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 UHCMC these regulations are met by submitting a formal protocol to the UHCMC 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 UHCMC, all activities that have the potential to involve humans, living or deceased, or specimens/data obtained from humans must receive a determination from the UHCMC Center for Clinical Research and Technology (CCRT) 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 form entitled “Activity Determination Form (Non-Human/Non-Research)” must be filled out and submitted to the CCRT at Lakeside 1400 (MS 7061) for review. A separate summary should accompany the request 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. The summary should also include a separate discussion of the use and disclosure of Protected Health Information (PHI) under the HIPAA Privacy Rule.
When the form is submitted, a designated representative of the CCRT will review the information and make the following determinations:
- Is the activity considered “research” under DHHS regulation 45 CFR 46.102(d) or under FDA regulation 21 CFR 56.102
- If no - the CCRT will make a formal determination that the activity does not qualify as research under Federal regulations and notify the investigator
If yes - the CCRT will continue the review process.
- Does the activity involve “human subjects” under DHHS regulation 45 CFR 46.102(f) or under FDA regulation 21 CFR 56.102
- If no - the CCRT will make a formal determination that the research does not involve human subjects under Federal regulations and notify the investigator.
- If yes - the CCRT will notify the investigator that the activity meets the definition of “human subject research” and will notify the investigator of the need to submit a full protocol to the UHCMC IRB for review and approval.