Table 1

Recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement

Ethical domainIssues requiring further guidance
Justification for cluster randomised trial (CRT) design
  • No change required.

Research ethics committee (REC) review
  • Make explicit the need for host and sponsor country review in low-resource settings.

  • Clarify when home institution REC review is required for investigators in specific roles. Investigators whose role is limited to protocol development or analysis likely do not require such review.

  • Multiple REC reviews are inefficient. Are there further means to streamline study review by RECs while ensuring adequate protections for research participants in low-resource settings?

Identifying research participants
  • Lay health workers are commonly involved in CRTs in low-resource settings. When should they be considered research participants?

  • Broadly, guidance is required on when health providers who deliver the study intervention are also targeted by the intervention and should be considered participants.

Obtaining informed consent
  • Address conflicts with national laws and guidelines with regard to waiver of consent.

  • Encourage lawmakers and ethics bodies to adopt provisions to allow for waiver of consent for CRTs.

  • When host and sponsor country REC reviews are required, the host country REC should undertake the primary responsibility in approving a waiver of consent.

  • Guidance on the timing of gatekeeper engagement is required. In low-resource settings, the CRT may need to be funded before extensive gatekeeper involvement in feasible.

  • Gatekeeper roles may be diverse and include involvement in protocol design enrolment, implementation and reporting. Role-specific guidance on gatekeeper involvement is needed.

  • Reference to ‘community consultation’ should be replaced with the broader term ‘community engagement'.

Assessing benefits and harms
  • Further guidance is required on the appropriate control conditions in CRTs in low-resource settings.

  • When CRTs seek to evaluate implementation or health services interventions designed to improve care delivery, usual care as delivered ought to be deemed acceptable even if it falls below national care standards.

  • Further guidance is needed on the responsibility of multiple stakeholders in sustaining effective interventions after CRT completion in low-resource settings.

Protecting vulnerable participants
  • Adopt a view of vulnerable persons as people who ‘may have an increased likelihood of being wronged’. The emphasis this places on contextual factors is relevant to low-resource settings.