Does Your Research Need IRB Approval?
Presenters:
Beverley Esparza, CIP
Assistant Director
Human Research Protections
Office of Research
UC Irvine
Chris Abernethy
Principal Contract and Grant Officer
Sponsored Projects Administration
Office of Research
UC Irvine
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• Define human subject research
• Determine when IRB review is necessary
• Examples: engaged in HSR
• Special considerations for sub awards
• Examples: not engaged in HSR
• Resources
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RESEARCH:
HUMAN SUBJECT:
45 CFR 46.102(d)
Research - a (1) systematic investigation, including research development, testing and evaluation, (2) designed to develop or contribute to generalizable knowledge.
45 CFR 46.102(f) Human
Subject - a living individual about whom an investigator (faculty, staff, or student) conducting research obtains (1) data through intervention or interaction with the
individual, or (2) identifiable private information.
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 Oral Histories
 Simulations of human experiments or data gathering for educational purposes
 Analysis of existing anonymous and/or de-identified data
 Analysis/Use of existing anonymous biological specimens
(except when testing an in vitro diagnostic device)
 Quality Improvement activities
 Internal program evaluations
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• Per the Office for Human Research Protections (OHRP), an institution/entity is considered engaged in a particular human subjects research project when its personnel or agents for the purposes of the research obtain:
• (1) data about the subjects of the research through intervention or interaction with them
• (2) identifiable private information about the subjects of the research; or
• (3) informed consent of human subjects
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• UCI Researcher is interested in conducting a national survey about the “Occupy Wall Street” movement. In addition, the researcher will conduct interviews with individuals involved in the movement. The researcher subcontracts with a survey firm to collect the survey data. The
firm will obtain informed consent. Both UCI and the survey firm are engaged in HSR and require IRB approval.
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•
• UCI Researcher initiates a research project that includes a blood draw and MR reviews.
A colleague at University of Nebraska will receive the specimens and identifiable
subject data to conduct the analyses. Both UCI and U of
N researchers are engaged in HSR and require IRB approval.
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What about projects with sub awards where sub award personnel are conducting activities related to human subjects research?
Is IRB approval required for the sub-award activities?
Answer: It depends on whether the sub-award personnel are engaged in HSR.
Is UCI IRB approval required for the sub-award activities?
Answer: It depends on whether UCI personnel are engaged in HSR.
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• UCI Researcher is interested in conducting a study that involves cognitive testing during MRI procedures. The researcher intends to subcontract with a local MRI outpatient facility . The UCI researcher will conduct the testing, but the MRI staff will assist by providing
technical assistance in operating the MRI machine. UCI is engaged in HSR; the MRI facility is not engaged. They are providing a service typically performed for non-research purposes.
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• UCI Researcher receives an NIH seed award. There is no specific HSR described in the award. The intent is to solicit proposals and some may be HSR studies.
The UCI
Researcher is not involved in HSR. UCI is not engaged; the sub-awardees conducting HSR require IRB approval.
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• For instances where it is uncertain whether the activity is human subjects research (HSR):
• Lead Researchers/Principal Investigators may complete and sign a Request for Determination of Non-Human
Subject Research form. This form is submitted to the IRB staff.
• The Human Research Protections staff or IRB Chair will sign the form once a determination has been made regarding the proposed activities and whether or not they constitute human subject research.
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HRP WEBSITE: HTTP://WWW.RESEARCH.UCI.EDU/ORA/HRPP/INDEX.HTM
From the index page (above), click on:
“Activities that require IRB review” for more info on this topic (and examples)
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TO ACCESS THE “REQUEST FOR DETERMINATION
OF NON-HUMAN SUBJECT RESEARCH FORM”
C L I C K O N “ S T I L L N O T S U R E Y O U R S T U D Y
R E Q U I R E S I R B R E V I E W ? ”.
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UCI Human Research Protections
Website: http://www.research.uci.edu/ora/h rpp/index.htm
Office for Human Research
Protections (OHRP) Engagement
Document: http://www.hhs.gov/ohrp/policy/en gage08.html
Activities that require IRB review: http://www.research.uci.edu/ora/h rpp/definition.htm
Request for Determination of Non-
Human Subject Research form: http://www.research.uci.edu/ora/fo rms/hrpp/RequestDeterminationNo n-HumanSubjects.doc
Beverley Esparza, CIP
Assistant Director
Human Research
Protections besparza@uci.edu
949-824-5746
Chris Abernethy
Principal Contract and Grant Officer
Sponsored Projects
Administration cabernet@uci.edu
949-824-1749
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T H A N K Y O U F O R Y O U R T I M E !
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