Consent process waivers and Consent documentation waivers are two different things

UAMS IRB Policy 15.3 describes the criteria that must be met when you either want to skip the consent process entirely (consent process waiver), or to not collect signed consent documents (consent documentation waiver). Please note that a consent process waiver and a consent documentation waiver are two different things. Different criteria apply to each, and the CLARA form must be filled out differently for each.

Consent process waivers are typically appropriate when the research involves no subject contact, such as fully retrospective chart reviews. (Remember: “fully retrospective” means the data you plan to collect already exist at the time of IRB approval.) That’s because such research could not practicably be carried out without the consent waiver, which is one of the criteria that must be met for such a waiver. The IRB will also consider waiver requests if you can show that including only subjects who can provide consent would bias your study sample. That is a different example of a study that could not practicably be carried out  without a waiver of consent, although that’s typically a harder case to make. And for an example that won’t be successful in requesting a consent waiver — telling the IRB it would be inconvenient, but not impossible, to complete a consent process. The IRB will require a consent process if it’s possible to complete one.

A waiver of consent documentation means that while you will have a consent discussion, you will not collect signed consent forms. We typically see these in things like focus group research, where a group consent process occurs, but no signed consent forms are used. Interviews done by phone, or on sensitive topics where the subject’s name will not be collected, are also appropriate for consent documentation waivers.

An important note about completing the new submission form in CLARA when you plan to request a waiver: If you are requesting a consent documentation waiver, please note that this means a consent process will still occur. So, in response to the new submission form question asking you to indicate the consent process you plan to use, click “informed consent.” The next question will ask if you plan to request a waiver of documentation. We often see people indicating, on that first query, that they are requesting a waiver of the consent process, when they are really requesting a waiver of documentation. In that case, we have no choice but to send back a contingency requesting a correction.