Research institute has scientific review prior to IRB review

IRB's time is free for safety, ethics

At least one research institute has found a solution to the problem of finding time for IRB members to review protocols for both the science and ethical issues.

The answer is having two separate committees, each charged with a more precise role.

"In my opinion, it's all advantageous," says Brenda A. Higgins, CIP, manager of regulatory affairs for the OhioHealth Research Institute, which is part of OhioHealth in Columbus, OH.

"It takes the scientific review off the shoulders of the IRB," Higgins says. "Then the IRB can focus on safety and being a patient advocate."

All members of the research committee and the IRB are unpaid volunteers.

There are 15 IRB members, including a chair who has been with the committee for about eight years, Higgins says.

Many members of the IRB have been serving on the committee for more than five years, including a retired medical sociologist who has served since 1990, she adds.

"So we have longevity on the IRB, and they seem to enjoy each other, which is nice," Higgins says.

The process is especially effective for investigator-initiated protocols that are done by medical residents, pharmacists, and nurses, Higgins notes.

Since OhioHealth has a teaching hospital, surgery residents, obstetrics/gynecology residents, and orthopedic residents are required to do a research project before they graduate, she adds.

Also there is a magnet program for nurses, so there are many nursing studies generated, as well.

"The research committee members can spend a lot of time looking at these protocols, and they can guide [the new investigators] and give them good advice," Higgins says.

Here's how OhioHealth Research Institute's two committees work:

Logistics: The research committee, which reviews protocols for scientific validity and will see the protocols first, meets on the first Wednesday of each month, and the IRB meets on the third Thursday of each month.

The two committees are composed of separate members, except for the IRB chair who also serves on the research committees, Higgins says.

"So he has familiarity with the studies by the time they get to the IRB," Higgins says.

Some studies given a scientific review are not submitted to the IRB, and these include expedited chart reviews, process improvement work, and retrospective reviews that the IRB chair can sign off on, Higgins says.

The scientific committee includes members who have expertise in various disciplines, including cardiology, oncology, epidemiology/statistics, infectious diseases, gynecology, hematology, pharmacy, etc. There are a dozen members and no alternates, she says.

The research committee's meetings typically last one hour, and the IRB's meetings last 3-4 hours. The research committee meets at 7 am, and the IRB meets at 4 pm—times that have proven most convenient for committee members, Higgins says.

The research committee gets a copy of the complete protocol, as does the IRB's selected reviewer/presenter for that particular protocol. Other IRB members receive a modified protocol with the application, abstract, and informed consent form, Higgins says.

"All IRB members have some part of the protocol, but only the reviewer and IRB chair have the complete protocol," she adds.

If a study involves a controversial or new device, then the IRB will ask the principal investigator to come to the meeting and explain it, but this usually is not necessary, Higgins says.

Six or seven days after the IRB reviews a protocol, a letter is sent to the investigator, Higgins says. The IRB also reviews all amendments and all adverse events.

The person who originally reviewed a protocol is assigned any information about serious adverse events that are reported, Higgins says.

"So there is a continuum there, and the reviewer looks at the SAE to determine whether it was study-related, and then sends the information back to me, and I report those findings to the full IRB," Higgins says. "I do the same thing for amendments that signal a change in the protocol."

What the scientific committee looks for: "Each protocol that goes to the research committee has to have two reviewers, and both have to do a written review," Higgins says.

The two written reviews are sent to the IRB reviewer and chair, along with minutes from the research committee meeting, she says.

The scientific committee answers the question of whether the study's science is sound, and the IRB looks at the study's safety, efficacy, and patient advocacy, Higgins adds.

"One example is a nurse who is doing a study about foreign-educated nursing because of the growing nursing shortage," Higgins says.

"We're bringing in nurses from other countries, and her study is how to get their impression of how helpful American nurses are to them," Higgins explains. "She has 10-12 questions for them, and her study will be an interesting piece because of the growing need for nurses."

The scientific review committee would ask her these types of questions:

• Is her sample size large enough to bring the results she's looking for?

• Is her questionnaire well done?

The scientific committee reviewed her questions for the nurses and questioned the way one question was worded, Higgins recalls.

The question was this: "Describe a negative experience that applies to nursing practice and which stands out as memorable."

The committee suggested the investigator also ask the subjects to describe a positive experience to obtain more information, Higgins says.

Once the investigator had incorporated the scientific committee's suggestions into her protocol design, she submitted it to the IRB because she planned to publish the study or present it at a conference, Higgins says.

"If you're going to represent the institution in any way, then it needs to go to the IRB for their approval," Higgins says.