Can the consent process be waived in prospective chart review studies?

Some studies involve reviewing patient charts for encounters that have not yet occurred. Investigators sometimes ask to waive the entire consent process for these prospective chart review studies. Please keep in mind that the IRB’s ability to waive the entire consent process is restricted by current regulations, and many prospective chart review studies would not qualify for the waiver.

The following criteria must all be met for an IRB to grant a consent process waiver:

  1. The research involves no more than minimal risk
  2. The waiver would not adversely affect subjects’ rights and welfare
  3. The research could not practicably be carried out without the waiver
  4. Whenever appropriate, subjects will be provided with additional pertinent information after their participation.

Number 3 is usually the toughest criterion to meet. The IRB typically will not waive consent just because it’s much easier to do a low-risk record review study without having to get subject consent. (“You mean we have to let all 200 patients that we’ll see in the next few months know that we want to review their medical records for research?” we’ve been asked. Um, yep, generally you do.)

Note that the part about “practicably” carrying out the research doesn’t refer to solely the potential challenges of carrying out a consent process. If requiring consent would bias your study results, your study couldn’t practicably be carried out without a waiver. An example would be a non-treatment study involving a population in which some patients would be cognitively impaired and other wouldn’t. If the IRB required you to get consent from the subjects themselves, you would only be able to enroll people without cognitive deficits, which would bias your population. Another case where the IRB may waive consent is for a study is for a review where 100 percent of the patients seen during a particular (usually brief) time period need to be included. These studies are typically multi-site projects looking at how certain conditions are handled in different institutions/parts of the country.

Another thing to keep in mind — while a prospective chart review may not qualify for a waiver of the entire consent process, it may qualify for a waiver of documentation of consent. See IRB Policy 15.3 for those waiver criteria.

In summary, if you’re doing a prospective record review study, please put some thought into how you might inform subjects about the research and either get their consent or give them an opportunity to opt out of participating. If you want to request a waiver of the entire consent process for prospective record reviews, the IRB will need a solid justification for granting such a waiver.