IRB Project
Application Review Form Instructions
Please enter information in the gray, expandable text boxes to fill out the form. If any questions are not applicable, please mark “N/A” in the appropriate box. If questionnaires will be utilized, please attach it to the end of this document or send as a separate file attachment. Incomplete information may result in a delayed review. Follow the instructions below to help avoid delay.
For new
applications:
1) Use the most current application form (www.uml.edu/research/institutionalcompliance).
2) Shaded areas expand as text is inserted.
3) Forms with incomplete responses, missing signatures, and/or attachments are considered incomplete and may be returned to the PI. All parts of an application must be received in order to be placed on a meeting agenda for review.
4) Do not attach cover letters.
5) Submit applications and all attachments to Stephen_Moses@uml.edu. Original signature pages must be either faxed to 978-934-3018 or sent by intercampus mail to 200 Dugan Hall.
6) Be sure to clearly indicate your email address and check it regularly after submitting an application should questions arise that can be responded to quickly.
7) Call 978-934-4134 for assistance or email Stephen Moses at the above email address.
8) Try to be available for the meeting if your application is receiving full review. Check the website or call ext. 4134 for meeting information.
For reviewed applications that requested
revisions:
1) Use the application form sent back to you from the IRB Administrator with the appropriate protocol number/version at the top. Use the track changes tool to allow the reviewers to see your changes to the initial application.
2) If a revised consent form is necessary, please follow the same procedure. If a consent form change is indicated but is not sent to the IRB Administrator, it will be considered an incomplete submission.
3) Use the review memorandum from the IRB Administrator outlining the committee concerns to see what you need to revise as requested by the IRB.
4) When your revisions are completed to the application and all necessary attachments, please send them to Stephen_Moses@uml.edu.
Forms Completed or Information Sent for IRB
review:
Project Application Review Form (for full or expedited reviews)
Application for Determination of Exempt Status (for exempt review)
Informed Consent Form, signed and dated by the Researcher(s)
Recruitment or advertising materials (flyers, brochures, newspaper advertisements, etc.)
Translation and “back translation” form
Official authorization from cooperating agencies or institutions
Complete research proposal with project description, including abstract and methods sections and grant if submitted for outside funding
Education Training Certification
PI Assurance and Signature Page-fax to 978-934-3018 or send intercampus mail to 200 Dugan Hall