Grant of $942,000 for Study on Multiple Sclerosisis One of Largest Research Grants Ever at TU

Friday, September 23, 2005

University of Tulsa psychology professor Michael Basso has received a federal grant of $942,000 to investigate the ability of people with multiple sclerosis, a neurological disease, to provide competent consent to take part in research experiments.

The three-year project is funded by the National Institute of Neurological Disorders and Stroke, a branch of the National Institutes of Health. It is one of the largest research grants ever received by a single faculty member at TU.

The goals of Basso’s study are to provide guidelines that can be used to decide which volunteers should not be accepted in a research study, yet also determine if there are ways to ensure proper consent among such people.

“As many as 70 percent of people with multiple sclerosis have difficulties with memory, attention and problem-solving, making it likely that some of these people will have difficulty making a wise decision on whether to participate in medical research,” says Basso.

Basso obtained promising results in a pilot study conducted with 15 participants.

The new study will rely on 90 people with multiple sclerosis and 30 people without multiple sclerosis. Participants will get paid $125 and receive money for lunch. Participation includes attending a single testing session of about three hours at TU. Those who travel from outside of Tulsa will be reimbursed for mileage. Escorts will get a meal and mileage costs.

The disease attacks tissues in the brain that connect neurons, causing a variety of impairments. Common symptoms include being forgetful, having difficulty in problem solving or understanding concepts, being slower in processing information, and difficulty in paying attention and concentrating. “These mental deficits pose a risk for making a competent decision to participate in an experiment,” says Basso.

Given that pharmaceutical companies need human subjects to test medications that they are developing to alleviate or cure the disease, the issue of consent is important in many ways. Researchers want good subjects and the subjects need to be well aware of the risks posed by taking such drugs. “So everyone wants to make sure that these volunteers make good decisions,” says Basso.

Basso says ethical principles require that researchers disclose the risks, benefits and alternatives of research participation, and that an individual’s decision be made autonomously. Normally, people are presumed competent.

Basso will use written tests to check for four basic capacities needed to make a good decision: understanding risks and benefits, appreciating what those risks and benefits mean to the person, capacity to engage in abstract decision-making, and ability to express a decision. He will also investigate whether repetition of information can help in obtaining informed consent.

Collaborating with Basso are several Tulsa neurologists, a psychology professor at Penn State, and a psychiatrist and a bioethicist from the University of Massachusetts.

The bulk of the grant is earmarked for salaries, including stipends for three graduate students and two undergraduates, and equipment, such as computers and printers.

Those interested in participating may contact Basso at TU at 631-5472. The project has a toll-free number, (866) 819-5019, and a website, www.orgs.utulsa.edu/cre.