When leaders at a small, private teaching college decided to shift their focus to more research, they hired a research director who could make that happen.
“When I came on board, we had an IRB, but it didn’t meet the requirements for the federal standards and Common Rule of the Federalwide Assurance [FWA],” says Megan Roth, PhD, director of research and sponsored programs and IRB chair at Abilene Christian University (ACU) in Texas.
“A new focus of the institution was to broaden research and do more grant seeking, and we wanted to revamp the entire focus to set up a system that was able and capable of receiving those funds,” Roth says. “When I came in, I had to look at the system and determine what wasn’t meeting those standards and what changes I needed to implement to take it to that level where we could apply and receive federal funding.”
Roth took the following steps to remake the human research protection program (HRPP) at the university:
• Identify problems. Soon after beginning work as the director of research, Roth reviewed existing processes and forms.
“I spent a month or two working within the existing system and trying to get a feel for how it was working and to identify areas that were problematic,” she says.
Then Roth read through federal regulations, meticulously noting all requirements and rules and outlining which of these were missing from the IRB’s existing policies and procedures.
“I had a notebook that outlined everything we needed to do to take it to that next level,” Roth says.
• Update forms and create new ones. The institution’s existing form was general, without specific questions.
“One of the problems was there was great variability in how much detail was provided on the form,” Roth says. “Some protocols that came in were very good and some were grossly lacking in information needed to make an assessment.”
This resulted in forms being sent back and forth multiple times, which frustrated researchers. ACU also had no clear process for determining exempt reviews versus full board, she says.
“A lot of studies were being over-reviewed,” Roth says. “Too much review is better than not enough, but it creates an unnecessary burden on everyone involved when studies are being improperly routed.”
Roth created all new forms. Since the IRB does not have an electronic platform, all forms were created for paper.
“I looked at a lot of forms from different institutions,” she says. “I combed through the regulations and looked at the key things that needed to be assessed.”
Roth looked for forms on other IRBs’ websites, but also participated in listservs and boards and asked research administrators for help.
“Research administrators are very, very generous, and we rely heavily on each other to not reinvent the wheel,” she says. “You can say, ‘Does anybody have a policy you wouldn’t mind sharing with me?’ and most folks are very happy to let you use what they have.”
Within a few months, Roth rolled out the new forms, which include forms for vulnerable populations, consent templates, and waiver of consent. ACU also implemented a process for properly routing everything and determining whether an effort involved human subjects research or was exempt.
• Train IRB members on changes. The IRB has 11 members and the support of one part-time administrative assistant. The administrative assistant receives the same training as the IRB members, Roth says.
Before the rollout of the new IRB system, Roth provided board members with a day of training on the forms and changes.
“I walked them through it and made sure they understood everything and had read through all the regulations before we had that meeting,” Roth says. “I helped them make the connection between regulations and the forms and what they are supposed to be assessing when they ask questions.”
Roth also showed IRB members how the new forms would make it easier for them to assess protocols and reduce the number of times a protocol needed to be sent back to the researcher for more information.
“There was a lot of back and forth that would drag out the approval process for a long time,” she says. “These new forms are more efficient because they get to the meat and potatoes of what you need to know to make your decision.”
IRB members recognized the need for a better system, so most of the changes were well received, she notes.
Other than a couple of situations where some board members disagreed with a decision, discussions showed they were open to changes. “Some had experience with IRBs at other institutions and knew we had to make some changes,” Roth says.
• Roll out the new system. Roth came on board in June 2015, and ACU rolled out the new system Oct. 1, 2015. She revamped all forms and the IRB’s website, which now has a page explaining every step in the IRB process, including:
- submitting an application;
- amending an active study;
- obtaining a continuing review;
- reporting a problem;
- meeting training requirements.
The website now includes a section of frequently asked questions and a forms database, where people can search for any form they might need.
Part of the rollout included Roth giving presentations on campus for faculty, showing them how the research submission process worked and what they might expect if they conducted a human subjects research project.
“For faculty, going from a short, vague form to a much longer system with many more questions and documents was a little bit daunting,” Roth says. “It was helpful for me to show them the specific meaning behind the questions.”
Roth showed faculty the new forms during her presentations and went through each process step by step.
“I talked about what the regulations require and how these questions tied into those things,” she says. “It really hits on the key points of the Belmont Report.”
This helps people connect the policies with regulations and the ethical basis behind both.
For example, a researcher might wonder why the study’s demographics need to be reported. Roth would help link that question to the Belmont Report, showing that the real intent is research ethics.
“We’re asking for very specific things that will help their protocol go through faster,” Roth says.
Several rollout talks took place at the faculty development center for faculty and deans. Others were given to student groups, targeting students who would be conducting summer research projects.
“The first year, I did six to eight different talks around campus to bring awareness to the changes,” Roth says.
Researchers’ reactions were similar to IRB members with most of them liking the change and appreciative of an improved IRB process, she says.
• Apply for FWA. Taking all of the notes she’d made from reading through the human research protection regulations, Roth wrote the policies and procedures (P&Ps) necessary to apply for FWA.
The 30-page P&P manual for FWA also serves as the IRB handbook. Because Roth already had written new forms, FAQs, and revised the website, much of the writing she needed for the P&Ps was already done, she says.
The main remaining work was to place the policy work into an organized narrative form. The handbook contains the following features:
- statement of principles;
- IRB organization and composition;
- information on running IRB meetings;
- procedures for initial review, continuing review, amendments;
- handling noncompliance problems;
- policies for record storage;
- handling classroom projects and quality improvement projects;
- handling external requests with people not affiliated with the institution, and dealing with additional topics.
The institution received the FWA and is ready to apply for federal funding for human subjects research, Roth says. “I feel like we have a system to manage that and apply for those studies.”
• Revise P&Ps as necessary. With the new Common Rule changes now expected to go into effect in 2018, Roth plans to revise the P&Ps to reflect those changes.
“I’m going to need to make some revisions to the forms and questions that we ask,” she says. “I started combing through the revisions in the spring, and my hope is to finish doing that this summer.”
Roth will review the changes, assess how they will affect the IRB processes, and make revisions reflecting those changes.
“Then, I’d like to get the changes rolled out in the fall of this year,” Roth adds.
A small university's human research protections program overhauled its processes to bring it up to the requirements of the Common Rule and Federalwide Assurance.
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