The IRB Quality Assurance Program assists the LECOM Office of Research in maintaining and ensuring continuing quality and standards for all IRB procedures. The program exists to heighten awareness of regulatory requirements and improve the ethical conduct of research in the Institutional Review Board’s approved research.

The LECOM Office of Research and IRB have the authority to observe, or have a third party observe, the informed consent process of research it has approved, and to verify that the study is being conducted as required and within the institutional policies and procedures and site-specific procedures, as appropriate. LECOM Office of Research staff or IRB members may perform site visits or use another party to verify information in the research study files under their authority.

The following documents may be used by the LECOM Office of Research and IRB to administer the IRB Quality Assurance program:

IRB Worksheet.doc
PI Interview Guidelines.doc
QA Program Instructions.doc
QA Project Checklist.doc
QA Project Worksheet.doc
QA Subject Record Checklist.docx