Table 1

Ethical guidelines for subject selection in concurrent COVID-19 trials

ChallengeJustice concerns in subject selectionOverlapping principles/applications of justice principleRecommendationsExplanation
Scientific uncertainty about risk/benefitsSocial value of research (ie, its representativeness and generalisability)Respect for persons
  • Multiple-armed trials may be preferable to avoid competition between trials and improve evidence generated.

  • Physicians must assume the role of neutral medical advisor and acknowledge uncertainty of risks and benefits inherent in trial.

  • Physicians adopt new communication strategies to explain the various trials.

Collaboration between trials may generate better evidence than stand-alone trials. Physicians are needed as advisors to patients who should be provided the opportunity to reflect on their decision to participate and make an informed decision.
Lack of transparency about concurrent trials
  • Social value of research (ie, its representativeness and generalisability)

  • Equitable distribution of benefit and risks

Respect for persons
  • Institutions ensure eligible patients are made aware of all clinical trials for which they qualify.

  • IRBs enforce a duty to disclose alternative therapies as well as restrictions on participating in multiple trials.

Without clear reinforcement, patients may not be aware of all trials available. Subject selection may favour certain groups, and discrimination (conscious or not) may occur.
Scarcity of investigational therapiesEquitable distribution of benefit and risksAccountability for reasonableness21
  • Clinical trials adopt an allocation principle in protocol and communicate to all patients and healthcare workers.

  • Clinical trials work with a task force to arrive at an allocation principle specific to the scientific parameters of the investigational product.

As investigational therapies will be limited, justice demands that there are clear rationales for who receives treatments. When reasonable disagreements exist, the decision-makers must be held accountable.
Existing structural inequalities and barriers to equity
  •  Social value of research (ie, its representativeness and generalisability)

  •  Equitable distribution of benefit and risks

  •  Minimise implicit bias

  •  Minimise structural barriers to participation

  • Implement a blinded system for approach or scoring system to avoid implicit bias.

  • Address language and technology barriers by adopting multiple recruitment strategies (consent forms in multiple languages, phone consent).

  • Implement a structural competency curriculum for physicians and investigators involved in research design.

All institutions and their clinical trials must diagnose and address barriers to access and equity, which may vary per medical institution.