Avoid common mistakes when dealing with the IRB

Volunteer for IRB service, if possible

Investigators often fail to see the connection between their research and the human subjects review process.

"Investigators need to understand this human subjects review process is part of the research and part of the intent to see things they didn't see when they were going to the protocol," says Brad Noren, MA, CIP, research and contracts administrator for the Oregon Health and Science University, department of ophthalmology in Portland, OR. Noren also has worked in an IRB office and helps investigators understand the regulatory requirements.

"The overall goal of all parties is to protect human subjects, and if that can be with collaboration, an almost peer review of the research, it can strengthen the research," Noren says.

"Too often the investigator comes into an IRB review with an us-versus-them attitude," Noren says. "They have an 'I'm a scientist and you're a bureaucrat' attitude."

Rather, they should see the IRB as a group of mostly research experienced people who want to facilitate research and make sure a trial is conducted effectively with as significant results as can be obtained, Noren says.

"Many investigators are used to getting critiques and criticisms through peer review from federal grants, and if they could see the IRB review as a similar mechanism of improvement of the science and protections of human subjects, then they could come out with stronger protocols and change their attitude," he adds.

Noren offers these tips on how to improve investigator-IRB relations:

Join the local IRB: "As a former IRB administrator, I would always encourage investigators to join the local IRB and provide service, which is the best way to understand the process," Noren says.

"I've seen cases where investigators who perhaps didn't appreciate the utility of the IRB would join the IRB and become valuable members, providing unique insight into their own practice in the clinic," Noren explains. "And I've seen people do a complete 180 from being very opposed to IRB review to supporting the process."

Address all points IRB raises in response to review: It will improve collaboration between the investigator and IRB if the investigator addresses all of the points an IRB raises in his or her response to the review, Noren suggests.

"When I help investigators write these responses, I take an electronic copy of the IRB review and insert spaces under every question, and that's where we insert our response," Noren says. "I use the IRB's format and put the investigator's response right under the question the IRB raised."

This is the most efficient way to make certain that every issue raised is addressed adequately.

Also, investigators should make sure they give a full, direct, and complete response, leaving no room for additional questions, Noren says.

"Don't provide extra information that's going to muddy the waters or distract from what the issue is," he adds.

For example, in one review in which Noren assisted an investigator, there was a question from the IRB about the biological samples. The IRB wanted to know whether blood or tissue samples would be retained and used for future research, Noren explains.

"That was never part of the original protocol, and in reassessing whether we needed those samples, we decided we didn't even need to take those samples," Noren recalls. "So we said, 'There is no intent to store samples for future research, and, beyond that, we've decided those samples are not even central to our real research question, so we're not going to be collecting those.'"

Provide literature citations when indicated: "Another thing you can do is provide citations from the literature if there are questions raised that are medical in nature and related to the standard of care or to what other physicians do in this sort of case," Noren says.

"Do a literature search and provide references from peer review literature that explain that it's consistent with current thought and standard of care from other institutions," Noren says. "This can strengthen the review response and help the IRB understand the physician investigator's position."

For instance, if the IRB had a question about whether a particular drug that the investigator proposes using in children has been used in children before, then the investigator should cite the other studies where this drug has been used in children, Noren says.

"The IRB still has to address a number of regulatory questions, but their minds can be put a little at ease knowing that this drug has been used before and that we now know a little more about associated risks than if this had been the first time it was used in children," Noren adds.

Literature citations is becoming more popular in IRB submissions, Noren notes.

"There's such a stigma and fear built up around the IRB review process, and, often times it is rightly so because the process can be such a black box: mysterious, arbitrary, and unpredictable," Noren says. "The bottom line is to use common sense, provide as much information as you can, provide information in a clear and concise manner, and understand in the best sense that it's a collaborative review process."

Request previews judiciously: It's a great idea to have the IRB office perform a preview of a protocol submission, but IRB staff tend to be overworked, so this request should be reserved for special cases, such as studies that pose significant risk, Noren suggests.

"When you get into a situation where you'll see there will be a difficult review, the IRB administrators that I know will make time in their schedules to sit down with you and talk about it," Noren says. "You wouldn't expect that with every review, but if you are a newer investigator or doing the type of research that might pose significant risks then it would be appropriate to ask for a consultation to talk about some of the issues."

Another option would be for a research department to hire staff who are knowledgeable about the regulations and the IRB process or to have senior investigators or study coordinators help junior investigators or study coordinators with the IRB review process, Noren suggests.

• Respect the IRB office's workflow issues: "The local IRB has an established process, and part of that process is to make sure the regulatory issues are addressed, and the other part is to manage the workflow," Noren says.

"Also, you should remove personality from the process to the degree that you're not having an argument with an individual, but you're discussing a matter of research with a peer of some sort, and you're both trying to get to the same place," Noren adds.