Polaris

SOP# IRB-009.0CompanyEffective Date: DD/MMM/YY14. Research on individual or group characteristics or behavior (including, but notlimited to, research on perception, cognition, motivation, identity, language,communication, cultural beliefs or practices, and social behavior), or researchemploying survey, interview, oral history, focus group, program evaluation,human factors evaluation, or quality assurance methodologies15. Research on drugs or devices for which an IND or an IDE (Investigational DeviceExemption) is not requiredThe expedited review procedure may not be used:1. When the research involves more than minimal risk to the subjects2. Where identification of the subjects and/or their responses would reasonably placethem at risk of criminal or civil liability or be damaging to the subjects' financialstanding, employability, insurability, reputation, or be stigmatizing, unlessreasonable and appropriate protections will be implemented so that risks related toinvasion of privacy and breach of confidentiality are no greater than minimal3. For classified research involving human subjects4. For studies intended to evaluate the safety and effectiveness of medical devices,including studies of cleared medical devices for new indicationsIf expedited review is being requested for the initial review of research, theInvestigator will submit the Initial Submission Form (Attachment A) and attach allappropriate documents. For expedited review of research that has already beenapproved by the IRB, the Investigator will submit a study packet to the IRB Secretarywhich will include the minimum of the following documents:1. A completed Expedited Review Form (Attachment B)2. The most recent version of the protocol and amendments, if applicable3. The current Investigator’s Brochure or Package Insert4. A draft Informed Consent Form5. Advertisements (if applicable) or subject recruitment materialsIf this is the first time an Investigator has submitted a study to the IRB, he/she shouldalso include a copy of his/her curriculum vitae.The IRB Secretary will review the study packet for completeness and will forward itto the Reviewer. The Reviewer may be the Chairperson or any primary or alternateIRB member who does not have a conflict of interest with the research proposal. TheReviewer may exercise the authority of the IRB, except he/she cannot disapprove aresearch project. If the Reviewer believes the research should be disapproved, he/shewill bring it to the attention of the full Board.IRB-009.0.doc© 2004 by CRC Press LLC