UC DAVIS OFFICE OF RESEARCH UCD Human Research Protection

UC DAVIS OFFICE OF RESEARCH UCD Human Research Protection Program Accreditation Miles McFann Nicole Walters IRB Administration Outreach, Training, and Education

Objectives AAHRPP Benefits of Accreditation Where Are We In The Process Faculty and Staff Preparation UCD Human Research Protection Program Investigator Manual

An independent, non-profit accrediting body, that ensures the HRPPs meet rigorous standards for quality and protection.

Benefits of AAHRPP Respect Competitive Edge Reduce Risk Enhance Standing

Where Are We In The Process Step 1 Step 2 Site Visit Application Process Prep for Site Visit AAHRPP Visit Council of Accreditati on Accreditatio n Determinati on

Faculty and Staff Preparation Grand Round Visits Monthly Brown Bag Series Interview Prep Listserv Announcements Website with Online Education

HRP-101: Human Research Protection Program Plan research.ucdavis.e du/irbadmin 7

UCD Human Research Protection Program Institution Researcher s HRP-101 Human Research Protection Program Plan IRB

What do mean when we say UCD is “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 9

Research FDA Definition: Clinical Investigation: An experiment involving a test article and control when the results must meet requirements for prior submission to the FDA or are intended to be later submitted to or held for inspection by the FDA OHRP Definition: Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 10

What are the three ethical principles of the Belmont Report? Respect for persons – autonomy Beneficence – do no harm Justice – distribution of risks and burdens 11

FWA (Federalwide Assurance)

What is UC stance on Payments for Referrals or Accelerated Enrollment? 13

Complaints Report To: IRB Chair IRB Administration Organizational Official Legal Counsel Deans Department 14

IRB Responsibilities Review Research: Approve Suspend Terminate Determinations Observation

Suspension or Termination

Organizational Official The Vice Chancellor for Research, Harris Lewin 17

HRP-103: Investigator Manual research.ucdavis.e du/irbadmin 18

PI Eligibility Faculty Members Paid Appointments 50% or greater

Researcher Training Minimal Risk: CITI or NIH online course Than Minimal Risk: CITI Clinical Trial CITI GCP 20

Review Types Not Human Subject Research (NHSR) Exempt Expedited Convened Meeting

What are decisions the IRB Committee may make when conducting a review? Approve Modification required to secure approval Deferred Tabled Disapprove 22

Record Keeping – Non FDA 3 years after the study is completed If children are included : 7 at least years after the 18 youngest child reaches the age of If research involves in vitro or pregnant women : 25 at least years If sponsored : review the CTA, contact the sponsor, or ask the Office of Sponsored Programs

Record Keeping – FDA The retention requirements outlined in the Clinical Trial Agreement (CTA) - or 2 years following the date a marketing application is approved for the drug/device for the indication for which it is being investigated; - or Or, if no application is to be filed or if the application is not approved for such indication, for 2 years after the investigation is discontinued and the FDA is notified

Emergency Use of an Unapproved Drug, Biologic, or Device: No Time for the IRB Unapproved Drug, Biologic, or Device Contact IRB Admin or IRB Chair (HRP-322) Emergency Use Worksheet (HRP-506) Emergency Use Template Consent Form Report to IRB within 5 days Drug/Biologic use submit IRB Protocol within 30 days

Emergency Use: The difference between the requirements for unapproved drugs and devices: Use of an unapproved Use of an device is not unapproved considered drug or biologic “research” and is considered the patient not “research” and a “subject” the patient is a “subject”

In Contrast, the DHHS looks at the data obtained through emergency research as: Patients cannot be considered a “subject” and the results cannot be included in “research” 27

Ancillary Committee Approvals Institutional Biosafety Committee Prior Approval Conflict of Interest Committee Prior Approval Radiation Use Committee Prior Approval Stem Cell Research Oversight Committee Concurrent Approval Cancer Center Scientific Review Committee Prior Approval 28

Reportable New Information New Risk Severe Harm Non-Compliance DSMB Reports and the rest 29

Questions? 30

Miles McFann, CIP [email protected]