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Policies and Procedures

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Chapter I - Purpose, Overview, Scope, and Definitions

Chapter II - Ethical and Regulatory Requirements For the Protection of Human Research Participants

Chapter III - Purpose of the Genetic Alliance Institutional Review Board

Chapter IV - Authority and Jurisdiction of the Genetic Alliance IRB

Chapter V - Investigators and Research Staff - Roles and Responsibilities of the Principal Investigator

Chapter VI - Conflict of Interest

Chapter VII - IRB Management

Chapter VIII - Determination if Planned Activity is not Research or Research not Involving Human Participants

Chapter IX - Determination That an Activity is Exempt From the Common Rule

Chapter X - General Procedures for IRB Submissions Involving Exempt Research

Chapter XI - General Procedures for IRB Submission Involving Non-Exempt Huma Participant Research

Chapter XII - Criteria for Approval of Human Participants Research

Chapter XIII - Requirements for Informed Consent

Chapter XIV - Participant Recruitment and Review of Outreach Materials

Chapter XV - Knowledge of Local Research Context

Chapter XVI - Special Populations

Chapter XVII - Considerations For FDA Regulated Research

Chapter XVIII - Protocol Life Cycle Issues: Amendments, Continuing Review and Closure

Chapter XIX - Deviations and Violations

Chapter XX - Compliance Monitoring and Oversight Activities

Chapter XXI - Serious or Continuing Non-Compliance

Chapter XXII - Reporting Unanticipated Problems, Adverse Events, Deviations, Noncompliance, and Suspensions and Terminations

Chapter XXIII - Suspensions and Terminations

Chapter XXIV - IRB Reliance Mechanisms

Chapter XXV - Research Involving Data and/or Biological Specimens

Chapter XXVI - Health Insurance Portability and Accountability Act in Research

These written policies have been harmonized for alignment with Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018) published by Division of Policy and Assurances, Office for Human Research Protections and have been further developed using policies from The University of Pittsburgh, Georgetown University Medical Center, United States Army Medical Research and Material Command, University of Massachusetts Lowell, Ohio State University, University of Cincinnati, and University of Virginia.


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