Office of Research Integrity and Outreach

IRB Submission Requirements and Application Forms for Paper-based Protocols

If you need to take action on an existing protocol (file a revision or amendment, file for continuing review, close the project, report an adverse event etc.) this should be done using the paper based system described below.

If you have any questions about whether or not you should be using e-Protocol please contact ORIO staff for guidance.


Submission Requirements:

Only complete protocol submissions will be accepted for review.  The ORIO will notify the principal investigator listed (via email) when a submission to ORIO is received in its complete form.

A submission is considered complete ONLY when it satisfies all four of these requirements:

1.    Each submission must utilize the appropriate form on the USM ORIO web site.

2.    Each submission must answer all questions fully and in sufficient detail to allow reviewers to make the determinations required.

3.    Each submission must include all attachments requested in the form. 

4.    Each submission must be submitted in two formats, as follows:

  • Electronically to Word .doc or .pdf format is required. 
  • Hard Copy, with required signatures, to the Office of Research Integrity and Outreach, University of Southern Maine, 7 Chamberlain Ave., Portland, Maine, 04101 (hard copy submissions can be dropped off in person or sent via intercampus or regular mail)

Application Forms: