The IRB has always encouraged researchers to think creatively about consent processes. The “standard” consent process — a discussion in a “quiet, private room,” and a handwritten signature on a consent form works for some studies, but not for all of them, even when there’s no pandemic raging. And now that we’re dealing with Covid-19, alternative consent processes may be required to minimize physical contact and reduce risk for research staff and potential subjects.
Here are some consenting ideas we’ve heard study teams discussing, and which the IRB would likely consider appropriate in certain circumstances:
Emailing or faxing the full consent form to a subject, and then having a consent discussion by phone. Options for returning the consent form in those cases include:
1) print, sign, scan, and email or fax back to the investigator;
2) print, sign, photograph the signature page, and text or email a picture of the signature page to the investigator;
3) type the signature and date into the emailed version of the consent document, save, and email to the investigator with a note stating that this is the LAR’s electronic signature (study teams, if you use this option, please make sure the consent form you receive contains the same text as the one you sent to the study team);
4) have the subject send a well-worded email back to the investigator stating the name of the study, that they have read and discussed the consent document, and they give their consent for the subject to participate.
When hospitalized participants are able to consent for themselves, we’ve had study teams propose to call the subject from the hallway outside their hospital room, and have the nurse caring for the subject carry the form into the patient. If the subject agrees, they can sign the form, and someone can take a picture of the signature page and return the picture to the study team. Alternatively, if the person obtaining consent is using appropriate PPE, the actual form can be returned to the study team, if physically handled appropriately to minimize risk of contagion.
What about when the subject cannot provide their own consent and their legally authorized representative is not on site due to visitation restrictions? Once again, here’s when alternative consent processes, such as a phone call followed by an email or faxed consent form, with the same signature provisions described above.
What has the FDA, whose regs are a little more hard-nosed about informed consent processes and documentation than the Common Rule is, saying about informed consent in FDA-regulated research involving Covid-19 patients right now?
We’re glad you asked. The FDA has amended its recent Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic to add a Q&A section, in which question 10 specifically addresses how to obtain consent from patients who are in isolation.
Remember to fully describe your consent process in the new submission; feel free to list more than one if you think you’ll need flexibility for individual patients. And as always, remember to thoroughly document your consent process in the study records, in accordance with IRB Policy 15.5.