Last update: 4.2.2020
Obtaining informed consent from patients with COVID-19 presents a number of challenges both because of decisional incapacity, as well as physical constraints as a result of isolation requirements. This guidance addresses some of the most common issues and concerns and outlines alternative methods for conducting the consent process and obtaining informed consent. This guidance should be considered in supplement to Institutional Policy on Research with Adult Participants Lacking Capacity to Provide Informed Consent.
- If the patient has impaired decisional capacity, due to intubation, loss of consciousness, etc., study teams should obtain consent from the legally authorized representative (LAR) in accordance with Institutional Policy.
- In the case that the subject/LAR is physically unavailable (in some cases, the LAR may also be following quarantine requirements), alternative methods for providing the consent document and obtaining informed consent should be considered.
Options for Providing the Informed Consent Form (ICF):
- If possible, the consent form should be provided to the subject/LAR in the isolation unit or quarantine space (the form itself may need to be discarded); OR
- Provide the participant/LAR with an electronic version of the ICF via a tablet, computer, or other device (this includes using UW approved document sharing options like WebEx or a Secure Box Folder); OR
- Provide the ICF via email (this requires written or verbal authorization to receive communications by email after being informed that email is not secure); OR
- Provide an audio recording of the ICF; OR
- Read the entire consent over the phone/WebEx (only do this if no other option is available).
- As always, study teams should review and discuss the ICF with the subject/LAR and answer their questions (this may occur by phone or other electronic communication like WebEx if direct communication with a participant/LAR is not possible).
- If the subject/LAR agrees to participate, the consent form should be signed if possible.
- If a paper consent was used and it is able to be removed from the subject/LAR isolation area, this should be done.
- Alternatively, the signed consent can be uploaded to a system such as REDCap (if possible), WebEx, a Secure Box Folder, or emailed to the study team.
- If it is not possible to obtain a digital image/electronic copy of the signed page, the study team should both document that an imaging/electronic device was not available and have a witness to the consent process.
- The witness should sign the consent form (and date the form for FDA regulated research). This is not a waiver of documentation. This assessment is based on FDA information sheet on Informed Consent.
- The entire consent process must be documented in the study records.
Considerations for the Informed Consent Process: