I was travelling in a taxi during the recent months and after I mentioned I work in clinical research the taxi driver decided to share with me that he has participated in a clinical trial once but he withdrew because he didn’t like the medication and he thought it did him more harm than good.
Unfortunately this is not the first case. Over the years I have met people who shared with me their experience in being approached to participate in clinical research and many declined after reading the informed consent form because they didn’t want to be guinea pigs.
All this just shows that we need a novel approach in informing participants about clinical trials and that the current inform consent process is failing people who not necessarily understand the ICF language.
It is known that majority of the participants in clinical trials are educated, have better connection with their health care provider and have interest in supporting research.
Over the years due to changes in the regulatory environment the ICF has become lengthy and overwhelming document, which not surprisingly push participants away. Although physicians and nurses are doing their best in explaining clinical research to potential participants, they are restricted by workload and resources and may not have the time needed for each individual person to understand the purposes of the research.
What could be changed in the informed consent process?
- Video-assisted informed consent – This type of aid to the consent process is a video, which explain the simple steps of participation in the clinical trial. It has already been used in paediatric trials and it was successful. Video could help approach low income participants who may struggle to understand the informed consent form. It could also be easily converted into different languages to break the language barrier.
- Web site supporting consent decision – Web site dedicated to the clinical trial with consent support video and additional materials could benefit participants by providing much more information than the actual ICF in more use-friendly manner.
- Booklets and support materials to help participants understand ethical considerations taken in research.
Supporting participants’ comprehension of research could provide long term benefit for everyone working in clinical research. It will improve general public understanding of research and will increase the level of satisfaction and positive experience from clinical trials. Moreover, it could help low income participants feel more comfortable with informed consent forms and participating in research.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 1 Sep 2016