The difference between informed consent and informed decisions
The difference between informed consent and informed decisions
Create an open dialogue to get both
With some complex tasks, it's often easier to break them down into more manageable parts, or to relate them to tasks we are more familiar with. These ideas may prove helpful in designing ways to approach informed consent.
"Informed consent is a process — a GCP process, and an ethical and legal process," says Linda Wolf, MS, Emerging Markets and Solutions, BBK Worldwide, Newton, MA, at the 44th Annual Drug Information Association meeting in Boston, MA.1 "Part of what makes up this process is the ability to make informed decisions."
"Coming from a communication background," Wolf says, "one of the first things I ask when we're looking at a study is 'Who are we talking to?' and 'Why are we talking to them?' and 'What is our purpose?'"
Because informed consent is a process, adds Wolf, it's necessarily more than a signature. "There's more than one perspective going into the building of the informed consent document," adds Wolf. "It's both an ethical document, in terms of protecting the subject — and there are a lot of people concerned with that element: the sponsor, the IRB, the patient, the site. But at the same time it's a legal concern — they're also protecting their own interests," explains Wolf
"And you have several audiences involved," she notes. "You have the patient, the sponsor, the IRB, the regulatory bodies in all the different countries, and the sites. It's really important to have a coordinated effort so that you're protecting the patient and helping the study sites communicate information to that person.
"So you might find it helpful to look at what's involved in making an informed decision," adds Wolf (see decision-making progression, left). "Patients go through this on a daily basis as to whether they want to stay in the study. Basically, the more communication and the more positive experiences they have in the study, the more likely they are to make the decisions to stay in the study.
"This understanding is essential to making a patient feel a part of the study, not apart from the study," Wolf notes. "This is an ongoing process. The communication doesn't end with enrollment. Things change during the course of the study — interim results and outcomes, for example. Patients want to know that they're contributing.
"Putting the patient at the center of this process and understanding the subject's mindset," stresses Wolf, "makes this a human dynamic. It's important to be proactive and anticipate the questions and concerns they may have. This is all part of making them feel like part of the study and developing their connection to it."
It's equally important to prepare sites for the possible reactions they might receive, adds Wolf. "Consider developing a guidance document for sites, based on the guidelines and the cultures you're working with. This goes with the informed consent form and will help sites know who conducts the informed consent, as well as the where, when, and why." (See the informed patient decisions worksheet.)
Another thing we found really helpful was a 'What to expect card,' says Wolf. "It gives people some really clear information about what they can expect over the course of the study.
"I had a really interesting discussion with someone recently who had been part of a small pox study where for several days after the injection she felt really sick," recounts Wolf. "This woman said, 'You know the suffering, the pain, that didn't matter to me because I felt so supported. I had people who cared about me and contacted me and gave me information about what was going to happen and why.'"
Reference
- Radical ideas for transforming the informed consent process. Presented at the 44th Annual Meeting of the Drug Information Association; Boston, MA; June 26, 2008.
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