According to the U.S. Department of Health and Human Services, a set of federal regulations known as the “Common Rule” protects people who participate in federally funded research. The regulation requires that a committee review and approve a study before allowing people to enroll in the research. This is the IRB.
Marian Jamison, professor in the School of Nursing, is the chair for IRB. She has been in this special position since the spring of 2021.
“I was asked by my Dean, who has been asked by the VPS office, which at the time was occupied by Dr. Mazachek as she was the VPA and the provost,” Jamison said.
Among her multiple educational certifications relating to the medical field, Jamison also achieved Master of Business Admin from the University of Kansas. With nursing, during undergraduate and graduate level, Jamison mentioned the content being jam packed with health care information which left no time for any business content.
“I graduated from nursing with my Bachelor’s degree knowing almost nothing about the business world,” Jamison said. “…I had friends who I talk to about business and when they talked, I was just in awe of the language they use…and I wanted to know more.”
Jamison currently teaches Health Care Economics and Quality Improvement in the doctoral program. She said she has been using the skills learnt from business school.
Jamison said IRB doesn’t look at studies that don’t involve human subjects.
“One of the requirements for any research that we would review is that it has to be human subjects as research participants,” Jamison said. “There are different organizations that approve animal studies, for example, and so we want to make sure that the rights of humans are protected. And as you can imagine most policies and procedures come about as a direct result of abuses in the past. And this is no exception.”
Steve Golden is a graduate nursing student in the Doctor of Nursing Practice program at Washburn, specializing in family practice. He is also a student member on the IRB. He shares his part as an active member.
“We are not expected to be experts in research like the doctoral level professors are, but we get to participate in part because it gives us a better grasp of what it looks like to safeguard participants in a research project,” Golden said. “So the Institutional Review Board is designed to take all those vulnerable populations that may end up participating in various studies and to look at, are they being given informed consent.”
Jamison, being Golden’s professor, reached out to him to be on the board because of his strong interest in research and how studies are structured.
Jamison said the average proposal number for research studies is about 55 a year. It is slowly increasing again after the pandemic but they are sporadic— they occur most frequently in early to mid semester with February and September being a busy time.
“We get applications from all over the university,” Jamison said. “I will say that probably most of them come from the psychology department. They do a lot of research but we get them from communications, we get them from sociology. We have quite a few from nursing that are actually not research but they are quality improvement projects.”
Since Washburn is not a research institution but rather a teaching institution, how does IRB work? Jamison said there is a central IRB that people can pay money to have their studies reviewed, which happens at multiple academic medical center studies. But Washburn’s IRB is considered to be a local IRB because it is just for its students and faculty who are doing research.
When talking about the origin of IRB, Jamison goes into the Belmont report.
“During World War II, there were a lot of atrocities that were done by German physicians on patients that were in concentration camps,” Jamison said. “They were so horrific that a lot of the American physicians and other international physicians got together and they created what was called the Nuremberg Code…it set out a bunch of principles for the IRB, and it really talked about informed consent and people should volunteer…”
But there were still shockingly horrible things that happened, even in America, in the name of research. Jamison said there is usually training that will highlight several major examples of unethical practices. When this came to life, a lot of congressmen got together and created the National Research Act of 1974 and as an outcome of that research, it created an organization that wrote the Belmont report.
IRB, as of present, mostly works toward protecting confidentiality of the research participants especially if it revolves around sensitive topics.
“Most of the time, we [Washburn] are doing surveys or projects and we are just trying to evaluate either the effectiveness of an intervention, or we are trying to survey people to find out their beliefs and their practices, behaviors, and their attitudes,” Jamison said. “So most of the research done at Washburn is not high risk research but having said that we will want to protect the rights of human subjects.”
The federal statutes that lay out the requirements of an IRB will identify those populations as children, prisoners, pregnant women, fetuses, LGBTQ and so on.
Being a Christian, Golden shows strong value for human life. He said there is a strong ethical component to protecting the lives of everybody. He looks back to various experiments done to people in the past which has led to the establishment of the IRB that we know of today.
“The case of Henrietta Lacks whose cells were used to study cancer and treatments and it did a lot of good for society but nobody asked her permission, right?,” Golden said. “There is the Tuskegee syphilis studies, I can’t remember, but where the African American men were subjected to basically not being cured of a disease that could have been cured for the sake of study.”
Golden said he understands that in order to progress in medicine and health care, we have to be able to study disease processes but we have to be able to do it safely and with the permission of the participants.
According to the Washburn website, the IRB application process is purely electronic. Applications submitted to the IRB should be sent via email from the faculty or faculty mentor’s MyWashburn email account to [email protected].
“That application asks for all the information that the IRB needs to know in order to render a decision,” Jamison said. “I read through those when they come in, and I decide what type of review is needed. If it’s a really low risk study, it might simply be an exempt review…if it’s an expedited review, here at Washburn, we have two reviewers, me and one other person that’s a member of the board.”
If it is a full review, which is sometimes called normal review, it usually involves either a vulnerable or sensitive population. Jamison, with her seven members of the IRB review it and they discuss almost all of their work through email.
“They [members] can communicate via email and then tell me what their thoughts are and I summarize them and then I communicate to the investigator,” Jamison said. “It is very common for applications to come in that are not clear or that maybe need more information…so I’m the first person that looks at them and then sometimes, before i send it out for review, I will send it back and ask for more information to make sure I have a complete application before I send.”
Jamison said the IRB consists of scientists and non-scientists, with at least one representative from the community.
“In Washburn, we have students at the committee,” Jamison said. “I have graduate students. Occasionally, I have undergraduate students on the committee, and they will review from the student perspective. So, I will have at least one student on every full review”
One of the requirements for submitting an application is to go through IRB tutorial training located at D2L. It has six modules which usually takes a couple of hours to complete.
Jamison said a lot of students at Washburn complete the IRB training even if they are not conducting research but if they are taking a research class. It can also be required if a class project involves collecting data or an independent research project.
With the IRB policy adjustments, the members also get updated at Washburn.
“Dr. Jamison just recently did a big update to a lot of the policies and the consents because things have changed in some of the federal languages,” Golden said. “I just follow the guidelines that she puts out but I know she meshes the federal guidelines with the university policies and we have different ethical considerations that we are trying to maintain.”
The board members work as volunteers. Golden said at the end of each spring semester, Jamison emails and asks if, among the students who are on, wants to remain on the board and who wants to be removed.
Edited by Bidhya Sapkota
