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Export Controls

Export Control are federal laws regulating the shipments and transmission of certain controlled goods, products, information, data, services, and technical specifications, to foreign nationals outside of the United States, or release of controlled technology or software to a foreign national in the United States.  15CFR § 734.2 (b)(1) 

Any release of controlled technology or source code to a foreign national is deemed to be an export to the home country or countries of the foreign national.  15CFR § 734.2 (b)(2)(ii) 

An example of an export is an actual shipment or transmission of controlled items from one foreign country to another foreign country; or release of controlled technology or software to a foreign national outside the United States.  15 CFR § 734.2 (b)(4)  

The reach of export laws and regulations on a college campus is broad, and can touch any department.  Export control obligations can be triggered by academic travel, presentation of research to foreign nationals, or taking certain data on a university-owned laptop into a different country.  

Export Control laws and regulations are for those engaging in the activities listed below, we encourage you to contact our office for discussions on export control compliance.  

       
  • Travel to foreign countries for conferences or to meet with foreign research sponsors or customers;    
  • Employ foreign national graduate students or researchers;    
  • Enter into research agreements or collaborations with foreign companies;    
  • Working or conducting research in offices or laboratories containing export controlled information, materials, or equipment.   

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.

Assistance and guidance are available from the Office of Research Integrity and Compliance (252) 328-9473.

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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 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

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