Open Library: IRB Web Updates for Researchers and Participants

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Open Library IRB Web Updates for Researchers and
Participants

• Lee Griner
• Editor, Institutional Review Board for Human Use
• October 1, 2004

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Topics

• Information for participants
• Policy on noncompliance
• New options for training
• Form revisions September 21, 2004
• Other additions to IRB web site

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Brochure for Participants

• Brochure
• English www.uab.edu/uabra/irb/subjects-rights-eng
  lish.pdf
• Spanish www.uab.edu/uabra/irb/subjects-rights-spa
  nish.pdf
• Large print www.uab.edu/uabra/irb/subjects-rights
  -large-print.pdf
• Request copies by email to lgriner_at_uab.edu
• Your name
• Your e-mail address
• Your telephone number
• Name of your employer (e.g., UAB, VA, Cooper
  Green)
• Name of your department or division
• Campus or Mailing Address
• Number of copies desired in English
• Number of copies desired in Spanish
• Number of copies desired in large-print English
• Order form in your hand-out today

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Web Site for Participants

• www.uab.edu/irb/participants
• Glossary of IRB-related terms and acronyms
• FAQ
• What kinds of studies are common at UAB? (see
  next slide)
• What is a "phase" in a clinical trial, and which
  one am I in?
• What are the risks of participating in a study?
• What are the benefits of participating in a
  study?
• Whom can I ask a question about the study?
• What if I don't want to enroll in the study?
• What if I want or need to stop participating?
• Will I be paid to participate?
• Will it cost me any money to participate in a
  trial?

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What Kinds of Studies Are Common at UAB?

• Listing of Clinical Trials at UABMaintained by
  UAB Insight, UABHS Office of Medical Publications
• UAB Office of Clinical ResearchHelps connect
  volunteers with ongoing clinical trials
• Cancer Center Clinical Trials Listing
• Center for AIDS Research Active and Upcoming
  Trials
• Division of Clinical Immunology and Rheumatology
• Department of Physical Medicine and
  Rehabilitation

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Other Resources for Participants?

• Please send web address or publication
  information of other resources to lgriner_at_uab.edu

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IRB Policy on Noncompliance

• www.uab.edu/irb/policy
• Section B.8.
• Procedures for Identifying and Promptly Reporting
  Unanticipated Problems Involving Risks to
  Subjects or Others, Any Serious or Continuing
  Noncompliance with 45 CFR 46 Or 21 CFR 56, Any
  IRB Determinations, and Any Suspension or
  Termination of IRB Approval
• The following 10 slides are reproduced from a
  presentation by Ferdinand Urthaler, M.D., IRB
  Chairperson

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Federal Law Requires That UAB Report Certain
Events

• to OHRP
• Office for Human Research Protections
• 45 CFR 46
• to FDA
• Food and Drug Administration
• 21 CFR 56

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Examples of Required Reports

• Serious or continuing noncompliance
• Suspension or termination of IRB approval

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Examples of Serious Noncompliance

• Falsification of IRB documents
• Research conducted without IRB approval
• Changes in protocol without prior IRB approval
• Deviation from the IRB-approved consent process
• Failure to maintain regulatory documents
• Inadequate oversight of research

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Examples of Continuing Noncompliance

• Repeated disregard of IRBs written requests
  concerning
• Missed deadline for renewal of approval
• Use of expired consent form
• Lack of IRB training
• Late reporting (e.g., adverse events, monitoring
  reports)
• Inaccurate document preparation

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Suspected Serious Noncompliance

• When the IRB determines that serious
  noncompliance may have occurred,
• PI
• Is notified in writing
• If IRB requests information, must provide within
  5 working days
• Office of the IRB (OIRB)
• May schedule a for-cause audit, to occur within 2
  working days and with limited advance notice
• Forwards preliminary audit findings to
• PI
• IRB Subcommittee on Compliance

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Subcommittee and Serious Noncompliance

• Subcommittee on Compliance meets with PI and OIRB
  staff, if necessary
• PI provides written clarification for
  subcommittee
• Subcommittee issues report and recommendation to
  IRB
• Copy of report goes to PI

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IRB and Serious Noncompliance

• IRB considers subcommittees report at its next
  fully convened board meeting
• Representative of subcommittee and PI both attend
  that IRB meeting
• IRB makes final determination on whether serious
  noncompliance has occurred
• If no occurrence, IRB minutes reflect finding and
  PI is notified

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Finding of Serious Noncompliance

