Updates in Research Protections Karen Allen Director, Research Protections Office of Research November

Agenda Updates in Research Protections –hSCRO –IACUC –IRB Future Plans –IACUC –IRB

hSCRO Improving Efficiency –Recommend and allow submission of continuing review application at the time of submission of modification request Benefits –Easier for Lead Researcher to complete both hSCRO transactions at one time –Resets annual approval cycle –Reduces hSCRO member review time –Do not recommend submitting modification at time of continuing review

IACUC UCI received full AAALAC accreditation No recommendations for improvement Reaccreditation required every three years

IRB July 26, 2011, the Department of Health and Human Services (DHHS) announced a plan to update the regulations regarding the protection of human subjects in research. A summary of the proposed changes can be changetable.html changetable.html

Where are we now? Waiting….

Rulemaking Process Advanced Notice of Proposed Rule Making (ANPRM) Notice of Proposed Rule Making (NPRM) Rule Open Comment Period

Actually…we’re moving on Improving Efficiency –Extended IRB Approval – up to three years for minimal risk research –Abbreviated Protocol Narrative for Extramurally Authored/Extramurally Sponsored Research –Single IRB Review – (IRB Authorization Agreements)

Extended IRB Approval Up to 3 years of approval Eligibility criteria –involving no more than minimal risk to participants (Expedited level of review) –not subject to federal oversight, and –not subject to UCI Conflict of Interest Oversight Committee (COIOC) review More val.htm val.htm

Abbreviated Protocol Narrative For Extramurally Authored/Extramurally Sponsored Research –Federal and Industry sponsored research –Must provide Master Protocol and Template Consent Form Benefits –Reduces Lead Researcher/Administrative Contact time to complete IRB documentation –Reduces errors in submission –Reduces HRP staff time for pre-review & IRB member review time

Single IRB Review A single IRB conducts the review of a multi- site studies –Collaborative research –Multi-site clinical trials UCI has established agreements with other entities –NCI Central IRB – Phase III cooperative group trials –UC campuses – all levels of review –Children’s Hospital of Orange County – all levels of review –Multiple protocol-by-protocol agreements

Changes in the works include… IACUC –Web-based IACUC Application IRB –Additional IRB Agreements LBMMC WIRB –Scientific Merit Review of Investigator-initiated studies (non-cancer related) will become part of IRB review process –Revisions to all web-based applications Other suggestions?

Suggestions or Questions? Contact… Karen Allen Director, Research Protections Beverley Williams Assistant Director, Human Research Protections Or any of our friendly Research Protections Staff – contact