Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

Abstract

Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk–benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies.

Research ethics review during the COVID-19 pandemic: An international study

“…Several of these contributions focus exclusively on one ERC, usually associated with an academic or health care institution. The literature includes descriptions of ERC operations during the pandemic in Central America and the Dominican Republic [17], China [18], Ecuador [19], Egypt [20], Germany [21], India [22–24], Iran [10], Ireland [25], Kenya [26], Kyrgyzstan [27], Latin America [28], the Netherlands [29], Pakistan [30], South Africa [31,32], Turkey [33], and the United States [34–36]. Most of these studies reported results from surveys, interviews, focus groups, and documentary analysis, including review of research protocols, ERC meeting minutes, and existing SOPs.…”

Challenges faced by ethics committee members in India during COVID-19 pandemic: A mixed-methods exploration

“…Approving the consenting process in the intensive care unit with PPE for participation in clinical trials with new drugs was a challenge faced by the EC members participating in our investigation. This was addressed by the approval of a process that would ensure video consent from patients or consent from legally acceptable or authorized representatives whenever possible, which was similar to the findings from studies conducted in Germany 16 . Waivers for consent were given only for secondary data analysis, retrospective studies and laboratory studies where leftover samples were used following de-identification 17 .…”

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

“…Maintaining the primacy of human rights and dignity in these situations can be challenging. Documented ethical issues in conducting research during PHEs include preparing RECs for accelerated review of studies, for instance through the establishment of ad hoc committees [3,6,[23][24][25][26][27][28][29][30]; ensuring appropriate research designs for scientific validity, social value and fair selection of participants [31]; promoting inclusive and adequate stakeholder engagement and informed consent processes [2,[32][33][34]; dealing with the specific ethical conundrum of clinical trials and human challenge studies during emergencies [35][36][37][38][39][40][41]; supporting appropriate data collection, storage and future use, including those relating to children [33,[42][43][44][45]; and maintaining mechanisms for ethics review whether in person or virtual [40,[46][47][48][49][50][51]. However, few studies specifically consider ethics review processes, procedures and governance frameworks for epidemics and public health emergencies in Africa [52].…”