IRB finds solutions to roadblocks in protocol submission process

Prevent incomplete, flawed applications

IRB offices routinely handle protocol submissions that are incomplete or flawed in other fundamental ways. These problems cause roadblocks that slow down the IRB approval process and frustrate investigators and IRB staff alike.

"Basically, we very often see protocols submitted that aren't complete or where there are problems with initial submission," says Donna B. Konradi, PhD, RN, CNE, chair of the IRB at the University of Indianapolis and an associate professor in the School of Nursing at the University of Indianapolis in Indianapolis, IN.

"Every time there's a problem, the IRB has to contact the investigator, and these problems have to be fixed," she adds.

This becomes a large time investment, slowing down the research process.

The solution is to anticipate the likely culprits and devise policies and process changes to prevent them from occurring.

"So our IRB had many discussions, and we talked about some of the most common problems," Konradi says. "We thought if we could put those problems out there and let our research community become aware of what the problems are, then that knowledge is very powerful, and maybe they could go through these and fix them."

The first step is to collect data about the most common errors and problems that result in stalls in the IRB approval process.

"We looked at a year and a half of submissions and identified the things that held up these protocols in the submission process, especially those that take the longest amount of time," Konradi says. "Then we put them into 10 categories."

These 10 categories of problems that result in stalls during the IRB submission process were reported to researchers and their staffs, along with potential solutions.

Researchers and faculty reported finding these very helpful, Konradi says.

Overall, the protocol submissions have improved since this solution was put in place, although some of that was related to the campus community becoming more sophisticated as researchers, she adds.

Several of the common problems involve how the protocol is completed — the nuts and bolts details typed into the electronic form. These are among the most common of the mistakes that result in stalled submissions. Others relate to omissions of pertinent information, often due to investigator's lack of knowledge about what's required.

Half of the categories include policies, data security, scientific design, research team qualifications, and links or inclusion of actual documents shown to research subjects.

Developing the list of common submission problems was not time consuming because many of these items had been discussed frequently at IRB meetings, Konradi says.

"We talked about the same problems over and over again," Konradi says. "When you see the same problem for the fourth time in a given month it gets very weary."

Also, researchers often complained about the IRB review process being so slow.

"So we opened up a dialogue and shared information and resources to create better common understandings," Konradi says.

Here are some of the most common IRB application problems and potential remedies:

• Incomplete protocol submission: Protocols often have missing information, including descriptions of the informed consent process and specific letters of informed consent or assent.

"In some instances, perhaps an investigator is doing a study with children who are 12, and there's an informed consent signed by the parent or guardian, but there is no assent document, so something is missing," Konradi says.

Also, submissions sometimes fail to include letters of cooperation or agreement, Konradi says.

"If we're doing a study with either another business or another university or non-profit organization, then we need a letter of cooperation," she adds.

Sometimes the recruitment materials are missing, and sometimes they failed to include a validation of human subject protection training, Konradi says. "Sometimes they're missing their data collection tools, and the most commonly missed tool is for demographic information."

Or investigators say they will collect demographic information, but they never tell the IRB what that information is.

REMEDY: "We've made an updated protocol submission checklist and included many of these elements on the checklist," Konradi says. "There's a link to the checklist on the protocol submission template."

When researchers open the submission template they can move back and forth, see what's ahead and what they've already completed. With this kind of fluid movement between sections, a checklist can be useful for helping them double-check their work for omissions and errors.

• Confusing submissions: Sometimes protocol submissions contain grammatical errors, misspellings, and lack of precision.

"They try to sound academic or use words incorrectly, and what they say is not what they intended to say," Konradi says. "They might use too much jargon, especially in documents going out to individuals they're trying to recruit for participation."

Or the information in the submission is inaccurate and confusing.

REMEDY: "We talked with investigators about having someone else read their work to help them avoid grammar/spelling errors," Konradi says.

"Sometimes they develop these protocols as a team, and every team member turns in their stuff, and they staple it all together," she adds. "But no one looks at everything as a complete product."

The solution would be to make sure teams work together in a way that the individual contributions are complete and not fragmented when put together, she says.

• Protocol inconsistencies: "The places where we see the most inconsistencies are in the description of research activities, informed consent documents, recruitment materials, and letters of cooperation," Konradi says. "Sometimes what they say on one document is not consistent with what is said on the other."

For instance, a protocol might say that participation in this research will take 20 minutes. But the informed consent form says participation takes 10 minutes, she says.

"Or they'll say that participant risk is X in the protocol submission, and then they'll identify something else as risk to participants in the informed consent, or maybe say nothing about risk during the recruitment period," she adds.

Researchers have to present the same consistency throughout all documentation, and this often does not occur.

"We see this especially often when people are developing their projects over a long period of time or when they submit information from a team and haven't reconciled all documents to make sure they're consistent," Konradi says.

REMEDY: IRBs should educate research staff about the need for consistency in their protocol submission, informed consent documents, and other materials.

Sometimes, all it takes is for someone to remind research staff that this is an issue that should be resolved.

"If investigators want us to spend less time in the review process, then they should reconcile all documents before attaching them to a protocol and submitting them," Konradi says. "If investigators can fix some of these things before it goes to the IRB, then the IRB can do its work much quicker."