Does Your Research Need IRB Approval?

Presenters:

Beverley Esparza, CIP Assistant DirectorHuman Research ProtectionsOffice of ResearchUC Irvine

Chris AbernethyPrincipal Contract and Grant OfficerSponsored Projects AdministrationOffice of ResearchUC Irvine

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OBJECTIVES

• 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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DEFINITION OF HUMAN SUBJECT RESEARCH

RESEARCH:

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.

HUMAN SUBJECT:

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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WHAT IS NOT HUMAN SUBJECTS RESEARCH?

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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ENGAGED = IRB APPROVAL REQUIRED

• 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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EXAMPLE: ENGAGED

• 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 sub-contracts 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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EXAMPLE: ENGAGED

• 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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SPECIAL CONSIDERATIONSSUB-AWARDS

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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.

EXAMPLE: NOT ENGAGED

• UCI Researcher is interested in conducting a study that involves cognitive testing during MRI procedures. The researcher intends to subcontract with a local MRI out-patient 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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EXAMPLE: NOT ENGAGED

• 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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DETERMINING WHEN IRB REVIEW IS NECESSARY

• 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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H R P W EB SITE: H T TP ://W W W .R ESEA R C H .U C I.ED U /O R A /H R P P/IN D EX .H TM

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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RESOURCES

UCI Human Research Protections Website: http://www.research.uci.edu/ora/hrpp/index.htm

Office for Human Research Protections (OHRP) Engagement Document: http://www.hhs.gov/ohrp/policy/engage08.html

Activities that require IRB review:http://www.research.uci.edu/ora/hrpp/definition.htm

Request for Determination of Non-Human Subject Research form:http://www.research.uci.edu/ora/forms/hrpp/RequestDeterminationNon-HumanSubjects.doc

Beverley Esparza, CIP Assistant DirectorHuman ResearchProtectionsbesparza@uci.edu949-824-5746

Chris AbernethyPrincipal Contract and Grant OfficerSponsored ProjectsAdministrationcabernet@uci.edu949-824-1749

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T H A N K Y O U F O R Y O U R T I M E !

GENERAL QUESTIONS?

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