Participant information sheets gone long

Posted on Oct 24, 2013 by Leslie Gelling in Ethics, informed consent, Research

Today I chaired a meeting of an NHS/NRES Research Ethics Committee (REC) and was once again astonished by the length and complexity of the participant information sheets being reviewed by the Committee. Amongst the applications on today’s agenda, three were for clinical trials of investigational medicinal products and the shortest information sheet was 19 pages and the longest 25 pages. Each of the information sheets included a huge amount of information.

There has rightly been a move to ensure that individuals considering participation in any research are provided with the information they need to make an informed decision before entering the research. But at what point does the volume of information, and the length of an information sheet, have a detrimental impact on the reader’s understanding of the research and what their participation will involve?

In the 1990s I recall a REC insisting that I produce a PIS of no more than one side of A4. This created an interesting challenge but it did ensure that the PIS focused on the key information that a potential research participant might need. Having shorter information sheets also placed greater emphasis on verbal explanation by researchers and on individuals asking appropriate questions of researchers.

There is now a real danger that researchers are trying to prepare information sheets that include all the information that someone might need or all the information researchers want potential participants to have? It would seem that clarity and precision has been replaced by anxiety that someone might enter a research study without knowing everything the researchers and RECs believe they should know. Unfortunately, the move to longer participant information sheets has not resulted in better-informed research participants.

Perhaps in the past research participants might not have received as much information as they should but it seems that we have now gone too far in the opposite direction. Some might argue this is because RECs have placed increasing demands on researchers to ensure that participants receive greater amounts of information. It could also be argued that researchers might have been influenced by our increasingly litigious society and so have tried to include as much information as possible, especially about possible side-effects, to avoid ‘you didn’t tell me that’ situations. This is most obvious in the increasing number of information sheets that now include ‘death’ as a possible side-effect.

Whatever the cause, participant information sheets are often too long and are more likely to risk confusion than to inform. It is time that both researchers and research ethicists gave considerable thought to how information is delivered to potential research participants.