Submitting a Protocol
ORSP – Human and Animal Protections has recently released an online application for determining exemption from IRB review (ADE). This submission tool will enable researchers and students to submit their project descriptions online to determine if they qualify for exemption. Please note that ADE submissions require a completed CITI training certificate.
The following documents are required for EVERY research protocol submission which is not determined to be exempt:
Signed Protocol Approval Form (PAF) for Faculty in PDF
Signed Protocol Approval Form (PAF) for Students in PDF
NIH or CITI Certificate(s) valid for the entire one-year approval period. Certificates are valid for 3 years from the date taken.
- Protocol Statement Template
Researchers must append ALL documents and scripts seen, heard, signed, or answered by potential or consenting participants, which may include:
- Recruiting script/text or recruiting flyers/letters/ads
- Informed Consent Document(s) or Implied Consent Document(s) for online surveys
- Final survey
- Interview questions
- Focus Group questions
- Debriefing Document(s) for research with deception
- Photo Releases (if using photographs of participants)
- Video Releases (if video recording participants)
If you are recruiting volunteers through a teacher, department, organization or agency, or if you are conducting research in the classroom, or at a business, organization or agency:
- Letter of permission to recruit and/or conduct research (on official letterhead).
Consult our Forms Library for all of the above forms and templates as well as additional forms we may require
Email all protocols (including appended documents) as Microsoft Word or PDF attachments to email@example.com. Be sure to include all the necessary forms with proper signatures and formatting. Protocols missing any required documents will not undergo pre-review until all outstanding forms are received.
New protocols, revisions, renewals, and modifications are reviewed on a rolling basis based on the date all materials are received. Check with your department for the deadline necessary for department staff to record, sign and submit all protocols to the Grad Studies office by the following dates:
- November 1: To enroll in the thesis/project class in the following spring.
- April 1: To enroll in the thesis/project class the following summer or fall.
We suggest that students planning non-exempt research projects turn in their protocols prior to the department and university deadlines to accommodate the revision cycle during the pre-deadline periods. For instance, submitting a non-exempt protocol to the Grad Studies office in September or early October will assure that the IRB will review it and any requested changes or clarifications before the end of the semester.
The most common documented reason for delay in the revision cycle is researchers’ delays in sending requested revisions. Protocols and revisions are reviewed in the order in which they are received, so every day counts.
Tips on Your Protocol
For both the Protocol and Informed Consent:
Use a 12-point font.
Participants and committee members must be able to see it.
Adapt the template to your own research.
Delete the parentheses, directions and italics from the final version. Adapt the template to present your own project information.
Use everyday language.
This will allow the widest audience, including the IRB members, to understand the purpose of your research, and the procedures you have planned, and any risks or benefits involved. Please do not use discipline-specific jargon or acronyms. If you must, please define them.
Separate your personal agenda from the research procedures.
The protocol is the place to tell the IRB how you plan to interact with your research participants to obtain the data. The informed consent tells the participants what will happen to them during the research project. The thesis is the place to state the conclusions drawn from the data you have collected. Keep personal bias out of the protocol and the informed consent. If you already know the answers, why are you bothering to do this research?
Informed Consent Guidelines
The informed consent must give prospective participants the information they need to make an informed decision whether to participate in a research project. Please use the template provided to make sure you include all the elements of informed consent.
Write at a sixth- to eighth- grade reading level.
Lay people, as well as IRB committee members and staff from outside your own discipline, must understand your informed consent document. Please make this document simple and informative. Writing it at a sixth to eighth grade reading level will allow the widest audience to be eligible to participate in your project.
Check the readability level of your consent form.
When you have finished writing your consent, go to the Word menu bar and choose “Tools/Options/Spelling and Grammar.” Check the “Check Grammar with Spelling” box and the “Show Readability Statistics” box. When you run a spell check, the readability statistics will be displayed when the spell check is finished.