Updates in Research Protections Karen Allen Director, Research Protections Office of Research...
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Transcript of Updates in Research Protections Karen Allen Director, Research Protections Office of Research...
Updates in Research Protections
Karen AllenDirector, Research Protections
Office of Research November 2012
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
Beverley Williams
Assistant Director, Human Research Protections
949-824-5746
Or any of our friendly Research Protections Staff – contact info @
http://apps.research.uci.edu/orastaff/staff.cfm