FAQ: Is it possible to obtain informed consent remotely due to the COVID-19 Public Health Emergency?
In an effort to maintain social distancing during the COVID-19 Public Health Emergency, face-to-face informed consent procedures are limited to therapeutic clinical trials.
As a means of offering flexibility and minimizing non-essential contact, investigators conducting therapeutic trials may utilize a remote consent process for the purpose of screening potential research participants during this public health emergency.
The remote consent process may be used to conduct screening procedures related to therapeutic clinical trials. This allows the investigator/designee and potential subject/legally authorized representative (LAR) to engage in the informed consent process via telephone, conference call, videoconference, telemedicine, or other method that has been prospectively approved by the UIC IRB.
The remote consent process cannot be used for research that involves administration of drugs, biologics, or devices without an in-person clinic visit (e.g., research in which study drugs would be prescribed and sent to the subject without any physical assessments). Research subjects will still need to sign the full consent form prior to receiving any of the above therapeutic intervention.
It is important to note that the plan to utilize a remote consent process must be prospectively reviewed and approved by the IRB at the time of initial review or via an amendment for studies already approved by the IRB. The submission must clearly describe the method (e.g., teleconference, videoconference, etc.) that will be used to conduct the remote consent process, request an alteration of consent to conduct the consent process in this manner, and confirm that the following procedures will be followed.
The procedures for the remote consent process are as below:
- The informed consent document must be sent (e.g., via email, mail, fax) to the potential subject/LAR in advance of the remote consent process. The conversation may not occur if the potential subject has not received the consent document, as they will need to refer to the document during the discussion.
- After verifying that they are speaking with the correct individual, the investigator/designee discusses the study with the potential subject either via telephone or video conferencing (e.g., telephone, conference call, videoconference, telemedicine, etc.).
- The conversation must include a witness. The rationale for the witness is to ensure that a third party has heard both sides of the conversation and observed the potential subject consenting to participating in the research. Since the witness does not need to be impartial and to ensure that the witness is present for the full conversation, it is preferred that the witness be someone selected by the person obtaining informed consent rather than a member of the potential subject’s household.
- The investigator/designee must document the conversation, including (at a minimum): the date and time the conversation occurred, how it occurred (e.g., telephone, video conference), the name of the witness and any other participants, confirmation that the subject/LAR received the informed consent document, and confirmation of verbal informed consent to conduct the screening.
- When the subject arrives at the clinic/hospital for the research intervention, consent must be re-affirmed and signatures of the subject/LAR and investigator/designee be obtained.
- The final informed consent document must be filed in the designated investigator/research file location.
- No therapeutic interventions may occur until all steps of the informed consent process are complete.