Human Research Protection Program

MCW/FH IRB SOPs, Policies & Guidelines

Advertising & Recruitment

• Advertisements (pdf)
• Recruitment Methods and Compensation (pdf)
• Recruitment and Enrollment of non-English or Limited English-Proficient Subjects (pdf)

Conduct of Research

• Definition of Human Subjects (pdf)
• Definition Research (pdf)
• Determining When Activities and Research Involving Human Subjects (pdf)
• Requirements & Qualifications to serve as a Principal Investigator (pdf)
• Responsibilities for Investigators Conducting Human Subject Research (pdf)
• Data and Safety Monitoring Plans (pdf)
• Eclipsed Progress Reporting Policy (pdf)
• Privacy and Confidentiality (pdf)
• Use of National Cancer Institute Central IRB (pdf)
  As of 10/23/2007, a determination had been made that MCW/FH would discontinue use of NCI CIRB as the IRB of record for all new cooperative group studies. A small group of ongoing studies may maintain NCI CIRB oversight while being conducted here.

Conflict of Interest

• Conflict of Interest for Investigators and Study Team Member (pdf)

Informed Consent

• Informed Consent for Human Subject Research (pdf)
• Submission, Review and Evaluation of National Cancer Institute Cooperative Group Consent Form (pdf)
• Legally Authorized Representatives (LARs): Who Can Consent on Behalf of an Adult Subject with Decreased Decisional Ability (pdf)
   

IRB Submission Review

• Submitting New Studies (pdf)
• Submission of Continuing Progress Reports (CPR) (pdf)
• Modifications to an Approved Project (pdf)
• Study Closure (pdf)
• Case Report / Case Study (pdf)
• Planned Emergency Research (pdf)
• Banking: Accumulating Health Care Data or Biospecimens for Future, Unspecified Research Purposes (pdf)
  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.
• Required training for Bank Custodians & Key Personnel (Requires ANGEL website log on)
   

Reporting to the IRB

• Requirements for Reporting to the IRB (pdf)

Research Involving Drugs, Devices, In-Vitro Diagnostics & Biologics

• Use and Storage of Investigational Devices (pdf)
• Use and Storage of Investigational Drugs and Biologics (pdf)
• Emergency Use of Investigational Drugs, Devices or Biologics (pdf)
• Treatment Use of an Investigational Drug, Device or Biologic (pdf)

Research With Vulnerable Populations

• Research Involving Pregnant Women and Children (pdf)
• Research Involving Prisoners (pdf)
• Research with Subjects Likely to Manifest or Develop Decreased Decisional Ability (pdf)

Regulatory Compliance

• Institutional Review Board Actions (pdf)
• Institutional Review Boards Records (pdf)
• IRB Approval Documents (pdf)
• Reconcile Federal Grants Contracts (pdf)
• Review and Evaluation of Outreach Activities (pdf)

Multi-Site Research

• Coordinating Center Responsibilities and Multi-Center Projects (pdf)
• Institutional Authorization Agreements & Other Review Mechanisms for Multi-Center Studies (pdf)

MCW/FH IRB Guidelines

• Guidelines for Registering a Clinical Trial on ClinicalTrials.Gov (pdf)