Improve IC process by taking a subject’s view
Subject advocate offers advice
IRBs and researchers could improve the informed consent (IC) process by looking at research participants from a different perspective, an expert says.
Research participants are part of a community that might view research distrustfully or who may not understand the benefits of research to society or know enough about their own rights in a study, says Corey Zolondek, PhD, research subject advocate at Wayne State University in Detroit.
"We need to make informed consent as understandable as possible and make sure the forms are written in a way that covers all of the regulations, but also be relatable and understandable to participants in research," Zolondek says.
Research participants should be fully informed about their legal rights, and all risks and benefits need to be clearly disclosed and explained, he adds.
And this process begins with recruitment.
Zolondek was involved with a panel of former research participants who said there were right and wrong ways of being asked to participate in a study.
For instance, one former participant discussed how the physician who presented the study did not make it clear whether interventions being discussed were standard of care or research, he recalls.
"So she went into the study and came to understand through the consent process that it was research, but during the recruitment it should have been clear that it was a research project," Zolondek adds.
"During the recruitment process, a study should be explained well enough that someone knows whether or not she wants to go to the next step of signing up for a study," he says. "Any recruitment materials, be it an advertisement or telephone recruitment, should present enough information to potential participants."
Zolondek’s role at Wayne State University is to handle questions and concerns participants might have about a study, especially when they involve confidentiality or privacy and the informed consent process, he says.
"Also, I discuss why research is important," he adds. "Being a person with a scientific background, I do understand that participating in research leads to significant benefits."
These types of concepts should be covered in the informed consent process, but among some populations it may be difficult to communicate without the help of someone who knows that community well, he notes.
"Especially in Detroit with a large minority population, there’s a lot of distrust of research and it’s difficult to communicate how it can have a benefit to the community," Zolondek says.
When holding a seminar on how to improve informed consent in a community, a researcher told Zolondek about a study where the consent process involved very little discussion between the person giving the consent and the participants. The study involved a medical intervention, and the principal investigator was concerned that participants were not presented information adequately, he says.
"They wanted better ways to present information to participants, so I suggested they take the technical language and find simpler ways of explaining it during the consent process," Zolondek says.
The informed consent form explained everything well with definitions in parentheses, but the people administering IC were not as knowledgeable about the study as they should have been, he adds.
"I suggested that they train individuals giving consent to participants until they understood the study well and could explain it without having to reference the consent form," he says. "The consenters should be knowledgeable enough to address any of the participants’ questions."
One concern that participants might have is what will happen if the person is injured.
"Who pays if an injury occurs?" Zolondek says. "This should be clear."
The informed consent process should make it clear who will pay for medical treatment in the case of an injury.
"A lot of studies have standard of care elements related to the study, and participants are expected to have insurance cover that aspect," Zolondek says. "Going into a study it may not be clear what the participant will pay versus what researchers or sponsors pay."
When researchers and IRBs review informed consent forms and the IC process, they might ask themselves what they would want to know more about if they were the ones participating in the study. If they present information clearly and accurately, there will be fewer opportunities for participants to misunderstand a concept, such as standard of care versus a treatment intervention strictly for research or what it means if the patient withdraws from the study, Zolondek notes.
For example, in some studies the participant might not be permitted to stop taking the intervention medication overnight because of health problems if the medication is not dosed down. This kind of information should be presented to participants during the IC process, Zolondek says.
"Present information to participants even if they do not have direct questions about it," he adds.