The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research. The regulations, CFR part 50 also cover the importance, rules and process of informed consent.
In 1996, the FDA amended its informed consent regulations to require that the consent form be dated by the subject or the subject’s legally authorized representative at the time the consent is given. The FDA took action amending the regulation because of issues with verifying that informed consent was obtained from a subject prior to participation in a clinical study for the reason that the consent document was not dated.
But, does the subject dating the informed consent document at the time of consent really ensure that informed consent was obtained prior to participation in the study? During a recent site visit, I noted while monitoring a subject’s consent that the informed consent date and screening date were the same, which is very common. One could assume:
- Informed consent was obtained first
- Then the subject completed screening procedures
It wasn’t until a conversation with the research coordinator about the site’s consenting process that I found out the research team was not obtaining informed consent until after screening procedures to guarantee the subject qualified for the study.
It got me thinking: the only way to ensure informed consent is obtained prior to participation, if screening and consent occur on the same day, is to require a subject to provide a signature, date and time. The time of consent can then be cross-referenced (with op reports, nurse’s notes, etc.) to verify consent was, in fact, obtained first.
Patient protection is vital. And this extra step of timing, a consent would further prove that patients were protected, regulations followed, and the study follows GCP; after all, proper documentation can prove that subjects were protected throughout a study. For an in-depth look at this concept of documentation, check out our whitepaper!
It has been 16 years since the regulation has been updated, do you think it is time for an update? Share your thoughts and experiences below!
Photo Credit: Brittany G