Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials

  1. Sophie M Rose
  2. Virginia L Schmit
  3. Thomas C Darton
  4. Nir Eyal
  5. Monica Magalhaes
  6. Josh Morrison
  7. Matthew Peeler
  8. Seema K Shah
  9. Abigail A Marsh

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Abstract

In human challenge trials, volunteers are deliberately infected with a pathogen to accelerate vaccine development and answer key scientific questions. In the U.S., preparations for challenge trials with the novel coronavirus are complete, and in the U.K., challenge trials have recently begun. However, ethical concerns have been raised about the potential for invalid consent or exploitation. These concerns largely reflect worries that challenge trial volunteers may be unusually risk-seeking or too economically vulnerable to refuse the payments these trials provide, rather than being motivated primarily by altruistic goals. We conducted the first large-scale survey of intended human challenge trial volunteers and found that SARS-CoV-2 challenge trial volunteers exhibit high levels of altruistic motivations without any special indication of poor risk perception or economic vulnerability. Findings indicate that challenge trials with the novel coronavirus can attract volunteers with background conditions, attitudes, and motivations that should allay key ethical concerns.

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    SciScore for 10.1101/2021.03.14.21253548: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The protocol was approved by the Institutional Review Board at Rutgers University (Study ID: Pro2020001023) and all participants provided electronic informed consent before beginning the survey.
    Consent: The protocol was approved by the Institutional Review Board at Rutgers University (Study ID: Pro2020001023) and all participants provided electronic informed consent before beginning the survey.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableGender was analyzed as a categorical variable, broken down into male (reference), female, self-describe or prefer not to say.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: Thank you for sharing your code and data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    These results should be interpreted in light of certain limitations. First, the survey was conducted in a sample of early volunteers who signed up with 1Day Sooner in April and May of 2020, the earliest weeks of its creation. Volunteers sampled here may not be representative of all challenge trial volunteers, and those who have subsequently volunteered may be different. We also cannot know what proportion of intended volunteers would pass exclusionary screening and consent to participate in a challenge trial. It is possible that this subset would be small or non-representative of the volunteers characterized in our study, similar to observations that altruistic marrow donors represent only a fraction of those who initially volunteer to donate39. However, we have no basis for assuming what specific changes in the composition of challenge trial volunteers would result in. In addition, our sample of controls, whilst recruited to reflect national United States characteristics established by 2019 census data (including age, gender, education and income), are not truly representative of the United States population as a whole. Nor can we rule out, based on our data, the possibility that challenge trial volunteerism reflects unmeasured biases related to the perception of risks and benefits, such as optimism bias10,40; the so-called preventative or therapeutic fallacy, which reflects a common assumption that any treatment offered by medical professionals must be potentially beneficia...

    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.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  2. Version published to 10.1101/2021.03.14.21253548v1 on medRxiv