Protection of participant and the investigators
Clinical investigators and sponsors should consult their Institutional Review Board (IRBs) or Institutional Ethics Committees (IECs) in deciding if the participants’ safety and rights are best served and protected by participating in the ongoing study or by discontinuing the IMP, intervention or even participation in the trial.
Most head and neck oncology trials are ongoing in an institutional setup where preemptive measures to contain the virus are already instituted. If the study is enrolling participants, provisions for investigator’s safety should be available at the site. If not possible, the sponsor should choose to withhold further intervention or monitoring until such safety measures are in place for the investigator.