Remote Consent Procedures: Revised FAQs due to COVID-19
The CIRB appreciates the rapidly changing environment and the unique challenges that you are experiencing during the COVID-19 public health emergency. The NCI and CIRB are collaborating to ensure patient safety while optimizing the flexibility necessary to conduct ongoing clinical trials. The CIRB COVID-19 page continues to list relevant guidance issued by the NCI. The CIRB Frequently Asked Questions Regarding COVID-19 and the CIRB page has been updated. Please continue to direct your questions to the CIRB helpdesk; we are monitoring questions closely and tracking issues of concern.
One area that has been updated with additional guidance is the Remote Consenting Procedures. Remote consenting is a deviation from the approved protocol; however, NCI is allowing this deviation, but only for use during the public health emergency to enroll participants who cannot be present at the study site. The use of Remote Consent is restricted to the COVID-19 public health emergency and does not require incorporation into the Study Specific Worksheets or the Signatory Institution Worksheet.
The purpose of Remote Consent is to allow the investigator/designee and potential participant to engage in the informed consent process in a way that is similar to what would be conducted in-person under normal circumstances. These conversations may occur via telephone, conference call, video conferencing, telemedicine, or other methods used by your organization. Since the participant needs to reference the informed consent document during the conversation, the informed consent must be sent to the participant prior to engaging in the informed consent conversation.
The NCI has directed that the Remote Consent Procedure must include a witness. While this may differ from your normal procedures, the NCI stipulated this requirement for all NCI-sponsored clinical trials under CIRB oversight. The rationale for this requirement is to ensure that another party has observed the informed consent conversation and has observed the participant consenting to research participation. The CIRB does not require that this witness be impartial, only that the witness be able to hear both sides of the conversation. The intent is to protect both parties if there is a dispute about the consent. Requirements for social distancing may dictate that the witness is in a different location than the investigator. Any arrangement is acceptable providing the witness can listen to both parties in the informed consent discussion.
The research record must document the witness’ name and that they were present for the informed consent process. The inclusion of the witness’ signature on the informed consent document is dictated by local institutional policy.
In past versions of the CIRB FAQs the term ‘investigator’ was used to describe the individual conducting the informed consent discussion; however, institutions may allow various designees to conduct the consent as dictated by local institutional policy.
Please refer to the updated Frequently Asked Questions Regarding COVID-19 and the CIRB for the detailed description of the Remote Consent Procedures. Once the public health emergency has passed, the NCI and CIRB will reevaluate this experience and provide direction for potential use of remote consent procedures in the future.