All consent process that involve direct interaction with subjects should be documented with a separate note in the research record, according to IRB Policy 15.5.
This extra documentation requirement takes on greater importance in situations like that presented by Covid-19. If your study is enrolling Covid-19 patients, you may not want to put study staff in close contact with participants to minimize risk of transmission. For subjects too ill to provide their own consent, you’d ordinarily ask their legally authorized representative (LAR) to sign. However, visitor restrictions at many institutions, including UAMS, mean LARs may not be available on site.
So you may need to think creatively about obtaining consent. Will you talk to the subject or LAR by phone? Have the subject sign a consent form, but instead of returning it to you, have the person take a picture of the signed signature page and text the picture back to you? Talk to the LAR by phone, and email the consent form back and forth for signature Alternative consent processes such as these make it critically important the consent process is thoroughly documented. (We recommend thorough documentation in all cases, but even more so during times you’ve had to adapt the consent process to extraordinary conditions.)
The following items are required to be included in an informed consent process note:
- The date the subject was entered into the study
- The title of the study
- The name of the Principal Investigator
- The name of the person or people obtaining the informed consent
- Statement that the subject or LAR was given a copy of the signed form.
Additional items that are not required, but are strongly recommended, especially in any sort of nontraditional consenting situation, to be included are:
- A description of how the consent process and signing and transmission of the consent form occurred (by phone? did the participant’s clinical provider provide the printed copy of the consent form while the study team discussed the study by phone? etc.)
- A description of anyone else present during the process (e.g. subject’s spouse or other family; study coordinator; Principal Investigator).
- The types of questions the subject had during the process or that the subject had no questions.
- Who the witnesses were and what, exactly, they witnessed — that the subject/LAR agreed to join the study? That the subject/LAR signed the consent form?
- Any other details specific to that particular consent process, such as the reason for any date discrepancies on consent form signatures, that help complete the description of the process.
If you have any questions about informed consent processes, please send an email to irb@uams.edu. We’d be happy to work with you to develop a consent process appropriate for your research. (Note that while the office can help, the ultimate decision about whether the consent process is appropriate rests with the IRB reviewer(s) who will ultimately approve the study.)