IRB 101: Introduction to Human Subject Research UC DAVIS OFFICE OF RESEARCH IRB 101: Introduction to Human Subject Research Prepared By: Miles McFann, CIP IRB Administration

Objectives Knowledge of the Ethical Principles Describe what the IRB does Know the definitions of human subject research Know the forms Describe the IRB process Helpful Tips

Ethical principles of Human Subject Research: Respect for persons – autonomy Beneficence – do no harm Justice – distribution of risks and burdens Jeopardy Question: What are these? In the form of a question Why the important to know? They are the ethical principles in which all our federal regulations, overseeing human subject research, are based upon

Institutional Review Board (IRB) UC Davis IRB Administration Protect rights and welfare of human subjects Approve/modify/disapprove research protocols involving human subjects Multi-campus collaborative review and agreements Education and training Administration and record- keeping UC COLLABORATIVE RESEARCH—A Streamlined Approach Multi-UC Campus Research at University of California Campuses and UC-Managed Laboratories Research to be reviewed by a single UC IRB instead of multiple UC IRBs For UCLA, UCSF, UCSD, UCB, UCI, UCSB, UCSC, UCD, LLNL, LBNL--research eligible for expedited or exempt review only For UCB, UC Davis, UCSF and LBNL- research eligible for full committee review as well as expedited and exempt review For UC Davis and LLNL—research for full committee, expedited or exempt review. Committee A – Clinical (12 interdisciplinary members) Committee B – Clinical (20 interdisciplinary members) Committee C – Social/Behavioral (6 interdisciplinary members) Committee D – Fast Track/Emergency (5 interdisciplinary members)

Research as defined by Department of Health and Human Services: What is Research? Research as defined by Department of Health and Human Services: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” Examples of systematic investigations include: surveys and questionnaires interviews and focus groups analyses of existing data or biological specimens epidemiological studies evaluations of social or educational programs cognitive and perceptual experiments medical chart review studies Examples of activities that typically are not generalizable include: biographies oral histories that are designed solely to create a record of specific historical events service or course evaluations, unless they can be generalized to other individuals services, courses, or concepts where it is not the intention to share the results beyond the UCD community classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the UCD community. 45 CFR 46.102(d)

data through intervention or interaction with the individual, or What is a Human Subject? A living individual about whom an investigator (professional or student) conducting research obtains: data through intervention or interaction with the individual, or identifiable private information. 45 CFR 46.102(f)

When is UCD “engaged” in human subject research? 1.If UC Davis is the federal grant recipient; 2. If for purposes of human subject research: (a) Data about subjects through intervention or interaction; (b) Identifiable private information (c) Informed consent from a research subject – even if all research activities are done at other organizations; UC Davis employees/agents obtain

Not Human Subject Research (NHSR) Review Types Not Human Subject Research (NHSR) Exempt Expedited Convened Meeting Let’s go over the difference between these review types: Not “Human Research”: Activities must meet the organizational definition of “Human Research” to fall under IRB oversight. Activities that do not meet this definition of are not subject to IRB oversight or review. Review the IRB Office’s “WORKSHEET: Human Research (HRP-310)” for reference. Contact the IRB Office in cases where it is unclear whether an activity is Human Research. • Exempt: Certain categories of Human Research may be exempt from regulation but require IRB review. It is the responsibility of the organization, not the investigator, to determine whether Human Research is exempt from IRB review. Review the IRB Administration’s “WORKSHEET: Exemption Determination (HRP-312)” for reference on the categories of research that may be exempt. • Review Using the Expedited Procedure: Certain categories of non-exempt Human Research may qualify for review using the expedited procedure, meaning that the project may be approved by a single designated IRB reviewer, rather than the convened board. Review the IRB Administration’s “WORKSHEET: Eligibility for Review Using the Expedited Procedure (HRP-313)” for reference on the categories of research that may be reviewed using the expedited procedure. • Review by the Convened IRB: Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.

Submitting to the IRB

IRB Documents (Available on the IRB Website) Human Research Protection Program Plan (HRP-101) Investigator Manual(HRP-103) Application Forms Initial (HRP-211) Continuing Review Progress Report (HRP-212) Modification (HRP-213) Reportable New Information Form (HRP-214) Template Protocol (HRP-503) Template Consent Document (HRP-502) SOPs on consent process and documentation (HRP-90, HRP-91) Designed w/input from investigators Clearly indicates what is needed Focuses on what the IRB must review to make a determination

Record/Data Research Submissions : Retrospective Chart Review: (data existing at time of initial IRB submission) HRP-211 Initial Application Form HRP-226 Administrative Approvals Protocol (Research Involving Record/Data Review) Prospective Chart Review (data not existing at time of IRB submission) HRP-211 Initial Application Form HRP-226 Administrative Approvals Protocol (Research Involving Record/Data Review) Consent Form (HRP-502) Advertisements (if applicable)

Common Research Submissions : Specimen Collection HRP-211 Initial Application Form HRP-226 Administrative Approvals Protocol (HRP-503) Consent Form (HRP-502) Surveys and/or Questionnaires (if applicable) Advertisements (if applicable) Survey/Interview HRP-211 Initial Application Form HRP-226 Administrative Approvals Protocol (HRP-503) Consent Form (HRP-502) Surveys and/or Questionnaires Advertisements (if applicable)

Forms online: www.research.ucdavis/irbadmin eDocument System: http://legacy.or.ucdavis.edu/edo cs/index.cfm For assistance contact: Miles McFann – mtmcfann@ucdavis.edu Nicole Walters – nicole.walters@ucdmc.ucdavis.edu

Principal Investigator Create Protocol Submit via eDocs Principal Investigator Review Request Revisions/ Information IRB Reply to Request Respond to Reviewer Review Response Approve Review Process

How Long Does Review Take? Initial Review Minimal Risk Research: 2 to 3 weeks Greater than Minimal Risk Research: 35 days Modifications 2 to 4 weeks Continuing Review

Yeah, it’s approved! Anything else?

Investigator Responsibilities after Approval Protected Human Subjects Comply with protocol requirements and determinations of IRB Avoid undue influence/coercion in enrolling subjects Ensure that informed consent is adequate and understandable to subjects Report new information Submit changes in research to IRB

Don’t enroll prisoners Don’t enroll prisoners. State of California does not allow biomedical research to be conducted on prisoners. De-identified doesn’t mean anything regulatory. Your data is one of the following three descriptions: Identifiable: the data will be directly labeled/recorded with the personal identifying information when acquired. Coded: the research personnel can link the research to personal identifying information when acquired. Anonymous: not be labeled with any personal identifying information, nor with a code that this research team can link to personal identifying information. Be consistent with the information amongst the documents (e.g. enrollment numbers, procedures being done, inclusion/exclusion criteria)

Address all the IRB analysts concerns and revisions request in a timely manner. Utilize and follow the Protocol and Consent Form Template instructions when creating your application and forms. Attach all relevant documentation. If it is listed on HRP-211 and applicable to your research, submit it. Have your research staff complete their human subject research certification (CITI and GCP training) prior to submission. Follow all UCDHS regulations.

Resources www.research.ucdavis.edu/irbadmin Investigator Manual Human Research Protection Program Plan Standard Operating Procedures Policies and Procedures Additional Training

Questions? Remind them of the Resources and Reference Handouts

Miles McFann, CIP mtmcfann@ucdavis.edu