compensation for research-related injury, risk management, infection control, incentives, COVID-19, interviews and data collection, study staff
In Malaysia, screening large proportions of the population for COVID-19 using the most accurate test (quantitative reverse transcription–polymerase chain reaction (qRT-PCR) was not feasible early during the pandemic because of a lack of health care facilities and skilled laboratory personnel. The country instead decided to develop rapid testing kits to scale up testing nationwide. A health care diagnostic company developed a new rapid testing kit for SARS-CoV-2 (the virus that causes COVID-19) using relatively noninvasive collection of saliva.
A researcher planned to evaluate the effectiveness of the rapid test kits using saliva samples from patients who had fever and who were being evaluated by clinic staff at the proposed study site. Adults who had COVID-19 symptoms and provided consent after being informed about the study were eligible for inclusion. In addition to free testing, it was planned that research participants would receive a voucher for a future medical check-up within the clinic.
The researcher told an unvaccinated research assistant who was hired for the study that the infection risk would be minimal because the assistant would be given safety training and disposable personal protective equipment (PPE) for the research work. Under the protocol, a medical staff member would complete a case report form for each participant as well as collect saliva and blood samples. The research assistant would conduct a brief interview with the participant, then deliver the case report, along with biological samples and the informed consent, to the researcher’s lab for further evaluation and storage.
Upon review of the proposal, the research ethics committee suggested that insurance coverage was needed for the research assistant and anyone else on the research team who would interact with symptomatic patients. The researcher, however, considered the protocol’s safety measures (safety training and PPE) as sufficient. The researcher reasoned that a 10- to 15-minute interaction with each patient for a baseline interview would not contribute significantly to an increased risk of contracting COVID-19. Furthermore, the researcher did not believe the study needed to adhere to good clinical practice standards given that, in their opinion, the study was not a clinical trial.
Questions
Should the researcher be required to provide separate insurance for research staff to cover research-related risks in this scenario? Why or why not?
What else could the researcher do to further minimize risk to the research staff?
Does it matter whether the study is considered a clinical trial?
What do you think about the research study providing research participants with a voucher for a future medical checkup as compensation for participation in the research study?
