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Eye of the needle: Informed consent and emergency medicine research
'It's a difficult option to thread'
Emergency medicine -- like the media and the global marketplace – is being delivered at the increasing speed of rapidly changing technology. However, regulations for conducting emergency medicine research are strictly old school.
They date back decades, and even the latest regulatory improvements are nearly 15 years old. This change took place in 1996 when the Food and Drug Administration (FDA) permitted informed consent waivers in certain emergency research.
As a result, researchers working to improve emergency medicine are required to obtain informed consent during a very rapid and fast-based medical encounter or take a series of labor intensive steps to meet the waiver's requirements.
"The exception from informed consent under emergency circumstances is a very restricted possibility for clinical research," says Tom Aufderheide, MD, professor of emergency medicine and associate chair of research affairs at the Medical College of Wisconsin in Milwaukee, WI.
"But it allows research to be done," he adds. "And we cannot improve emergency care in any other way, so for the practice of emergency medicine I am grateful to have this opportunity."
The public greatly benefits from emergency medicine research, and IRBs recognize this fact.
"We've been involved in a number of trials over the last 15 years, including the public access to defibrillation trial," Aufderheide says.
The Public Access Defibrillation (PAD) research, published in the mid-2000s, found that more people would survive cardiac arrest in public locations when trained laypersons safely used automated external defibrillators.
"It's a trial that evaluated public access to automated defibrillators that are now in airports and airplanes and other locations and that have saved countless numbers of lives," he adds. "Our IRBs believe the processes we use for both community consultation and public notification are rigorous and provide the community with an opportunity to understand what's going on in the community and provide us with feedback," he adds.
Aufderheide and other emergency medicine researchers have come up with complex, exhaustive strategies for meeting the FDA waiver requirements.
"We're in the eye of the needle; It's a difficult option to thread," says David Clark, PhD, assistant dean for clinical research and professor of psychiatry at the Medical College of Wisconsin in Milwaukee, WI.
Many paths to community consultations
Clinical research (CR) sites seeking an informed consent waiver for emergency medicine research have to hold community consultations, public notification, and then follow-up with the public's complaints and concerns.
The first step is community notification, which should not be confused with obtaining community consent for a study, Clark and Aufderheide say.
"This is where the investigator puts together a surrogate community that likely would be entered in a trial and explains the study to that community," Aufderheide says.
Typically, the community consultation will include a discussion of the study's purpose, what informed consent means, how informed consent will not be obtained, and what the study's risks and benefits are. Plus the public is encouraged to provide feedback about the proposed research.
IRBs should be involved in the community consultation process. The IRB's role includes documenting the public's feedback, identifying their objections, deciding whether there is an overall acceptance of the research within the community, and determining if the process has resulted in acceptable community consultation, Aufderheide says.
It takes months to satisfy the requirement for consulting the community, so an investigator's heart has to be into it, Clark says.
"You need to take the temperature of the community, finding out if they understand the study, the importance of the study, what's involved, and what objections they have," he explains. "If the investigator does this right, and it involves a series of public events, then they will have a pretty good feeling for the area where the study will take place."
Through the community consultation, researchers receive feedback about the study's acceptability and implementation.
"There is not a single correct way to perform community consultation," Aufderheide says. "There are different methods available, and the optimal approach should be developed collaboratively by ethicists and the IRB based on an understanding by the local community."
The key to a successful community consultation is to know your audience, Clark says.
For instance, if a trial involves heart disease, then investigators might think about ways of attracting older people who have heart problems, especially those in socially marginal groups whose rights might be abridged, Clark says.
There are a variety of ways to hold a community consultation. Clark and Aufderheide describe these methods:
Town hall meetings: One method involves inviting the public through local media to attend large town hall meetings at a community center or other public site. CR staff, investigators, and IRB representatives attend. Community members directly interact with investigators after a research presentation that has been IRB-approved, Aufderheide says.
"The town hall meeting can be a very effective way," he says. "Investigators can go to those meetings, describe the study, and get feedback from those groups."
CR professionals can videotape the meeting, pass out study contact information, and obtain feedback.
All comments and concerns are documented, and investigators and the IRB have to meet soon after the meeting to determine whether acceptable community consultation occurred, Aufderheide says.
Clinical research sites might hold five to eight community meetings over a six-month period, Clark notes.
"We pull in as many people as we think might be affected by the study, and we send out a public notice," he says.
Clinical trial sites should keep in mind that actual attendance for these community meetings will be far less than expected, and it will take CR staff months to successfully invite a suitable number of people.
If there are too few people attending, then the feedback likely will be skewed to the special interests of the small group motivated enough to attend. So researchers have to work hard to bring in more than 20 attendees.
For instance, in Aufderheide's experience, researchers spent six months inviting people to the town hall meetings, receiving commitments to attend from 2,000 people.
"Then we had about 150 people actually attend," he says. "So it's challenging in this day and age for people to take time out of their busy lives and show up."
Focus groups: Another model for community consultation is the focus group model in which smaller groups of 10-15 people are brought together to discuss the research.
For example, a study that will enroll people who have seizures could invite these patients and their family members to a focus group session.
"We'd ask them what it would be like for them if they were swept up in a study," Clark says. "We have these town hall meetings with as big of a group as we can get, and then we have smaller focus groups."
Random digit dialing: A third way to satisfy community consultation requirements is to hold random digit dialing, Clark says.
"We all hate to get those calls on Saturday," he adds. "But we found that if we script a good description of a study and have meaningful questions, hiring professional groups, we can get hundreds and hundreds of randomly-sampled residents."
The process involves a structured telephone survey that asks specific questions about the study, explains the study over the phone, and asks about the demographics of the person being called, Aufderheide explains.
"The survey obtains their feedback on the acceptability of doing the study with an exception to informed consent and how they feel about it," he adds.
Typically, these calls are made to 500 or more people in a community.
"It's a very objective way to assess a community's feelings about a study," Aufderheide says.
Random digit dialing is particularly helpful in studies where there isn't an easy-to-engage target population, he says.
A good example are studies that focus on trauma from gunshot wounds, he adds.
"There is no focus group for people with gunshot wounds, and these are the type of people who won't show up to a town hall meeting," Aufderheide says. "So random digit-dialing is an approach that probably is most effective."
The 10-15 minute calls ask people to give their thoughts on how a particular research project might impact their rights and welfare, Clark says.