For $950, Engineering alum Tony Cabanero said he allowed clinical researchers conducting a study at the University Hospital to insert a syringe in each of his cheeks, one of them injecting a pain-inducing saline solvent. Meanwhile, the IVs in each of his arms carried an experimental medicine, of which Cabanero does not now remember the name, into his bloodstream.
This procedure was repeated several times with varying doses of the solvent and the drug to investigate the drug’s ability to inhibit pain, he said.
Cabanero added that the doctor conducting the research told him that he would experience discomfort 30 percent as intense as the worst pain imaginable. He scanned the highlighted portions of the paperwork and listened to the doctor’s reassurances that he had conducted this experiment multiple times and that nothing disastrous had ever occurred to the human participants in his previous trials.
“I really didn’t care what they were doing; I just signed and wanted the money,” Cabanero said.
Susan Goold, director of the Bioethics Program and associate medical professor, said many people that participate in clinical testing like Cabanero do not understand what exactly their commitment entails.
“One of the things that we know nationally, even internationally, is people often don’t know what they are volunteering to do. They sign long consent forms that they may not read. Or if they do read them, they do not understand them,” said Goold.
To combat this problem, Goold applied for and received a grant for $1.5 million from the National Institutes of Health to create a program to teach researchers from any field how to better inform research candidates of what is expected of them before they consent to participate. The program seeks to thereby improve communication between researchers and participants.
Goold said the program will be implemented mid- to late spring.
She said the motivation for the program did not derive from any specific incident at the University, but out of her desire to improve the already functioning process of informed consent.
Instead of the traditional semester-long course, Goold’s program will offer a series of scheduled conferences for researchers. The curriculum will use multiple teaching methods, including selected readings, lectures and small-group exercises where the researchers can practice obtaining consent from each other.
The class will culminate with a simulation in which researchers will attempt to obtain consent from a pretend participant, called a simulated patient instructor.
The researchers will then be assessed on their communication skills — whether they conveyed all of the relevant information and assured that the patient understood all facets of the experiment, said assistant Medical School Dean Casey White.
Those devising the curriculum are still finalizing the three scenarios that will be used to train the SPIs, said White. She also said a test run will be conducted in March or April of this year to eliminate potential problems. SPIs are also used for medical students and residents.
In its premiere year, the course will be tailored to researchers affiliated with the University. Goold predicts that the course could be offered to researchers from other universities and research centers after its third year. She added that she hopes this course will serve as a paradigm for people from other universities to follow.
The course will also prepare the researchers to handle delicate situations such as those involving persons who distrust the medical community, participants in studies that involve taboo subjects, such as illegal drug use or sex, and children who need consent from their parents for a study, according to a written statement.
Goold said she wants the curriculum to encompass all aspects of research with human participants.
“This program will not only guide ethics in medical research, but also survey research, health research and epidemiological research. Basically, anything (involving) human volunteers,” she said.
The grant money will be allocated to faculty from the Medical School, Nursing School, Dental School and School of Public Health, as well as other personnel, and will pay for supplies and equipment.