PI finds board policies toughen over study time
PI finds board policies toughen over study time
Rigor, attitudes change since 2002
It's one thing to sense that IRBs are demanding more and are becoming more cautious during protocol reviews. But it's the rare principal investigator who has a long, multi-site study in which it's readily apparent that the IRB reviews have become more rigorous.
The change has occurred during a decade of more intense media scrutiny of human subjects research, as well as increased government regulations of research.
"We are running a multi-site study of post-baccalaureate graduate nurse residency programs and have over 44 IRBs reviewing the research protocol," says Mary Krugman, PhD, RN, FAAN, director of professional resources at the University of Colorado Hospital in Aurora, CO.
Since the study began in 2002, it has enrolled more than 5,000 graduate nurse participants at sites across the country. The project started in academic medical centers and is now beginning to branch out to community-based hospitals, Krugman says.
The idea is to measure outcomes of the graduate nurse transition into practice and satisfaction with the residency program at baseline, six months, and one year, she adds.
"Graduate nurse residents go on line to a database run by the University Health Care Consortium and answer survey instrument questions," Krugman explains. "We look at their graduate nursing experience, and satisfaction with the residency program."
Krugman received her own institution's IRB approval for the exempt study after review in 2002. It's since had continual reviews by the IRB as the study is updated and progresses. Krugman sends that submission and approval material to site coordinators at each site participating in the study.
"In 2002, when we first did an IRB application here, it worked pretty seamlessly," Krugman notes. "Most of the sites would look at what our IRB had done and accept the review's rigor."
Krugman's own involvement in the 40-plus site's individual IRB approvals was minimal at first.
"I normally didn't have to get involved, since the site coordinators followed their own institutional IRB procedures, using the multi-site protocol, but increasingly I'm seeing IRBs wanting to know more about me as principal investigator and to have me more involved," she says.
It was more common six years ago for the other IRBs to accept the review packet as it was and to conduct an exempt review of the material, she says.
As the study continues to add sites and enroll new participants, the IRBs have demanded more information and have had more elaborate requirements.
"Increasingly, there are more demands by IRBs for more data and information, requiring extra legwork by site coordinators," Krugman says. "The landscape is changing increasingly with the regulations tightened."
For instance, one site's IRB required Krugman to register and be listed as co-investigator at their site and to join their IRB, she says.
Other IRBs have requested Krugman to submit additional professional information, including a curriculum vitae, even though her credentials include a Collaborative Institutional Training Initiative (CITI) certification. CITI was founded in March 2000 as a Web-based education and training collaboration between the University of Miami and the Fred Hutchinson Cancer.
"The range of IRB responses has gone from totally accepting the package to handing the site coordinator extremely elaborate requirements," Krugman says.
Individual sites' IRBs also have become more concerned about how the participants' privacy will be protected as they complete on-line surveys, Krugman says.
"What we've seen gradually over the years are more prescriptive requirements by the IRBs," Krugman says. "It's just the environment."
The past six years have been a time when IRBs and research institutions faced more government scrutiny and changing human subjects research regulations, as well as the full implementation of HIPAA privacy requirements, Krugman notes.
As a PI of a large, multi-site study, Krugman respects how each IRB fulfills its obligations, she says.
"Each IRB in its own region has its own requirements," Krugman says. "I think one needs to be prepared for a changing, fluid environment."
The trend appears to be that each IRB now has its own submission material requirements and the IRBs no longer simply accept the paperwork that has been approved by previous IRBs, accompanied by a cover sheet from the site coordinator, Krugman explains.
"I'm more involved now in supplying information and data directly to the IRBs, rather than through the site coordinator who uses my materials," she says.
"Every time nationally there's some breach in protection of human subjects, it results in changes in regulations, which is understandable," Krugman says.
It's one thing to sense that IRBs are demanding more and are becoming more cautious during protocol reviews. But it's the rare principal investigator who has a long, multi-site study in which it's readily apparent that the IRB reviews have become more rigorous.Subscribe Now for Access
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