Continuing Review

1
Continuing Review

• Presented by
• Karen Jeans, PhD, CCRN, CIP
• Program Analyst, COACH

2
Objectives

• Describe what is meant by continuing review
• Describe VA requirements for continuing review
• Calculate dates for continuing review expiration

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What is Meant by Continuing Review?

• Term is undefined in the Federal Regulations

4
What is Continuing Review?

• Monitoring on-going projects thru continuing
  review at intervals appropriate to the degree of
  risk, but not less than once per year.
• VHA Handbook 1200.05, Paragraph 7.(g) page 15
• An IRB shall conduct continuing review of
  research covered by these regulations at
  intervals appropriate to the degree of risk, but
  not less than once per year . . .
• 21 CFR 56.109(f) and 38 CFR 16.109(e)

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Criteria for IRB Approval (.111)

• Required determinations
• Risks to subjects are minimized
• By using procedures consistent with sound
  research design
• When appropriate, using procedures already being
  performed
• Risks are reasonable in relation to benefits
• Selection of subjects is equitable
• Informed consent will be sought prospectively
• Informed consent is appropriately documented
• Research plan makes adequate provisions for
  safety monitoring
• There are adequate provisions to protect privacy
  and confidentiality
• B. When appropriate, additional protections for
  Vulnerable Subjects

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Continuing Review

• Decisions Made by the IRB at Continuing Review
• Are subjects adequately protected through the
  current approved protocol?
• Informed consent issues
• The informed consent process is appropriate
• Written informed consent document is accurate and
  complete
• Any significant new findings are provided to the
  subject

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Continuing Review

• What is required to be submitted to the IRB by a
  Principal Investigator at Continuing Review?

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Continuing Review VHA Handbook 1200.05
Requirements

• Brief summary of the research methodology and
  procedures
• Number of subjects entered and withdrawn
  (including the reason for withdrawal) for the
  review period and since the inception of the
  research project
• The gender and minority status of those entered
  into the protocol
• Number of subjects considered as members of
  specific vulnerable populations
• A copy of the proposal and all approved
  amendments
• A copy of the current consent document for the
  IRB to review
• A copy of the current HIPAA Authorization
  document, if separate from the informed consent

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Continuing Review VHA Handbook 1200.05
Requirements

• Information that may impact on the risk benefit
  ratio such as AEs, unanticipated problems, and
  complaints regarding the research
• Research findings to date, if available
• Summary of the DSMB or DMC meetings (if
  applicable) or findings based on information
  collected by the data and safety monitoring plan
  submitted in the initial proposal
• An assurance that all SAEs and UAEs have been
  reported as required and
• New scientific findings in the literature, or
  other relevant findings, that may impact on the
  research.

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Continuing Review Lapses in IRB Approval - VHA
Handbook 1200.05

• If the continuing review does not occur within
  
• the timeframe set by the IRB, the research
  is
• automatically suspended.
• NOTE For suspended research, enrollment for
• new subjects cannot occur continuation of
• research interventions or interactions in
  already
• enrolled subjects should only continue when
  the
• IRB or IRB Chair, in consultation with the
  Chief
• of Staff (COS), finds that it is in the best
  
• interest of individual subjects to do so.

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Continuing Review Lapses in IRB Approval - VHA
Handbook 1200.05

• Once notified of the suspension, the PI must
• immediately submit to the IRB Chair, a list
  of
• research subjects for whom suspension of the
• research would cause harm. The IRB Chair,
  with
• appropriate consultation with the Chief of
  Staff,
• determines if the subject may continue in the
  
• research.
• If the study is FDA-regulated, the Chief of
  Staff
• and IRB Chair must follow FDA requirements
  in
• 21 CFR 56.108(b)(3) in making their
  decision.

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Continuing Review VHA Handbook 1200.05

• Whose responsibility is it to make sure a
  protocol does not lapse?
• Both the Investigator and IRB have different
• roles

13
Continuing Review VHA Handbook 1200.05

• Notification of Lapse of Approval
• Sponsoring agent, private sponsor, ORD, ORO, or
  other Federal agencies must be informed, as
  appropriate
• When is it appropriate to notify these agencies?

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Continuing Review VA vs. Everyone Else

• What is the difference between a lapse in
• approval and a suspension of IRB approval?
• A lapse in approval is a passive process.
• A suspension of IRB approval is an active
• process.

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Lapse of Approval Following Expiration of
Continuing Review Interval

• Issue 1 What about the investigational
  pharmacist?
• Issue 2 What happens to subjects entered into a
  study
• during a period when the studys
  continuing review approval period lapsed?
• Issue 3 What happens to subjects enrolled
  during a period when the studys continuing
  review approval lapsed and it was due to an
  administrative error within the IRB (study
  requiring review by a convened IRB left off
  the agenda)?

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Determination of Continuing Review Dates

• When Does Continuing Review Expire?
• The convened IRB meets on March 1, 2007 and
  approves Study A for a continuing review period
  of one year pending minor revisions. The
  revisions are approved by expedited review of the
  IRB Chairperson on March 7, 2007.
• The convened IRB meets on March 1, 2006 and
  approves Study B for a continuing review period
  of one year pending major revisions. The
  revisions are reviewed and approved by a convened
  IRB on April 1, 2006.

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Determination of Continuing Review Dates

• Continued
• The convened IRB meets on March 1, 2005 and
  approves Study C for a continuing review period
  of one year pending major revisions. The
  revisions are reviewed and approved by a convened
  IRB on March 1, 2007.
• The convened IRB meets on March 1, 2006 and
  approves Study D for a continuing review period
  of one year pending minor revisions. The
  revisions are reviewed and approved by a convened
  IRB (the IRB does not allow expedited review
  procedures) on April 1, 2007.

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Annual Revision Date Keeping the Same Date

• If continuing review occurs annually, and the IRB
  performs the continuing review evaluation 30 days
  before the IRB approval period expires, the IRB
  may retain the anniversary as the date by which
  the continuing review must occur.

19
Annual Revision Date Keeping the Same Date

• The IRB approves a protocol requiring full board
  review on March 1, 2006. Continuing review
  expires on March 1, 2007.
• 2. The convened IRB reviews the protocol for
  continuing approval on February 15, 2007 and
  approves the study for one year. Continuing
  review expires on March 1, 2008.
• 3. The convened IRB reviews the protocol on
  January 27, 2008 and approves the study for one
  year. Continuing review expires on January 27,
  2009.

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Guidance on Continuing Review

• Office for Human Research Protections
• Guidance on Continuing Review dated January 15,
  2007
• http//www.hhs.gov/ohrp/humansubjects/guidance/con
  trev0107.htm

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QUESTIONS