Polaris

SOP# IRB-001.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. Authority and ResponsibilityThe Company IRB has the authority and responsibility to:1. Review research activities and to approve, disapprove, or ask for modifications ofthe research.2. Require progress reports from Investigators so that the board can conductcontinuing review of the research at intervals of not less than one year.3. Determine which studies need review more often than annually.4. Require Investigators to report changes to the protocol to the IRB prior toimplementation, except where necessary to eliminate immediate hazard tosubjects.5. Suspend, restrict, or terminate the approval of previously approved research thatis not being conducted according to the IRB requirements or Federal Regulations.6. Perform audits of study sites to evaluate the consent process and compliance withthe protocol and regulations.Every IRB member will be expected to understand and promote the ethical principlesoutlined in The Belmont Report and to have a thorough knowledge of the FederalRegulations (45 CFR 46 and 21 CFR 50 and 56), International Commission onHarmonization guidelines (ICH), and Company policies and procedures governingresearch involving human subjects.B. Investigator Non-ComplianceIf an Investigator has failed to comply with the protocol or IRB requirements,including continuing review, the Investigator will be notified in writing about theboard’s concerns. If there is inadequate or no response from the Investigator, at thenext meeting, the board will decide if:1. Approval of the study should be suspended or withdrawn (i.e., no additionalsubjects will be enrolled in the study);2. The IRB should perform a site audit; or3. Other corrective action is needed.This discussion, decision, and timeline for correction will be included in the meetingminutes.If non-compliance is not corrected in the timeframe required, the board will close thestudy and will report the Investigator to Company management and to the appropriateregulatory authority, as required by regulation.IRB-001.0.doc© 2004 by CRC Press LLC