BOX 6-4
Synopsis of the National Cancer Institute Central Institutional Review Board Process

  1. The CIRB receives a completed application, protocol, informed-consent form, and related materials from the cooperative group conducting the clinical trial through NCI.

  2. The full board conducts an initial review and approves the protocol.

  3. After the protocol is activated by the cooperative group, all review documents are posted on a website for access by the participating institutions.

  4. A local investigator at a participating institution decides to enroll subjects in a CIRB-approved protocol. Either the investigator or the local IRB downloads the application packet to facilitate review.

  5. The local IRB chair or subcommittee conducts a facilitated review, concentrating on issues specific to the local context.

  6. The local IRB notifies the CIRB administrative office through the website of its acceptance of the protocol.

  7. The CIRB becomes the IRB of record for the protocol and is responsible for continuing review as well as review of subsequent amendments and any serious adverse events reported by the individual centers performing the trial.

  8. The local IRB is responsible for reviewing serious adverse events that occur locally and oversight of the local conduct of the study.

SOURCE: Adapted from NCI, 2004.

the study (Box 6-4). This model system could be expanded for use in multicenter clinical trials in areas of research other than cancer, including spinal cord injury research.

Coordination of Care and Cure Efforts

It is important that ongoing efforts related to patient care and rehabilitation after a spinal cord injury be coordinated with efforts in developing therapeutic interventions for spinal cord injuries. A number of sites and systems can be used to conduct clinical trials of interventions for spinal cord injuries. The Model Spinal Cord Injury Systems of Care, funded by the National Institute on Disability and Rehabilitation Research (see Chapter 7), offers the resources of 16 hospitals and rehabilitation centers across the country with a known patient base and the staff and facilities that could be enlisted to conduct clinical trials. The resources of the Model Spinal Cord Injury Systems of Care have been used to conduct clinical trials of the drugs 4-aminopyridine (fampridine) and sildenafil (Viagra) (Northwest Regional Spinal Cord Injury System, 2000). In addition, most major hospital centers



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