Do PIs really understand the submission process? 

Education specialist offers tips you can pass along

You’re all on the same team — right? At times it doesn’t seem so. "Sometimes, the way people look at the IRB process and its documentation is that it’s just one more hurdle they have to jump through in order to conduct their research," says Sarah Frankel, PhD, education specialist at the Human Studies Committee of Washington University School of Medicine in St. Louis. "And, yes, it’s part of a process, but the real goal of the IRB is to protect the participants in the study, so it’s not being done to prevent research."

It’s always a good idea to build rapport with the IRB office and to think of the IRB as a service provider that can assist clinical trials staff and investigators in conducting good research and keeping subjects safe. Keeping this in mind, there are a number of ways the clinical trials office can improve the IRB submission process, including the following:

1. Be proactive.

"Call the IRB and ask questions," Frankel says. "Don’t wait until you get a letter from the committee."

Clinical trials staff also should familiarize themselves with the entire IRB review process and learn what the board is looking for in a protocol, she notes.

"Here, we’re happy to help people understand the process and why there are different processes in place," Frankel says.

"If you have any questions about a trial that may be submitted, the IRB staff are available and willing to talk to you about how to submit through their system," she says. "At Washington University, we spent a lot of time developing forms to guide the submitter through the process."

It’s preferable to give IRB staff a quick call with a question than to submit a proposal that may be incomplete or inaccurate, Frankel adds.

It’s also a good idea to observe an IRB meeting, which will help clinical trials staff and investigators gain insight into why certain questions arise and who the IRB members are, she adds.

2. Develop a good foundation in research ethics.

Clinical trials staff who have a good foundation in research ethics and clinical practice will understand better why things are done the way they are during the IRB review process, Frankel notes.

"Having that foundation helps you to know what to expect," she says. "We’re fortunate at Washington University because we have workshops and course offerings by the IRB."

And human subjects protection and ethics courses need to be taken by study coordinators, as well as researchers, Frankel says.

"This is so they will understand their role and what’s happening and help the investigator that much more," she says.

3. Build bridges between IRB and study coordinators.

The IRB should have a lot of contact with study coordinators since this is part of building rapport between the research team and IRB, Frankel says.

This bridge includes an open door policy in which study coordinators can call the IRB whenever there’s a question or concern.

"Principal investigators [PIs] are not always available and many have other duties besides research, so that’s why it’s important that the study coordinator is well trained," Frankel says.

Also, it helps if a protocol is written with a lay audience in mind, since some IRB members are not scientists and may end up asking more questions if the technical writing of a protocol is too complex, she says.

4. Make certain study coordinators do not serve as PI substitutes.

One common mistake is that busy PIs will send a study coordinator to the IRB meeting, and this could lead to inadequately answered questions and a delay in approval, Frankel says.

"When the committee invites the investigator to speak, they really want to see the investigator," she says. "It’s all right to invite a study coordinator to come along with the investigator, but occasionally an investigator will send a study coordinator instead."

When the IRB begins to ask questions about the fundamentals of the study, including design and methodology, the investigator is the person who will need to answer these items, Frankel says.

"The study coordinator may give an answer, but maybe not give as in depth an answer as the committee is looking for," she says. "Usually, if the investigator is asked there’s a point of contingency that needs to be qualified, and they may need background to clarify a contingency point so they can move forward."

5. Check IRB application to make certain everything is included.

Another common mistake is that PIs sometimes forget to include a minor point in their description of a study, and this could lead to more paperwork down the road.

For example, a study designed as a retrospective chart review for the years 1999 and 2000 should include both years in the proposal, but perhaps also include 2001 if there’s a possibility researchers will want to analyze those data as well, Frankel says.

"That’s something minor, but any change to your protocol you will want to get IRB approval first," she says.

6. Be very familiar with regulations regarding expedited review and exempt research.

"It helps if research staff understand the types of studies deemed minimal risk," Frankel says.

It also helps if research staff understand the policies the IRB has for using the categories of expedited review and exempt research, Frankel notes.

"At some institutions, everything goes to the full board, and other institutions like ours have an expedited review mechanism," she says. "We have individuals who sit on the full board and are designated to do the review."

Another benefit to learning the regulations is that when research staff begin to look at the types of studies that fit expedited and exempt, they have a better understanding of the study’s level of risk, Frankel adds.

"Maybe someone expects a study to be a minimal risk study, but the protocol is much more complex than the other ones in that category," she says.