• If the IRB determines that serious noncompliance
  has occurred,
• The OIRB notifies the PI
• The IRB forwards its report to the Authorized
  Institutional Official, who
• Notifies OHRP and the sponsor of the research
• Notifies any other appropriate federal officials
  (such as FDA, if applicable), appropriate UAB
  research personnel, and the Provost
• The IRB may suspend or terminate its approval of
  the protocol

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Suspension or Termination for Noncompliance

• If the IRB suspends or terminates previously
  approved research,
• The OIRB notifies the PI
• The IRB forwards its report to the Authorized
  Institutional Official, who
• Notifies OHRP of the IRBs finding
• Notifies any other appropriate federal officials
  (such as FDA, if applicable), appropriate UAB
  research personnel, and the Provost

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Resources

• UAB IRB Policies and Procedures
• www.uab.edu/irb/policy
• 45 CFR 46
• www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.ht
  m
• 21 CFR 56
• www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/C
  FRSearch.cfm?CFRPart56
• OIRB
• Phone [phone]
• Email irb_at_uab.edu
• Web www.uab.edu/irb

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Questions? IRB Contact for Subcommittee on
Compliance

• Tracey Craddock
• tcraddoc_at_uab.edu
• 934-3789
• AB 470, 0104

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New Options for IRB Training

• www.uab.edu/irb/training
• Dunn Chadwick book, quiz, and evaluation
• Protecting Study Volunteers in Research A Manual
  for Investigative Sites
• Paperback 400 pages
• Publisher CenterWatch 3rd edition (April 2004)
• ISBN 1930624441
• CME and Nursing Contact Hours (NCH) available
  through University of Rochester Medical Center
• UAB IRB training credit available after CME or
  NCH completed

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WebCT courses

• Investigator 101
• Requires CD checkout from OIRB
• Conflict of Interest Review Board
• Slated to be required by CIRB in future
• Ethics of Statistical Power
• Aimed at nonspecialists
• Research Involving Children and Adolescents
• Defined as under 19 years of age

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Completing an IRB WebCT course

• View all the information associated with the
  course (CD or WebCT course material)
• Pass the quiz(zes) for that course ( 70/100)
• Complete, sign, and submit the IRB Verification
  of Training Statement (www.uab.edu/irb/forms)
• Credit is granted when
• The Course Instructor reports completion to the
  OIRB
• The trainee submits the Verification of Training
  Statement

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Training Questions?

• www.uab.edu/irb/training
• OIRB 934-3789
• Marilyn Milton
• mtam_at_uab.edu
• Lee Griner
• lgriner_at_uab.edu
• irb_at_uab.edu

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Form revisions September 21, 2004

• www.uab.edu/irb/forms
• The only change to IRB forms revised 09/21/04 is
  the removal of Social Security Number for
  researchers
• Watch for upcoming revision to include some other
  unique, numerical identifier, such as UAB
  Employee Number

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On the Horizon . . .

• Starting this week, submissions for renewal of
  IRB approval that are
• Approved with minor limited modifications AND
• Still within the previous IRB-approval period
• Will be allowed to continue to enroll if only
  minor changes are needed.
• All such approvals will be clearly marked with
  the date by which an approved response is required

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Example

• Minor changes requested to the consent form
• Will allow use of the existing consent form for
  up to 5 working days from the renewal
  notification date (i.e., usually a Friday)
• Will require submission and approval of revised
  consent form within those 5 working days to allow
  uninterrupted enrollment (i.e., by the following
  Friday).
• If the revised form is not submitted or cannot be
  approved within 5 days, then approval will lapse
  unless the form is approved before the previous
  approval period ends.
• NOTE This practice can be used only if
  sufficient time remains in the IRB-approval
  period. If IRB approval lapses, then the study
  will be interrupted until approval can be
  restored.

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Other additions to IRB web site

• www.uab.edu/irb/new
• 2005 meeting schedule
• www.uab.edu/irb/schedule
• IRB rosters 1990-2004
• www.uab.edu/irb/members
• OHRP Guidance on Research Involving Coded
  Private Information or Biological Specimens
  (August 10, 2004)

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Summary

• Updated information at
• www.uab.edu/irb/participants
• www.uab.edu/irb/training
• www.uab.edu/irb/policy
• www.uab.edu/irb/forms
• www.uab.edu/irb/new

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Further Questions?

• General
• irb_at_uab.edu
• Training
• Marilyn Milton (mtam_at_uab.edu)
• Lee Griner (lgriner_at_uab.edu)
• Compliance
• Tracey Craddock (tcraddoc_at_uab.edu)
• Policy
• Sheila Moore, IRB Director (smoore_at_uab.edu)
• Ferdinand Urthaler, M.D., IRB Chairperson
  (furthalr_at_uab.edu)