Cultural issues should be addressed in IC process
Use IC to tell a story
When research involves an international or multicultural population, there can be informed consent issues that no one anticipates — not even the best-informed IRB.
For example, HIV researchers in Africa discovered that research participants were anxious about having their blood drawn for a totally unexpected reason: "The women didn't know their bodies continually made new blood, and they thought, 'I have a certain amount of blood, and if you keep taking blood out of me it will hurt,'" says Cynthia Woodsong, PhD, director of social and behavioral sciences at the International Partnership for Microbicides in Silver Spring, MD.
Woodsong learned of this misconception from a staff member in Rwanda.
"So I developed information, a page and illustrated sheet that can be made into a poster that talks about some of the blood issues," Woodsong says.
The illustrated sheet shows a woman character named Rose who stands next to a five-liter jug, which represents how much blood is in the human body.
"Then we show someone holding a vial, showing how much blood we'll be taking," Woodsong says.
There also is a picture of a sun and moon on the page. These represent day and night, the amount of time it takes for the body to replenish the vial of blood that is drawn.
The educational sheet is as much for the informed consent counselor as it is for the research participant, Woodsong notes.
"The illustrations help the counselor remember what to say," she says.
Researchers guided by their IRBs could anticipate informed consent problems related to cultural misconceptions if they take a few extra steps when developing the informed consent process.
A first step would be to ask local and service delivery staff for assistance. They might know which misconceptions or beliefs are prevalent and could read over informed consent materials to see if there are any potential problems.
"Spend time with local practitioners and talk to local staff," Woodsong suggests. "I've interviewed hospital and clinic staff and community leaders not associated with a trial."
Also, IRBs and investigators should view the informed consent process as a way to tell a story.
"What's on paper is the legal information, but it doesn't tell the story of what a person is getting into, like what you would tell a friend," she says. "The key point is to not develop your materials from sitting in your office, but from active collaboration with people in the communities and research centers."
The research center staff has a much better idea of what participants will understand. Community advisory boards and other stakeholders also can be helpful with identifying what participants need to hear, and they can be a good sounding board for new informed consent approaches, she adds.
For instance, Woodsong developed illustrated instructions on how women participants in a trial using vaginal rings should insert the rings. She used an illustration of the character Rose putting her ring in to show how it is done. When Woodsong shared this illustration with community advisors, she learned that the illustration gave women and men the wrong impression.
"When the community looked at the picture of her putting the ring in they thought she could be playing with herself," Woodsong says. "It could be misconstrued."
So the drawing was changed to one with Rose holding the ring in her hand, and that drawing was included on an informed consent flip chart that accompanies the IC form.
When researchers obtain feedback from local experts, they should make sure the experts know what they did with the feedback, Woodsong advises.
"Say to them: 'Here's what you told us; here's what we did with what you told us,'" she suggests. "We often take from them and don't give back."
Woodsong's story approach includes an enrollment IC assessment checklist that can be adapted for different types of trials.
"What I've trained staff to do is have the woman tell a story of the trial," Woodsong says. "You ask her, 'If a friend of yours was thinking about joining the study, what are all of the things you think she should know?'"
Then the staff member goes through the checklist as the woman speaks, making sure she understands each important item. If the woman/participant forgets to mention something important, the informed consent staff member can ask about that specific item.
Here are the eight open-ended questions/statements on the enrollment informed consent comprehension checklist:
- Please describe your understanding of the purpose of the study.
- What do you understand that you are being asked to do in this study?
- What do you understand about possible risks that might happen as a result of being in the study?
- What will happen if you do not join the study?
- Please tell me about the different groups of women in the study.
- How will the information about you be protected?
- What are the benefits to you of participating in this study?
- What should you do if you have any questions about what is happening in the study?
The checklist also has a column for comments and a section with checkboxes related to the outcome, such as whether the subject demonstrated comprehension of all required points and decided to enroll in the study.
Woodsong developed the checklist while at Family Health International of Research Triangle Park, NC, where she previously was employed as a scientist. Since then, it's been used by several international research organizations and on various trials.
Another IC checklist is for ongoing IC comprehension, and it can be adapted to assess comprehension of specific clinical trial procedures. For example, the HPTN 035 ongoing IC comprehension checklist has these questions/statements, in addition to some included in the enrollment checklist:
- Please tell me about the different groups of women in the study.
- If a woman always uses study gel, but does not use condoms, can she get HIV?
- What should women do if they have a question about the study or a problem related to being in the study?
- Are women who join the study allowed to leave the study?
When researchers and IRBs follow the "tell a story" approach to informed consent they will find that consent forms can be shortened by several pages, Woodsong notes.
Instead of using a visit-oriented format that details exactly which procedures will be done at each visit, often repeating items, the story approach simplifies the information: "When you come in every month for a visit we'll give you a blood test; when you have a blood test, we'll do the following things," she explains.
The approach can be further simplified with wording that lists how many blood tests and other procedures will be conducted throughout the study.
"They tell the story about what is of concern to the participants, rather than following a clinical protocol," Woodsong says.
IRBs can sometimes hinder this simplification process by asking for more information, she says.
From the IRB's perspective the informed consent form always is too long, but there also are things that weren't explained well enough, Woodsong says.
"We're told to keep it brief, but get in all of the important points," she adds.
It would facilitate a better informed consent process if IRBs would interpret the regulations regarding informed consent more generously, Woodsong says.
"IRBs are following their interpretation of the letter of the law and not keeping abreast of developments and innovations and research ethics," she says. "So the people living and breathing and debating research ethics may move on to simpler or more generous interpretations of things."