Small IRB develops, finds ideal solutions to problems
Small IRB develops, finds ideal solutions to problems
Achieving IRB quorum, measuring quality, etc.
The IRB office at Memorial Medical Center in Johnstown, PA, began as many small IRB offices do, with one part-time employee. As the workload increased to about 80 protocols per year, the office turned the part-time position into a full-time administrator position, and organizational procedures were put in place.
But despite a structured daily routine and office support, the IRB has experienced some growing pains, which have resulted in the IRB office developing its own best practices to meet these challenges.
"I came into the IRB office with a background in medical records, but no previous IRB and research experience," says Paulette M. Vandzura, MA, CIP, the IRB administrator for Memorial Medical Center.
"One of my strongest personality characteristics is that I structure day-to-day processes, streamline them, and live by the rule of 'Do it once,'" she says.
The IRB's chairman served as Vandzura's mentor and helped her meld her skills with the needs of a fulltime IRB office, including paying attention to the details that would enable her to streamline processes and improve quality.
Here are some of the IRB challenges and Vandzura's best practice answers:
• Problems achieving IRB quorum: One of the recent challenges the IRB faced was a repeated loss of quorum, which was a dramatic problem to investigators who would then have to wait another month to have their protocols reviewed, Vandzura says.
"Sometimes when the timing was critical, we'd set up a teleconference call," Vandzura says. "But those are difficult for members to attend."
In one 12-month period, the 11-member IRB lost quorum three or four times, which is a significant problem for a small organization, Vandzura says.
The reasons why some of the IRB members were unable to attend certain meetings were understandable because they had clinical responsibilities that took priority over the IRB role, she says.
"For example, we have on the board a chairman of the department of emergency medicine," Vandzura explains. "And we have a busy ER, so when the ER is busy, he needs to be there."
So the solution was to recruit volunteers to be alternate members of the IRB, Vandzura says.
The IRB recruited four alternate members, including one additional community member, she says.
"The first time we picked a community member alternate, the person was an educator," Vandzura notes. "We invited him because at some point he had had a conversation with our chair and had expressed an interest in the IRB."
This member served for some months, but had to resign when promoted to state board of education job.
"His replacement was a woman from a higher education background whom I knew personally," Vandzura says. "I knew her work traits and attitude and I thought she would be interested when approached."
The three alternates who have scientific and medical backgrounds were all people who had contacted the IRB as interested parties, Vandzura says.
"We have two physicians who spoke up one day and said they were interested in the IRB and research and would like to serve if we ever had an opening," she recalls. "So we talked it over and decided to ask them to join us as alternate members."
The IRB alternates receive the same training and have the same requirements as full voting members. They are asked to view a video on protecting human subjects, and they are given an IRB handbook and HIPAA handbook, Vandzura says.
"We ask them to read the Belmont Report and Nuremburg Code, and we ask them to sign a document saying they have read those items," she says. "We also provide one in-house seminar every year for IRB members, and it's focused around an issue involving IRB work."
Each month, the alternates are sent the full IRB protocol packet, and they are expected to show up prepared, as though they will have a vote that month, Vandzura notes.
Alternate members also are included in the annual recognition dinner and in the awards program when they have achieved five and 10 years of service.
"I'm the only one at the meeting who is sure who is voting, and everyone participates in the discussion," she says. "Even if alternates raise their hands to vote when their vote isn't necessary, it doesn't matter because I know who is there and who can vote and which votes count."
So far there have not been any highly contentious issues in which the vote was very close, Vandzura adds.
Since adding the four alternates, the IRB hasn't lost a quorum, although it would have lost quorum several times without their presence, she says.
• Measure IRB quality: The IRB uses a customized questionnaire to gather the opinions of research investigators, nurse study coordinators, and others in research about the IRB.
The IRB used as a guide the IRB Researcher Assessment Tool (IRB-RAT), developed by Patricia Keith-Spiegel and Gerald P. Koocher of the Children's Hospital and Harvard Medical School in Boston, Vandzura says.
But the adapted questionnaire has only 13 questions.
"We felt we wouldn't get as good a response if we sent out a questionnaire as detailed and with as many responses as the IRB-RAT requires," Vandzura says.
The questionnaire was sent to 49 people who were asked to make an anonymous response by Oct. 20, 2006. Within a couple of weeks, responses came from about one-third of those queried, she says.
"We just said their feedback would allow us to look at our performance and give us a sense of perceived strengths and weaknesses and areas where we might improve our service," Vandzura says.
The questionnaire features questions, such as these:
- Does the IRB demonstrate respect toward investigators?
- Is our Web site organized and easily navigated, and does it provide the documents you feel you need?
- Does the IRB offer helpful suggestions for how to improve your protocol?
- If the IRB requires revisions, do you receive a detailed summary that's easy to understand in terms of what's required?
With the results, Vandzura will create a spreadsheet and statistical analysis of the responses and then publish these on the Web site.
"I'll probably send the investigators queried a report and mention what the IRB has decided to do with the information," she adds. "Then I'll open the dialogue and ask for additional help in improving the IRB Web site."
In the responses thus far, there appears to be a trend regarding lukewarm reviews of the IRB's Web site, Vandzura notes.
"It's not getting rave reviews," she explains. "It's pretty much getting ho-hum reviews on whether it's easy to navigate and whether materials provide good guidance."
So Vandzura plans to discuss possible improvements with investigators or to send out another questionnaire to find out what they think is lacking and where improvements are needed.
• Use Microsoft Word's auto-text: "It's wonderful for saving yourself carpal tunnel syndrome," Vandzura notes.
"When you're in a Word document, and there's something you want to put in auto-text, you highlight and open auto-text," she explains. "I use the number of the research study."
Anytime Vandzura needs to put the study's number into a report or letter, all she has to do is type the IRB's four-digit tracking number, and the research study title pops up.
The IRB office at Memorial Medical Center in Johnstown, PA, began as many small IRB offices do, with one part-time employee. As the workload increased to about 80 protocols per year, the office turned the part-time position into a full-time administrator position, and organizational procedures were put in place.Subscribe Now for Access
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