Human subject researchers at California Lutheran University were asked to pause all in-progress projects after the recent discovery that the university’s Institutional Review Board policies did not align with federal guidelines. Implications of the issues are unclear, but could include impacts on graduate students’ ability to graduate on time, timely completion of faculty research and even affect federal funding such as grants.

The IRB’s purpose is “to carry out the University’s policies regarding the protection of the use of human and animal subjects in research,” according to Cal Lutheran’s website. 

All research that is conducted on campus using human subjects—including faculty, undergraduate and graduate research—must be reviewed by the IRB. This research falls under three categories: exempt, expedited or full board reviewed. 

Provost and Vice President for Academic Affairs Leanne Neilson said in the past few years there have been changes to speed up the on-campus IRB process.

“There was a lot of frustration among the faculty because the IRB process was taking too long,” Neilson said. “Taking weeks or even a month or two.” 

One of these changes was how IRB members reviewed full board research. Neilson said instead of meeting face-to-face, which is standard protocol, members were communicating with one another over email.   

Neilson said there were 146 research projects approved last year including undergraduate, graduate and faculty projects, and that two-thirds of those were expedited. 

Associate Professor of Communication Monica Gracyalny was named new chair of Cal Lutheran’s IRB in fall 2019. After being appointed, Gracyalny noted potential concerns with IRB processes. Gracyalny referred The Echo to Cal Lutheran Media Relations when asked to comment. 

Beyond issues with policies and Standard Operating Procedures, there were issues with training and documents, according to a PowerPoint presentation presented at a faculty meeting on Oct. 14. 

Informed Consent Forms, required to ensure participants understand the scope of their participation in a project, need to be updated according to the presentation. Additionally, forms for collaborative research with other institutions need to be signed by both institutions and kept on file. It is unclear what processes Cal Lutheran was previously following. 

A new training program for researchers and IRB committee members, Collaborative Institutional Training Initiative, is being implemented to replace the no longer offered training from the National Institutes of Health. CITI training was offered to faculty on Friday, Oct. 25.  

It was also noted that there was no non-Cal Lutheran affiliated member of the committee as required by federal law, according to the Electronic Code of Federal Regulations. 

Previous Chair of the IRB and Associate Professor of Exercise Science Steven Hawkins said his committee was unaware of the issues. Hawkins said Cal Lutheran’s lack of a compliance officer, which most research universities have, would have made it possible for some things to be “overlooked or misinterpreted.” 

There are seven members on the IRB, each serving a three-year term. There are federal requirements regarding board diversity, including that it should include members from various departments at a university, according to the Electronic Code of Federal Regulations. 

Last week, a new consultant signed a contract to join the Cal Lutheran IRB to help review procedures and put a timeline together, Neilson said. Neilson said she did not know the expected time frame for how long the review would take to be completed and for research to resume. 

However, in an email sent to Cal Lutheran faculty on Friday, Oct. 25, Neilson said the external consulting firm should have “preliminary results of their review by the middle of next week.” 

“We all want this to happen as quickly as possible,” said IRB task force member and Professor in the Department of Languages and Culture Sheridan Wigginton. “I mean a significant portion of our career paths rely on research moving forward. So this has to be resolved and it has to be resolved as quickly as possible, but it has to be done correctly because having started this process, like we have to keep going down the right path, you know we can’t cut corners.” 

Wigginton said the IRB task force committee is separate from the main IRB, and was formed after issues were discovered to examine “record keeping” and “procedural issues” along with working with outside consultants. 

Wigginton said she accepted the faculty executive committee’s offer to join this task force because she recognizes the urgency in examining current practices. 

Human subject research is required for certain graduate programs and undergraduate capstone courses. Neilson said she wants to work with students to ensure they graduate despite a delay in their research process, and has contacted anyone who has applied for IRB review in the past two years. 

“We’ve asked them, you know, tell us where you are in the process,” Neilson said. “We’ve asked them if you have a particular timeline and that’s really important, let us know. So we’re going to take a look at that and try to, you know, take that into consideration as far as our timing.” 

For undergraduate capstone classes, Neilson said some faculty members may change the assigned project for students. However, completing an undergraduate capstone project is still required to graduate. 

“We want to certainly work with anybody that’s worried about that [on-time graduation],” Neilson said. “Because it’s critical for us that students are able to complete their degree. That’s the number one priority.” 

Though Neilson said she does not have a single answer regarding the implications that the research pause may have for graduate and undergraduate students, she is still hopeful the university will resolve this issue quickly for students to graduate on time. 

“We want to make sure everything is fixed and everything’s all cleaned up,” Neilson said.