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IRB administrator revises IC policies & procedures
Interests of reading and hearing-impaired included
Very few informed consent policies are extensive enough to convince one IRB director that the protections are extended to everyone who might be asked to participate in a study.
"We do have an informed consent policy, but I knew we needed to address formally the process that went along with informed consent for those people who could not undergo the normal or usual consent process," says Jana L. Lacera, RN, MSA, human protections administrator and director of the IRB and Bio-Ethics for Community Healthcare System in Munster, IN.
"How do you address people who don't speak English or don't speak it well?" Lacera says. "We do have a language line we could use, but it's never been written down anywhere."
Lacera had created all of the IRB office's policies and procedures from the ground up a few years ago when she was offered a job to be the IRB office's first director. Before she had completed the task, the institution was audited by the FDA during a routine visit, she says.
"Your hands sweat when you get that call on a Monday morning, and it was just a routine visit, and we came out very, very well," Lacera says. "We had only one recommendation because I hadn't completed our medical device policies yet."
Within two weeks, Lacera had finished those policies, as well, and resubmitted the policies to the FDA.
Now, she has returned to the informed consent policies to improve those.
"Our policies did nothing to address the people who can't read, and we have a low rate of literacy in our country," Lacera says.
Lacera also identified the hearing and visually impaired as potential research participants who would have trouble with the standard consent process.
Having spent years as a nurse and director of an intensive coronary care unit, Lacera often encountered patients with these communication issues.
"So, often we'd see patients who had procedures explained to them and their families, but they really didn't understand," Lacera says. "I think it's very important in protecting the rights of the patients that they understand what we're telling them."
"When I started working for the IRB, I found the informed consent forms daunting, even though I'm a medical professional," Lacera says. "So I thought, 'How does the average person get through the 25-page consent form?'"
Although the IRB and investigators have strived to have these forms written to an eighth grade reading level, Lacera is unconvinced that they've succeeded in this goal.
"I go over every single consent form written for our IRB, and I can tell you they are not written to an eighth-grade reading level," she says.
The problem is that many people who provide input to the informed consent forms are professionals who do not work directly with participants, and they each have their own professional language and terminology that ends up in the document, she says.
"I understand that we health care professionals speak a different language, and lawyers need to understand they speak a different language, and not all of our subjects understand those languages," Lacera says.
Lacera decided to fix these problems through a revision of the policies and procedures concerning informed consent. Here's how she did it:
• Look at what other IRBs have done: "I love to look at other people's Web sites, and there are some wonderful policies and procedures out there," Lacera says.
Most institutions include their forms and rules online, sharing their information with others in the human subject protection field.
But despite a thorough look at IRB Web sites from coast to coast, Lacera was unable to find any policies and procedures that covered all of her concerns.
"Nobody addresses informed consent further than non-English language patients," she says. "I only saw one policy and procedure that talked about low literacy, and it alluded to that within the process of oral presentation."
• Address the major barriers in written policy: Lacera selected these three areas to revise in the informed consent policies and procedures:
- English as a second language participants: "If the patient or subject doesn't speak English, or doesn't speak English well, then the investigator will have to provide an interpreter, and the interpreter cannot be a family member or friend," Lacera says.
It's well documented that using informal interpreters can lead to communication problems since most people are not fluent in translating medical language, Lacera explains.
"So, the policies will require a certified interpreter," she adds. "We have a large Spanish-speaking population and a rather large Indian population."
The hospital already contracts with a telephone interpreting service, and this can be used by researchers, as well, Lacera notes.
- Deaf participants: These potential participants pose a unique challenge, so Lacera proposes placing them in a separate category. "We have a sign language interpreter we can contract with," Lacera says.
- Low literacy/blind participants: Participants with either of these challenges are addressed in one category because they both would have problem with a written informed consent, Lacera says.
"What we're going to have to do is look into training witnesses so they can be objective observers of the informed consent process," Lacera explains. "And when they co-sign the consent, they are actually witnessing that the subject understood the consent, including the risks and benefits of what they've been told."
The trained witness would need to be someone who is not involved in clinical research, but could be a volunteer from among the institution's staff, she notes.
"I would like to be able to train several people within the system on what is a good informed consent, so they could be trained witnesses, trained observers," Lacera says.
The training would be similar to what IRB members experience, including a video about human subjects protection, she adds.
• Seek input from others: "Right now, I'm finishing the policy on overcoming barriers to informed consent, and then I'll take it to the clinical research staff for their input," Lacera says.
She'll ask for answers to these questions:
- Is this something that's doable to the investigator?
- Does this make the process too cumbersome?
"I'll listen to their input, see what they think, and make revisions before presenting it to the IRB," she says. "By that time, hopefully, we'll have corresponding clinical research suggestions in place also."
The informed consent revisions should take about four months before they are ready to be included on the IRB's Web site, Lacera says.