The Central Institutional Review Board Initiative (CIRB www.ncicirb.org) was created to better support medical research efforts by reducing the administrative burden on local Institutional Review Boards and medical researchers while protecting human research participants. Beginning in January 2001, the Adult CIRB has been meeting twice monthly to review Phase 3 Cooperative Group trials. The Pediatric CIRB began reviewing all NCI-approved COG Phase 2, 3 and Pilot protocols beginning in November 2004. Both Boards are composed of individuals who represent a broad range of oncology scientific and nonscientific disciplines covering the public health sector. These may include health professionals such as oncology physicians, nurses, patient representatives, pharmacists, ethicists, and attorneys. As none of the Board members are NCI employees, the Board collectively is made up of public members. There are 6 general areas in which forms are completed. These include CIRB: helpdesk, enrollment, membership, direct deposit, application, and reviewer forms. The enrollment form was developed to collect information for any new sites that are interested in enrolling into the CIRB Initiative. The membership documents were created to collect information on the members of the CIRB. There are currently two Boards (Adult and Pediatric), with 18 members on the Adult Board and 15 members on the Pediatric Board. The application forms are required to be submitted to the CIRB in order to complete a submission for review. The reviewer forms are completed by the Board Members when they submit their reviews. The CIRB Helpdesk Survey seeks to collect information that can be used by the CIRB in a systematic fashion to improve operations and enhance reviewer satisfaction with the initiative. The remainders of the forms are necessary in order to facilitate a complete review of protocols by the CIRB with the absence of conflict of interest in place.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
CIRB SAE Reviewer Worksheet (Attach 6K)