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Operations of the IRB

  1. Meetings
    1. IRB meetings are scheduled as required
    2. For applications requiring full IRB review, the IRB chair assigns one primary reviewer and at least one secondary reviewer. The primary reviewer is assigned consistent with protocol and reviewer expertise. Secondary reviewers may be assigned using additional factors. Assigned reviewers will lead the discussion of the protocol during the formal meeting. Other IRB members will review summary information, but have access to the complete study documentation upon request.
       
  2. Voting Requirements
    1. In order for research to be approved, it must receive the approval of the majority of those voting members present at the meeting. Note: All members (or alternates if necessary) must vote on each proposal.
    2. Principal investigators, including those who may also be IRB members, may offer information and answer questions about their protocols at a convened meeting, but may not be present during voting.
    3. Materials submitted for review, discussions of protocols, and individual votes are considered confidential and should not be discussed outside of the meeting context. Members will be asked to sign a confidentiality form when joining the board.
       
  3. Documentation
    The IRB prepares and maintains adequate documentation of IRB activities, including, but not limited to:
    1. Copies of all research proposals reviewed, approved sample consent documents, and continuing reports submitted by investigators.
    2. Copies of all correspondence between the IRB and the investigators.
    3. Records of continuing review activities, updated consent documents, and summaries of on-going project activities.
    4. Other correspondence or documents generated by the IRB.
       
  4. Document Retention
    1. All documents and records required to be saved will be retained for a minimum of three (3) years after the completion of the research.
    2. The IRB Chair will maintain record of a list of the current IRB members and written procedures for the IRB.
    3. All forms submitted or retained as evidence of informed consent must be preserved by the IRB indefinitely.
       
  5. Conflict of Interest
    1. All IRB members are responsible for identifying and avoiding any situations in which they, either personally or by virtue of their position, might have a conflict of interest, or may be perceived as having a conflict of interest, in connection with a matter before an IRB of which they are a member.
       
  6. Training
    All IRB members will complete training regarding the protection of human research participants every two years at http://phrp.nihtraining.com. Members will submit a copy of the completion certificate to the IRB Chair to be retained with IRB documents and records.
     
  7. Non-Compliance
    Any non-compliance to IRB policies and procedures will be investigated by the Chair of the IRB. Any actions against the violator will be taken as deemed necessary.