MENU
ePIRATE
Click the ePIRATE icon to work
on your electronic IRB submission.


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 July 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 of information and updates about the revised Common Rule roll out. 
  • Studies submitted on or after July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements. 
  • The revisions to the Common Rule go into effect July 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 07.19.18. 
  • 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. 
The short form consent (both the English and Spanish versions) has been updated. The new version date for the short form is 10/09/2017. In addition, an attestation of translation has been obtained for the Spanish translated version of the short form and is available on the UMCIRB website under "Forms, Docs & Templates". Please be sure to use this new template when submitting a short form for IRB review and approval.
Users will now select "Final Report" on the left side of each study's workspace to close a research study. This option was added to help users navigate to the correct application more easily when they are ready to close a study. Brief tutorials have also been added to the website.

Common Rule & Other Changes

COMPLIANCE DATE DELAYED: On Wednesday, January 17, 2018 OHRP announced the delay of the compliance date for the changes to the federal rule governing human research (Common Rule). The following is an excerpt from their announcement: 

"The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the "Federal Policy for the Protection of Human Subjects" (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. 

The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions. Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations."


The Revised Common Rule - click here to read a copy of the revised Common Rule which contains tracked changes. 


The following table provides a basic summary of the upcoming Common Rule changes:

Revised "Human Subject" Definition
  • The definition of "human subject" has been altered to now include identifiable bio-specimens. Identifiable bio-specimens and identifiable private data are treated the same in the final rule. 
 Informed Consent Changes
  • 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 might not want to take part in the research. Click here to view samples of a concise summary introductory paragraph.
  • 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. 
Revised Exempt Categories 
  • 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. 
Continuing Review Requirement Changes
  • Some minimal risk studies will no longer be required to undergo annual continuing review.
Single IRB Requirement for Cooperative Research
  • Changes to the Common Rule mandate the use of a single IRB for multi-site, cooperative studies. This requirement will be effective January 19, 2020. 
 How do these changes affect you?
  • The revisions to the Common Rule go into effect July 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date. 
  • Remember, the revised Common Rule does not apply to FDA-regulated studies.
  • New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new studies submitted on or after 07.19.18. 
  • Revised SOPs will be posted on the UMCIRB website.
  • Existing expedited studies approved prior to 07.19.18 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 the UMCIRB 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.