Human Research Protection Program

MCW/FH IRB SOPs, Policies & Guidelines

Advertising & Recruitment

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

Conduct of Research

• Definition of Human Subjects
• Definition Research
• Determining When Activities and Research Involving Human Subjects
• Requirements & Qualifications to serve as a Principal Investigator
• Responsibilities for Investigators Conducting Human Subject Research
• Data and Safety Monitoring Plans
• Eclipsed Progress Reporting Policy
• Privacy and Confidentiality
• Projects Deferred to the National Cancer Institute Central IRB (NCI CIRB)
• Public Data Sets
   

Conflict of Interest

• Conflict of Interest for Investigators and Study Team Member

Informed Consent

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

IRB Submission Review

• Submitting New Studies
• Submission of Continuing Progress Reports (CPR)
• Submission of Conversion Continuing Progress Report (CPR)
• Modifications to an Approved Project
• Study Closure
• Case Report / Case Study
• Planned Emergency Research
• Banking: Accumulating Health Care Data or Biospecimens for Future, Unspecified Research Purposes
  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

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

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

Research With Vulnerable Populations

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

Regulatory Compliance

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

Multi-Site Research

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

MCW/FH IRB Guidelines

• Guidance of Enrollment of Subjects during "delay gaps" of available approval documents
• Guidelines for Registering a Clinical Trial on ClinicalTrials.Gov