August 2013

101.1 Organization Policy on Exempt Research

101.2 Organization Policy on Research Laboratory Testing Results

102.1 Organization Policy on Determination of “Human Subject Research” and Exempt Research

102.2a Organization Policy on Quality Improvement/Quality Assurance Activity

102.3 Organization Policy on Single Case Reports and Case Series

102.4 Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles

102.6 Organization Policy on Bone Marrow Transplant Procedures in Children

102.7 Organization Policy on Provision of Research Samples for Clinical Testing

103.5 Organization Policy on Meeting Procedures

103.6b Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others

103.7 Organization Policy on Investigator Non-Compliance

103.10b Organization Policy on Assignment of IRB Review

103.11 Organization Policy on Committee on Outside Interests (COI) and the JHM IRB

103.19 Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB

103.22 Organization Policy on Institutional Biosafety Committee (IBC) and the JHM IRB

103.23 Organization Policy on Credentials of Research Team and Documentation Required from Non-Hopkins IRBs and Study Sites

103.24b Organization Policy on Device Research Requirements

103.26 Organization Policy on Electronic Submission of Information to the JHM IRBs

107.1 Organization Policy on IRB Composition and OHSR Staff Qualifications

109.2 Organization Policy on Communicating JHM IRB Actions to Investigators

109.4 Organization Policy on Allegations of Undue Influence over the JHM IRB

109.6b Organization Policy on Continuing Review of Approved Research

109.7 Organization Policy on Expired JHM IRB Approval: Protocols and Consent Forms

111.1 Organization Policy on Convened Meeting Primary Reviewer System

111.5 Organization Policy on Scientific Review

111.7 Organization Policy on Sample Size

111.9 Organization Policy on Investigators as Study Participants

111.11 Organization Policy on Financial and Personal Conflict of Interest Policy for IRB Members

113.1 Organization Policy on Suspension or Termination of IRB Approved Research

114.2 Organization Policy on Cooperative Research and Multi-Center Studies