Research Microscope Lab

Human Research Protection Program

IRB Policies and Procedures

Learn about all current MCW IRB policies and procedures for Investigators and project teams in their conduct of human subject research.

IRB Policies and Procedures

IRB Submissions and Review

Case Reports and Case Studies (PDF)

Registration Projects: Review under FLEX Criteria (PDF)

Quality Assurance / Quality Improvement Projects (PDF)

Submitting New Studies (PDF)

Amendments (PDF)

Continuing Progress Reports (CPR) (PDF)

6-Year Renewals (PDF)

Study Closure (PDF)

Planned Emergency Research (PDF)

Banking: Accumulating Health Care Data or Biospecimens for Future, Unspecified Research Purposes (PDF)

  • All Investigators & study staff must complete training for Bank Custodians & Key Personnel (Register for D2LTraining module)
  • The activity of collecting and storing data or biospecimens for future, unspecified research purposes is considered a "research activity" subject to IRB review and approval - independently of the IRB review/approval required for specific studies with the same data/biospecimens

Vulnerable Populations

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

Research Involving Children (PDF)

Research Involving Department of Defense (DoD) Funding and/or Military Participants (PDF)

Research Involving Pregnant Women (PDF)

Research Involving Prisoners (PDF)

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

  • Legally Authorized Representatives (LARs): Who can Consent on Behalf of an Adult Subject with Decreased Decisional Ability (PDF)

Use of Human Fetal Tissue in Research (PDF)

IRB Guidance

MCW IRB Guidance Documents
  • Notifying Study Subjects of New Information (PDF)
  • Guidelines for Documentation of Human Subject Research (PDF)
  • Enrollment of Subjects during "delay gaps" of available approval documents (PDF)
  • Registering a Clinical Trial on ClinicalTrials.Gov (PDF)
  • Projects using de-identified, discard biospecimens for the evaluation of in-vitro diagnostic devices (PDF)
  • Negotiating Consent Document Language for Clinical Trial Sponsors (PDF)
  • Reporting a Possible HIPAA violation and/or Data Breach (PDF)