12.07.2015 Views

Polaris

Polaris

Polaris

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CompanyIRB MEETING MINUTES TEMPLATEMeeting Minutes for ___________(date)__________Chair: • Name Guest (if applicable): • NamePresent: • Name • Name • Name• Name • Name • NameCALL TO ORDERThe meeting was convened at ____ at by _______, IRB Chair. A quorum waspresent.OLD/UNFINISHED BUSINESSReview and approval of minutes from meeting held ______________ were reviewed.Suggested changes were noted.APPROVED by a vote of __ for __ against __ abstainINITIAL REVIEWSPrincipal Investigator:Protocol Title:Protocol Summary:Discussion:General:Specific (include the following headings):• Scientific design.• Risks/benefits (Assign a level of risk here or at the time of the IRB decision andvote below. If children are to be enrolled, cite the regulatory reference).• Subject selection (Discuss populations to be studied and recruitment plan).• Additional safeguards for vulnerable subjects.• Minimization of risks to subjects.• Privacy and confidentiality.• Consent document (Document if all required elements are present).• Additional considerations (e.g., ionizing radiation; collaborative research; IND,other. State if these considerations do not apply).• Document the reason(s) for the minority opinion(s).Stipulations (number the stipulations):Minutes Template.doc© 2004 by CRC Press LLC

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