- 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 of 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 data 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 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.
- For existing studies; ORIC is evaluating whether the changes will apply to these studies after the effective date.
- 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.
electronic Portal for Institutional Research at ECU
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.
Who can I contact for help with ePIRATE?
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.
Who should I email if I have a question or feedback?
Please email any questions or feedback about ePIRATE to email@example.com. 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.
Is in-person help available?
Yes, feel free to contact ORIC to schedule one-to-one or group ePIRATE training.
Tips on ePIRATE Resource Assistance
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:
- Name/Contact Information
- Study Number/PI Name
- Detailed Issue
All requests for assistance will be triaged in order to help users with the most acute needs first.
- Investigator - you conduct research requiring approval from an IRB, you may be a faculty member, staff or student.
- Research Personnel - you are a study coordinator or other member of a research team
- Faculty Mentor/Supervisor - a faculty member who accepts responsibility for activity overseeing the conduct of approved human research where the PI is either a student resident, fellow or visiting faculty.
- Department Approver, Dean or Associate Dean - you serve in one of these roles and are required to provide a signature of approval for research to be conducted in your area
- Ancillary Approver- you are a VMC/ECU Institutional Approval for Research Group member
- IRB Committee member - you serve as a full, alternate or ex-officio member of one of the IRB committees
- HPA/Administrator - you are an affiliated Human Protections Administrator/ECU Administrator
- Consultant - you have been called upon to serve as a consultant in either the conduct or review involving human participants
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.
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.