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Announcements

  • Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect July 19, 2018. 
  • The changes to the Common Rule do not apply to FDA-regulated studies. 
  • ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out. 
  • Studies submitted on or after July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements. 
  • The revisions to the Common Rule go into effect July 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date. 
  • New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 07.19.18. 
  • Revised SOPs will be posted on the UMCIRB website. 
  • Existing expedited studies approved prior to January 19, 2018 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with ORIC, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.  
  • Keep our website and the ePIRATE homepage checked for continuing and updated information. 
  • Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
  • Remember, the revised Common Rule does not apply to FDA-regulated studies. 
The short form consent (both the English and Spanish versions) has been updated. The new version date for the short form is 10/09/2017. In addition, an attestation of translation has been obtained for the Spanish translated version of the short form and is available on the UMCIRB website under "Forms, Docs & Templates". Please be sure to use this new template when submitting a short form for IRB review and approval.
Users will now select "Final Report" on the left side of each study's workspace to close a research study. This option was added to help users navigate to the correct application more easily when they are ready to close a study. Brief tutorials have also been added to the website.

Investigators & Coordinators

General Information

Determination Worksheets

Other ECU Links Related to Human Research

  • Brody School of Medicine – Clinical Trials Office

  • REDCap - a secure, HIPAA-compliant, web-based application for building and managing online research surveys and databases.

  • ECU - Survey Review & Oversight Committee - a committee established to oversee scheduling of surveys with less overlap; avoid duplication of data collection efforts improve the quality of surveys with an overarching, goal of preventing "survey fatigue" on the ECU campus. Please visit the SROC web site if your research involves surveying ECU faculty, staff, or students.

  • Institutional Biological Safety Committee (IBC) – The IBC is the core of the biosafety program at ECU. Any research project that involves the use of potentially infectious materials must be declared and registered with the IBC. This also includes projects involving gene therapy. The IBC reviews the protocols and ensures that the materials are handled properly and that appropriate training takes place. Biological safety specific training is also offered for blood borne pathogens, infectious materials shipping, and biological safety cabinet use.

  • Identity Theft Protection Committee (ITPC) - In order to implement and ensure compliance with legal requirements governing SSNs and PII, ECU established the Identity Theft Protection Committee (ITPC) to oversee ECU's compliance with this regulation in regard to the collection, segregation, disclosure and security of SSNs and PII and the development of related policies/regulations.

    The ITPC is also responsible for approving the collection and use of SSNs and PII.

    Questions concerning the requirements of this regulation should be directed to the Identity Theft Protection Committee (ITPC) at ITPC@ecu.edu 

  • Clinical Information Steering Committee - The Clinical Information Steering (CIS) Committee oversees the adoption and use of healthcare-related information technologies. CIS's partnership with ITCS provides a uniform process for the Brody School of Medicine, ECU School of Dental Medicine, ECU Allied Health, ECU College of Nursing and ECU Physicians to request and receive guidance in the selection, development and implementation of hardware, software systems, databases and third party IT services that support clinical research and operations for the purposes of assuring compatibility with existing East Carolina University and Vidant Health healthcare-related information technology systems, promoting operational efficiency, limiting storage of patient information outside of the university's designated Electronic Health Record (EHR) system(s), and ensuring both patient and university data are protected within the scope of applicable university policies, government regulations and state laws. 

Research Ethics, History and International Protections

Government Agencies/Commissions

International Agencies

Organizations