Steps for Developing a Request for Initial Review
Determine your timeline
Investigators should plan to submit their Request for Initial Review at least two months prior to beginning their research.
Determination letters for faculty, staff, and student multi-semester Applications for Initial Review that are reviewed at an Exempt (from continuing review) level or an Expedited review level, can bet returned in 2-4 weeks from the time of submission.
Determination letters for students conducting research for a 1-semester class that are reviewed at an Exempt (from continuing review) level or an Expedited review level, can bet returned in 7-10 days from the time of submission.
However, determination letters are not the same as approval letters. Investigators may receive a determination letter indicating that their protocol is approved and they may begin collecting data. Alternatively, investigators may receive a determination letter requesting modifications that must be re-reviewed before the protocol can be approved.
Download the Appropriate Forms
There are two forms (find forms here) that every investigator needs for a Request for Initial Review: Form 101 Request for Initial Review Checklist, and Form 102 Request for Initial Review. In addition, depending on the nature of the research, investigators may need one or more addenda. The forms page also has consent templates, assent templates, recruiting script templates, and others.
Obtain Necessary Documents from Other Organizations
For example, investigators who are conducting research in a school will need to provide a Letter of Cooperation from the school (and sometimes district). Researchers from other institutions who would like to recruit MSU Denver students as participants will need to provide the MSU Denver IRB with an approval letter from their institution. There are several other circumstances. Check the appropriate addenda for guidance.
Complete the CITI Program training
Beginning September 1st, all Primary Investigators, Research Assistants, and Faculty Advisors are required to complete the CITI Program training and submit certificates of completion with the Application for Initial Review. See the CITI Training page for information on how to access the program.
Ask Questions if You Have Them
Contact Dr. Ann Morrison, IRB Chair, at email@example.com or 303-352-7083 with questions.
Fill out the Request Forms
All Applications for Initial Review that are incomplete will be returned to the investigator, so it is important to respond to every question as thoroughly as possible before submitting an application. Some addenda ask the same or similar questions to the Request for Initial Review. Please copy and paste so that every section is complete.
Submit the Request for Initial Review
Send all forms via email as attachments in .doc or .docx to Dr. Ann Morrison, IRB Chair, at firstname.lastname@example.org. Also include CITI Program certificates (those will be .pdfs) for all investigators, Research Assistants, and Faculty Advisors.