IRB celebrates 40 years of protecting patients’ rights

Forty years ago, Gundersen raised the bar for research of human subjects with the creation of its Institutional Review Board (IRB). Efforts to promote the highest ethical standards in research continue today.

Gundersen’s IRB celebrated its 40th anniversary Feb. 24, including special recognition of Bob Bendiksen, PhD, founding member who remains on the Board (center). Pictured with Dr. Bendiksen are Dr. William Agger (left) and Bud Hammes, PhD (right). 

The seven-member IRB (also referred to as the Human Subjects Committee at Gundersen) is responsible for reviewing all medical and behavioral research conducted at our institution to ensure the safety and rights of volunteers are protected. This means every study must meet the highest ethical standards and comply with all federal and state regulations and other healthcare standards. Research participants must be informed of the risks, benefits and procedures involved in a study.

“Clarity and consistency are two of the things we’re looking for,” states Robert (Bob) Bendiksen, PhD, founding member of Gundersen’s IRB and the only original member who remains on the committee. “We have a responsibility to our community to identify any research project, or aspects of a research project, that raise ethical questions. It is our job to make sure those questions are asked and addressed.”

Questions that could be raised include such things as:

• Are a sufficient number of side effects listed on the consent form?
• Is the procedure accurately reflected so there are no surprises to the patient?
• Is it clear whether tissue specimens will be used for future research, including genetic research?
• Who will pay for costs of research, including treatment of side effects?

Questions like these help ensure the highest ethical standards are met and help avoid history from repeating itself.

Gundersen’s IRB was created in 1976 after Congress passed the National Research Act in 1974. The law required all research done in institutions receiving federal funds to have a local IRB. It was enacted partly due to the infamous Tuskegee syphilis study and other historical cases of unethical research.

“We modeled our program after one at Yale University Medical School. Before any study gets to our IRB committee, it must first be reviewed and approved by Gundersen’s Research Committee that examines the scientific merit of the study. We have high rigor here in our ethical research review process and it has been consistently high,” states Dr. Bendiksen.

Gundersen’s IRB was designed so the majority of its members would be from the community. Dr. Bendiksen is one of those dedicated community volunteers whose background as a professor of sociology at the University of Wisconsin-La Crosse (with specialties in medical sociology and sociology of death and dying) and as a journal editor has been a natural fit.

Dr. Bendiksen says the sense of service to his community has kept him committed to the IRB for the last 40 years. “It’s been gratifying to be a small, but sometimes significant participant, in medical research at Gundersen. I was fortunate to have the full support of UW-La Crosse which values research, teaching and community service.”

Bud Hammes, PhD, chairman of Gundersen’s IRB, says Dr. Bendiksen has made an immeasurable contribution to patient care and safety over his 40 years of voluntary service. “He was a board member at Lutheran Hospital (1981-87), but has also reviewed one to two research protocols each month for 40 years. He has always provided thoughtful and in-depth comments to improve research so the enrollment of our patients in research met the highest ethical standards.”