Research site obtains informed consent at each and every visit
Children's assent also sought continuously
When IRBs approve a clinical trial site's informed consent documents, they often have no way of knowing how the informed consent process is played out at the site.
IRB members might hope that each CR site takes time to speak with research volunteers on a continual basis and answering questions that volunteers might not even know to ask. But, realistically, how often does the care and diligence the IRB promotes end up being employed at the site level?
There is at least one clinical trial site that follows a practice and philosophy that informed consent is a continual process that must be affirmed at each site visit.
The philosophy is that this is both the right thing to do and that it is the best way to be proactive and address the sorts of problems that sometimes lead to volunteers dropping out of clinical trials, says Brian Berendts, BSN, RN, CCRC, senior clinical research coordinator of Bernstein Clinical Research Center in Cincinnati, OH.
Bernstein Clinical Research Center conducts pediatric asthma and allergy treatment studies that involve minimal risk, Berendts says.
"The biggest risk is their asthma may flare up or the medicine may not work," Berendts says.
Berendts provides informed consent in a way that ensures both the child and parent understand what is being proposed and have time to truly think about it.
Parents often retain very little of what health care providers tell them because of the stress of being in that situation or because of distractions, such as younger children tagging along, Berendts notes.
"So normally what we try to do with these studies is give the kids and parents a cooling-off period," he says.
"It works great with adults, but we try to emphasize it with a pediatric study where the family comes in, or maybe the parents by themselves read through the informed consent document," Berendts explains. "They may not sign anything right away, and if they do, we try not to do any procedures on that first visit."
Here's an insider's look at how the CR site conducts informed consent in pediatric trials:
1. Assess the child's interest in the research.
"I like to meet with the parent and child together because for the child, the parent is his support system," Berendts says. "We're strangers to the child, especially if he's never done a study here before."
So parents and children sit together in a private room with the research coordinator to discuss the informed consent document.
"As a clinician, I will assess what the relationship is between the child and parent and try to pick up on any coercion regarding study participation," he says. "I want to be sure the child is here because he's interested and not because the child wants to help the family pay the electric bill."
Even children as young as age four will have a clear opinion about whether they wish to do something, Berendts notes.
"Children have the right to say, 'No,' and it has to be binding," he says.
Even children who don't say no verbally might be suggesting that with their body language.
"Silence does not equal 'Yes,'" Berendts says. "Silence to me equals 'No.'"
So if a child appears to be uncomfortable, and if Berendts asks him if he really would like to do this study and he just stares at the study coordinator or looks at his mother for the answer, then Berendts would count that as a 'No' answer.
"I really need the answers to come from them, and I document the child's verbal response to me," he says. "I want to hear children say, 'Yes, I want to be here.'"
Children who answer, "I don't know" or who are completely silent, are not assenting to a trial, Berendts adds.
2. Give the family time to read through the informed consent document.
Whenever possible, Berendts gives families time alone to discuss the study and IC document.
"I say, 'Tell me when you're done reading,' and then I leave them alone," he says. "When I go back in, I see who has questions."
Often, the children and parents do not have questions, so it's helpful to give the family additional time to review the informed consent, which is why Berendts will let them take it home and think about it before signing the document.
"The cooling-off period helps because the parent may not want to ask a question about how dangerous the drug is to their child in front of their child — they'll wait until they get home," Berendts says. "I give everyone my cell phone number and ask them to call me and ask me any questions they have."
3. Use conversational openers to re-consent.
When Berendts greets a family at a visit, he'll ask how they're doing and whether they've had any problems since the last time they were in.
"No matter what procedures I have to do, I'll ask them what has changed," he says.
Then Berendts will ask the child and family if they know what they'll be doing that day and answer any questions they have about the procedure.
He'll also directly ask them if they still want to be in the study.
"If I'm getting a vibe that they don't want to be there then I'll say, 'Do you still want to do this, or is this something you're having second thoughts about?'" Berendts says. "What's going on in your head?"
This direct approach works well because people often are afraid to ask what they might think is a dumb question. Yet, if they don't ask it, there could be negative consequences regarding their continued interest in the study, he notes.
"It's confusing to be involved in a clinical trial, and the consent form might be 20 pages long, so we want them to ask questions," Berendts says.
If the volunteer seems confused or uncomfortable, Berendts might show them the consent form again and discuss the various procedures listed on it.
"I encourage parents to keep that consent form with my business card attached to it and put it up with a magnet on the refrigerator," he says. "This way they'll always know my number and what they'll be doing here."
At times, the family continues to be uncomfortable, and perhaps their concerns cannot be allayed, so Berendts will make it easy for them to say they no longer wish to participate in the trial.
"If I get the sense that they're done with the study, then I don't push it," he says. "If they say, 'I'm not sure anymore' or 'I just don't know if I have the time,' and we can't work it out, then we'll say, 'Studies aren't for everyone, so it's okay if you don't want to participate.'"
The research staff will conduct an exit interview with the patient and family and provide any standard care they might need.
4. Provide continual informed consent assessment with all research staff.
"Right now we're doing a study where we do X-rays of children's wrists, and the X-ray technician might be doing her own assessment [of the child's assent] at the same time," Berendts says.
The X-ray procedure takes about 10 minutes, and during that time, the nurse practitioner and physician might pop into the room and ask questions about how everything is going and whether the child or parents have any questions, he adds.
"This all goes back to the research coordinator coordinating everybody's input into what's going on," he says.
5. Document every consenting encounter.
Research staff should write down each time they've asked a volunteer questions regarding informed consent or assent.
"If you don't write it down then you didn't do it," Berendts says. "I write the same sentence: 'Patient verbalized continuing interest in study participation,' or 'Patient verbalized positive desire to continue participating,' and that's all I need to write."
Research staff might ask 40-plus questions, but the point is to record at each visit that the volunteer still is interested in participating, he says.
"With children, ask both the child and parent, and write both answers down," Berendts says. "Depending on the IRB's requirements, the child will sign an assent form too."
When IRBs approve a clinical trial site's informed consent documents, they often have no way of knowing how the informed consent process is played out at the site.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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