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Institutional Review Board

Organizational Policies

 

Name of Policy No.
Organization Policy on Exempt Research 101.1
Organization Policy on Research Laboratory Testing Results 101.2
Organization Policy on Determination of “Human Subject Research” and Exempt Research 102.1
Organization Policy on the Definition of Research as it applies to Clinical Practice and Public Health Activities 102.2
Organization Policy on Quality Improvement/Quality Assurance Activity 102.2(a)
Organization Policy on Single Case Reports and Case Series 102.3
Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles 102.4
Organization Policy on Bone Marrow Transplant Procedures in Children 102.6
Organization Policy on Provision of Research Samples for Clinical Testing 102.7
Organization Policy on HRPP Assurance of Compliance with DHHS Policy 103.1
Organization Statement of Commitment to the Principles Governing Human Subjects Research  103.3
Organization Policy on List of IRB Members 103.4
Organization Policy on Meeting Procedures 103.5
Organization Policy on Reporting 103.6(a) 
Organizational Policy on Prompt Reporting of Reportable Events 103.6(b)
Organization Policy on Data and Safety Monitoring of Proposed Research 103.6(c)
Organization Policy on Review of Changes in Approved Research 103.9
Organization Policy on Ancillary Reviews for Human Subject Research Studies 103.10(a)
Organization Policy on Assignment of IRB Review 103.10(b)
Organization Policy on Committee on Outside Interests (COI) and the JHM IRB 103.11
Organization Policy on Human Subjects Research Compliance Training 103.12
Organization Policy on Transfer of Protocol among JHM IRBs 103.14
Organization Policy on Visitors to the IRB 103.15
Organization Policy on Support for the JHM IRB 103.16
Organization Policy on Policy Development and Communication 103.18
Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB 103.19
Organization Policy on Drug Use and Control in Clinical Investigations 103.19(a)
Organization Policy Investigational Drug Service (IDS) and OHSR 103.20
Organization Policy on Clinical Radiation Research Committee (CRRC), the Radioactive Drug Research Committee (RDRC) and the JHM IRB 103.21
Organization Policy on Institutional Biosafety Committee (IBC) and the JHM IRB 103.22
Organization Policy on Credentials of Research Team and Documentation Required from Non-Hopkins IRBs and Study Sites 103.23
Organization Policy on Principal Investigator Responsibilities  103.24(a)
Organization Policy on Device Research Requirements 103.24(b)
Organization Policy on Registration of Clinical Trials 103.25
Organization Policy on Electronic Submission of Information to the JHM IRBs 103.26
Organization Policy on Research Funded by or Conducted with Federal Departments and Agencies 103.27
Organization Policy on IRB Composition and OHSR Staff Qualifications 107.1
Organization Policy on Consultants 107.2
Organization Policy on Training and Evaluation of IRB Members and Chairs 107.3
Organization Policy on Quorum, Voting Status of IRB Alternate Members, and JHM IRB Member Attendance 108.1
Organization Policy on Responsibility for the Human Subjects Protection Program (HRPP) 109.1(a)
Organization Policy on IRB Authority to Review Research 109.1(b)
Organization Policy on Communicating JHM IRB Actions to Investigators 109.2
Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc. 109.3
Organization Policy on Allegations of Undue Influence over the JHM IRB 109.4
Organization Policy on IRB Actions 109.5
Organization Policy on IRB Actions to Disapprove Research 109.6(a)
Organization Policy on Continuing Review of Approved Research 109.6(b)
Organization Policy on Expired JHM IRB Approval: Protocols and Consent Forms 109.7
Organization Policy on Monitoring the Consent Process and Research Procedures in Ongoing Research 109.8
Organization Policy on Expedited Review of Proposed Research 110.1
Organization Policy on Convened Meeting Primary Reviewer System 111.1
Organization Policy on Payment or Remuneration to Human Subjects 111.2
Organization Policy for Participation of Post-Doctoral Fellows In Human Subjects Research 111.3
Enrolling Employees in Human Subject Research Policy (GEN010)  
Enrolling Students in Human Subject Research Policy (GEN011)  
Organization Policy on Scientific Review 111.5
Organization Policy on Sedation Policies for Research Protocols Involving Diagnostic, Operative and Invasive Procedures 111.6
Organization Policy on Sample Size 111.7
Organization Policy on Research Involving Vulnerable Populations 111.8
Organization Policy on Investigators as Study Participants 111.9
Organization Policy on Minimizing Risks Associated with Research Participation 111.10
Organization Policy on Financial and Personal Conflict of Interest Policy for IRB Members 111.11
Organization Policy on Privacy and Confidentiality 111.12
Organization Policy on Recruiting Study Subjects 111.13
Organization Policy on Governing Physician Role in Research Consent Process
 		 111.14
Organization Policy on Suspension or Termination of IRB Approved Research 113.1
Organization Policy on Cooperative Research and Multi-Center Studies 114.2
Organization Policy on IRB Records 115.1
Organization Policy on Protocol Record Retention Requirements for Investigators  115.2
Organization Policy on Informed Consent Process and Documentation 116.1
Organization Policy on Translation of Consent Documentation  116.3
Organization Policy on IRB Review of Federal-Approved Consent Documents for Federally-Supported Multicenter Clinical Trials  116.4
Organization Policy on Use of Research Data in Cases of Questionable Consent Documentation 116.5
Organization Policy on Signing the Consent/Assent Document    117.1
Organization Policy on Research Involving Pregnant Women, Human Fetuses and Neonates B203
Organization Policy on Review of Research Involving Prisoners C304
Organization Policy on Research Involving Children D403
Organization Policy on Informed Consent and Pediatric Subjects Who Reach Adulthood While Enrolled in a Human Subjects Research Study D403.1
Organization Policy on Review of In Vitro Diagnostic Device Protocols (with or without Commercial Sponsors) FDA50.1
Organization Policy on Clinical Investigations with FDA “Test Articles” FDA 312/812
Organization Policy on Humanitarian Use Devices FDA 814.1
Organization Policy on Investigational Drug Services Disclosures for Participant Safety Reasons  IDS.1
Organization Policy on Pathology Department Activities to Establish and Verify Laboratory Performance Specifications PATH.1
Organization Policy on Planned Emergency Research and Requirements for Waiver of Consent in Planned Emergency Research 21 CFR 50.24; DHHS Emergency Research  Consent Waiver PER 1
Organization Policy on Incidental Findings Associated with Research Imaging Procedures OHSR.1
Organization Policy on JHM Response to Sponsor Requests for Economic Data OHSR.2
Organization Policy on Press Releases and other Planned Publicity for Clinical Research Studies OHSR.3
Organization Policy OHSR.4 JHM Policy Governing Use of Human Biospecimens to Derive Immortalized or Pluripotent Stem Cell Lines (BIO001)  
Organization Policy on Sponsor Responsibilities ORA.1
Organization Policy on Prospective Reimbursement Analysis ORA.2
Organization Policy on Tobacco Company Funding ORA.3
Organization Policy on Maryland State Law Requirements: Maryland House Bill No. 917 (Hubbard Act) SL1
Organization Policy on State of Maryland Mandatory Disease and Condition Reporting - Diseases and Conditions Reportable by Health Care Providers and Others SL2
JHU IRB Authority Policy   
Investigator-held INDs/IDEs