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Organization Policy on Exempt Research
101.1
Organization Policy on Research Laboratory Testing Results
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 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
Organization Policy on HSPP 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)
Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others
103.6(b)
Organization Policy on Reporting Death of a JHM Research Participant
Organization Policy on Data and Safety Monitoring of Proposed Research
103.6(c)
Organization Policy on Investigator Non-Compliance
103.7
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
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
Organization Policy on Electronic Submission of Information to the JHM IRBs
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
Organization Policy on Recruitment of Employees
111.4(a)
Organization Policy on Recruitment of Students
111.4(b)
Organization Policy on Scientific Review
111.5
Organization Policy on Research Involving Vulnerable Populations
111.8
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 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 Institutional Review of IRB Approved Research
112.1
Organization Policy on Suspension or Termination of IRB Approved Research
113.1
Organization Policy on JHM Facilitated Review for NCI Central IRB and NCI Pediatric Central IRB
114.1
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 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 Review of In Vitro Diagnostic Device Protocols (with or without Commercial Sponsors)
FDA50.1
Organization Policy on Clinical Investigations with FDA “Test Articles”
FDA 50.2
Organization Policy on Sponsor Responsibilities
ORA.1
Organization Policy on Maryland State Law Requirements: Maryland House Bill No. 917 (Hubbard Act)
SL1
SL2
If you have any comments, questions or suggestions you may contact the JHM IRB at:
