For international consent, clarity is key
Conversational tone is more engaging, expert says
Creating clear, truly understandable informed consent documentation can sometimes be a challenge for IRB members and researchers, particularly in the area of international research. Making sure that details are not lost in translation and that the documentation meets U.S. federal and international regulations can also present some difficulty.
"It’s particularly challenging with international research because each country has different rules that govern research," says Jacob Stoddard, BA, CIP, senior IRB protocol analyst at The Ohio State University’s Office of Responsible Research Practices. "We make sure researchers go through that country’s approval process as well, as it’s a precursor to our IRB offering final research approval."
OSU is conducting more research in China, India, and Brazil, and is establishing gateways in those countries by forming partnerships with universities and research entities. The university is also seeing a growing amount of research in Africa, particularly in Kenya and South Africa. OSU’s study abroad program sees many undergraduate students developing research projects in these and other countries.
Expanding research overseas
"At The Ohio State University, we see a growing amount of international research, especially in social and behavioral sciences," Stoddard says. "As researchers went overseas to conduct more and more projects, one of the challenges they faced was developing an informed consent process that respected the culture and the social norms while maintaining and being in line with federal regulations in the U.S. One of the practices we focus on is putting processes in place to help the researchers develop a consent process to best explain the research."
When considering language for an international consent form, Stoddard has these recommendations:
- Do your homework on the country in which the research will take place, and especially look at the literacy levels of the study population.
- Create a list of cultural consultants. These can be members of the university staff or community who are knowledgeable with cultures in the studies.
- Have the consultants look over the consent language and make sure there are no confusing translations or terms with which participants may be uncomfortable.
- Create sample consent templates that researchers and student investigators can tailor to the population being studied.
- Create checklists or other IRB review tools to ensure that IRBs consider a population’s social and cultural norms when reviewing international study protocols.
When reviewing international research consent forms, the OSU IRB focused on several key factors, including studying the population and making sure IRB members and researchers are knowledgeable about the culture. Some consent forms are written more conversationally instead of as a long speech. OSU also uses cultural consultants, who are volunteers from the university or global research community who are knowledgeable about certain cultures. The IRB attempts as much as possible to use consultants within the country to be studied. "The consultants take a look at the consent script to determine any translation issues, that the language will be easily understood by the participants, and give us feedback on the culture as a whole," Stoddard says. "For instance, researchers may be studying a culture where a researcher would need to get the approval of a patriarch or chieftain before going out and talking to individual members of the family or community. The consultants support the IRB in making informed decisions. We gather as much information as possible in advance so the IRB can inform the researchers of any concerns during the review process."
Don’t become lost in translation
Cultural consultants make sure that elements of the informed consent translate well and that examples used in the language will make sense to international participants. For example, a researcher in South America tried to explain that participants would be part of random groups. The difficulty lay in trying to explain the word "random" — the researcher equated the term with flipping a coin, though the translation said, "Random is like throwing money in the air," a nonsensical phrase. "What also comes up is that the idea of flipping a coin is something we’re familiar with, but that doesn’t mean it symbolizes chance all over the world," Stoddard says. And with a tribal culture, "All information collected will be anonymous" may be a confusing idea; a better statement is, "We will not write your name down." "That’s more in line with the language of that particular group," Stoddard says.
Creating verbal consent
For the behavioral and social research and other minimal risk studies at OSU, researchers will often get a waiver of consent documentation and use verbal consent instead. In some cultures, participants may be intimidated by signing documents that appear to be legal and official, and verbal consent scripts can be written more conversational or informal in tone. "We’re seeing this more and more in international research, especially in developing countries which do not have a prevailing Western influence," Stoddard says.
The IRB office at OSU worked with research professor Dr. Richard Gunther from the OSU Political Science Department to develop a sample verbal consent template for researchers to use. The university does not require the use of that particular template, but employs it as a starting point for developing verbal consent. "We look over the form to make sure certain regulatory information is there, and we use the consultant for the international form. We have them look over the study protocol and consent to help the IRB understand before the review if there are any risks or cultural norms that we need to be aware of to help conduct a project that will be beneficial to the research."
The biomedical studies, Stoddard says, sometimes use consent forms with more visual elements, such as pictures and graphics, to better explain the consent process to subjects in other cultures. For instance, a researcher from another institution described four vials of blood as "small glass bottles," which frightened participants into not signing up, as they envisioned glass soda bottles. A new visual form showed the actual size and shape of the vials. "The forms may explain a blood draw with a picture of what that means and how much blood will be taken," he says. "They figured out ways to make the process more visual."
Instead of being written as a speech that some participants could find intimidating, the verbal consent template is more conversational and can encourage participants to ask more questions and engage in discussion about the study. The sample template starts off with the researcher introducing him- or herself and explaining the research project. The participant is told that the study is voluntary, and that the participant’s name will not be linked to anything he or she says or does. (For more on the verbal consent template, see the above box.)
"We do see in countries where the majority of the population does not speak English, researchers will utilize a verbal consent for behavioral research," Stoddard says. "If the fear is that a signed document is a legal concept — in that culture, it just makes a lot more sense to do a verbal consent that’s more in line with the cultural expectations and to not intimidate potential participants."