The quality of informed consent in clinical trials

Posted on Jun 3, 2013 by Leslie Gelling in informed consent, Research

Clinical research is undoubtedly dependent on the recruitment of suitable participants; without them research is non-existent. Much emphasis is placed on the quality of the different components of the research endeavor with researchers needing to comply with the requirements of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and other codes and guidelines. But how much focus is there really on the quality of participant recruitment and the acquisition of freely given informed consent?

It can be tempting to drive recruitment as hard as possible in an attempt to recruit as many participants as possible as quickly as possible. Like much else in healthcare and research, obtaining informed consent can be target driven. Striving to achieve recruitment targets, however, can have a negative impact on research for two main reasons.

First, there is the possibility that significant numbers of participants might withdraw from the research after giving informed consent if they don’t have sufficient time to consider their participation and the possible implications for them and others. This could result in valuable time being wasted and sometimes the need to recruit additional participants to replace those lost. Second, hasty recruitment could result in the recruitment of participants who are less compliant and who provide weak data for the research.

Failing to recruit, or having potential participants decline an invitation to join a study, can be perceived as a negative outcome for the informed consent process. Many researchers will be proud of, or even boast about, their provision of information to successful recruitment conversion rate? However, it might be a more relevant, and a better indicator of quality, if some potential participants who are approached do not consent to participate in the research. This might suggest that those approached didn’t feel obliged to participate in the research and did feel able to make a freely informed decision. But how many researchers maintain a record of the number of conversion failures? Would pharmaceutical companies and/or sponsors interpret such data as an indicator of a weak site; one that might not be asked to participate in future studies?

Whilst acknowledging that informed consent is key to GCP, is it time researchers started to think about Good Recruitment Practice (GRP)? This would inevitably require evidence of training in recruitment and consenting strategies and procedures but, more importantly, should also require researchers and sponsors to demonstrate evidence of quality in the way they identify, inform and recruit participants to their research. Could evidence of GRP be used by research funding bodies and research ethics committees as evidence that research sites take the quality of participant recruitment seriously?

Allowing an individual to make a free and informed decision is fundamental to both the Nuremberg Code and the Declaration of Helsinki but do researchers and sponsors devote sufficient time to consideration of the quality of recruitment to the research they are engaged in?