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An Institutional Review Board (IRB) is a federally registered committee responsible for reviewing and monitoring research involving human subjects. Its role is to protect the safety, rights, and welfare of research participants and to ensure compliance with federal and state regulations and university policies.

Research Integrity & Compliance (RIC) supports the IRB that reviews and oversees 51³Ô¹ÏÍøhuman subjects research.

The IRB must review all research studies that meet the federal definition of Human Subjects Research (HSR) prior to initiation.

There are three types of IRB review that may take place: Exempt, Expedited, and Full Board Review.

A submitted research project will typically fall into one of the following categories, as determined by the IRB:

• Requires IRB review and approval (via either Expedited or Full Board Review)
• Qualifies for an Exempt determination (this must be confirmed by RIC)
• Does not meet the definition of Human Subjects Research (HSR)

All research involving human subjects requires IRB review prior to initiation. However, depending on the specifics of your project, if the activity does not meet the federal definition of Human Subjects Research (HSR), formal IRB review and approval may not be required.

In order for the HRPP to make this determination, researchers should submit their proposed study in Cayuse, selecting Activities that may not meet the federal definition of “Human Subjects Research” as the Project Type when completing the Basic Information section of the application form.

For any questions, please contact researchcompliance@smu.edu.

Exempt human subjects research qualifies for an exemption from certain federal regulations, but still requires IRB review. Exempt projects are different from projects that are determined to be Not Human Subjects Research (NHSR).

Exempt studies do not require ongoing IRB review (Continuing Review) after being verified by the IRB as Exempt. That is why the determination letter for an Exempt study states “Verified” rather than “Approved.”

Exempt determinations must be made by Research Integrity & Compliance (RIC). Researchers cannot self-determine that their study is Exempt.

Only individuals who are engaged in Human Subjects Research (HSR) should be listed. For example, this can include individuals who:

• Recruit participants
• Obtain informed consent
• Interact or intervene with participants
• Access, collect, or analyze identifiable private information or identifiable biospecimens

Individuals not engaged in HSR (e.g., those working only with de-identified data* or providing administrative support) should not be listed.

*De-identified data: Data that cannot reasonably be used to identify a participant, either directly or indirectly at any point of time during the research (e.g., no names, IDs, or linkable codes).

Whether your study should be reviewed by the 51³Ô¹ÏÍøIRB or by an external IRB depends on if 51³Ô¹ÏÍøis considered “engaged” in the research. It is not simply a question of where the research is taking place.

51³Ô¹ÏÍøis typically considered “engaged” in research when:

• 51³Ô¹ÏÍøinvestigators are involved in the design, conduct, or reporting of the research
• 51³Ô¹ÏÍøpersonnel are interacting with participants or accessing identifiable data
• The research is supported by 51³Ô¹ÏÍøor external funding awarded to SMU

In many cases, the 51³Ô¹ÏÍøIRB will be the appropriate reviewing IRB. However, in collaborative or multi-site studies, an external IRB may serve as the IRB of record.

Note: The use of a non-51³Ô¹ÏÍøIRB must be reviewed and approved by Research Integrity & Compliance (RIC) in advance. Researchers should not independently decide to rely on an external IRB.

Log in to using your 51³Ô¹ÏÍøSingle-Sign-On (SSO). From the Products dropdown (top right), select Human Ethics. Click + New Study.

For further navigation guidance, please refer to the  or visit RIC’s Cayuse Human Ethics webpage.

Obtaining informed consent from research participants is one of the core requirements for IRB approval. Informed consent must:

• Provide key information that participants need to make an informed decision about participation
• Be presented in a way that is clear, understandable, and allows for questions
• Ensure participation is voluntary, without coercion or undue influence

In most cases, IRB applications must include consent materials unless the requirement is formally waived by the IRB (e.g., records review studies that do not involve contacting subjects).

Research Integrity & Compliance (RIC) provides consent templates within the Cayuse study application.

If you are a student completing a new study application form in Cayuse Human Ethics as part of a Course-Based Research Experience (CBRE), your project will not require formal IRB review. This includes class assignments to complete an IRB application for educational purposes, for which there is no intent to conduct actual human subjects research.

These projects are typically designed to:

• Simulate the IRB application process
• Help students learn how to design and submit a research protocol

To clearly identify these submissions in the Cayuse system, include “CBRE” at the beginning of your study title (e.g., CBRE – Study Title) when you are filling out the application form.