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2010 Changes to Organizational Policies

The following policies were updated during the 2010-2011 AAHRPP re-accreditation process.

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 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 (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 ReasonsIDS.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



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