One size does not fit all when it comes to the consent process
[Editor’s note: In this issue of Clinical Trials Administrator, there is coverage of some of the important issues discussed at the 14th annual Society of Clinical Research Associates (SoCRA) Conference, held Sept. 23-25, in Lake Buena Vista, FL. The cover story in this issue and a follow-up story in the December issue look at how research sites can work toward obtaining fully informed consent. Also, inside is a story on best practices in managing clinical trial sub-sites.]
Develop multiple strategies for minorities and the elderly
Clinical trial sites continue to struggle with finding the best strategies for executing an informed consent process, although there are many good ideas employed at research institutions across North America.
Several speakers at the 14th annual Society of Clinical Research Associate Conference (SoCRA), Sept. 23-25, in Lake Buena Vista, FL, discussed best practices in consenting minorities, older adults, and in monitoring the informed consent process.
With clinical trials and research making headlines lately, there is a heightened awareness of ethical considerations in clinical trials, but informed consent has long been a very important part of research, says John Wright, BS, CCRC, IRB administrator at the Baylor College of Medicine in Houston. Wright spoke about working toward fully-informed consent at the SoCRA conference.
Sometimes an important strategy in providing informed consent is to acknowledge past research problems, particularly if these are on people’s minds from news articles reporting deaths among research subjects, suggests Lyndon V. Evans, CCRP, RN, research manager with CancerCenters of the Carolinas in Greenville, SC. Evans spoke at the SoCRA conference about going beyond the document in informed consent.
Also, new research presented at SoCRA highlights how important it is for researchers working with older adults to spend more time with subjects than usual during the informed consent process, says Lorraine Frazier, DSN, RN, NP, an associate professor in the School of Nursing at the University of Texas in Houston. Frazier spoke about informed consent and understanding of genetics among older adults and at the SoCRA conference.
Frazier and Menayra Caro, BS, CCRP, IRB/regulatory specialist at the Lakeland Regional Cancer Center in Lakeland, FL, offer these ideas for improving informed consent when working with minority or older populations:
• Improve the consent process for minority populations.
For those who believe translating an informed consent document into a foreign language is as simple as hiring a contracting translation service, Caro would like to burst their bubble.
"Most translators are not aware of the federal [research] guidelines, and even though the English version strictly follows those guidelines, when it’s translated into Spanish, they may disregard the guidelines," Caro says.
Caro, who is Puerto Rican, once reviewed an informed consent document that had been translated from English into Spanish, and she saw a very strange difference: In the English version, a description said the subject would be injected in a thigh, while the Spanish version said the subject would be injected in a muscle.
"When the translator was requested to correct it, she said the thigh was the muscle, but the problem is that not every muscle is a thigh," Caro recalls.
Another problem has to do with selecting a reading comprehension level for minority patients, Caro says.
"A lot of people are not aware that the reading levels for the Spanish-speaking community is third grade," Caro says.
This means a consent form would need far simpler language than what commonly is used and even simpler than federal regulations, which request a fifth-grade reading level, Caro notes.
Some consent forms continue to be written and translated into language that’s so technical that even trained research professionals like Caro can’t understand them, she says.
Another problem that crops up with clinical trial sites work minority subjects is finding good verbal translators, Caro says.
The most common practices for translating for the Spanish community are to have a patient’s relative act as an interpreter or using a bilingual physician or other health care professional as a translator, Caro says.
Using a family member might be the very worst translation method because the research site is putting the family member in the role of acting in the subject’s best interest, when there might be other personal motivations that get in the way of the person fulfilling that obligation, she says.
"Are there any financial interests? And how will the person effectively describe procedures to the patient?" Caro asks.
Having a bilingual physician translate also poses problems because some patients might feel intimidated or coerced by a physician who is describing the clinical trial, Caro says.
"So the most feasible practice is to have a bilingual health care professional, who is not related to the patient and not connected to the physician investigator, but who works at the site with patients, be the translator," Caro suggests.
At the very least, clinical trial sites should make an effort to hire bilingual staff whose language skills correspond with sites’ minority populations, Caro says.
"Having this staff promotes and establishes trust," Caro adds. "So that’s the biggest and best thing sites need to do if they want to enroll minorities, recruit them, and retain them."
• Keep informed consent simple when working with older adults.
Clinical trial coordinators and investigators need to pay particular attention to informed consent language when working with adults over age 65, particularly when a clinical trial involves genetics, Frazier says.
With a $10,000 grant from PARTNERS, a University of Texas sponsor that funds nursing research, researchers conducted a focus group study to find out how well older adults understood research terms and informed consent, Frazier explains.
There were 23 subjects with a mean age of 78, and they were divided fairly evenly between Caucasians who lived in an assisted living facility, African Americans who received meals and education at a community support center, and Hispanics who visited a medical clinic, Frazier says.
"For the long term we wanted to develop a culturally sensitive approach and design materials to work with those populations when we asked for consent to genetic research," Frazier says.
Five themes came out of the focus group sessions, and they were as follows:
— Older adults defined genetics as something passed down from one generation to another, as well as something that can skip a generation and which is affected by the environment.
"For example, African Americans suggested it was a family curse; the Hispanic group thought it was an illness caused by someone who didn’t like you, perhaps like witchcraft," Frazier says. "And Caucasians saw it as a family weakness."
— The older adults would justify genetic testing only if they trusted the research and the institution, Frazier says.
Despite their views, participants routinely said they would have genetic testing if their doctor recommended it, and it didn’t matter what else they learned about it, Frazier says.
"For research, they said they would participate if they trusted the researcher and the institution," she adds.
— Older adults also had concerns about disclosing clinical trial information to their families.
"They didn’t want to worry about diseases they didn’t know they had, and they had some suspicions of the medical community," Frazier says. "And some were worried about family issues, including insurance, jobs, and prospective marriage partners for grandchildren and whether genetic information would affect that."
While some participants said they wanted their families to know what was going on, many said they would tell only their children and leave it to their children to tell the grandchildren, Frazier notes.
— Another concern expressed by older adults was that the informed consent process be communicated on an individual basis. The participants expressed an interest in hearing stories and seeing pictures to illustrate what was being told, Frazier says.
"Principal investigators need to be aware that this population is very vulnerable, particularly in an acute care setting, and they need to take more time with them," Frazier says. "Use less or no medical jargon, and they like the use of stories to explain things."
For example, a story might tell of a lady who had this type of disease with this genetic variation, and she went on to do fine, while another person with similar disease didn’t do as well, Frazier says.
— A common phrase that came up with older adults was "acting my age," Frazier says.
"They used that term a lot," Frazier says. "’At my age,’ they’d say, they’d want to give back to society, and developmentally, this was appropriate for their age."
Their motivations for considering participating in research were altruistic, and this also makes them vulnerable, Frazier notes.
"They were not interested in genetic tests for clinical testing only, but were interested in something that could help future generations," Frazier says. "It’s a good reason for participating, but we need to be sure they understand the risks and benefits to them and to their family members."
One other finding of the focus group study is that the older people were concerned that their blood samples might be used for something they didn’t want them to be used for or that they would be subjected to bad needles, Frazier says.
"I never would have thought about that as a concern," she notes.
"They also didn’t want information asked of them that was too personal, and they were concerned about the lack of transportation and parking costs," Frazier adds.
What these findings suggest is that clinical trial coordinators and investigators need to keep the informed consent process simple, allowing plenty of time for older subjects to ask questions, Frazier says.
"I think that older people tend to trust more and tend to like people in authority to be more directional, and they tend to trust other people to make decisions for them more than younger populations," Frazier says.