OHRP opens discussion on clinical trial use of the short consent form
OHRP opens discussion on clinical trial use of the short consent form
Revised regulations expected next year
Traditionally research sites and IRBs have been hesitant to embrace use of the informed consent short form, but that may soon change.
The Office of Human Research Protections (OHRP) of Rockville, MD, is developing a revised draft document on the informed consent short form, specifically targeting the use of the form in circumstances where subjects do not know English.
"We have recognized there is a need to expand and update that guidance, and we're in the process of doing that now," says Julie Kaneshiro, policy team leader for the division of policy and assurances at OHRP.
"The FDA also has a comparable regulatory provision for the short form, and they are also in the process of developing draft guidance material," Kaneshiro says. "It's difficult to predict when it will be done, but we hope we'll have it completed within the next year."
The regulations (45cfr46.117(b)(2) and 21cfr50.27(b)(2)) permit researchers to use a short form translated into the language spoken by a subject to be used to document informed consent. The consent process must be witnessed, and the IRB needs to approve a summary script that a translator uses to inform potential participants, 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, held Sept. 25-26, 2006, in Durham, NC.
Subjects sign the short form, and a witness signs the short form and a copy of the summary, which is given to the subject, Borasky says.
According to the current regulations, the short form written consent document must state that the elements of informed consent have been presented orally to the subjects or the subject's representative, and there must be a witness to the oral presentation.
Also, the IRB-approved written summary documents what is said to the subject.
Typically, investigators use the long informed consent form as a resource in writing the summary that is used along with the short form, Summers says.
The short form itself contains standard boilerplate information about research and human subjects protection, including a series of statements about the consent process, Borasky says.
These statements include information about how the study is voluntary and the participant has the right to not participate. The IRB-approved language also may include a summary of what's in the regular consent form, Borasky adds.
The current guidance on the short form was published in 1995, and a lot of changes have occurred in human subjects research and clinical trials since then, including the demographic trend of increasing numbers of American cities dealing with new residents who do not speak English.
For instance, a Denver public health department in Colorado handles patients from around the world, including many who speak Spanish, says William Burman, MD, medical director of the Infectious Diseases Clinic.
Burman is involved in research regarding tuberculosis, and uses the short form for those who speak non-English and non-Spanish languages, such as Ethiopian.
"In the case of Spanish-speaking patients, the appropriate thing to do is have the full consent form translated into Spanish, but we also have patients from every other place in the world," Burman says. "And they're also eligible for clinical trials in tuberculosis, and if we don't have a mechanism for a short form than we can't enroll them."
If the institution were to translate the entire informed consent form into every language spoken by potential subjects, it would result in a tremendous expense, Burman says.
"So the short form enables us to offer enrollment to patients who come from areas of the world where we can't predict that there will be a significant number of patients from that area," Burman says.
Burman and other researchers have access to generic short forms that have been translated into 20 different languages.
"It's a short statement of the boilerplate part of the consent form, including the right of the person to not be involved in research, yet to get medical care, and the person's right to withdraw from research at any time, and how to get additional information," Burman says. "It could be used for literally any study, and would be available to anyone who needs it."
There are a variety of settings in which it's appropriate to use the short form, and some of these settings might be where the population is illiterate, but English-speaking, says Elyse I. Summers, JD, public health analyst in the division of education and development at OHRP. Summers also spoke at the National Human Subjects Protections Conference, held Sept. 25-26, 2006, in Durham, NC.
"The sense I get is that some institutions are a little wary about using the short form because they're concerned it won't meet their needs, or there might be added burdens in using it," Summers says.
More researchers might use the short form if they considered that it can be targeted in a way that makes it of universal value, Kaneshiro says.
"The regulations don't lay out specific scenarios in which it can be used," Kaneshiro says. "Where we have seen it used the most often, or at least in a way that generates the most questions, which can be an indicator, is in the area of non-English speaking potential research participants."
Any discussion about using the short form also raises the question of whether the current informed consent process is truly the most beneficial, Summers notes.
"OHRP's Dr. Bernard Schwetz in public forums has recognized that the informed consent documentation situation, as it sits today, with 35-page long documents, may not really be true and beneficial informed consent for people," Summers says. "So as an office, OHRP recognizes there might be appropriate uses of the short form, and that if the safeguards are in place and if the whole informed consent transaction is meaningful and substantive, then there might be situations in which using the short form along with the summary makes the interaction more meaningful for the prospective subjects."
The short form helps to refocus the consent process back to oral communication, which is where it belongs, Burman says.
"Study after study says that what is remembered is not what is in the informed consent form, but what is said," Burman says.
Since investigators must use a translator to read the short form and summary to subjects, then the conversation with the subject can take over an hour, he notes.
The main drawback to using the short form has to do with ongoing management of non-English speaking participants, Borasky says.
"These participants are working in a trial where they don't understand the language, and that could be a challenge and complication to the protocol," Borasky explains.
Burman says his research team uses the same translators by telephone who are used for clinical care patients who do not speak English or Spanish, Burman says.
These translators can be called whenever subject or patient visits are scheduled.
When investigators anticipate having participants who speak a foreign language, they should provide the IRB with a plan for translating conversations, Kaneshiro says.
"The written summary will be read by the interpreter," Kaneshiro says.
Also, the interpreter will translate the research team's answers to subjects' questions, Summers says.
Traditionally research sites and IRBs have been hesitant to embrace use of the informed consent short form, but that may soon change.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.