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Organizational Policies

** List of Guidelines and Policies updated during the 2016 AAHRPP reaccreditation **

Name of PolicyNo.
Organization Policy on Exempt Research101.1
Organization Policy on Research Laboratory Testing Results101.2
Organization Policy on Determination of “Human Subject Research” and Exempt Research102.1
Organization Policy on the Definition of Research as it applies to Clinical Practice and Public Health Activities102.2
Organization Policy on Quality Improvement/Quality Assurance Activity102.2(a)
Organization Policy on Single Case Reports and Case Series102.3
Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles102.4
Organization Policy on Bone Marrow Transplant Procedures in Children102.6
Organization Policy on Provision of Research Samples for Clinical Testing102.7
Organization Policy on HSPP Assurance of Compliance with DHHS Policy103.1
Organization Statement of Commitment to the Principles Governing Human Subjects Research  103.3
Organization Policy on List of IRB Members103.4
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 Others103.6(b)
Organization Policy on Reporting Death of a JHM Research Participant103.6(b)(i)
Organization Policy on Data and Safety Monitoring of Proposed Research103.6(c)
Organization Policy on Investigator Non-Compliance103.7
Organization Policy on Review of Changes in Approved Research103.9
Organization Policy on Ancillary Reviews for Human Subject Research Studies103.10(a)
Organization Policy on Assignment of IRB Review103.10(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 Communication103.18
Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB 103.19
Organization Policy on Drug Use and Control in Clinical Investigations103.19(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 Sites103.23
Organization Policy on Principal Investigator Responsibilities 103.24(a)
 Organization Policy on Device Research Requirements103.24(b)
Organization Policy on Registration of Clinical Trials103.25
Organization Policy on Electronic Submission of Information to the JHM IRBs103.26
Organization Policy on Research Funded by or Conducted with Federal Departments and Agencies103.27
Organization Policy on IRB Composition and OHSR Staff Qualifications107.1
Organization Policy on Consultants107.2
Organization Policy on Training and Evaluation of IRB Members and Chairs107.3
Organization Policy on Quorum, Voting Status of IRB Alternate Members, and JHM IRB Member Attendance108.1
Organization Policy on Responsibility for the Human Subjects Protection Program (HRPP)109.1(a)
Organization Policy on IRB Authority to Review Research109.1(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 Actions109.5
Organization Policy on IRB Actions to Disapprove Research109.6(a)
Organization Policy on Continuing Review of Approved Research109.6(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 Research110.1
Organization Policy on Convened Meeting Primary Reviewer System111.1
Organization Policy on Payment or Remuneration to Human Subjects111.2
Organization Policy for Participation of Post-Doctoral Fellows In Human Subjects Research 111.3
Organization Policy on Recruitment of Employees111.4(a)
Organization Policy on Recruitment of Students111.4(b)
Organization Policy on Scientific Review111.5
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 Populations111.8
Organization Policy on Investigators as Study Participants111.9
Organization Policy on Minimizing Risks Associated with Research Participation111.10
Organization Policy on Financial and Personal Conflict of Interest Policy for IRB Members111.11
Organization Policy on Privacy and Confidentiality 111.12
Organization Policy on Recruiting Study Subjects111.13
Organization Policy on Governing Physician Role in Research Consent Process
 
111.14
Organization Policy on Institutional Review of IRB Approved Research112.1
Organization Policy on Suspension or Termination of IRB Approved Research113.1
Organization Policy on JHM Facilitated Review for NCI Central IRB and NCI Pediatric Central IRB114.1
Organization Policy on Cooperative Research and Multi-Center Studies114.2
Organization Policy on IRB Records115.1
Organization Policy on Protocol Record Retention Requirements for Investigators 115.2
Organization Policy on Informed Consent Process and Documentation116.1
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 Documentation116.5
Organization Policy on Signing the Consent/Assent Document   117.1
Organization Policy on Research Involving Pregnant Women, Human Fetuses and NeonatesB203
Organization Policy on Review of Research Involving PrisonersC304
Organization Policy on Research Involving ChildrenD403
Organization Policy on Informed Consent and Pediatric Subjects Who Reach Adulthood While Enrolled in a Human Subjects Research StudyD403.1
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 DevicesFDA 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 WaiverPER 1
Organization Policy on Incidental Findings Associated with Research Imaging ProceduresOHSR.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 OHSR.4 JHM Policy Governing Use of Human Biospecimens to Derive Immortalized or Pluripotent Stem Cell LinesOHSR.4
Organization Policy on Sponsor ResponsibilitiesORA.1
Organization Policy on Prospective Reimbursement AnalysisORA.2
Organization Policy on Tobacco Company FundingORA.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 OthersSL2
Johns Hopkins University Policy on Classified and Otherwise Restricted Research 

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