| 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 |
|
