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Building Support for an Independent Review Model

Case Study:  National Cancer Institute Central Institutional Review Board
                        Rockville, Maryland
                        AAHRPP Accredited Since 2012

The Situation
The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides research review services for the NCI Cancer Therapy Evaluation Program (CTEP), which coordinates one of the largest publicly funded oncology clinical trials organizations in the world. No other institute in the National Institutes of Health (NIH) supports a CIRB that reviews this volume of clinical trials.

Like many other central IRBs, the CIRB has stepped up its commitment to streamline the review process so that ultimately, new drugs and treatments will be available more quickly. What sets the CIRB apart, however, is its responsibility as a government entity.

“We operate in the public interest, and that’s a differentiating factor,” says Jacquelyn Goldberg, J.D., Head, NCI CIRB Initiative. “The public is relying on us to open more trials to participants—and to make sure those trials are conducted ethically and with appropriate human subjects protection.”

To help fulfill its obligation to the public, the CIRB is transitioning to an independent model of review for NCI CTEP-funded clinical treatment trials. In 2012, the CIRB began conducting the local context review and serving as the IRB of record.

The Challenge
The primary challenge was to build support for the independent model among the following:
  • The more than 300 research organizations representing nearly 1,000 entities that were already taking part in CIRB-reviewed clinical trials.
  • Institutions that were not yet participating in NCI CTEP-funded treatment trials.
Both groups needed to be assured that the independent model would reduce their administrative burden without sacrificing the quality of the review and protections for research participants.

The Solution
The CIRB took two bold steps to address these concerns:
  • Piloted the new, independent model—and surveyed participating sites to assess their reaction to the change. The yearlong pilot included 1,218 studies that were rolled over from the facilitated review model. Pilot institutions opened new studies 189 times, with a median time of two days to open a study.
  • Pursued AAHRPP accreditation to give organizations an objective assurance of high standards. “AAHRPP has emerged as our ‘Good Housekeeping seal,’ one of the few true markers of quality,” Ms. Goldberg explains. “We felt that by attaining AAHRPP accreditation we would signal our commitment to quality.”
The Results
In both instances, the NCI CIRB was rewarded with positive results.

Pilot participants acknowledged the high quality of the CIRB review, the increased efficiencies, and the reduced workload at the local level. Participants reported shorter waiting times for the start of accrual for trials and greater ability to offer more clinical trials. Equally important, 78 percent of pilot participants said they felt “very satisfied” or “extremely satisfied” with the independent model. Furthermore, 84 percent would recommend the independent model to colleagues.

The CIRB experienced similar success in attaining AAHRPP accreditation. Three months after the pilot concluded, NCI CIRB became the first NIH entity to earn the right to display the AAHRPP gold seal.

“AAHRPP accreditation is an important affirmation of the high quality of the ethics reviews and the administrative processes conducted by NCI’s CIRB,” says Jeffrey Abrams, M.D., Associate Director, CTEP, “and provides enhanced credibility, which has encouraged us to expand the CIRB effort to cover phase 1-2 multicenter, NCI-sponsored trials in the future.”