IRB Update Meeting

1
IRB Update Meeting

• Thursday, May 24, 2007
• Babcock Auditorium

2
Agenda

• Radiation Safety when to click the box
• Industry Relations
• Advertising for Clinical Trials
• New/Revised Policies
• Miscellaneous

3
Industry Relations

• Janice Grace
• Director of Industry Relations
• IRB Update May 24, 2007

4
Clinical Trials with Industry

• All clinical trials require a contract between
  Wake Forest and the sponsoring or supporting
  company
• Documentation about the study needs to be routed
  to Industry Relations to allow negotiation of
  appropriate agreement
• Studies should be routed to Industry Relations no
  later than IRB submission, preferably sooner

5
Routing Clinical Trials

• Route minimum of required documents
• Completed and signed Route Form
• Protocol (can be draft if complete enough to give
  study dynamics)
• Completed and signed Research Agreement
  Questionnaire (located on our web site)
• Route additional documents as soon as possible
• Internal Budget
• Sponsor Budget
• Consent Form (draft)

6
Contacts and Resources

• Janice Grace, Director
• Robyn Gore, Industry Relations Officer
• Tina Hungerford, Industry Relations Officer
• Kristy Mabe, Industry Relations Officer
• Kristina Leonard, Administrative Assistant
• See our website for further information on
  processes

7
Advertising for Clinical Trials

• Clinical Trials Website
• Infinity
• Plasma Screen TVs
• More information on how we will align all three
  methods of advertising is forthcoming

8
New Policies effective June 1

• Charges for IRB Review (minimal revisions)
• Advertisements (minimal revisions)
• Payment of Recruitment Incentives (minimal
  revisions)
• Research Related Injury (major changes to sponsor
  liability language)
• IRB Authorization Agreements (NEW)
• Individual Investigator Agreements (NEW)
• Event Reporting (NEW)

9
Research Injury Language

• SPONSOR shall reimburse for reasonable and
  necessary medical expenses (the Covered
  Expenses) incurred by research subjects for
  medical care, including hospitalization, in the
  treatment of adverse reactions arising from study
  drugs, devices, intervention, procedures and
  tests following their administration or use in
  accordance with the protocol, which expenses were
  not caused by negligence or misconduct of any
  person in the employment of Wake Forest
  University Health Sciences or to your own failure
  to follow instructions. The SPONSOR is not
  responsible for expenses that are due to
  pre-existing medical conditions or underlying
  disease. The research subjects medical or
  hospital insurance and other third party payors
  are not responsible for any of the Covered
  Expenses.

10
Implementation of the new Sponsor Liability
Language

• Template language regarding sponsor liability
  will now be in line with Industry Contracts
• Required for all Industry Sponsored Drug and
  Device studies effective June 1
• Current consents DO NOT need to be amended

11
Important Note about Translating Consent Forms

• When enrolling non-English speaking subjects, you
  must have a consent form translated in language
  understandable to the subject
• Use of a translator and English consent is no
  longer acceptable

12
Changes to the ICF template

• Changes to the ICF Template will be made next
  week new version posted by June 1
• Liability Language will be updated
• Translation box will be deleted

13
Misc

• Faculty Leaving? Report this to the IRB Office
  ASAP
• Information Security Policies General
  Information page of eIRB
• Security and Data Management Statement
• eMR and Part 11 Compliance Statement

14
eIRB tips

• When revising/amending consents, edit and delete
  old versions
• Amendments remember what is in the description
  is what will be printed in your approval memo

15
Questions

• Jeanie Baird Boards 1 3
• Jeannie Tullock Boards 2 4
• Mark Tolliver IRB AA Responsible for ALL CR
  applications and IRB Invoicing
• Wendy Murray Events, Deviations, etc.