Short form translation saves time, costs
Experts also say it can increase enrollment
Translation of full informed consent forms into other languages can be a costly and time-consuming endeavor for researchers, particularly if there are few non-English speaking participants in a study. To ensure the equitable and diverse enrollment of subjects, many research institutions use short form consent, a brief form that describes the elements of informed consent in the subject's native language. Short form consent can help ensure that a greater number of subjects have access to a clinical trial.
"People come here from all over the world [for treatment]," says Heather Cathrall, MBE, CIP, assistant director, IRB Operations at The Children's Hospital of Philadelphia (CHOP). "We wanted to make sure that the subject selection was equitable and they had access to the trials we have."
For studies with a very small number of non-English speaking subjects, translating the entire consent form became a time and cost burden to researchers. CHOP introduced the short form consent process to alleviate the cost burdens and ensure that a greater subject population could be enrolled in studies.
The short form contains brief explanations of all the elements of the consent form, including what the study entails, risks and benefits, etc., in the participant's native language. An interpreter from CHOP's Language Services department reads the consent form to the participants (in the case of CHOP, to the parents or guardians of the participant), and the study team is present to answer questions. When everyone feels comfortable that the participants understand the study and what to expect, the interpreter and the participants sign the short consent form, and the study team and interpreter sign the English version of the form.
At first, the institution's interpreters were hesitant to sign the short forms due to the wording. "One of the struggles we had until recently was that, even though the study summary documents were IRB approved, the interpreter would say they did not want to sign the form because they didn't feel comfortable," says Amy Schwarzhoff, BS, CIP, director of human subjects research at CHOP. The vice chair of the Committee for the Protection of Human Subjects collaborated with representatives from Language Services to craft consent form language that was acceptable to everyone. "Everyone felt that it met the requirements of the consent process and wasn't overpromising anything," she says. (For examples, see box on page 44.)
The documents are already IRB-approved, so an investigator does not have to seek an amendment for an approved document if it must be added. The language of the short forms is generic, and the form includes spaces for investigators to add names, contact information, study name, and other required information. Because the forms are already approved, permission can be given quickly if the need for a form arises.
"Every once in a while, there will be a study team who didn't anticipate these participants and didn't get approval ahead of time [to use the short form]," Schwarzhoff says. "We can usually turn the request around in a couple of days."
When a researcher encounters a subject who speaks a language not already in the form database, he or she will use the available resources to have the English form translated. Though there is some initial cost, it is more manageable than translating an entire consent form — and can greatly expand future study subject pools. "There is some cost with the translation, but when the form is used in 200 studies, it can expand your subject pool," Cathrall says.
"It [short form consent] makes adding new subjects a lot faster and less labor intensive," Schwarzhoff adds. "It also makes reviewing studies quicker than it would be otherwise."
Researchers from the University of Pennsylvania also use short form consent. If a researcher enrolls a study participant who speaks a language for which there is not already a form, he or she can request to have the English short form translated, and the new form is kept on file. If a particular researcher submits many requests for a particular short form, he or she is then asked to translate the entire consent form. "We don't require the entire translation when it's an incidental enrollment of the [non-English speaking] subject," says Tracy Ziolek, MS, CIP, director of Human Research Protections at the University of Pennsylvania in Philadephia.
One of the biggest issues with the consent process when using the short form, she says, is making sure the subject is comfortable with the process and that he or she understands what is going on.
"For me the most important piece is the documentation of the consent witness stating if the process was rushed, if the subject understood it all, etc. If there were any roadblocks to consent, that is going to affect the relationship," Ziolek says. "The short form is just the anchor form — informed consent still needs to occur."
Ziolek offers these tips for developing a short form consent process.
- Decide on the wording. First things first, Ziolek says, everyone must agree on the content for the English version of the short form. Investigators, IRBs, study subjects, and everyone involved should be comfortable with the document's wording.
Look to other institutions for inspiration. If you're not sure where to start, see what other institutions are doing. "I would say that if you're starting from scratch, the best thing to do is contact a colleague at another institution; institutions are usually open to sharing information," Ziolek says. "If another institution asked, I would say 'Help yourself' — it's a collaboration among all of us." Make sure that the wording is appropriate and captures the information your IRB wants to capture.
She also recommends sharing foreign language translations of the short form. The form describes the consent in general terms, and the general information — contact numbers, investigator names, study title — can always be changed, she says. "The short form doesn't have the most argued-over language; there's no language on injury or other things people get tripped up over," Ziolek says. "That's why I think it's easier to share forms of this nature, because they don't have the specifics in them."
Educate researchers on the process. The biggest potential roadblock to consent, Ziolek says, is the researcher or subject not having all the pieces of the consent puzzle. If a researcher is not aware of these resources, there may not be a translator provided, or the consent process may not be fully documented. "There's a disconnect with people who are not familiar with it [the process]," she says. "Case by case, we walk them through what is required for their circumstances, and we'll tell them what pieces of the puzzle are missing. The Penn clinical manual is also quite helpful with utilizing the forms."
Education is also one of the pieces of the puzzle, Ziolek says. "I would hate to think someone missed out on participation because the researcher didn't know what they could do," she says. "Knowing that it's an available option and knowing how to use it are two big pieces of education."