Standard Operating Policies and Procedures

 

Doc. #  Title                                                                                                                             

001      Development, Approval and Maintenance of Human Research Protection Program Policies and Procedures

002      Institutional Commitment to Human Research Protection Program

003      Roles and Responsibilities of Human Research Protection Program Staff

004      Activities Subject to IRB Jurisdiction

005      Knowledge of Local Research Context

006      Composition of IRB

007      IRB Member Conflict of Interest

008      IRB Member Training

009      Community Outreach

010      IRB Committee Determinations/Motions

011      IRB Review of Human Subjects Research – Exempt

012      IRB Review of Human Subjects Research – Expedited

013      IRB Review of Human Subjects Research – Full Board

014      Amendments to Previously Approved Applications or Claims for Exemption

015      IRB Continuing Review

016      Legally Effective and Prospectively Obtained Informed Consent

017      Documentation of Informed Consent for Human Subjects Research

018      Waiver of Informed Consent

019      Assent/Dissent by Children or Persons with Cognitive Disabilities

020      Approval and Expiration Dates on Informed Consent Documents

021      Special Categories of Research: Children

022      Special Categories of Research: Prisoners

023      Special Categories of Research: Persons with Cognitive Disabilities

024      Human Research Protection Program Assessment and Improvement

025      Complaints Regarding Human Subjects Research

026      Protocol Deviation/Violation Reporting

027      Reporting of Unanticipated Problems or Serious Adverse Events Involving Risk to Participants or Others

028      Investigating and Managing Potential Issues of Non-Compliance

029      Suspension or Termination of IRB Approval

030      Reporting to the Appropriate Institutional Officials and the Department or Agency Heads

031      IRB Office Records

032      Institutional Conflict of Interest (DRAFT policy)

033      Office of Sponsored Programs/Office of Research Integrity and Protections Coordination

034      Institutional Official’s Authority and Responsibilities

035      IRB Office Staff Employment Requirements

036      Recruitment/Advertising

037      Payments to Research Participants

038      Individual Financial Conflict of Interest

 

Glossary of Terms