Investigators hold less favorable views of IRB than do research assistants
Familiarity breeds less content
An anonymous survey of investigators, research administrators, and project managers found that principal investigators and co-investigators tend have a less favorable impression of IRBs and IRB staff than do the research assistants and project managers.1
The study found that while all respondents had a favorable view of the IRB's role in facilitating ethical research, investigators tended to view the IRB as a barrier to their research.1
The people who are supposed to oversee research and have the most experience doing so, such as investigators, were the ones who had a more negative view of the IRB, says Ricardo Cruz, Jr., MPH, MA, a researcher and medical student at Boston University Medical Center (BUMC) in Boston, MA. Cruz also has worked as an IRB analyst and worked in the IRB office for about six years.
Cruz conducted the study with the hypothesis that more human subjects research ethics training and experience would lead to greater satisfaction with the IRB.
But his study found the opposite: Respondents with more research experience and ethical training had a more negative view of the IRB.1
Researchers and research staff were asked to rate the following statements1 according to whether they strongly disagreed, moderately disagreed, disagreed, had no opinion, agreed, moderately agreed, and strongly agreed:
- The IRB does provide valuable suggestions that improve my chances of obtaining IRB approval on future protocols.
- The IRB fully understands and acts within the scope of its function.
- The IRB staff is helpful and supportive.
- The IRB does review my protocols in a timely fashion.
- The IRB does provide valuable input that improves the design or methods of my research.
- The IRB does provide a rationale for any required changes to my research protocols.
- The IRB treats investigators with respect.
- The IRB staff is cordial and professional.
Cruz theorizes that targeted human subjects research training may help to improve the relationship between the IRB and research community.
"We need more specific training, rather than training for the overall research community," he says. "We could breakdown the training into what investigators and co-investigators should be doing and into what project managers and research assistants should be doing."
"Everybody has a specific role in research, and so they should be taught in different groups that reinforce their different responsibilities," Cruz says. "That will kind of improve relationships with the IRB, and it will hammer in the actual function of the IRB and what it is."
BUMC's current human subjects educational programs received mixed reviews from the survey's respondents, he notes.
"Here at Boston University we have various educational components," Cruz says. "The National Institutes of Health [NIH] provides the first exposure to human subjects research training."
There is an on-line training mode and a didactic version in which one of the IRB chairs will teach researchers and research staff about the history of the IRB, its function, and the regulations that are followed, Cruz says.
"In addition to that we do a monthly on-line newsletter called the Clinical Research Times, which is specifically designed to help the research community submit protocols," Cruz adds.
It's an up-to-date newsletter that delineates various policies, he says.
When study respondents were asked which training they found the most satisfactory, their top pick was the NIH training, Cruz notes.
"That makes sense because that's their first exposure [to human subjects research], and it's very detailed training," Cruz says.
Survey respondents gave positive views of the IRB's newsletter, he says.
BUMC's human subject protection training on-site was ranked the lowest, and attendance rates for those sessions were low among those who responded to the survey.
IRBs and IRB staff have a difficult job trying to satisfy everyone and turning around protocols quickly, he notes.
"When I was working at the IRB, analyzing protocols and turning them around, you'd have people who were very satisfied and would drop you a quick e-mail, saying, 'thank you for your timely response — you were very helpful,'" Cruz recalls. "And then you'd have people who no matter how long it took you were not happy."
At BUMC, the IRB worked to improve investigator-IRB relationships by inviting investigators to come to the meetings, Cruz says.
"We'd discuss the protocol while they were outside the room and then bring them into the meeting to see if some issues could be addressed at the meeting," he says.
One of the reasons why investigators might have a less favorable opinion of the IRB than do their research assistants could be the result of their being less involved with the studies on a day-to-day basis, Cruz suggests.
"It seems like the problem is that many investigators take on many studies, and it's questionable how involved they are on a day-to-day basis," he says.
This is another reason why targeted educational sessions are necessary.
"It all comes down to subject protection, and if investigators aren't overseeing the day-to-day function of a study, then it's kind of hard to see whether project managers or research assistants are dealing with the subjects appropriately."
Reference
- Cruz R, Woodson J, Allensworth-Davies D, et al. Is there a correlation between human subjects research training and satisfaction with the IRB? Abstract presented at the 2007 Annual Public Responsibility In Medicine & Research (PRIM&R) Human Research Protection Programs Conference; Boston, MA: Dec. 1-4, 2007.
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