Irene Cooke Sherri Mizrahy Stacey Robinson Gary Russell To ask a question during todays meeting email sslaterufledu FORUM Outline Briefly go through IRB ID: 681494
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IRB, IACUC, ACSTina Butts ● Irene Cooke ● Sherri Mizrahy ● Stacey Robinson ● Gary Russell
To ask a question during today’s meeting, e-mail
sslater@ufl.eduSlide2
FORUM OutlineBriefly go throughIRBIACUCACSProtocol-project correlationDISCUSSION !!!
To ask a question during today’s meeting, e-mail
sslater@ufl.eduSlide3
IRB and IACUCFaculty oversight committees (peer review)Regulations specify - committee composition, community members, expertiseCommittees report to Institutional Official, Dr. Norton, VPRPublic meetings – open, feel free to attend
To ask a question during today’s meeting, e-mail sslater@ufl.eduSlide4
Role of IRBProtect rights and welfare (physical and psychological) of humans in research studyAlso oversee tissues and data (if identified)Ensure compliance with all regulatory requirementsReview research protocols Assess ethics of research
Promote fully informed and voluntary participationMaximize safetyOversee Conflict, Protected Health Information etc.Review
human subject welfare
concerns
Suspend activities, if neededSlide5
AAHRPP AccreditationUF is getting AAHRPP accredited - meets minimum regulatory standards but also meets rigorous external standards for ethics, quality and protection for human subject researchMore requirements for PIsSlide6
IRB ProtocolTakes 2 days to 6 weeks for approval depending on typeExempt, expedited, full boardExempt status determined by IRB, not PIHave initial approval, then continuing review (CR) annuallyContinuing ReviewIRB reviewer or Board may question need for continuing
study if poor accrual or study
has been going on so long, the science
is outdated
CANNOT
do human subject research without approved
CR
Electronic reminders for CR sent at -90, -45, -7 days
ANY modifications to protocol need to be submitted and approved by IRB BEFORE implementing
This includes
fundingSlide7
UF IRBsIRB-01: HSC, biomedical researchIRB-02: CLAS, social, behavioral, educational researchIRB-03: UF JAXIRB-04: WIRBSlide8
UF IRB-0120 members (7 serve as Exec. Members) including 1 community member, 11 alternates, consultants as needed, 3 office board members for admin. approvals Meets 1st and 3rd
Wednesday of each month
8:30
a.m. to 2:00
p.m.
~ 100 researchers, over 1200
active protocols Slide9
Role of IACUCProtect animal subject welfare Ensure animals used for experiments are treated humanely and pain/stress is minimized Only covers
vertebrate live animalsCadaver/tissue protocol required for animal tissue research or dead animal
research
Ensure compliance
with all regulatory requirements
Evaluate
animal care and use program
every
6
months
Inspect facilities
every
6
months
Review
animal use protocols
Review
animal welfare concerns
Suspend activities, if
neededSlide10
AAALAC AccreditationUF is AAALAC accredited - meets minimum regulatory standards but also meets external standards to achieve excellence in animal care and useTo ask a question during today’s meeting, e-mail
sslater@ufl.eduSlide11
IACUC ProtocolTakes 2 - 4 weeks for approval depending on type of review. – Full Committee, Designated or Administrative ReviewHave initial approval, then annual review (report of what has been done in past year; USDA requirement)Annual renewal valid for 3 years; then need to do full protocol review (PHS requirement) CANNOT do animal subject research without approved protocolElectronic reminders for
AR sent at -90, -60, -30 days
ANY
modifications to
protocol need to be submitted and approved by
IACUC BEFORE
implementing
This includes
fundingSlide12
UF IACUC23 total members including 2 community members, 2 non-scientist members, 3 alternatesSupport staffMeets 1st and 3
rd Tuesday of each month12:30
to 4:00 p.m.
~ 450
researchers, over 1200 active protocolsSlide13
ACSResponsible for research animal care and well-being at UFAnimal orderingAnimal daily care/well-beingMouse models core and Rodent Breeding servicesCoordinate export/import of rodentsSurgical support servicesAnimal space assignmentsBilling for animal care etc.
Census managementProtocol transfers/relocationsFacility access/key distributionsSlide14
Project (UFIRST)- Protocol (IRB, IACUC)1 project can have many protocols 1 protocol can have many projectsProject expiration date tied to protocol expiration dateProject exemptionApproval to start work prior to protocol approvalRequest exemption from Irene
Project extensionKeep project funding open if protocol lapses
Request extension from IreneSlide15
Request for Exemption/ExtensionQuestions PI needs to answer:Project title or PeopleSoft/UFIRST number(s) associated with the project/awardThe reason for the request (why the project needs to be extended before the protocol is approved?)What’s the status of the protocol? (e.g. PI has not submitted the proposed protocol to the Committee for review, protocol is pending review, etc.)Time-frame of exemption (how much time will be needed? Be specific. e.g. 2 weeks, 1 month, etc.) Include a statement/confirmation that no human or animal (whichever is applicable) subject research will be conducted until the protocol is approvedSlide16
In ConclusionHere to help and support youWork togetherContact Sherri, Gary, Tina, Stacey at any time
To ask a question during today’s meeting, e-mail
sslater@ufl.eduSlide17
Questions?To ask a question during today’s meeting, e-mail sslater@ufl.edu