Low- and Middle-Income Countries: A Qualitative Study of Healthcare Professionals

“…28 The lead researcher (FMB) is a qualified physiotherapist with qualitative research experience. 29…”

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

“… Vulnerable patients need to be included in emergency care research in LMICs in order to improve care for these populations. 9 [ 9 , 12 , 13 , 14 , 15 , 16 , 18 , 22 , 23 ] Consent 12 [ 8 , 9 , 12 , 13 , 14 , 15 , 17 , 18 , 20 , 22 , 26 , 27 ] Surrogate consent Surrogate decision-makers may experience impaired decision-making capacity due to a high emotional and psychological burden and lack of health literacy and knowledge. A stepwise or continuous consent model may be considered to improve the quality of surrogate consent.…”

“… There is no clear consensus on who is the most appropriate surrogate decision-maker. 5 [ 9 , 12 , 14 , 26 , 27 ] Community consent Community consent allows consent of members that the community denies the right to give consent, which raises questions of the appropriate balance of autonomy and risks/benefits between the individual and the community. 4 [ 9 , 14 , 16 , 17 ] Waived consent There is international variation in practices and policies regarding waived consent.…”

“… 5 [ 9 , 12 , 14 , 26 , 27 ] Community consent Community consent allows consent of members that the community denies the right to give consent, which raises questions of the appropriate balance of autonomy and risks/benefits between the individual and the community. 4 [ 9 , 14 , 16 , 17 ] Waived consent There is international variation in practices and policies regarding waived consent. Conditions for a waiver of consent vary across countries but include that the research could not otherwise be performed and must demonstrate an appropriate risk/benefit profile.…”

“… Conditions for a waiver of consent vary across countries but include that the research could not otherwise be performed and must demonstrate an appropriate risk/benefit profile. 1 [14] Consent assessment Assessment of the quality of consent and whether the consent model is appropriate is needed. 2 [ 12 , 17 ] Community engagement Communities can be engaged in emergency care research in a variety of ways, and formal structuring of community engagement is helpful.…”