Medical College of Wisconsin IRB Policies & Procedures

Advertisements (PDF)

Epic Recruitment Tools Request Form (DOCX)

Recruitment Methods and Compensation (PDF)

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

Subject Payments for Research Participation (PDF)

CareEverywhere for Research (PDF)

Definition and Determination of Human Subjects Research (PDF)

Departmental Review (PDF)

Human Subject Research Protection (HSRP) Training Requirements (PDF)

Requirements & Qualifications to serve as a Principal Investigator (PDF)

Responsibilities for Investigators Conducting Human Subject Research (PDF)

Data and Safety Monitoring Plans (PDF)

Lapsed IRB Approval of Human Subject Research (PDF)

Privacy and Confidentiality (PDF)

Public Data Sets (PDF)

Conflict of Interest for Investigators and Project Team Members (PDF)

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

Informed Consent Process for Human Subject Research (PDF)

Informed Consent Document 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)

Withdrawal of Informed Consent (PDF)

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

Multi-Site Projects and Investigator Responsibilities (PDF)

Reliance Agreements for Multi-Site Studies (PDF)

International Projects (PDF)

Handling and Reporting of Subject Inquiries or Complaints (PDF)

IRB Actions (PDF)

IRB Records (PDF)

IRB Approval Documents (PDF)

Observation of Research Activities (PDF)

Registering a Clinical Trial on ClinicalTrials.gov (PDF)

Research Consent Storage: Electronic Copies of Paper ICFs (PDF)

Routine Review Process (PDF)

Projects Deferred to National Cancer Institute Central IRB (NCI CIRB) (PDF)

Reliance Agreements for Multi-Site Projects (PDF)

Use and Storage of Investigational Devices (PDF) (PDF)

Use and Storage of Investigational Drugs and Biologics (PDF)

Emergency Use of Investigational Drugs and Biologics (PDF)

Emergency Use of Investigational Devices (PDF)

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

Expanded Access Use of Investigational Devices (PDF)

Non-Cancer Human Gene Transfer Scientific Review Committee Instructions and Application Form (PDF)

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 Economically or Educationally Disadvantaged Persons (PDF)

Research Involving Native American or Alaskan Native Tribes (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)