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CHS Policies & Procedures

I. Introduction

II. Committee on Human Studies

III. Initial Review of Research (by Full Committee & Expedited Review)

IV. Research that is Exempt from CHS Review

V. Continuing Review of Research (by Full Committee & Expedited Review)

VI. Studies Requiring Continuing Review More than Annually

VII. Modifications / Amendments to an Approved Study

VIII. Reporting & Review of Unanticipated Problems involving Risks to Subjects and Others

IX. Definitions of Adverse Events and Unanticipated Problems

X. Non-Compliance: Investigations and Determinations

XI. Reporting to Regulatory Agencies and/or Institutional Official

XII. Suspensions, Terminations, Administrative Closures, Investigator-Initiated Voluntary Suspension or Termination

XIII. Post-Approval Monitoring/Auditing of CHS Approved Studies

XIV. Study Files

XV. Cooperative Agreements/IRB Authorization Agreements (IAA)

XVI. Vulnerable Populations

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CHS Contact Information

Phone Number: 617-309-4329 or 617-309-4314

Fax Number: 617-309-2542

e-mail: CHS@joslin.harvard.edu

Page last updated: March 21, 2013