Patient participation in high-risk research could benefit novel drug trials
Published on September 19, 2013 at 2:47 AM ·
Individuals have a right to participate in risky research trials, which might harm their health or even kill them, and institutional review boards (known as research ethics committees in the UK) – which are responsible for deciding whether a particular research trial can take place in a given institution – are potentially impeding the progress of research by rejecting such studies on ethical grounds, according to a Viewpoint published in The Lancet today [Wednesday 18 September].
Dr David Shaw, of the Institute for Biomedical Ethics, at the University of Basel, Switzerland, argues that “Institutional review boards should never reject a study because it poses too high a risk to participants, and that their role should be confined to ensuring that risks and any potential benefits are fully explained to potential participants. Everyone should have the right to participate in research without paternalistic decisions about risk being made on their behalf.”
It has been argued that patients who participate in trials – particularly those who are terminally ill – are often under what is termed “the therapeutic misconception”, whereby they wrongly believe that they will benefit from participation in a study, even if they are told they might not. Ethics committees frequently deny approval for trials where patients are seen as unlikely to benefit from treatment offered during the trial.
However, Dr Shaw argues that instead of this overly paternalistic approach, institutional review boards should instead ensure that trial participants fully understand the risks involved, and if they still want to take part, they should not be prevented from doing so. Furthermore, he suggests that relaxing attitudes towards patient participation in risky research could greatly benefit some research programmes, particularly for novel drugs where, in the early stages of development, trials are often difficult or impossible to approve, because of uncertainty about prospective harm or benefit.
“Why potential participants should be denied the opportunity to participate in trials that pose even higher risks if they wish to do so, is unclear,” says Dr Shaw. “Competent adults can, for example, go skydiving, potholing, or bungee jumping. All of these sports are highly dangerous and, unlike research, confer no benefit to society. For example, skydivers have a one in 100 000 risk of death at each jump, and the injury rate is about one in 200. Almost half of bungee jumpers sustain at least minor injury. Why should people not be allowed to run similar or higher risks by participating in societally beneficial clinical research? Although a lot less fun, and also potentially fatal, participation in such research has the potential to help people and demonstrates solidarity with one’s community.”
“To stop people participating in high-risk research denies them the right to help their communities, patients worldwide, and future generations of patients…Assisted dying is increasingly regarded as acceptable in many developed countries; if healthy people are allowed to participate in high-risk sports that might kill them, and sick people can be assisted in ending their lives, why should both groups not be able to risk dying in a way that potentially benefits society?”
Categories: Pharmaceutical - Medical Devices