How Improper Consent Can Lead to a Warning Letter

While working on a recent project involving researching FDA warning letters, it astonished me the number of investigators and investigative sites who had issues with informed consent.  I was surprised at the seemingly little familiarity study staff had regarding Federal Regulations when it came to the informed consent and the consenting process.

Many of the warning letters referenced consent issues such as failing to obtain consent according to 21 CFR 50 by:

1. Not obtaining informed consent prior to any study procedures
2. Not using an informed consent approved by the IRB
3. Failing to obtain informed consent at all

Who is ultimately responsible for training investigators and study staff on how to properly obtain and document informed consent?

According to 21 CFR 812.00, “An investigator is responsible for….protecting the rights, safety and welfare of subjects under the investigator’s care…..”  Failure to properly obtain informed consent is a failure to protect subjects.  Every investigator should know that a subject has a properly signed and dated consent form prior to administering an investigational product or implanting an investigational device.  In the clinical setting, a patient cannot get on the table in the OR without a properly signed, dated, and documented consent form.  There are many checks and balances… from surgeons, nurses, anesthesiologists, etc. The consent is that patient’s ticket to the table.

So why do investigators, the majority of whom are physicians, fall short when consenting subjects for research?   One thing, of course, is it is not always the investigator who consents the subject.  However, according to 21 CFR 812.100, “An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50…” Ultimately, the investigator is responsible for informed consent and he/she must always be aware of what the study staff is or is not doing.  This is how the investigator performs oversight of the clinical trial.  By reading a number of warning letters, it was clear that investigators did not always have a tight grip on “oversight” (a topic for another blog…).

Per the regulations, the Investigator bears all responsibility for consenting (among other things), and anyone becoming an Investigator should be familiar with the regulations they have to follow.  However, based on these findings, somehow we are still falling short.  Maybe there needs to be a standardized, documented training procedure in place to be completed by all study staff working in research who are delegated the responsibility of consenting subjects.

What are your experiences with informed consent?  How can we ensure proper consenting takes place?  Please share your thoughts and ideas with us.

Photo Credit: Andy on Flickr