Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable

Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable
Commentary
Rafael Dal-Ré, Arthur L Caplan, Teck Chuan Voo
European Journal of Internal Medicine, 27 June 2022
Open Access
Excerpt
…Obtaining participants’ informed consent is one of the basic safeguards for ensuring ethically conducted clinical research. Investigators must provide potential participants all reasonable relevant trial information so that they can make an informed decision. How investigators seek participants’ informed consent should be consistent with international ethical standards. First, informed consent must be obtained from patients with capacity. If a patient is incapable of consenting (e.g., intubated patient), the investigator must seek informed consent from their legal representative. During the pandemic, at the trial design stage, investigators of the four aforementioned ad-RCTs (Table 1) decided that deferred consent was an acceptable approach as they realized that many potential trial participants would be incapable of providing consent and having access to the patient’s legal representative could be extremely difficult to obtain. Their decisions were backed by the research ethics committees involved in the review and approval of the ad-RCTs’ protocols. Patients unable to consent were included in the trial and informed consent obtained once they were able to provide it (or when the legally authorized representative became available), rendering the consent deferred. However, deferred consent must fulfil several conditions to be ethically acceptable. Second, trial investigators should seek the informed consent of potential participants before randomization, which ensures that all participants receive the same information on the trial procedures and available treatments in all study arms. This is applicable to any RCT, but it is even more relevant when it is likely that the legal representative of many participants will be involved. The participant’s legal representative should decide considering to what extent study participation promotes the individual’s clinical interests, and to this end should know all the therapies under assessment…