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 1

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 2

DEFINITION OF HUMAN SUBJECT RESEARCH RESEARCH: 45 CFR (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 (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. 3

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 4

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 5

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. 6

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. 7

SPECIAL CONSIDERATIONS SUB-AWARDS 8 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. 9

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. 10

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. 11

HRP WEBSITE: From the index page (above), click on: “Activities that require IRB review” for more info on this topic (and examples) 12

TO ACCESS THE “REQUEST FOR DETERMINATION OF NON-HUMAN SUBJECT RESEARCH FORM” CLICK ON “STILL NOT SURE YOUR STUDY REQUIRES IRB REVIEW?”. 13

RESOURCES UCI Human Research Protections Website: rpp/index.htm rpp/index.htm Office for Human Research Protections (OHRP) Engagement Document: gage08.html gage08.html Activities that require IRB review: rpp/definition.htm Request for Determination of Non- Human Subject Research form: rms/hrpp/RequestDeterminationNo n-HumanSubjects.doc Beverley Esparza, CIP Assistant Director Human Research Protections Chris Abernethy Principal Contract and Grant Officer Sponsored Projects Administration

THANK YOU FOR YOUR TIME! GENERAL QUESTIONS? 15