When do I need an IRB protocol?
You need an IRB protocol when you are doing research on human subjects. Research means any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject is a living individual about whom a research investigator (whether faculty, staff or student) obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information or records. (See page 2 of the Policy and Procedures Manual.)
A protocol is not required for program review, unless you intend to disseminate the results. Dissemination includes publication; presentation at a conference or seminar; or a thesis or dissertation.
All of the following research activities involving human subjects are subject to the review and approval of the IRB:
Who can be a PI?
Only ISU faculty members, faculty associates or staff can act as the Principal Investigator on a protocol. Click here for forms. The PI must sign the first page.
How do I submit a Protocol?
Download and complete the most recent IRB Submission Form and all relevant appendices from the web site. Be sure the PI signs the first page of the submission form. Then give the protocol to your department representative.
Department Representatives
The completed protocol must be reviewed by a department representative. If your department doesn’t have a representative or if the PI is the department representative, then send the signed protocol to Research Ethics and Compliance at Mail Code 3330 and it will be sent to a representative from another department.
If the Department Representative or the department submits several protocols a year, it is advisable for the department to have more than one representative to facilitate protocol submission. We encourage reps/PIs from different departments to work out a quid pro quo and review protocols for each other.
How long does a review take?
A protocol that has been reviewed by a department representative and designated as Exempt needs to be reviewed by the chair of the IRB Executive Committee. This generally takes one week. For the past calendar year, the mean time from receipt to response for Exempt protocols has been 4.1 days.
A protocol that has been reviewed by a department representative and designated as Expedited needs to be reviewed by a member of the IRB Executive Committee. This generally takes two weeks. Then it must be reviewed by the chair, which generally takes one week, for a total of three weeks. For the past calendar year, the mean time from receipt to response for Expedited protocols has been 9.5 days.
A protocol that has been reviewed by a department representative and designated as Full needs to be reviewed by the entire IRB Executive Committee at the monthly meeting. Department reviewed protocols must be received at least two weeks prior to the meeting at which they will be reviewed. The PI will be notified of the committee’s decision usually within 24 hours of the meeting.
Protocols may need revision by the PI before approval can be granted. The chair is usually able to review the revisions within a week of receiving them.
How do I submit a protocol for a class project? (Batch Protocol)
To aid in processing class-originated research protocols the IRB suggests a "batching" of the protocols together. There would be one, single protocol submission for all of the essentially identical projects. The instructor would complete one IRB Protocol Submission Form together with one protocol narrative. The instructor will also submit one informed consent document and/or script that will be used by all of the students doing the research.
The instructor would then attach to this basic protocol submission two additional elements. The first element would include descriptions of the particular variation(s) each student, or group of students, will take on the project. This typically will include: a listing of the questions to be asked (for interview-type research activities) or instrument to be administered (for survey-type research activities); a more detailed specification of the characteristics of the subjects to be recruited for that particular activity, if appropriate; and any additional conditions or design elements that will be used exclusively for that activity. (See page 20-22 of the Policy and Procedures Manual.)
Does classroom work require IRB approval?
All student research is subject to IRB review following guidelines outlined in Illinois State University Policy for the Protection of Human Research Subjects. Class research projects (including independent studies) require review by the IRB only if they are intended for generalization (e.g., publishing, presenting, or archiving), contain more than minimal risk encountered everyday, or involve a protected class of citizens (e.g., mentally incapacitated persons, children, prisoners, pregnant women, or economically or educationally disadvantaged persons).
Class-only projects that may be disseminated in the future must be reviewed (e.g., student research symposia). IRB review must occur prior to any data collection.
Class projects designed to “practice” systematic investigation techniques need not be reviewed when they involve supervised training of new members of a profession. Examples include teacher trainees practicing evaluation, clinical interns practicing assessment or diagnosis, and student journalism reporters practicing interviewing, etc. These activities should still communicate applicable or reasonable elements of informed consent (e.g., institutional affiliation, purpose of investigation, risks, benefits, voluntary participation, permission to withdraw, etc.). (See page 24-25 of the Policy and Procedures Manual.)