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Public notice: Pay for ads, but seek free publicity
An 'obligation to let as many people know as possible'
Public notification under an informed consent waiver for emergency research can be a tricky business. After investigators engage in community consultation and the IRB concludes their efforts were successful, then they need to notify the public about the study and its waiver from informed consent.
"Public notification is going to the media, TV, radio, newspaper, and announcing plans for the study," says Tom Aufderheide, MD, professor of emergency medicine and associate chair of research affairs at the Medical College of Wisconsin in Milwaukee, WI.
"It's a broadcast to the community that the study is going to be done," he adds.
Researchers can generate free publicity by letting local news reporters know about their plans, and they can ask community groups to put notices in their newsletters.
These notices should briefly explain the study and ask people to call or notify investigators if they have any questions, concerns, or feedback.
All comments obtained are taken to the IRB.
"The trick is to pay for some advertising and to exploit public service advertising too," says David Clark, PhD, assistant dean for clinical research and professor of psychiatry at the Medical College of Wisconsin in Milwaukee, WI.
"Ads can be very expensive," Clark adds. "While we have an obligation to let as many people know as possible, we need to operate within budgets."
Researchers should welcome local reporting on their emergency medicine studies and offer writers any assistance they can, he says.
They might attract media interest by putting a human element to the story. For instance, with an emergency medicine study involving the Public Access Defibrillation (PAD) research, investigators could explain to reporters how some people will die in a public place because no one has ready access to a life-saving device. The local heart association might even be able to put reporters in touch with people who have lost a loved one to a heart attack that occurred in a public location.
For magazines and publications that can go in-depth on the story, investigators could explain what research informed consent is and how difficult it would be to require researchers to obtain informed consent each time an emergency medicine patient appeared at the hospital.
"When you have seconds to minutes to react, there is not enough time to do informed consent in the way it's supposed to be done even if a family member were present," Clark says.
"A lot of studies are done off the back of the ambulance," he adds.
If researchers do their jobs well during the public notification stage, it's likely they will receive a variety of comments, complaints and questions from the public, Clark notes.
"We have a sterling investigator who has been willing to go the extra mile and pioneer the ways we get feedback," he says.
Conflict with civil liberties
In one complaint, a person objected to the possibility of a family member being recruited into the study under an informed consent waiver, he recalls.
"The person who came to us and the patient had such a deep civil liberties belief in the principal of consent that they said they would never allow themselves to be in a study where they weren't asked to enroll," Clark explains.
In this particular study, the public service announcements told people that if they thought there was a possibility they might be enrolled in the study, they could wear a wristband that would exclude them from the research.
This particular complainant had heard the announcement, but also objected to having to wear a wristband, Clark says.
For members of the public with this type of objection, the IRB and investigators came up with a solution to have the person's medical alert bracelet programmed to say that if the person was a candidate for the study that he didn't want to be in the study, he adds.
This change satisfied the patient's objections.
Complaints made during the public notification process have to be addressed or else they could result in the IRB having concerns about approving the study, Clark notes.
"An IRB would be reluctant to endorse the study unless there was a distinct majority of the community who felt comfortable or supportive of the study and unless the kind of objections raised sounded as though they could be raised reasonably," he explains.
Even a strong, vocal subgroup that felt their rights were being violated could lead to a chilling influence over the IRB, he adds.
In Aufderheide's experience, most people who are entered in emergency medicine trials are very grateful for having researchers optimize their outcomes.
"The purpose of community consultation and public notification is not to attain 100% knowledge within the community about the study, because that's never going to happen," Aufderheide says. "The purpose is to derive feedback and do the best job you can to notify the community."
Investigators need to understand the community's feelings about the study through both the community consultation and public notification processes. And they need to document all feedback and how concerns were addressed.
This phase of public notification is informing the IRB where the notification process stands and what changes have been made to satisfy the community's complaints or concerns, Clark says.
"Public notification is a rigorous process that can take six months to a year to complete," Aufderheide says. "Once the IRB thinks the public notification process is complete and acceptable, then the IRB can give investigators approval to start the study."