Addressing the challenge for expedient ethical review of research in disasters and disease outbreaks

Abstract

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a situation of crisis, that pre‐arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries.

Modes of influence: what can we learn from international codes of ethics for health-related research?

“…However, in Schuklenk's view the claim that the principles in the document are regarded as universal is seriously undermined by their 'demonstrably problematic production process' (Schuklenk, 2017: 172). 18 See, for example, Aarons (2019) for a critique of CIOMS guideline 20, which makes recommendations for pre-evaluation of proposals to be mobilised in emergency or disaster situations: informed by the situation in the Caribbean, Aarons proposes alternative plans for such situations. See also Barugahare and Kutyabami (2019), who question the absence of East African voices in the revision of the CIOMS guidelines, but also observe that, given their generality, there is scope for local and regional interpretation and application of these.…”

A scoping review of ethics review processes during public health emergencies in Africa

“…The need for rapid, expedited ethics review of study protocols to facilitate a speedy investigation into disease pathogenesis as well as therapeutics and interventions required to curb the spread and impacts of the diseases was a crosscutting theme in the papers reviewed [60]. A central idea here entailed constituting ex-temporal committees or processes of review, including joint and multiple reviews [23,56] to reduce the propensity for long and duplicated reviews [3,4]. Such a framework, which allows for representatives of individual RECs to form part of the ad hoc committee, allows for a central review and approval process for which the final decision will be reported back via the same channel, thus reducing the time for the review of articles.…”

“…At the core of this emphasis is the need for study protocols, and research review processes to strengthen, not minimise, important ethical principles -from respect for persons, the imperative to do no harm, maximise benefit and minimise risks under beneficence, to demonstrating fairness and justice particularly in the selection of study participants -during infectious disease outbreaks [66][67][68]. These findings are also captured in the broader literature on the implementation of research during pandemics and disasters [47,69,70], as well as the ethical considerations that researchers and sponsors must bear in mind in their design and implementation of studies that involve human subjects [4,43,65], especially those from vulnerable communities and populations [70].…”

“…The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) accounted for over 624 million infections and over 6.5 million deaths globally in late 2022, and caused the coronavirus disease 2019 (COVID- 19) pandemic [1]. The COVID-19 pandemic forced governments, multilateral public health organisations, humanitarian organisations, and academic institutions to undertake research urgently to understand SARS-CoV-2 and respond to the pandemic [2][3][4][5][6][7]. Research is still needed to generate knowledge on SARS-CoV-2 transmission, to develop vaccines and treatment, and to understand the long-term impacts of infection [3,8].…”

A systematic literature review of the ethics of conducting research in the humanitarian setting

“…Future research/initiatives: Strengthen the relationships between humanitarian aid groups and academic institutions. [11,59] Research is justified insofar as it is not compromising relief efforts [60] MSF's refusal to participate in research on treatment rationing [55] The evolution form pure researcher to researcher-practitioner [61] Justification for research in conflict setting [62] Explanation of MSFs ethics of studying HIV medication rationing [63] Generally limited resources in these settings [64] Effective research design might inhibit optimal treatment initiatives [53] Reassessing a participant's consent during the experiment [44] Informed consent in the setting of a particularly fatal disease [46] Use of a "gatekeeper" when seeking informed consent [21] A more nuanced view of consent might be more suitable for emergencies [21] More flexible approach to consent [22] "Humanitarian misconception" [27] Challenges of consenting children [65] Consent during disasters may be coercive [23] Exclusion of groups may undermined justice [38] Regional collaboration for ethical review [66] Dynamic consent [38,44] Participants may find it difficult to separate consent for research from receiving aid [27,38,46] Use of gatekeepers for attaining consent [21] Acceptance of less rigid consent procedures in the humanitarian setting [21,22] Forcing participants to relive trauma for the purpose of research raises ethical questions [44,65] Unavoidable coercion [23] Tensions:…”