Policy History

11/28/2001 - Tissue Policies

Note: Wording of new policies adopted by PRC for tissue collection protocols:

Prospective, tissue collection studies from Lineberger Comprehensive Cancer Center should be reviewed by the PRC committee.

They should be submitted to the PRC and will be reviewed for scientific merit and study design.

They should include a Lineberger protocol template with an LCCC number

Patients should be registered in the Lineberger database

They should include an appropriate IRB application

They should be subject to prospective statistical review.

Retrospective analysis on existing tissue samples or radiographic studies will not require PRC review if they do not involve more than chart review and do not require specific patient interventions.

12/4/2002 -Policy review of Registry Submissions to the PRC

For Registry studies:

An IRB application (with or without an accompanying protocol) should be submitted along with the appropriate Consent Forms for all Registry studies. No separate LCCC formatted protocol is required. A single, non-statistical PRC reviewer will be assigned to each Registry study to confirm the legitimacy of the Registry and that the protocols are not intended as studies on which the UNC Principal Investigators will be collecting treatment data for internal use or publication. Issues of confidentiality and Informed Consent will primarily be addressed by the IRB and not the PRC.

The PRC will vote to approve or disapprove the study with comments for the PI that are intended for his or her discretionary use in regards to the Consent Forms or application.

09/20/2004 - Policy for Retrospective Chart Reviews

Retrospective studies for which an investigator is applying for an IRB expedited review need not submit an application to the PRC. If the IRB does not grant an expedited review and feels that PRC review is necessary, they will forward such studies to us at which time the PI will be asked to submit a formal Letter of Intent and/or PRC application.

01/19/2005 - Submission Procedure for Cooperative Group trials using Protocol Office Services

As of 1/19/2005, for all cooperative group studies that require Protocol Office support, the PRC requests that PI's submit the protocol along with the Letter of Intent. The PRC will review this study once and then send the approval letter to the PI and the Regulatory department within the Protocol Office. The Reg department will then prepare the IRB application and consent forms and then submit these directly to the IRB for approval. In the past, the process included an LOI review of a cooperative group study, then preparation of the entire packet for re-review by the PRC before submission to the IRB. This new policy is written with the purpose of maintaining adequate scientific review of cooperative group studies while also streamlining the submission process.

02/16/2005 - Policy for Use of NCI's Central IRB for Pediatric Studies

Due to the creation of an NCI Central Institutional Review Board (CIRB) for Cooperative Group (NSABP, CALGB, COG, GOG and ACOSOG) studies, there will be a new mechanism by which the PRC will review such trials, starting initially with Children’s Oncology Group (COG) protocols. Cooperative Group protocols with CIRB approval will now be available on the www.ncicirb.org website. Study PI’s will submit this approved protocol, CIRB approval and consent forms (formatted to fit UNC template) to the PRC Coordinator for “administrative” review. These COG protocols will go through “administrative” review by 1 PRC reviewer outside of normal meeting times. These studies will be evaluated using the new study evaluation forms and will be given a risk and complexity score, per normal protocol. Once an “administrative” review is complete, the result of this review will be put on the next PRC agenda, for notification purposes. If the reviewer does not approve the study, it will go to the PRC full board for review. As of 11/03/2005 COG protocols are still the only Cooperative Group studies to which this policy applies.