In an effort to make clinical research trials more comfortable for participants, the University of Nebraska Medical Center has created a Research Subject Advocate office (RSA).
The new office will be headed by Bruce Buehler, M.D., former director of UNMC’s Munroe-Meyer Institute and chairman of the department of pediatrics, and Deb Meyer, a research nurse at UNMC.
One of the main focuses of the RSA office is to make sure subjects get to participate in trials while maintaining their comfort and dignity.
"We act as the subjects’ eyes and ears," Meyer said. "We make sure they are completely comfortable with their choice to participate in a trial, and we serve as a resource for them should questions and concerns arise before, during and after the trial."
In this way, Dr. Buehler said, the RSA compliments the UNMC Institutional Review Board (IRB), which reviews medical center research protocols and makes sure subject safety is maintained.
"We have one of the best IRBs in the world," Dr. Buehler said. "They do a wonderful job of protecting subjects and making sure our research is up to standards. We supplement their mission by giving the subjects a place to go to ask questions about the trials they participate in."
The RSA, which was formed out of UNMC’s Clinical and Translational Science Award (CTSA) grant planning process and developed as part of the new UNMC Center for Clinical and Translational Research, also works to educate those who conduct the trials and potential subjects about the research process.
"Safety of subjects enrolled in clinical trials is our first priority at UNMC," said Jennifer Larsen, M.D., associate dean for clinical research in the College of Medicine and leader of UNMC’s efforts to secure a CTSA. "The Research Subject Advocate office has been charged to meet with community groups to discuss concerns they have about clinical research, as well as with individuals for concerns about specific trials.
"The Research Subject Advocate office also will work with and educate trainees and young investigators about research safety issues, particularly as new regulations are implemented."
This educational effort will require Dr. Buehler and Meyer to visit sites across Nebraska and beyond where UNMC is involved with clinical trials.
"The educational aspect of the RSA office will be very helpful because the staff will meet face to face with clinicians and subjects to discuss the details of the clinical research process," said Bruce Gordon, M.D., professor of pediatrics and co-chairman of the UNMC IRB. "This will help UNMC’s research enterprise gain a bigger presence in the state and help increase participation in our clinical trials."
The importance of sensitivity when dealing with the subjects will be among the main points of emphasis when RSA officials meet with health care workers who conduct clinical trials.
"We want those who are conducting our trials to keep in mind the fact that our subjects have volunteered their time to participate in these trials and thus they should be treated with the utmost respect for their contributions," Dr. Buehler said.
The office also will examine clinical trials to help improve their accessibility to subjects.
"Our IRB does an amazing job of making sure the science and research is at the highest standards," Meyer said. "Our goal is to be able to look at the trials as a subject would and make suggestions that would make the trials easier and more comfortable for the subjects."
Making sure paperwork and study-related literature is understandable and making sure subjects know exactly what they have signed up for are among the issues the RSA will focus on.
"Our goal is to help humanize the clinical research process," Dr. Buehler said. "We hope this yields more informed subjects who find the process to be a friendly, comfortable and rewarding experience."
For some people, like 18-year-old Chris Rodenborg of Bloomfield, Neb., participating in a clinical research trial is a way to help make a difference for future generations.
Rodenborg lives with his parents and two brothers. Of the five family members, Chris is the only one who does not have Type 1 diabetes. But he does have some of the antibodies that accompany the disease.
His case is of great interest to diabetes researchers who want to know why he doesn’t have the condition while the rest of his family does. They also want to see what changes will occur in him should he develop diabetes.
A while back, at the behest of an endocrinologist, Rodenborg started to take part in a clinical trial that examines what factors influence the onset of Type 1 diabetes.
"I agreed to do this trial because it stands to help people who have diabetes," said Rodenborg, who each day watches the other members of his family take the incessant steps necessary to treat their diabetes. "I want to do anything I can to help."
In essence, this is the "legacy aspect" of clinical research, Dr. Buehler said, when people participate in trials that will have no benefit for themselves but may lead to advances in care and treatment that may benefit others.
"These people want to have a legacy of helping others," Dr. Buehler said. "Oftentimes, these volunteers will be very ill and participating in a clinical trial is one of the last things they can do to help others who come after them."
For more information on the RSA office, call Meyer at (402) 559-6941.
UNMC is the only public health science center in the state. Its educational programs are responsible for training more health professionals practicing in Nebraska than any other institution. Through their commitment to education, research, patient care and outreach, UNMC and its hospital partner, The Nebraska Medical Center, have established themselves as one of the country’s leading centers in cancer, transplantation biology, bioterrorism preparedness, neurodegenerative diseases, cardiovascular diseases, genetics, biomedical technology and ophthalmology. UNMC’s research funding from external sources now exceeds $82 million annually and has resulted in the creation of more than 2,400 highly skilled jobs in the state. UNMC’s physician practice group, UNMC Physicians, includes 513 physicians in 50 specialties and subspecialties who practice primarily in The Nebraska Medical Center. For more information, go to UNMC’s Web site at www.unmc.edu.