Non-Human Non-Research Determination FAQ

Am I conducting Human Subjects Research?

Federal regulations (45 CFR 46 and 21 CFR 50) state that research involving human subjects, directly or through the use of records, tissues, or other indirect means, must receive IRB review and approval prior to implementation. At University Hospitals these regulations are met by submitting a formal protocol to the UH IRB . If the IRB deems the activity to meet the definition of “research” involving “human subjects”, then the protocol will be reviewed and approved in one of the following three ways: Exempt, Expedited (non-Full Board review), Full Board.

Often researchers engage in projects that may not qualify as “research” or involve “human subjects”, under the Department of Health and Human Services (DHHS) or the United States Food and Drug Administration (FDA) regulations as cited above. At UH, all activities that have the potential to involve humans, living or deceased, or specimens/data obtained from humans must receive a determination from the UH Clinical Research Center (UHCRC) regarding the nature of the activity and the type of review required.

If an investigator believes that the activity being conducted does not qualify as human subject research, the investigator must access the electronic IRB system iRIS and complete a new application to the IRB. In section 5.0 of the application (after the section on study personnel), you will be asked “Are you requesting determination as to whether your project is Human Subject Research?”, answer “yes” to this question (and “no” to the other questions). The application will automatically route you to the remainder of the determination questions that you need to complete.

Be prepared to provide sufficient information to describe the proposed activity, the specific objectives, the type of information to be used, the methods in which the data or specimens will be collected and stored and how confidentiality will be maintained. Also, you must address of the use and disclosure of Protected Health Information (PHI) under the HIPAA Privacy Rule.

Once the application is submitted, a designated representative of the UHCRC will review the information and determine whether the project requires IRB review. If the project is deemed “not human subject research”, investigators will receive a letter indicating such. If the project does qualify as Human Subject Research under OHRP and FDA regulations, the investigator will receive correspondence from the IRB stating that a full application for IRB review and approval must be completed in order for the project to proceed.

Note: failure to obtain IRB approval for Human Subject Research prior to engaging in the research will result in a finding of non compliance with the Federal regulations and institutional policies.

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