Name of Policy
|
No.
|
Organization Policy on Exempt Research
|
101.1
|
Organization Policy on Determination of “Human Subject Research” and Exempt Research
|
102.1
|
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
|
103.6(b)(i)
|
Organization Policy on Data and Safety Monitoring of Proposed Research
|
103.6(c)
|
Organization Policy on Investigator Non-Compliance
|
103.7
|
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 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 Institutional Biosafety Committee (IBC) and the JHM IRB
|
103.22
|
Organization Policy on Principal Investigator Responsibilities
|
103.24(a)
|
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 (HSPP)
|
109.1(a)
|
Organization Policy on IRB Authority to Review Research
|
109.1(b)
|
Organization Policy on IRB Actions
|
109.5
|
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 Payment or Remuneration to Human Subjects
|
111.2
|
Organization Policy on Scientific Review
|
111.5
|
Organization Policy on Financial and Personal Conflict of Interest Policy for IRB Members
|
111.11
|
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 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 Review of Research Involving Prisoners
|
C304
|
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 afety Reasons |
IDS.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 Sponsor Responsibilities
|
ORA.1
|
Organization Policy on Maryland State Law Requirements: Maryland House Bill No. 917 (Hubbard Act)
|
SL1
|
Organization Policy on Pathology Department Activities to Establish and Verify Laboratory Performance Specifications
|
PATH.1
|