Best Practices Spotlight

IRB is leader in developing multisite research tools

IRB is part of consortium

With federal regulators shifting toward policies that would facilitate more central IRBs for multisite research, human subjects research protection offices need to take note and develop guidelines and tools for handling shared IRB responsibilities in multisite trials, an expert says.

The health sciences institutional review boards office at the University of Wisconsin–Madison is ahead of the curve with a long list of multi-site research tools and the development of the Wisconsin IRB Consortium.

"We developed a lot of these tools in part because we were told there is more of a push from the feds for collaborative research, and this relates to the community-based research we see," says Carol Pech, PhD, associate director, health sciences institutional review boards office.

"There is a push on the national level for increased cooperation, and we're kind of on the leading edge of that," she adds.

Regulators and research institutions also have been interested in how they can make the IRB review process more efficient for multisite studies. The answer is to have a single IRB of record for some multisite research, Pech notes.

With these goals in mind, the institutional review board's office added a long list of links and tools about multisite research and IRB review on its website.

"We are clear in our message to researchers that we're aware of the increase in collaborative research, so we'll make it easier for them," Pech explains.

"Many researchers are not familiar with the federal requirements for IRB oversight and research rules," Pech says. "So some of this is to raise awareness among researchers that if you are working with someone outside the institution they need to be named on the study."

The IRB office's Web pages include a variety of links and pages related to multisite research. Examples of these are as follows:

  • Overview of IRB Requirements for Multisite and Collaborative Research;
  • IRB of Record Request;
  • Deferral of IRB Oversight;
  • IRB Requirements for Multisite and Collaborative Research;
  • Frequently Asked Questions about Exemptions, Not Human Subjects Research Projects, and Multisite Research Requirements;
  • UW-Madison HRPP Policy on Multisite Research;
  • Completing the IRB Application for Multisite/Collaborative Research Studies;
  • Checklist for Investigator-Initiated Multisite Studies (See story about checklist, page 65.);
  • How to Submit a Request to Defer IRB Review to Another IRB.

The institution spent close to two years putting together a consortium, for the purpose of facilitating multisite research and using an IRB of record, with the Medical College of Wisconsin, Aurora Health Care in Milwaukee, and Marshfield Clinic in Marshfield, Pech says.

"Including us, our consortium has the four largest institutions in the state," Pech says.

When any of the four members of the consortium are involved in a multisite study they can name a single IRB of record between them. So if one IRB encounters a multisite study that includes another member of the consortium, the IRB will send the other member or members a letter and ask if they would like to defer to that IRB as the IRB of record for the study, Pech says.

Right now, the IRB-of-record process has involved minimal risk and non-clinical research, such as retrospective chart reviews, but the IRB is trying to expand this to include some standard clinical trials as well, Pech adds.

"We have general guidelines on when we can serve as an IRB of record and how to apply for it," she says.

UW-Madison has created a decision tree for determining the IRB's requirements for studies involving collaborators and others outside of the institution.

"We often send the decision tree out to researchers after an IRB consultation, saying, 'Here is information you might find helpful,'" Pech says.

"This is one of the sections of the website we highlight," she says. "We want investigators to know we are interested in being the IRB of record, so we try to be as proactive as we can."

Excerpts from the decision tree are as follows:

  1. Will personnel not affiliated with the UW/UWHC/Madison VA be engaged in research for this study?
  2. If no, then external personnel do not need to be listed on the study team in the IRB application, but activities of the external personnel must be described in the IRB application and protocol, and a letter of support from an external site not engaged in research may be required (for example, if the site will be used to recruit subjects).
  3. If yes, then are you asking that the HS-IRBs serve as IRB of record for the external personnel or site?
  4. If yes, then external personnel must be listed on the study team in the IRB application and external personnel must complete human subjects training; also, activities of the external personnel must be described in the IRB application and protocol and a request for the HS-IRBs to serve as IRB of record must be included in the initial review application.
  5. Are the external personnel affiliated with an organization or entity with an IRB?
  6. If yes, then an IRB authorization agreement (IAA) will be needed for studies not involving Wisconsin IRB Consortium Members or Meriter; the IRB office will facilitate the completion of the IAA.

Since the decision tree and other multisite study tools were created there has been an increase in studies listing outside personnel, Pech notes.

"We receive more questions: 'I saw this on your website; how does it work?'" Pech says.

Also, the development of the consortium and availability of online multisite study tools has led to a huge jump in collaborative research, she says.

"We measure volume by the number of agreements we have for multisite trials and IRB of record reviews," Pech explains. "It's a proxy for how much we're seeing of this collaborative research."

In 2004 there were no studies referred to other institutions and only two where UW-Madison was the IRB of record. In 2010, there were 38 studies deferred to another institution and 37 where the university's IRB agreed to serve as the IRB of record, she says.

"So it's a significant increase," Pech adds.