In November 2021, the Chair of the Northern B Health and Disability Ethics Committee (HDEC), Mrs Kate O'Connor, informed NEAC that the HDECs were seeing seveal study amendments that asked to introduce double COVID-19 vaccination as an inclusion criterion to participate in health and disability research.

Mrs O’Connor explained that this exclusion criterion has, as of yet, only been seen as an amendment to previously approved studies rather than in new applications.

Mrs O’Connor noted that vaccination status as an inclusion criterion raises the question of equity in accordance with the National Ethical Standards for Health and Disability Research and Quality Improvement, 2019 (the NEAC Standards). As per the NEAC Standards, all persons should have equal opportunity to participate in research.

In response to the HDECs, NEAC advised that:

  • it agrees with the overarching principles of access
  • vaccination status could be relevant in vaccine studies, for instance, but not as a general exclusion criterion
  • while there are no ethical grounds to exclude potential participants generally, there will be logistical barriers created by vaccine passport requirements in terms of accessing sites
  • it proposed that the HDECs continue to decline amendments to approved studies that aim to exclude potential participants based on vaccination status alone, where there is no scientific justification for their exclusion and require new studies not to have such exclusions, unless justified against the NEAC Standards.

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