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

  1. Alice Faust
  2. Anna Sierawska
  3. Katharina Krüger
  4. Anne Wisgalla
  5. Joerg Hasford
  6. Daniel Strech

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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.

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  1. Version published to 10.1186/s12910-021-00666-8
  2. ScreenIT

    SciScore for 10.1101/2020.08.11.20168773: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: Sampling: The sample included 52 German RECs that participate in the assessment of clinical study proposals as required by German law and professional regulations and that are members of the umbrella organization “Association of Medical Ethics Committees in Germany” (AKEK: Arbeitskreis Medizinischer Ethik-Kommissionen).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    The exploratory survey reported here has the following limitations. First, many responses focused on the areas of scientific validity and informed consent, which may be related to the fact that the questionnaire explicitly asked about challenges and solutions regarding “statistics/study quality”, “informed consent”, and “other issues”. However, the broad spectrum of challenges and proposed solutions mentioned shows that many responding RECs expanded the focus. Second, we received a response rate of 42%. It is possible that the RECs that responded were the RECs where particular challenges in connection with COVID-19 studies frequently arose. As described above, our survey did not aim to make a statement about the frequency of challenges but rather about the qualitative spectrum of the challenges described. Third, we could not verify the information on the number of applications processed. Currently, there are many international contributions that address ethical issues in COVID-19 research, such as in “challenge studies” [16] or in “high-demand trials” [17]. Our status quo analysis on ethical issues based on feedback from 22 German RECs broadens our understanding of the spectrum of ethical challenges in COVID-19 research as perceived from those involved in the concrete review and oversight of COVID-19 studies. Further research on ethical challenges and proposed solutions as perceived by principle investigators and other stakeholder groups could complement this picture. Practic...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • No funding statement was detected.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2020.08.11.20168773v1 on medRxiv