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.
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 email@example.com.
ePIRATE is the fully electronic IRB submission, review, and tracking system that eliminates the need for paper documents. Your research files are easily accessible through ePIRATE. At any time you may view the status, known in ePIRATE as "study state", of your submission. Features include electronic submissions including initial applications, amendments, and reportable events, continuing review reminders, and easy access for department chairs and other administrators to view up-to-date research submissions.
If you wish to speak with someone for assistance with ePIRATE, please call ORIC at 252-744-2914. This line is staffed Monday-Friday from 8:00 AM to 5:00 pm.
Voicemail will also be regularly checked by ORIC staff. Voicemail's will be returned within one business day.
Please email any questions or feedback about ePIRATE to firstname.lastname@example.org. This email account is monitored by ORIC staff Monday-Friday from 8:00 AM to 5:00 pm. Emails will be responded to within one business day.
Yes, feel free to contact ORIC to schedule one-to-one or group ePIRATE training.
When contacting ORIC for help with ePIRATE, please be as specific as possible about the type of problems you are experiencing with ePIRATE. The more information ORIC staff has about the issue you are encountering, the better they can effectively assist you. We request the following information from all users contacting the office for ePIRATE assistance:
All requests for assistance will be triaged in order to help users with the most acute needs first.
Click on the link below for a tutorial on how to login to ePIRATE.
When you sign in to ePIRATE and navigate to your study’s workspace, you can look in the top left corner of the screen for a quick update. For example, the following study is in a state of “Pre Submission” indicating it has not been submitted by the Principal Investigator yet. Mouse click to enlarge.
In this case, the study is in the “Department Review” state. At ECU, all human research studies must be approved by a department level approver before moving forward. Once the department approves the study, it will move to a new state. Mouse click to enlarge.
Click Here to download instructions.
I have an existing study in ePIRATE. Can I copy it for use as a template for new study submissions in the future?
Click Here to download instructions.
Click image to enlarge