Some research institutions are not waiting for the changes to IRB review suggested by the Notice of Proposed Rulemaking (NPRM) and have already been developing consistent, structured models for collaborative review.
These existing collaborative review models might serve as best practices for other IRBs if and when every research institution uses the single IRB of record model as proposed in the NPRM.
“Ever since the Advance Notice [of Proposed Rulemaking] came out, people are confident the single IRB of record will be required or strongly recommended,” says Tracy A. Ziolek, MS, CIP, director of human research protection at the University of Pennsylvania in Philadelphia.
The University of Pennsylvania has proactively designed a collaborative review process that outlines responsibilities of the IRB of record, as well as relying IRBs and investigators.
Collaborative review makes sense from a practical standpoint: “People have been forced to recognize the fact that IRBs all do the same thing,” Ziolek says. “If somebody has done that job and done it well — and there are a lot of well-run IRBs in the country — then why reinvent the wheel at your own site?”
Developing a collaborative review process is a work in progress, Ziolek notes.
“It’s been a trial and error process,” she says. “If something works we try it again, and if it doesn’t work we scrap it.”
Most of the IRBs with which they’ve worked have been willing to be flexible and creative in preparing for this, Ziolek says.
“We’ve learned some useful lessons, such as there will be technical barriers,” she adds. “Every IRB has its own submission system database and giving outsiders access will be a struggle.”
Ziolek offers the following suggestions on how to facilitate collaborative IRB review:
1. Develop a collaborative review template.
“I encourage people to develop a template that is as close to one-size-fits-all as possible and to get the legal department to agree to its text,” Ziolek says. “Then, if it doesn’t work, go back to legal and revise it.”
The template should be brief — maybe three pages — and limited to high-priority items in the authorization agreement process, she suggests.
“The big ticket items are in there: reportable events, reportable noncompliance, and who’s responsible for research staff,” she adds. “Most of the time the template will work and the template drives the procedure.”
A division of responsibilities document will outline for each type of submission what the IRB of record, the relying IRB, and the study team are doing, Ziolek says.
2. IRB of record reviews protocol and initiates authorization agreement.
Once the protocol is approved and the sites all have received materials and are ready to rely on the IRB of record, then it’s time for the authorization agreement to be signed. The IRB Authorization Agreement (IAA) designates a single IRB of record that is responsible for the initial review and continuing oversight of the research. It describes the roles and responsibilities of each institution.
The University of Pennsylvania’s three-page IAA lists each institution’s name, address, phone number, and fax. It has a checkbox for the relying IRB and provides space for the IRB to list the specific protocol’s name, the principal investigator’s name, the IRB protocol number, the sponsor or funding agency, and the award number.
The IAA also states that the university will be responsible for appropriate execution of the contract and any corresponding consent form revisions, local content review of the consent form, and assessment of reported financial conflicts.
There are additional links for a principal investigator assurance form and a list of additional terms and responsibilities. The IAA’s final section is for notification requirements, stating that the relying institution must disclose all material pertinent to the agreement to the IRB of record, including any unanticipated problems, serious or continuing noncompliance, suspension or termination of research by the sponsor, and reports that require forwarding to federal agencies.
3. Establish roles for continuing review.
Once the study is underway, the role of relying IRBs generally is minimal, Ziolek says.
Usually the IRB of record doesn’t hear from the relying IRBs at this stage unless they have a question, their personnel has changed, or something has gone wrong, she adds.
“For the continuing review, if there is any concern about the progress note from an individual site, we’d ask for clarification about what’s going on,” Ziolek says.
The IRB of record continues to follow the same practice as for the initial review in the event of any changes or modified materials, she notes.
“We utilize progress note reporting to do a brief analysis if a site is struggling,” she says.
Also, the IRB of record should have a mechanism for providing auditing for a study and to make sure everything is done compliantly, Ziolek says.
“There is opportunity to utilize self-reporting at the continuing review,” she adds. “The continuing review is an opportunity to use self-assessments of the conduct of researchers at relying institutions.”
Some research institutions are not waiting for the changes to IRB review suggested by the Notice of Proposed Rulemaking and have already been developing models for collaborative review.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content