Immunisation for medical researchers: an ethical and practical imperative

Participants in medical research are the most valuable resource within health research, and their wellbeing must be regarded as paramount. Australia’s national statement on ethical conduct in human research1 establishes that the burden is on researchers to safeguard the health, wellbeing and autonomy of their research participants. We argue that additional guidance is required in an area that has not been widely considered in the ethical research literature and policy: immunisation coverage of the research team.

It is acknowledged that health care workers with immunisation-preventable diseases infect their patients.2,3 There is no reason to believe that researchers are exempt from transmitting these diseases to their participants. There are national guidelines4 that provide evidence-based recommendations on immunisation for people at occupational risk, but this guidance does not specifically refer to researchers.

We present a case study to illustrate the issue. We undertook a cross-generational longitudinal study examining environmental, lifestyle and genetic factors influencing health and wellbeing across the lifespan. The study, based at a medical research institute, involved recruiting pregnant women in collaboration with the local health district. University researchers sought honorary appointments for recruitment and data collection in the hospital setting, with the expectation that we would be required to prove immunisation currency, according to relevant state health policy.5 When the resultant honorary researcher appointment applications were approved, we were not required to show any immunisation status. There may be several reasons for this: first that individuals classifying risk may interpret the rules differently; and second, employment status in clinical research studies with multiple researchers from different organisations is complex.

The study researchers reviewed the university immunisation guidelines and found that those on clinical placements in state health facilities required immunisation coverage, but for all others, including researchers, immunisation was voluntary. After careful consideration, we decided that ensuring the research team was fully immunised was the most ethical way to approach our research. In consultation with an infection control specialist at the local health district, we agreed on several immunisations or evidence of serological immunity.

To fulfil our responsibilities as ethical researchers, we believe it is essential that all researchers who have direct contact with participants are fully immunised, using national guidelines, against relevant diseases. The prevention of avoidable harm appears to be an ethical imperative, but we can find no consistent guidance in this area for researchers at a national or international level. We suggest that it is appropriate for the National Health and Medical Research Council to consider guidance on immunisation coverage of researchers who have direct contact with participants, rather than leaving it to individual research ethics committees.