For all the years I’ve been in this industry, I’ve wondered why we haven’t learned from the horrific events scattered throughout its history. Why do we continue to make mistakes, go against the regulations, and sometimes do bad research?
I was hoping that the preconference program, “Integrity in Research: Responsible Conduct in Research Concepts and Cases” with Sharon Shriver (PRIM&R's Director of Programs) and Bradley Woods would answer this question. The information presented made the participants think in ways that were outside of the box. Then it happened: Sharon said, “Researchers don’t wake up and say, ‘Hey, today I’m going to falsify my data.’”
Sharon went back to a quote given in 1974 by William Summerlin, who referenced “…a combination of mental and physical exhaustion, a heavy clinical and experimental workload and pressure to publicize positive results.” I realized that even in 1974 we were putting extreme pressure on researchers to not only conduct research, but also to provide positive data results.
Eric Poehlman, a physician working on obesity and aging, ostensibly had every intention of doing solid research and providing data that could influence the medical world. However, he went on to falsify data for 17-NIH funded grant applications. Over 200 of his medical journal articles came into question. He had defied the public’s trust. When asked why, he said, “I had placed myself in an academic position in which the amount of grants that you held basically determined one’s self-worth. Everything flowed from that. With that grant I could pay people’s salaries, which I was always very, very concerned about. I was on a treadmill and I couldn’t get off.”
Pressures like these continue today. As an IRB coordinator, I’ve repeatedly seen the pressure researchers are under to bring in more money and prestige and build a better name for their institution. I’ve had conversations with them. I’ve heard the cracks in their voices. I’ve seen their jobs age them. In a country that has some of the best medicine, why do we continue to pressure those who research it?
With any problem, we need solutions. Here are some ideas mentioned in the session:
- First, we should find the money to provide additional support for staffing that will lead to better compliance, less pressure, and possibly better patient care.
- Second, each institution needs to provide its full support to a solid human research protections program. Providing adequate resources and staffing ensures that education and knowledge can be shared and implemented more easily.
- Finally, put resources into examining researcher workloads. Sometimes we see physicians and researchers as beyond human. They’re not. We expect them to see a certain daily amount of patients, do research, analyze data, and publish the results—building credit for themselves and the institution.
As a coordinator, I’ve learned to work hand-in-hand with researchers to get through regulations. It’s time institutions step up and do the same. Researchers are only human.
DeEtte Burns, CIP, started in the industry 18 years ago after applying to work in the medical records department of The Iowa Heart Center in Des Moines, Iowa. Eventually her career moved her to Mercy Medical Center in Des Moines then to the Medical College of Wisconsin in Milwaukee and she now works for Ascension Wisconsin as the senior IRB Coordinator. Her passion is helping prepare her colleagues for the CIP exam and she has been overseeing the CIP Facebook page for 6 years.
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
Save the date for PRIM&R's 2018 Advancing Ethical Research Conference, taking place November 14-17 in San Diego, CA.