Informed consent in research, clinical trials, and the provision of information
Seeking freely given informed consent has been a central requirement for all research involving human participants since publication of the Nuremberg Code (1947) and then the Declaration of Helsinki (1964). Research ethics committees (RECs) will spend much of their time scrutinising both recruitment processes and participant information sheets in considerable detail. They will want to know that potential participants are provided with the information needed to make an informed decision about whether to participate in research – i.e. has informed consent been freely given?
One less positive development relating to informed consent in recent years has been the production of increasingly long information sheets. Ten years ago RECs encouraged researchers to provide information to participants on a single page of A4. Now it is not uncommon for information sheets to have as many as 25 pages. It could be argued that this has created a paradox. Information sheets have become increasingly comprehensive (and long) but potential research participants are less likely to read the information provided to them. This may potentially raise questions regarding informed consent.
The National Research Ethics Service (NRES) needs to take some responsibility for this given the information they require researchers to include in their information sheets. Researchers and sponsors should also take some responsibility. They have become increasingly risk averse. Therefore they try to include vast amounts of information, especially about potential side-effects – to avoid possible accusations that participants were inadequately informed before consenting to participate in their research.
Written information sheets are, of course, just one part of the process of seeking informed consent. What the RECs cannot scrutinise is how verbal information will be delivered. Both researchers and RECs appreciate that potential research participants, especially when stressed, often do not remember information provided verbally, or have selective memory. This makes written information sheets important. Likewise, there does need to be some thought given to how information sheets can be made more accessible and how information can be delivered during recruitment.
There has been a move to using summary information sheets. These allow potential research participants to read a briefer summary of the research before deciding if they need to read the full participant information sheet. It is a little surprising, however, that other means of providing information have not been tried more widely. Video (including DVDs or vodcasts) and audio files (including CDs and podcasts) have been used, by a small number of researchers, as effective means of providing information to potential research participants. Videos in particular offer an opportunity to show where research activities will happen or how complex procedures will be completed. It is not clear why there is such reluctance to use anything other than written information. It is time that researchers began to explore, perhaps as part of larger clinical trials, different approaches to delivering information to potential research participants, in order to obtain freely given informed consent.← Research nurse role in managing clinical samples to maintain transparency and sample integrity New Induction Framework aimed at clinical research staff working in the NHS →