Some studies are right for short form, with precautions
Short consent need not mean lax protection
IRBs sometimes reject an investigator's request to use the short informed consent form, even when it would meet regulatory and ethical standards.
The short form is a generic informed consent form that can be translated into different languages and used in lieu of a detailed informed consent document when a participant does not speak or read the dominant languages of a particular study's subject population, says David Borasky, CIP, director of the Office of International Research Ethics for Family Health International of Research Triangle park, NC. Borasky spoke about the short consent form at the National Human Subjects Protections Conference called, "Crossing the Line: What is Acceptable Risk?" held Sept. 25-26, 2006, in Durham, NC.
The regulations [45cfr46.117(b)(2) and 21cfr50.27(b)(2)] permit the short form that is translated in that language to be used to document informed consent. When using the short form, the consent process must be witnessed, and there has to be a summary script approved by the IRB that a translator will use to informed potential participants, Borasky explains.
The script summarizes what is in the regular consent form, covering all of the main elements, and then the subject is asked to sign the short form in their own language and is also given copies of the English-version consent form that is signed by the study staff, Borasky adds.
Specifically, the regulations say that only the short form is to be signed by the subject or the representative, but the witness must sign both the short form and a copy of the summary. And the people obtaining consent must sign a copy of the summary.
Federal regulations permit that process, but sometimes IRBs are uninformed about how and why the short form is used.
When Denver, CO, investigators first approached IRBs about a tuberculosis study and requested to use the short informed consent form for the handful of participants who speak a minority language, the IRBs flatly refused, recalls William Burman, MD, medical director of the infectious diseases clinic at the Denver Public Health Department in Colorado. Burman also spoke about the short form at the National Human Subjects Protections Conference.
"The answer we got back was 'You can't do it,' because the IRBs weren't aware of this aspect of the regulations," Burman says. "We told them, 'We're not making up anything new — this has always been in the regulations.'"
Once investigators communicated in greater detail the existence of the short form procedure in the regulations and how they intended to use it, the IRB endorsed the short form and even had it published in 20 different languages on the Web site for affiliated investigators to see and download, Burman says.
"In general, at our site, we've had increasing use of the short form, but it's still not accepted at every site," Burman notes.
The consent form makes perfect sense for the Denver TB research, he says.
"We deal with patients who come through from all over the world, so we can predict some languages that will be very common, and one of those for us is Spanish," Burman says. "Fifty to 60 percent of our patients speak Spanish, so in that case the appropriate thing to do is have the full consent form translated."
But there also are patients from remote areas of the world who are eligible and ideal candidates for a clinical trial involving TB, but if there is no mechanism allowing the use of a short form, the site can't enroll them, he explains.
To have the lengthy informed consent document translated into an Ethiopian patient's language, for instance, would be tremendously expensive, Burman adds.
"So the short form enables us to offer enrollment to patients who come from areas of the world where we can't predict there will be a significant number of patients from that area," he says.
Patients who are eligible for a study and the short form are provided a translator by telephone, Burman says.
"These are the same translators we use for clinical care," he says. "We don't have translators for all languages, so we use a commercial translation service that is expensive."
Regulations require that the translator use an approved summary of the study, and the translator is expected to go over the short form word-by-word, because not all patients are literate, Burman adds.
"Rather than create an independent document that is IRB approved for a study, we use the study's original consent form," Burman says.
The translator discusses the entire consent form with the subject in a conversation that could take more than an hour, he adds.
This way the clinical trial site can be certain the subject knows what is in the long consent form without having to spend the thousands necessary to have it translated into another written document.
And this method ensures a strong informed consent process, Burman notes.
"Ideally, the use of the short form could refocus the consent process back to where it belongs: to oral communication," Burman explains. "Study after study says that what is remembered by research subjects is not what's in the informed consent form, but what is said."
While the short form can be a useful tool for some sites, it should only be used with proper preparation and without compromising the rights of potential participants, Borasky says.
One of the dangers of using a short form and oral translator is that the quality of the translation will not be ideal, he says.
"Anytime you use translators, you need to chose them carefully because an inexperienced translator who is not familiar with the [research] language used in the consent form could have some variability in the quality of information given to subjects," Borasky says.
"Another concern is if you did enroll someone successfully with the short form, what would happen if the person had questions later on and nobody on the study team could speak the person's language and answer those questions," Borasky adds.
Even finding a witness to watch the subject sign the short consent form poses potential problems because the regulations don't define what a witness is, and if a family member is used, this would be less than ideal, he says.
"I think the short form should be considered in situations where enrollment of people qualified for the short form is compelled for reasons of justice," Borasky says. "I think when investigators are looking to use the short form, it's not merely a matter of convenience — they have to have a compelling reason why."
IRBs sometimes reject an investigator's request to use the short informed consent form, even when it would meet regulatory and ethical standards.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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