Full review vs. a primary reviewer system: IRBs discuss pros and cons
Best solution not always easy to decide
Whether an IRB’s protocol volume is small, medium, or large, it’s not easy to decide whether to have the entire board read every page in a protocol submission or have a primary and/or secondary reviewer system in which point people take on the bulk of the work.
"All too often, the whole reason for a full board review is I need seven different pairs of eyes and seven different sets of experiences to look at the protocol," says Sally Mateja, CIP, IRB coordinator at the IRB for Murray (KY) State University.
"From my experience, I know that I get a much more in-depth review when I have seven people looking at something than when I have two," she says. "So in my opinion, all seven members need all materials because I don’t know how someone can make an informed judgment based on someone else’s opinion."
The Murray State IRB does have a subcommittee of two members who review the protocols that qualify for expedited review, Mateja notes.
"The decision is made in subcommittee and reported back to the board at the monthly meeting," she says. "The subcommittee is not allowed to decline a protocol, but can send it back to the full board to review."
Also, the selected reviewers of an expedited review case are not permitted to be someone from the same department as the principal investigator, Mateja says.
When IRB members meet, they are prepared with questions and concerns, and the IRB chair manages and directs the meeting, she explains.
Investigators are strongly encouraged to attend and answer the board’s questions, and the entire process is handled collegially, Mateja says.
"We have only 10-12 full board protocols a year," she notes. "We have around 100 reviews a year, but most are expedited reviews."
The expedited reviews include survey research, while the full board reviews tend to be sociobehavioral studies, including prisoner studies and psychological studies that deal with sensitive materials, Mateja says.
Studies with more than minimum risk involving children must go before the full board also, she adds.
The IRB’s board includes a biologist, psychologist, organizational communications specialist, a lawyer and past judge, an education specialist, a speech therapist, and a zoologist, Mateja says.
"There is a wide range of talent and specialties, and each one of these people brings something different to the table," she says.
So by requiring each board member to read all the materials submitted with each protocol, the IRB is ensured a wide variety of opinion, Mateja notes.
"That makes a big difference in what you bring to the forum; and for us, that is the best way to do things," she says.
A different point of view
On the other hand, the ethics review board (ERB) at St. Thomas Hospital in Nashville, TN, has a primary reviewer system for new protocols, and it works very well, reports Martha Green, CIM, ERB coordinator.
The ERB averages about two to four full-board reviews per month and has a caseload of 10-15 continuing reviews, she says.
"They are always biomedical studies, but some are chart reviews and data collection," Green adds. "Over the course of the year, we do have some studies that are exempt, and we use expedited review on some that are minimal risk, such as chart reviews, so long as they’re compliant with privacy regulations."
"We assign a primary scientific reviewer and a community member for new studies," Green says. "That doesn’t mean the rest of the IRB is excused from reading through the material, but the people who are assigned know it’s their responsibility to lead the questions and answer with the principal investigator."
The ERB also uses primary reviewers for amendments, revisions, and continuing review. If there’s a reason something needs to go the full board, it will be sent there, and the primary reviewers will lead the board in discussing the item, she adds.
St. Thomas ERB administrator Penny Clark, RN, CIM, previously has worked with an ERB that didn’t use the primary reviewer process, and she found that it resulted in less focus on safety.
"Everyone was responsible for the materials in the packet, and people took less of a leadership role in directing the discussion and conversation," she says.
The primary reviewer system works well and can be used to encourage primary reviewers to call principal investigators prior to meetings to clarify issues, Clark adds.
"I’d like to see them go that route more," she says. "I see a lot more consistency of reviews of all studies with better discussion of risks."
The ERB’s primary review system extends to continuing reviews in which one reviewer ensures that all qualifications are met and then makes a recommendation to the board, Clark says.
The IRB at the University of Maryland, Baltimore County, also uses primary reviewers in the case of expedited review protocols, but does have a primary and secondary review system for full board reviews, as well, says Timothy Sparklin, MSW, CIM, administrator of the human and animal research protections at the school.
"The whole board gets the packet, and the primary reviewer will lead the discussion," he says. "The primary reviewer talks about the issues, concerns, questions; and once that occurs, the board discusses the whole protocol."
The 12-member board has a small workload, a handful of full board reviews per year, Sparklin notes. Although there is a primary reviewer, it’s apparent that the entire board will review the protocols and raise their own questions and concerns, he says.
"I believe the process works very well," Sparklin says. "Having this primary review system provides timely information and comments."
For example, if a particular expedited review protocol is not being handled as quickly as it should be handled, then he can call the reviewer assigned to the protocol and find out what’s going on.
"We usually have about 150-160 total reviews and renewals per year," Sparklin reports.
Thomas E. Ball, MDiv, CIM, program director for the National Association of IRB Managers Inc. in Atlanta, has served on IRBs that use the primary reviewer system, as well as on a board that uses the full review system.
"I would probably support the primary reviewer system based on my IRB management job at Northside Hospital in Atlanta vs. my 10 years of Kaiser IRB membership here," he says. "At Northside, I had a primary reviewer system and two primary reviewers for each protocol, and they would be systematically selected rather than randomly selected."
The reviewers would include one scientific IRB member and one lay reader, Ball notes.
"The opposite system is to send all board members every packet and overload everybody," he says. "If you overload everybody, then no one is likely to be well prepared; but if you balance the work out, you are more likely to get a good reviewer."
Under the primary review system, the other board members would receive a copy of the consent form and a summary, Ball says.
"They know what is going on and what investigators are telling subjects and what is asked of subjects," he says. "So they’re really not lost, and they can skip the other stuff."
In Ball’s experience, the primary reviewer system results in some IRB members becoming experts on a particular protocol, and both the reviewers and full board liked the responsibility being divided in that way, he says. Since every member of the IRB would serve as a primary reviewer on some protocols, the workload was evenly divided.
St. Thomas Hospital’s ERB meets twice a month, and all members are trained and experienced, says Green. "We take maybe seven or eight ERB members and staff to the PRIM&R [Public Responsibility In Medicine & Research] conference, including board community members.
"We went to a Food and Drug Administration-sponsored seminar in Florida early this year, and there again we had four community members attending," Green reports.
ERB members also receive training through a human research subjects handbook, a three-part video, and a notebook that lists specific policies, procedures, and forms, she reports.
Potential members also are asked to observe two or three ERB meetings to make certain they’ll be comfortable taking part in discussions and voting, Green adds.