EFGCP Advocates Change to Consent Process

Information provided to clinical trial participants during the consent process is lengthy and difficult to understand—or at least that's the common belief. There's an urgent need to improve the information supplied and work out how sponsors, researchers, and subjects can work together to influence law, policy, and ethics and hence change these regulatory requirements and current culture.

Brussels will be the location for the EFGCP’s annual conference on informed consent.

This is the crux of the latest message from the European Forum for GCP (EFGCP), which has pledged to focus its efforts on reforming the consent process over the coming months.

"It has long been recognized by all groups that the information for potential participants is not fit for its purpose—to explain a research study to someone considering whether to join. The current regulations and culture that demand 'Information by Volume' do not lead to informed consent," noted the EFGCP in a press release dated July 7. "It's time for change, but how can we bring this about?"

At its annual conference, to be held on January 24-25, 2012 in Brussels, Belgium, EFGCP is concentrating on improving information and empowering patients. It will address the questions: What do patients want and need to know? What are the barriers to change? Can a risk-based strategy help? Who should be persuaded of the need to change? Can ethics committees ensure adequate and complete information? How can you deal with trials in emergencies and unconscious patients?

The delay from consent rituals in emergency situations has important consequences and results in avoidable mortality and probably morbidity in participants in the trial, noted Prof. Ian Roberts of the Clinical Trials Unit, London School of Hygiene and Tropical Medicine, in a letter published in The Lancet on March 26.

"Far from protecting the interests of patients participating in research, requirements for written informed consent and the resultant delay in starting treatment could be lethal," he wrote. "The delay in starting treatment can obscure a real treatment benefit from the administration of a time-critical treatment."

The need for an urgent trial treatment excludes the possibility of fully informed consent, even in patients who are conscious and whose relatives are available, according to Roberts. Informed consent procedures, like other well-intentioned public health interventions, should be assessed rigorously, he pointed out.

Roberts and his colleagues studied data from the Medical Research Council's CRASH Trial, a multicenter randomized controlled trial of corticosteroid administration in acute severe head injury, which provides an estimate of the delay associated with the requirement for written consent. On average, compared with hospitals that waived the need for consent, initiation of treatment was delayed by one to two hours in hospitals where written consent from relatives was required. This delay would not occur if the treatment was given (or withheld) outside the context of a clinical trial, in normal clinical practice, they wrote.

At the EFGCP meeting, workshops will discuss how technology can improve the consent process, how to teach investigators to better inform participants, and experiences with national differences in information package constitution. Plenary sessions will address the cultural aspects (particularly in developing countries), the challenges in ensuring that patients are truly informed in the ICH regions, and what ICH regions can learn from the informed consent process in developing countries.

EFGCP intends to publish a report for wider dissemination, and aims to change the regulatory requirements and current culture. EFGCP is a non-profit organization established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe.

For more details on the annual conference, contact conferences@efgcp.eu or visit www.efgcp.eu.