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Brown Bag Series LG110A McKnight Brain Institute 121:30


'Costs to Consent' (Deborah Townsend, ... (Shelly Ogiste, IRB Quality Assurance Coordinator) June ? ... May 13: 'Quality Assurance Audits' (Shelly Ogiste) June ? ... – PowerPoint PPT presentation

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Title: Brown Bag Series LG110A McKnight Brain Institute 121:30

Brown Bag Series LG110A McKnight Brain
Institute 12-130
  • April 8 Informed Consent (Linda Fallon)
  • AND
  • Costs to Consent (Deborah Townsend,
    Clinical Trials
  • May 13 Quality Assurance Audits
  • (Shelly Ogiste, IRB Quality Assurance
  • June ?? Research Integrity, the Dos, Donts,
    and What Ifs. (Robert Kolb, GCRC)

IRB Forms Ensuring That All Research
Involving Human Subjects Meet Federal, State, and
University Guidelines
  • Terry Lemesh
  • Education Coordinator
  • (352) 846-1494

RE Computer Compatibility
  • I learned last week that Office 2007 (or Word
    2007) is working less than ideally with our
    forms. I have placed an order with our IT
    department in order to be able to make our forms
    compatible with this newest version (and keep it
    compatible with 2003). I will notify you all
    when I've had the opportunity to address the
  • In the meantime I can only suggest to either ask
    your IT professional to also install Word XP on
    your machine (the University has a campus wide
    site license so they should be able to do this at
    no cost - on both your work and home computer).
  • Thanks!
  • Michael Mahoney
  • February 19, 2007

Introductory Questionnaire Non-Human/Exempt
Non-Human and Exempt Rule of Thumb Exempt HIPAA
Waiver Non-Human Confidentiality Agreement
  • Non-Human Must answer NO to all 4 questions
  • Investigator Information
  • Include Sub-Is UFID (Web Tracking)
  • PI cannot sign as supervisor
  • Dates If federal (NIH) need 2 copies of grant
  • Study Procedures
  • 1. In detail
  • 2. Include data variables
  • Human Subject Involvement (NoNon-Human)
  • 5. Specific dates
  • 6. Best high estimates
  • 10 11. Need answers, no matter what type.
  • 12a. Example age, diagnosis, lab results
  • 12b. Should be NO, since you are receiving it
    already coded.
  • 12b. Key code should be N/A

Introductory Questionnaire Expedited and Full
Expedited and Full Board IQ Steps to Success
  • Hidden Text Tools-Options-View-Hidden Text
    (has check mark)
  • Contact Info (top left box)
  • Addendum M (if not Full Board)
  • Addendum A Always!!
  • 3. Select and attach appropriate Addendum
  • 8. If vulnerable Please select and justify at
    bottom of box.
  • 10. The PI, or research staff (Listed on Addendum
  • 11b. If Addendum R is requested, you have the old
  • 15. Expected length of time subject participates
  • 20. Print document, should calculate, if not
    right click-update field
  • 30. Length of time study will remain open
  • 32, 33, 34. All must be NO- If not Contact Mike

Addendum A (Page 1) PIs Supervisor Must
Sign, Not PI
Addendum A (Page 2) Include ALL of the
Research Team UFID s (web tracking) Include
Roles (Co-PI, Sub-I, Coordinator)
Addendum M (Determines if submission is
Expedited or Full Board)
  • Make sure you can see the Hidden Text (yellow
    highlights will show) (Tools, Options, view,
    Hidden Text, OK)
  • Make sure the study meets the 3 qualifications
    for the Expedited Review

Addendum H (Waiving IC for Enrolling)
  • Common Errors
  • 3. Modification of Informed Consent EX
    Telephone consent, Non-English speaking
  • 5. Waiver of Documentation of Informed Consent
    (no identifiers) EX Letter on top of a survey
    explaining the study OR Announcing verbally what
    the study is about and this is the survey being
    used OR Telephone survey with no identifiers
    (This is usually NO)
  • 6. Yes Include HIPAA Waiver

HIPAA Waiver http//
  • Common Errors
  • PI must initial 3,4,5, 6.
  • PI must sign and date at the end.
  • 2. Complete answer.
  • 3 ab. Complete answers.
  • 4. Complete answer.

Addendum J (If Vulnerable Subjects are Included)
  • Common Errors
  • 1. UF/Shands/VA staff PI supervises.
  • 1. UF Students PI supervises. ALSO must answer
  • 2. Must justify. Be thorough.

Addendum K (K is for Kids)
  • Child under 7 years cannot assent.
  • Where there is a box, please explain in detail.

Addendum V (If Veterans are Included)
  • Dont forget to submit your studies to SCI and
    RD committee for review and approval before
    conducting the study!!
  • http//
  • http//

Addendum W (If Women are Included)
  • Common Errors
  • If there is box (explanation or description) next
    to your selection, please give a detailed answer.
  • Some questions (for example 7, if yes is chosen,
    please complete both (a) and (b).

  • Common Errors
  • UFID not included
  • Incorrect IRB
  • Incorrect Title
  • 8. If a box is selected the materials must be
    submitted with this form.

Continuing Review Study Closure If there is a
box after your selection, please complete as
  • Common Errors
  • 1. Attach a Clean Current copy of Protocol
  • 4. Yes Provide Sponsors name
  • 11. Other has no HIPPA Waiver involved.
  • 19, 21, 22. Since last approved complete, even
    if its the first year of the study
  • 23. Since Study Started should equal total of
    24-30. Since Last Approval should equal 24-30
  • 37. General description
  • 43. Yes Check box and indicate when there will
    be a report available OR if no report will be

Continuing Review Closure Cont.
  • 49 (CRContinuing Review CClosure)
  • Clean current copy of Protocol CR, C
  • Most recently sign ICF with identifiers blacked
    out CR, C
  • Clean, unstamped ICF in current format CR ,C
  • Cumulative Adverse Event Table CR, C (if none,
    write none on the form)
  • Minor Deviation Tracking Log CR, C
  • DSMB Only if you have one
  • Audit Report Only if you have one
  • New Info on risk/benefit CR,C
  • Project Revision Form CR only if submitting a
    revision also
  • Publications or meeting proceedings only if you
    have one

Unaffiliated Investigator Agreement (If a PI from
outside of UF is listed on the Protocol) PI from
outside UF signs (they will need UFID )
Confidentiality Agreement If you are receiving
information from another university If a
subject is not consented and we are sending out
their data to another university.
Standardized Text http//
Web Tracking http//
Brown Bag Series LG110A McKnight Brain
Institute 12-130
  • April 8 Informed Consent (Linda Fallon) AND
    Costs to Consent (Deborah Townsend, Clinical
    Trails Compliance Office)
  • May 13 Quality Assurance Audits (Shelly
  • June ?? Research Integrity, the Dos, Donts,
    and What Ifs. (Robert Kolb, GCRC)