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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 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 for information and updates about the revised Common Rule roll out. 
  • Studies submitted on or after January 19, 2018 will be reviewed under the revised Common Rule. We are currently evaluating whether the changes will apply to studies existing prior to January 19, 2018. 
  • The definition of "human subject" has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private information are treated the same in the final rule. 
  • Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or why they might not want to take part in the research. 
  • Overall, there are four new elements of informed consent; one new required element and three new optional (i.e."if applicable") elements. These new elements are generally related to the secondary use of data and samples and genomic research. 
  • The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category; currently this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories. 
  • Some minimal risk studies will no longer be required to undergo annual continuing review. 
  • Changes to the Common Rule mandate the use of a single IRB for multisite, cooperative studies. This requirement will be effective January 19, 2020
  • The revisions to the Common Rule go into effect January 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 01.19.18. 
  • 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. 

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

Sierra Fountain
University Program Associate, COI
252-328-9473

conflict of interest video