updates in research protections

Updates in Research Protections

Karen AllenDirector, Research Protections

Office of Research November 2012

karen.allen@uci.edu

949-824-1558

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 found @ http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html

Where are we now?

Waiting….

Rulemaking Process

Advanced Notice of

Proposed Rule Making

(ANPRM)

Notice of Proposed

Rule Making (NPRM)

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 information @ http://www.research.uci.edu/ora/hrpp/extendedirbapproval.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

949-824-1558

karen.allen@uci.edu

Beverley Williams

Assistant Director, Human Research Protections

949-824-5746

beverley.williams@uci.edu

Or any of our friendly Research Protections Staff – contact info @

http://apps.research.uci.edu/orastaff/staff.cfm