A couple of weeks ago I was in the hospital with a friend discussing a new treatment.
You probably know the drill: information brochure here, contact information there, appointments here, signature here, signature there, ….
Wait …. what was that?
Was that an informed consent?
Checking the last document on the pile requested to sign, indeed, it appeared that that concerned a patient information letter and consent page for health care data being collected within the context of a registry. Upon my question for some clarification, the nurse reacted surprised “no-one ever refused participation before”. Regardless the fact that I think it is important to participate in postmarket data-collection efforts, especially when talking about relative new treatments, in this post I wanted to (re) emphasize some key aspects of the informed consent process that went wrong here:
Obtaining informed consent for any type of study is a process, where the consenting HCP is supposed to discuss all aspects of the concerning study that are relevant to the subject’s decision to participate. The declaration of Helsinki specifies that
“After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent …”
Given the way the information was presented as well as the nurse’s reaction to my question, I honestly doubt she understood what was relevant herself, and she definitely needed some (re)instruction in order to be considered as ‘appropriately qualified’.
Luckily the patient information letter was well written and contained the information relevant for the concerning project. Which also helped to overcome the second issue, which is that a possible study participant is supposed to be
on all relevant aspects of the study before signing the consent form.
The nurse did mention that the study concerned a registry, but forgot to clarify the related aspects that the treatment would not be affected, and there were no additional risks due to study participation. More important for this kind of data collection, however, was knowing how data-privacy would be handled, since under the current EU data privacy regulation also coded health care data are considered personal. Quoting Erik Vollebregt:
“Not a week passes in which I am not explaining to a (mostly US) company that taking off some identifiers does not (I repeat NOT) render personal data anonymous for EU GDPR purposes when the coding is reversible (and even if the key is held by a third party) so it remains personal data regulated under the GDPR.”
And, indeed, very much in line with the GDPR, the information letter explained that
- health care data would be processed in a coded fashion,
- non-hospital personnell might be reviewing the (non-anonymized) hospital files,
- withdrawal of consent was possible at any time and without any impact on the treatment provided.
So after reading the patient information letter, my friend could be considered being fully informed on the project at hand.
Time to understand
By reading and discussing the meaning of the aspects addressed in the patient information letter, we also more or less dealt with the 3rd ‘pain point’ of the informed consent process at hand, namely that it should provide
“ample time for the subject to read and understand the informed consent form …”
And don’t be mistaken under ISO 14155 and the MDR, a clinical investigation includes post-market observational studies when safety & performance data collections are involved.
So what should we do?
With the above in mind, there are a couple of things, I believe we can do to improve: First is to create awareness on the key aspects of the informed consent process, especially emphasizing that they also apply for post-market observational studies (or Phase IV studies in case of drug studies) due to data protection regulations… Hence this blog post.
Second is to ensure (ongoing) training on this topic for each and every type of study, again, including post-market observational studies, paying attention to it during site initiation and monitoring, and not assuming that all of those involved in clinical research nowadays understand what the informed consent process is about, and
Last, in ISO 14155/ GCP trainings spend more attention to the rationale for the different aspects of the informed consent and how these aspects relate to different types of clinical studies.
With the above we may not be able to fully ban informed consent malpractices, but, referencing the title of this post, should be able to learn.
Feel free reaching out to discuss any of the above or in case you require support with your site initiations or monitoring for your clinical study.