Office of Research Subject Protection IRB Policies

Number Title
201.1 Mission Statement
201.2 Overview, Purpose, Scope of the IRB
201.3 IRB Structure
201.4 IRB Member Education
201.5 Confidentiality of IRB Proceedings
201.6 IRB Meeting Minutes
201.7 Definition of Research as it Applies to Roswell Park Cancer Institute Staff (RPCI) Staff


Number Title
202.1 Basic Review Criteria/Harm and Risk
202.2 IRB Review Procedures
202.3 Advertisement and Payment of Research Subjects
202.4 Frequency of IRB Review/Risk Benefit Analysis
202.5 Expedited IRB Review
202.6 Exemptions from IRB Review
202.7 Submission Procedure for Full Board IRB Review
202.8 Modifications to Previously Approved Research
202.9 Continuing Review


Number Title
203.1 Informed Consent
203.2 Effective Dates of Protocols and Consent Forms
203.3 Unanticipated Problems Involving Risks to Subjects or Others - Reporting and Review
203.4 Organization Policy on Reporting
203.5 Process for Notification of Participants
203.6 Determination of Human Subject Research
203.7 IRB Review of Clinical Trial Websites


Number Title
204.1 Investigational New Drug Application (IND)
204.2 Investigational Device Exemption (IDE)
204.3 Compassionate Exemption/Emergency Use
204.4 Policy on Single Case Reports and Case Series
204.5 Additional Requirements for Research Supported by Other Federal Agencies


Number Title
205.1 Phase I Committee Meeting Minutes
205.2 Grant Process
205.3 Data Safety Monitoring Board
205.4 Quality Assurance Program
205.5 Conflict of Interest
205.6 Reporting Concerns About the Research Subject Protections Program
205.7 Process to Suspend or Terminate Approval of Research
205.8 Management of Non-Compliance
205.9 Policy on Financial and Personal Conflict of Interest for IRB Members


Number Title
206.1 Guidelines and Responsibilities of Investigators
206.2 HIPAA and Research and De-Identification
206.3 Research Involving Pregnant Women, Fetuses and/or Neonates
206.4 Obtaining Research Samples from Employees / Students / Volunteers / Healthy Subjects
206.5 Prisoner Research
206.6 Additional Protections for Children
206.7 Coordination of Research Efforts with Outside Institutions/PIs
206.8 Investigator Agreement
206.9 Collection, Storage (Banking) and Use of Tissue in Research


Number Title
207.1 Human Genetic Research Guidelines