Human subject researchers were ordered to halt all ongoing research at California Lutheran University in the fall semester of 2019, after a thorough investigation revealed that the Institutional Review Board’s process of reviewing research proposals was inadequate. Now, an administrative staff member is serving the IRB coordinator to ensure that the IRB stays compliant with federal regulations. 

“From where we were to where we are now, we have made a lot of progress in only one semester,” Monica Gracyalny, associate professor in communication and current IRB chair said. 

All research that was paused was reevaluated and either allowed to continue or modifications were asked to be made prior to continuing. 

The updates to the IRB come after an outside consultant agency stepped in to help revise key policies and procedures. 

Research project applications may fall under three categories; exempt, expedited, or full board reviewed. A majority of the applications that have been processed in the past at Cal Lutheran have been reviewed as exempt or expedited according to Gracyalny. The improved recordkeeping and operational procedures will allow the IRB to view these statistics and make improvements to the application process. 

Although metrics are not yet available regarding how long the new process for research approval will take, Gracyalny said the “goal is two to three weeks from when somebody submits to when they get their initial response.” The IRB is working on a new system that will allow researchers to monitor where they are in the application process. 

As part of the application process, researchers and faculty must complete the new Research Ethics and Compliance Training, CITI, a training program available for university members that replaces the discontinued training from the National Institute of Health. Completion of the training provides a nationally recognized certification valid for three years. 

There was no evidence found to support any allegations of unethical research being conducted at Cal Lutheran, Gracyalny said. 

All students and faculty conducting research involving human subjects must submit an application to the IRB where it is processed and reviewed, in order to ensure that research is conducted ethically and in accordance with federal and state regulations. Cal Lutheran’s IRB failed to be compliant with the 2019 Code of Federal Regulations’ functional and operational standards guidelines. 

According to the Code of Federal Regulations, 45 CFR 46.107, “Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.” 

The current IRB consists of six diverse members and is now federally compliant. 

Gracyalny is spearheading the transition to compliance, ensuring that students and faculty are able to carry on with research at Cal Lutheran. 

“All research involving human subjects other than class projects, regardless of the methodology, should get submitted to the IRB,” Grayalny said. 

Classroom research projects, however, fall under the discretion of the professor as to whether or not the study should be submitted for board review. 

Researchers can find information on how to determine what classifies as human research as well as what research may be exempt on the Cal Lutheran Institutional Review Board webpage. 

The appointment of an IRB coordinator addresses prior concerns regarding the lack of a compliance officer. 

“Serving on the IRB is a lot of work, and faculty members who serve as board members also have a ton of other obligations. This can lead to an oversight when changes happen,” said Current Chair of the Psychology department and former IRB committee member, Rainer Diriwaechter, in an email interview. “Luckily, we now have a part-time position designated exclusively to our IRB. It’s not ideal (a full time position would have been better,) but it certainly is a big step up from what we had,” Diriwaechter said.