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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 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 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 Agencies103.27

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

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 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 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 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 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 SpecificationsPATH.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 DataOHSR.2
Organization Policy on Press Releases and other Planned Publicity for Clinical Research StudiesOHSR.3

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

Johns Hopkins University Policy on Classified and Otherwise Restricted Research

 

 


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