ePIRATE
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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 went into effect January 21, 2019. 
  • The changes to the Common Rule do not apply to FDA-regulated studies. 
  • UMCIRB SOPs, templates, and the ePIRATE electronic IRB submission system have been revised accordingly. 
  • Click on the tab labeled Common Rule Changes in the UMCIRB website for more information about the changes.  
  • Studies submitted on or after January 21, 2019 will be reviewed under the revised Common Rule. Studies approved prior to January 21, 2019 will continue to fall under the pre-2018 Common Rule requirements. 
The following UMCIRB informed consent templates have been revised:
Consent Letter Template for Expedited Survey Research v. 1.21.19
Consent for More than Minimal Risk Research v. 1.21.19
Consent for No More than Minimal Risk Research v. 1.21.19
Genetic Testing Consent Template v. 1.21.19
Language for Use in a Sponsor's Consent Template v. 10.1.18
Parent Permission Form Template: No More than Minimal Risk Research v. 1.21.19

Please begin using these templates immediately and discard any old templates you may have stored on your desktop. 

The revisions primarily involve changes to consent elements that will be required under the revised regulations, effective January 21, 2019. These revised templates can be found on our website as well as in ePIRATE. 

NIH Grant Recipients: A new NIH Human Subjects System (HSS) will replace the current NIH Inclusion Management System (IMS) for the reporting of data about human subjects and clinical trials. NIH will launch this new system on June 9, 2018 and it will be available within the eRA Commons site. More information can be found here.

Effective October 1, 2017, the NIH began automatically issuing CoCs to all ongoing or new research funded by the NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information. NIH awardees no longer have to apply for a CoC. Language to include in consent documents have been added to the consent templates on the UMCIRB's website. More information about CoCs can be found on the NIH website.

 The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board (sIRB) of record for multi-site research became effective January 25, 2018. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.

This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy. 

Investigators are encouraged to consult with the Office of Research Integrity and Compliance (ORIC) prior to including an sIRB plan in their application if they have questions about whether or not ECU should cede IRB review to another IRB or assume the responsibility of being the IRB of record (Reviewing IRB).

You may review the NIH posting regarding sIRB review by clicking here

If you have additional questions about the sIRB review process or IRB reliance agreements, please call the ORIC at 252-744-2914, or email your question to umcirb@ecu.edu.

  • The revisions to the Common Rule go into effect January 21, 2019 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 01.21.19. 
  • Revised SOPs will be posted on the UMCIRB website. 
  • Existing expedited studies approved prior to January 21, 2019 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. 

Investigators & Coordinators

General Information

Data Use Agreements (Using & Disclosing PHI for Research)

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