MCW IRB Member Policies and Procedures

To support compliance with the federal regulations and institutional policies, the following SOPs have been created to outline the processes and expectations for MCW IRB Members when reviewing research under the oversight of the MCW IRB.

IRB Member Policies and Procedures

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Review of Advertisements and Recruitment Processes

Advertisements, Recruitment Methods and Compensation (PDF)

Recruitment and Enrollment of Non-English Speaking Subjects (PDF)

IRB Member Expectations and Committees

Assigning Reviewers and the Use of Consultants (PDF)

Conduct and Expectations of the IRB Members (PDF)

Institutional Review Board Committees (PDF)

Review and Evaluation of IRB member Service (PDF)

Conflict of Interest

Conflict of Interest - IRB Committee Members (PDF)

Informed Consent

Informed Consent for Human Subject Research (PDF)

Recruitment and Enrollment of non-English or Limited English-Proficient Subjects (PDF)

Research with Subjects likely to Manifest or Develop Decreased Decisional Ability (PDF)

Review of Submissions

Initial Review: Primary and Secondary Reviewer Responsibilities (PDF)

Planned Emergency Research (PDF)

Privacy and Confidentiality (PDF)

Review of Amendments (PDF)

Review of Continuing Progress Reports (CPR) (PDF)

Review of Exempt and Expedited Projects (PDF)

Review of 6-Year Renewals (PDF)

Review of Reportable Events (RE) (PDF)

Multi-Site Research

Multi-Site Projects and Coordinating Center Responsibilities (PDF)

International Projects (PDF)

Regulatory Compliance

Use and Requests to Quality Assurance/Quality Improvement (PDF)

IRB Actions (PDF)

Meeting Minutes and Conduct of the Meeting (PDF)

Emergency or Expanded Access Submissions

Emergency Use of Investigational Drugs, Devices or Biologics (PDF)

Expanded Access Use of an Investigational Drugs and Biologics (PDF)

Expanded Access Use of Investigational Device (PDF)

Planned Emergency Research (PDF)

Vulnerable Populations

Recruitment and Enrollment of Non-English Speaking Subjects (PDF)

Research Involving Children (PDF)

Research Involving Pregnant Women and Fetuses (PDF)

Research Involving Prisoners (PDF)

Research with Subjects Likely to Manifest or Develop Decreased Decisional Ability (PDF)