ECU Fifth Street

Welcome to the Office of Research Integrity & Compliance

The mission of the Office of Research Integrity & Compliance (ORIC) is to:

  • Provide services to ECU faculty, staff, students, and affiliate employees in areas of research compliance;
  • Ensure the best possible protections for human rights and welfare in research;
  • Promote research compliance through education, consultation, and oversight; and 
  • Facilitate research that will positively impact public services and regional transformation.
ORIC is dedicated to cultivating a culture of ethics, integrity, and compliance with applicable laws, regulations, and policies. The office coordinates compliance measures on both the academic and health sciences campuses. ORIC acts as a resource for the university's concerns regarding compliance requirements. Our goal is to help facilitate research and ensure it is done safely, ethically, and within the constraints of the federal and state laws as well as institutional policies and procedures.

ORIC is charged with compliance matters including:

  • Use of humans in research
  • Conflict of interest (for both research and non-research related interests);
  • Responsible conduct of research;
  • Health Insurability, Portability, and Accountability Act as it applies to research; and
  • Use of unmanned aircraft systems. 

 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 January 21, 2019.
  • 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 for information and updates about the revised Common Rule roll out.
  • Studies submitted on or after January 21, 2019 will be reviewed under the revised Common Rule. Currently approved studies 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. 
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 questions 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 requirement. 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.