Rules, Regulations & Standard Operating Procedures

for Human Research Activities

University & Medical Center Institutional Review Board

Office for Human Research Integrity

This page is currently undergoing revision.

While we revise this page you will still have access to our current standard operating procedures (SOPs) and rules by clicking on "Manual" below.  We are updating our SOPs and rules and revising this page to make it more user friendly. We hope to make it easier for you to locate the SOP or rule that you need by listing each separately and making it a link to its own separate document. As we proceed you will see the list of SOPs and rules grow under the sub-headings below.

• Manual (Version October 2009)

I. ECU's Human Research Protection Program

II. Institutional Roles and Responsibilities

III. Human Research Activities

IV. Food and Drug Administration Regulated Research

V. Informed Consent

VI. Investigator Roles and Responsibilities

• Continuing Review

• Unanticipated Problems Involving Risks to Participants and Others
• Defining and Reporting Protocol Deviations 

VII. Institutional Review Board (IRB) Roles and Responsibilities

VIII. ECU Office for Human Research Integrity

• Fees--Standard Operating Procedures
  *If a sponsor needs an invoice for IRB fees, please contact the UMCIRB office*
• UMCIRB Correspondence: Electronic Signatures
• OHRI Quality Improvement Activities

IX. Research Participants

• Research Involving Children