The policies of the SPU IRB are also designed to protect University members who conduct research, and students who conduct research under their supervision. These policies apply to all research activities that involve human participants.

Definition of Research
The definition of Research used by the SPU IRB comes from the Office of Human Research Protections (OHRP), the federal agency within the Department of Health and Human Services that oversees IRB's. Research is defined as “a systematic investigation ( i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.” Research designates “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.”

More simply put, The IRB is responsible to review and approve any proposed research with human participants that occurs outside of established or commonly accepted educational settings involving normal educational practices such as regular course evaluations or student assessment. OHRP refers to this as the “common rule” when ascertaining the need for IRB review.

Any project outside of the common rule that meets all of the following criteria needs to submit an IRB application for data collection approval.

1. Systematically collects data from multiple human participants and. . . .
2. Stores the data for analysis, and. . .
3. Publicly presents or archives in printed / electronic form a summary of the results that will be available to others outside of normal classroom activities.

Before completing your IRB application please read the SPU IRB User guidelines.  You can find both documents at the link below. You may also need to document informed consent. You can find the template and checklist for informed consent below. If you are unsure if you need to document informed consent form, please see the FAQ link below or check with your Research Coordinator.

Submit two hard copies of the application with any documented protocol (such as the questionnaires or assessment instruments that you propose to use) to your School or Department Research Coordinator. DO NOT submit via e-mail.

Research Resources		Research with Human Subjects		Federal Human Subject Assurance Training	IRB Members Only
	FAQ's		IRB Policies		(Password protected)
	SPU IRB User Guidelines		OHRP
	Tips for Completing an IRB application		SPU IRB Charter
	IRB Sample Application
	IRB Application Form
	Risk Guidelines for Exercise and Testing Prescription
	Informed Consent Template
	OHRP Checklist for informed consent
	Sample Debriefing Form
	On-line Training Program

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