To ask a question during today’s meeting, e-mail sslater@ufl.edu IRB, IACUC, ACS Tina Butts ● Irene Cooke ● Sherri Mizrahy ● Stacey Robinson ● Gary Russell Housekeeping Items: Silence phone Bathroom locations Exits (in case of alarm) Refreshments (in fridge, help yourself) Write names on board so that I can see them Will take break in middle Introductory Talking Points: Many many research compliance areas Many participants in class with varying needs Will provide broad 20,000 ft overview of compliance areas In future, you can take specific compliance area training However, remember that your compliance areas may change – position in different department, PI gets DOD funding etc. This session will not get to all compliance areas This session will not provide process details – how to do each form etc. Please keep informal, discuss, ask questions etc. To ask a question during today’s meeting, e-mail sslater@ufl.edu

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

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

UF IRBs IRB-01: HSC, biomedical research IRB-02: CLAS, social, behavioral, educational research IRB-03: UF JAX IRB-04: WIRB This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

To ask a question during today’s meeting, e-mail sslater@ufl.edu AAALAC Accreditation UF is AAALAC accredited - meets minimum regulatory standards but also meets external standards to achieve excellence in animal care and use This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong 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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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 This is a break-out activity to get things going Count off, form groups of 4-5 people each Ask them to discuss definition of “research” and “compliance” and put it together. Do not use i-phones to google the Webster definitions What does it mean to you in colloquial terms Each group to provide their meaning of the definition of research compliance Give 10-15 minutes for this exercise Collate their answers on a board (Steve to help with this) Discuss their responses – all are correct, there is no right or wrong

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

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