IRB, IACUC, and ACS in Research Oversight

IRB, IACUC, ACS Tina Butts Irene Cooke Sherri Mizrahy Stacey Robinson Gary Russell To ask a question during today s meeting, e-mail sslater@ufl.edu

FORUM Outline Briefly go through IRB IACUC ACS Protocol-project correlation DISCUSSION !!! To ask a question during today s meeting, e-mail sslater@ufl.edu

IRB and IACUC Faculty oversight committees (peer review) Regulations specify - committee composition, community members, expertise Committees report to Institutional Official, Dr. Norton, VPR Public meetings open, feel free to attend To ask a question during today s meeting, e-mail sslater@ufl.edu

Role of IRB Protect rights and welfare (physical and psychological) of humans in research study Also oversee tissues and data (if identified) Ensure compliance with all regulatory requirements Review research protocols Assess ethics of research Promote fully informed and voluntary participation Maximize safety Oversee Conflict, Protected Health Information etc. Review human subject welfare concerns Suspend activities, if needed

AAHRPP Accreditation UF is getting AAHRPP accredited - meets minimum regulatory standards but also meets rigorous external standards for ethics, quality and protection for human subject research More requirements for PIs

IRB Protocol Takes 2 days to 6 weeks for approval depending on type Exempt, expedited, full board Exempt status determined by IRB, not PI Have initial approval, then continuing review (CR) annually Continuing Review IRB 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or Board may question need for continuing study if poor accrual or study has been going on so long, the science is outdated CANNOT do human subject research without approved CR Electronic reminders for CR sent at -90, -45, -7 days ANY modifications to protocol need to be submitted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 funding

UF IRBs IRB-01: HSC, biomedical research IRB-02: CLAS, social, behavioral, educational research IRB-03: UF JAX IRB-04: WIRB

UF IRB-01 20 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

Role of IACUC Protect animal subject welfare Ensure animals used for experiments are treated humanely and pain/stress is minimized Only covers vertebrate live animals Cadaver/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 needed

AAALAC Accreditation UF is AAALAC accredited - meets minimum regulatory standards but also meets external standards to achieve excellence in animal care and use To ask a question during today s meeting, e-mail sslater@ufl.edu

IACUC Protocol Takes 2 - 4 weeks for approval depending on type of review. Full Committee, Designated or Administrative Review Have 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 protocol Electronic 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 funding

UF IACUC 23 total members including 2 community members, 2 non-scientist members, 3 alternates Support staff Meets 1st and 3rd Tuesday of each month 12:30 to 4:00 p.m. ~ 450 researchers, over 1200 active protocols

ACS Responsible for research animal care and well-being at UF Animal ordering Animal daily care/well-being Mouse models core and Rodent Breeding services Coordinate export/import of rodents Surgical support services Animal space assignments Billing for animal care etc. Census management Protocol transfers/relocations Facility access/key distributions

Project (UFIRST)- Protocol (IRB, IACUC) 1 project can have many protocols 1 protocol can have many projects Project expiration date tied to protocol expiration date Project exemption Approval to start work prior to protocol approval Request exemption from Irene Project extension Keep project funding open if protocol lapses Request extension from Irene

Request for Exemption/Extension Questions PI needs to answer: Project title or PeopleSoft/UFIRST number(s) associated with the project/award The 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 approved

In Conclusion Here to help and support you Work together Contact Sherri, Gary, Tina, Stacey at any time To ask a question during today s meeting, e-mail sslater@ufl.edu

Questions? To ask a question during today s meeting, e-mail sslater@ufl.edu