Conflict of Interest

East Carolina University and its employees develop relationships with external entities that may create actual, potential, or the perception of conflicts of interest and commitment.  Such conflicts are common in active academic enterprises. These relationships benefit the external entity, East Carolina, and the region.  Interests that conflict, have the potential to conflict, or create the perception of a conflict, must be identified, reviewed, and managed properly. Management of these interests maintains objectivity, the integrity of the academic and research process, and protects East Carolina and its members.

External Professional Activities for Pay (EPAP) is any activity that is 1) not included within ECU employment responsibilities; 2) performed for an entity, public or private, other than ECU; 3) undertaken for compensation; and 4) based upon the professional knowledge, experience, and abilities of the EPA employee.  Approval of all EPAP's is required prior to engagement.

The University of North Carolina Board of Governors (UNC-BOG) and ECU Policy requires all EPA faculty and non-faculty EPA employees to complete and submit conflict of interest disclosures annually. UNC-BOG and ECU Policy also requires the submission of notices of intent to engage forms by all EPA faculty and non-faculty EPA employees engaging in external activities.  The Activities, Interests, and Relationships (AIR) management system enables these disclosures.

Federal regulations under the National Institutes of Health (NIH) require institutions receiving federal funding to enforce policies and procedures ensuring investigators disclose interests that render an actual, potential, or perceived financial conflict of interest (FCOI).  Such disclosures are required at the time of proposal submission. ORIC will identify and review FCOI's and jointly work with investigators to develop specific management plans to reduce, or eliminate FCOI's prior to the expenditure of federal funds.  Please be aware that other federal agencies and non-federal sponsors may adopt NIH-FCOI regulations.

Quick Links

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. 
East Carolina University is co-sponsoring an OHRP (Office for Human Research Protections) Research Community Forum titled "Community Engagement: Current Challenges and New Directions". The Forum will be held September 25-26, 2018 in Greenville, NC. The workshop day will feature interactive presentations on applying the HHS regulations, with a focus on the revised Common Rule. The conference day will focus on thought-provoking topics related to community engagement, and include breakout sessions on research with vulnerable populations and the role of patient advocates. Check out the agenda and view the full program!

You can find the agenda and more information about registration here

The following UMCIRB informed consent templates have been revised:

Consent Letter for Expedited Survey Research v. 02.05.18

Consent for More than Minimal Risk Research v. 02.16.18

Consent for No More than Minimal Risk Research v. 02.05.18

Genetic Testing Addendum v. 02.05.18

Language for Use in a Sponsor's Consent Template v. 02.08.15

Parent Permission Form Template: No More than Minimal Risk Research v. 02.05.18

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

The revisions involve primarily changes to Vidant Health contact information and minor grammatical/editorial changes as needed. These revised templates can be found on our website as well as in ePIRATE. 

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 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. 

If you will be traveling internationally on behalf of ECU, please submit a completed International Travel form for export control review and approval. Please submit this form as soon as you become aware that you will be traveling internationally. Click here to access the form.

Staff Contacts

Norma Epley
Director
252-744-1971

Robert Haberstroh
University Program Associate, COI
252-744-4140

conflict of interest video