Polaris

SOP# IRB-002.0CompanyEffective Date: DD/MMM/YYThe non-scientific member should not be vulnerable to intimidation by theprofessionals on the Board and his/her services should be fully utilized by the IRB.The IRB will include at least one member who is not otherwise affiliated withCompany and who is not part of the immediate family of a person who is affiliatedwith Company.Every non-discriminatory effort will be made to ensure the IRB is not composedentirely of men or women, so long as no selection is made to the IRB on the basis ofgender alone.When research involving a vulnerable population is being reviewed, at least onemember of the Board should have the appropriate background and experience inworking with these subjects.One individual can satisfy more than one of the membership requirements for theboard.The IRB may invite individuals with competence in special areas to assist in thereview of issues that require expertise beyond or in addition to that of the IRB. Theseindividuals may contribute to the discussion, but may not vote on the research.D. IRB ChairpersonThe IRB Chairperson will:1. Conduct meetings in an efficient and fair manner, and according to standardparliamentary procedures.2. Follow the agenda created for each meeting.3. Set a tone of openness to encourage dialogue in the meeting.4. Respect the diverse backgrounds, perspectives, and sources of expertise of all IRBmembers, especially for the contributions of the non-scientists, and the ability tofoster such respect among the IRB members.5. Uphold IRB judgments that may not always be popular with Investigators.6. Invest adequate time, interest, and commitment to provide guidance and expertiseto IRB members and Investigators.7. Assure that the Board receives appropriate and sufficient administrative support,meeting space, and other necessary resources to function efficiently, and willreport deficiencies in this support to Company management for correction.IRB-002.0.doc© 2004 by CRC Press LLC