Remote and Electronic Consent 

1. Are there options to transition to a remote consent process instead of an in-person consent process during the COVID-19 pandemic?

Yes, since many research subjects cannot be recruited or seen in person there are several options that can be utilized to obtain consent/assent. Please remember that at all times you need to follow the hospital guidelines for which clinical research activities can be conducted.

Option 1: Remote Consent

The consent form may be sent to the subject or the subject's legally authorized representative by facsimile or e-mail with scanned attachment. The consent/assent discussion may then be conducted by telephone/zoom/ or other forms of video conferencing. After the consent discussion, the subject or the subject's legally authorized representative can sign and date the consent form and
  • return the document to the clinical investigator by facsimile or 
  • scan the consent form and return it through a secure e-mail account or
  • take a picture of the signed consent document and return it through a secure e-mail account.

For all of these remote consent options:
  • All methods to have verbal discussions and return the consent form must be HIPAA compliant. If you have any questions about whether the method you want to use is HIPAA compliant you may contact research computing.
  • These methods may also be utilized for obtaining assent.
  • Any pages that require signatures or check boxes must be returned by one of the methods above. When you have received the signed pages the investigator or designee needs to sign the form and merge the returned signed pages (and those with check boxes) with the remainder of the consent so there is a record of the entire consent form that was utilized. This then becomes part of the research record.  
  • Include in a note to file that the consent form was provided to the participant, consent was obtained, the method used to obtain consent, that the subject signed a separate copy, date/time and the method used to return the consent document.
  • You may find more information about this process in our IRB Guidelines and Policies web page.

You do not need to submit an amendment to utilize these options as long as the mentioned conditions can be met.

Option 2: Electronic Consent

If the technology is available, electronic methods of transmitting and obtaining a signature on an informed consent/assent form may be utilized. The hospital currently supports the Redcap e-consent application.  REDCap is not 21 CFR Part 11 compliant which means it is not acceptable for FDA regulated studies. If other forms of electronic consent become available and supported through the hospital this information will be provided to the research community. In addition, if you have a specific need to utilize an electronic consent method for FDA-regulated research or want to establish a REDCap eConsent application please contact  Kris Bolt in Clinical Research IT (CRIT).

You do not need to submit an amendment to transition to REDCap eConsent. If you are proposing any other method or option please contact the IRB Office as it is likely you will need to amend the protocol and we will need to discuss the specifics of the request.