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Policies and Standard Operating Procedures

Version Number

Title

MSH TOR

Mount Sinai Hospital REB Terms of Reference

SOP TOC

Table of Contents

SOP GOT

Glossary of Terms

SOP REF

References

100 General Administration (100-108)

SOP 101

Authority and Purpose

SOP 102

Research Requiring REB Review

SOP 103

Training and Education

SOP 104

Management of REB Office Personnel

SOP 105A

Conflicts of Interest – REB Members and REB Office Personnel

SOP 105B

Conflicts of Interest – Researcher

SOP 105C

Conflicts of Interest – Organization

SOP 106

Signing Authority

SOP 107

Use and Disclosure of Personal Information

SOP 108

Standard Operating Procedures Maintenance

200 REB Organization (201-204)

SOP 201

Composition of the REB

SOP 202

Management of REB Membership

SOP 203

Duties of REB Members

SOP 204

REB Office Personnel Serving as REB Members

300 Functions and Operations (301-303)

SOP 301

REB Submission Requirements and Administrative Review

SOP 302

REB Meeting Administration

SOP 303

Document Management

400 Review of Research (401-407)

SOP 401

Delegated Review

SOP 402

REB Review Decisions

SOP 403

Initial Review – Criteria for REB Approval

SOP 404

Ongoing REB Review Activities

SOP 405

Continuing Review

SOP 406

Research Completion

SOP 407

Suspension or Termination of REB Approval

500 Reviews Requiring Special Consideration (501)

SOP 501

REB Review During Publically Declared Emergencies

600 REB Communication and Notification (601-602)

SOP 601

Communication – Researcher

SOP 602

Communication – Research Participants

700 Informed Consent (701)

SOP 701

Informed Consent Form Requirements and Documentation

800 Responsibilities of Investigators (801)

SOP 801

Researcher Qualifications and Responsibilities

900 Quality Management (901-902)

SOP 901

Quality Assurance Inspections – SOP not currently applicable at MSH

SOP 902

External Inspections and Audits

SOP 903

Non-Compliance