For studies initially approved on or after January 21, 2019
See the table below to download a copy of the entire Standard Operating Procedure (SOP) or individual sections of the SOP.

Document IDDocument Title
SOP-B-001Click here to download a copy of the entire SOP
SOP-B-002Human research Protection Program
SOP-B-003Quality Assurance
SOP-B-004Education & Training
SOP-B-005"Human Subjects" and "Research" Determinations
SOP-B-006Exempt Determinations
SOP-B-007Multi-site and Collaborative Research
SOP-B-008Research Previously Approved by Another IRB
SOP-B-009IRB Reliance Arrangements in Multi-Site Research
SOP-B-010NIH Single IRB (sIRB) for Multi-Site Research
SOP-B-011MaineHealth Institutional Review Board
SOP-B-012IRB Actions, Failure to Respond, Appeals
SOP-B-013IRB Review Process
SOP-B-014Suspensions and Terminations
SOP-B-015Documentation and Records
SOP-B-016Obtaining Informed Consent from Research Subjects
SOP-B-017Vulnerable Subjects in Research
SOP-B-018FDA-Regulated Research
SOP-B-019Unanticipated Problems Involving Risks to Subjects or Others: A Type of Reportable New Information
SOP-B-020Noncompliance
SOP-B-021Complaints
SOP-B-022Other Reportable Information
SOP-B-023Reporting to Federal Agencies, Departments, and Organizational Officials
SOP-B-024Investigator Responsibilities
SOP-B-025Sponsored Research
SOP-B-026Conflict of Interest in Research
SOP-B-027Participant Outreach
SOP-B-028Health Insurance Portability and Accountability Act (HIPAA)
SOP-B-029Special Topics

Institutional Review Board

509 Forest Ave
Portland, Maine 04101
207.661.4474
MMC_IRB@mainehealth.org

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