ePIRATE
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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 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 of 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

NIH Grant Recipients: A new NIH Human Subjects System (HSS) will replace the current NIH Inclusion Management System (IMS) for the reporting of data about human subjects and clinical trials. NIH will launch this new system on June 9, 2018 and it will be available within the eRA Commons site. More information can be found here.

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 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. 02.05.18
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 question 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. 

Vidant Health

Center for Research and Grants 

VH CRG Diagram

 The Vidant Health Center for Research & Grants (VH CRG) serves as the one-stop-shop for all research and grant activity initiation, facilitation, and support at Vidant Health. The CRG is a cross functional team of experts that are focused on three goals:

  1. To protect the public impacted by research and grants.
  2. To support a culture of inquiry.
  3. To facilitate excellence throughout the Research and Grant life cycle. 

Correspondence related research or grant activity at VH should be forwarded to the following email accounts:

 MailboxPurpose Email Address 
Clinical TrialsAll internal and external clinical trial needs (i.e. legal documents, Services Review Form (SRF), Clinical Trials Participant List (CTPL), etc.) crg.clinicaltrials@vidanthealth.com
Communication All internal and external research and grant communication requests. (e.g. Letter of support, research events, etc.)crg.communication@vidanthealth.com
 
DataAll internal and external requests for Data, Research Smart Phrases, Research Flag and Research Consent uploads, etc. crg.data@vidanthealth.com 
DisseminationAll internal and external request for Vidant Health dissemination, dissemination support for Pre & Post publications, etc. crg.dissemination@vidanthealth.com 
PI InitiatedAll internal and external Principal Investigator initiated requests (i.e. legal documents, proposal development, student research, etc.) crg.pi.initiated@vidanthealth.com 
General RequestsAll external requests for research collaborations on a Vidant Health Campus, including poster review and approvals and Quality Improvement Worksheet submissions and approvals, etc. crg.requests@vidanthealth.com 
BillingClinical Trial Participant List submission; Vidant invoices; all billing inquiries.  crg.billing@vidanthealth.com
Grants Letters of support/commitment requests and general grant questions or inquiries. Vidant information to include in grant applications to include DUNS or EIN numbers.  grants@vidanthealth.com 
ResearchGeneral research inquiries involving Vidant Health and Vidant Health Center for Research and Grants intern interest.research@vidanthealth.com 

CRG Forms

 Research Forms for All Research:Services Review Form 
 Data Forms:Data Request Form
Data Request Form Guide
Sample Data Request Form 
 ECU/External PI's:External PI Agreement (coming soon)
Clinical Trials Forms: Clinical Trial Job Aid
Clinical Trial Participant List Form
External Enrollment Report 

CRG Training & Information Sheets

  • Dissemination Pathways
  • Research 101 
Training for investigators and key study personnel and any others who are interested. These programs seek to improve research involvement, increase inter-professional research collaborations, promote professional role development, and clinical competency using evidence based research. For more information or dates of upcoming training contact CRG at crg.requests@vidanthealth.com

CRG Educational Series: Research 101
CRG Educational Series: Dare to Discover
CRG Educational Series: Navigate the IRB
CRG Educational Series: Don't Wait Disseminate
CRG Educational Series: Then Translate

  • All Clinical Trials Mandatory Training Updates
The link below is a survey monkey, which will allow you to complete the Vidant Research Updates Training 1. This training will discuss the recently updated requirements to complete research at Vidant Health. Also, this training is required for PEP certification and renewal. If you have any questions or would like to schedule a time to discuss one-on-one with Vidant staff, please contact crg.clinicaltrials@vidanthealth.com.