| 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 Primary Reviewer as Consent Designee for the Study Being Reviewed | 103.13 |
| 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 | |
