Letter to Principal Investigator, Submission Tips
Dear Principal Investigator/Study Coordinator:
Thank you for your interest in submitting a study for review by the New Hanover Regional Medical Center Institutional Review Board (IRB). Our goal is to ensure patient safety and responsible conduct of research.
All of the forms that you will need for your submission to the IRB are located on this webpage. Please come back to the website with each submission to make sure you are using the most up-to-date forms.
As you begin, you will need to submit your forms (application, data collection sheets, and if applicable consent , administrative attachment, and protocol) electronically to both the Clinical Research Officer and to the IRB Coordinator for a regulatory review prior to official submission. We have found this prescreening process to be very helpful in expediting the approval process.
Once we inform you that your application is ready for official submission, each study submitted for IRB review should have all of the required attachments and copies as outlined on the research application. Should any of the required documents or copies be missing, the study will be returned to the Principal Investigator for resubmission. This delay could cause the study to be deferred to the next month's agenda. For studies that require Full Board review, the study should be submitted no later than the first Friday of the month to be reviewed on that month's agenda. All study correspondence with the IRB should reference the study name as it appears on the original application, the study protocol number (if applicable), the name of the Principal Investigator, and the assigned IRB#.
Upon receipt of your study, you will be notified if your study meets the requirements for full-Board review. If so, this notification will provide you the date, time, and location for your presentation. The IRB meets on the third Wednesday of each month at 12:00 noon. If you are submitting a new study for full Board review, you are required to attend this meeting to present a brief overview of your study and answer potential questions. If you do not come, your study will be tabled until such time when you can be present at a regularly scheduled meeting.
Should you have any questions, please contact the IRB Coordinator at 343-4621.
Institutional Review Board
Use the most up-to-date forms from the IRB website. There will be a date next to the form indicating the last update.
Double-check your submission to make sure all documents are attached, appropriate signatures have been obtained, and all copies are copied double-sided and have been collated correctly.
Always provide a complete paper copy of your submission for the IRB file copy with the original legible signature.
When amendments or updates require changes to the consent form only copy the pages of the consent that contain changes for the IRB copies. Highlight or track change all of the changes that have been made so that they can be easily located.
All IRB forms are Word Forms and you need to click the box or press your "x" key to check a box. These forms are locked to ensure that a question or section is not accidentally deleted. The forms do not allow for spell check or easy editing. In order to edit long sections of the forms we suggest that you cut and paste the section into another Word document for editing, and then paste the edited information back into the submission form.
Make sure the title of the study, the assigned IRB#, the name of the PI, your name, a contact phone number, and complete address are on all submissions to prevent delays in processing.
Make your consent forms look exactly like the NHRMC IRB template. Delete the instruction page prior to submission. If part of the template language does not apply to your study, modify it to meet the requirements of the study or take it out, unless it is part of a required section.
- If you have questions, ask!