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Continuing Review VA Requirements

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Title: Continuing Review VA Requirements


1
Continuing ReviewVA Requirements
  • Kevin L. Nellis, M.S., M.T. (A.S.C.P.)
  • Program Analyst
  • Program for Research Integrity Development and
    Education (PRIDE)

2
Topics
  • IRB and Investigator requirements of continuing
    review
  • IRB approval dates
  • Requirements when IRB approval expires

3
Continuing Review Research Must be Substantive
and Meaningful
  • Includes, but not limited to
  • Review of the ongoing level of risks and benefits
  • Assessment of the need for special safeguards to
    protect subjects
  • Review of the adequacy of ongoing protection for
    potentially vulnerable individuals

4
Considerations for Continuing Review
  • IRB must conduct continuing review of research at
    intervals appropriate to the degree of risk, but
    not less than once per year 38 CFR 16.109(e)
  • IRB must have written procedures for determining
    which projects require review more often than
    annually (38 CFR 16.103(b)(4)(ii)).
  • Review may be by the convened IRB or by expedited
    review, if appropriate
  • IRB approval criteria must be satisfied

5
Investigator Submits Protocol Summary Written
Status Report
  • Brief summary of the research methodology
  • Number of subjects entered and withdrawn
    (including reason) for the review period and
    since the inception
  • Summary of complaints regarding the research
    since the last IRB review
  • Gender and minority status of those entered into
    protocol, if appropriate
  • Number of subjects considered to be members of
    specific vulnerable populations

6
Investigator Submits Protocol Summary Written
Status Report
  • Copy of the current informed consent form(s) and
    any new proposed informed consent form(s) along
    with a description of changes in the new form
  • Current HIPAA authorization
  • List of all amendments since last IRB approval
  • Information that may impact on the risk benefit
    ratio, such as SAEs and complaints regarding the
    research

7
Investigator Submits Protocol Summary Written
Status Report
  • Summaries, recommendations, or minutes of the
    Data Monitoring Committee (DMC) meetings (if
    applicable) or findings based on information
    collected by the data and safety monitoring plan
  • Assurance that all identified unanticipated
    internal or local SAEs, have been reported as
    required to the IRB of record
  • Summary of all unanticipated problems involving
    risks to subjects or others, and all internal or
    local SAEs

8
Investigator Submits Protocol Summary Written
Status Report
  • Research findings to date, if available
  • Relevant multi-center trial reports
  • New scientific findings in the literature, or
    other relevant findings, that may impact on the
    research
  • PI statement certifying that all subjects on the
    master list signed an informed consent form prior
    to undergoing any study interactions or
    interventions (unless waived by IRB)

9
At Continuing Review
  • All IRB members must receive and review a
    protocol summary and a status report on the
    progress of the research
  • At least one voting member of the IRB (i.e., a
    primary reviewer) needs to receive a copy of the
    complete protocol, including any modifications
    previously approved by the IRB.
  • All IRB members have access to the complete IRB
    protocol file and relevant IRB minutes

10
IRB Ensures
  • Approval criteria are satisfied
  • Informed consent is accurate and complete
  • Informed consent form, HIPAA authorization, and
    protocol are consistent
  • Significant new findings that may affect the
    subjects willingness to continue participation
    are provided to the subjects

11
Expedited Continuing Review
  • If expedited, IRB Chair or designee should
    receive and review all documentation and complete
    protocol
  • Reminder Determinations and protocol-specific
    findings justifying those IRB determinations must
    be documented in either the IRB protocol file or
    the minutes

12
Master List of Subjects
  • IRB must ensure that the master list of subjects
    entered into the study contains only those
    subjects who have signed an informed consent form
    (unless waived)
  • May rely on assurances from the PI and audits
    conducted by the RCO

13
IRB Approval Date Convened IRB
  • No Conditions date of the convened IRB meeting
    at which approval was granted
  • Minor Conditions date the study was approved
    by the convened IRB contingent on minor
    conditions being addressed (NOT the date that the
    conditions are verified)
  • Note Substantive Conditions defer approval

14
IRB Approval Date Expedited IRB
  • All conditions met date the IRB Chair, or
    experienced IRB voting member(s) designated by
    the IRB Chair, signs IRB approval to the research
    study

15
If Approval Expires
  • Local research office must promptly notifying the
    investigator
  • Investigator must stop all research activities
    including, but not limited to
  • Enrollment of new subjects
  • Continuation of research interventions or
    interactions with currently participating
    subjects
  • Data analysis.

16
If Approval Expires
  • Investigator must immediately submit to the IRB
    Chair a list of research subjects who could be
    harmed by stopping study procedures.
  • IRB Chair, with appropriate consultation with the
    Chief of Staff, determines if subjects on the
    list may continue participating in the research
    interventions or interactions

17
If Approval Expires
  • Once the study approval has expired, IRB
    re-review and re-approval must occur before the
    study can resume
  • The IRB cannot retrospectively grant approval to
    cover a period of lapsed IRB approval

18
30 Day Rule
  • When continuing review occurs annually and the
    IRB performs continuing review within 30 days
    before the IRB approval period expires, the IRB
    may retain the anniversary date as the date by
    which the continuing review must occur. There is
    no provision for any grace period to extend the
    conduct of research beyond the expiration date of
    IRB approval. Therefore, continuing review and
    re-approval of research must occur on or before
    the date when IRB approval expires.

19
Timeline Example Convened IRB - No Conditions
  • Convened IRB meets on March 15, 2009 and approves
    the protocol with no conditions
  • Continuing review and re-approval of research
    must occur on or before the date when IRB
    approval expires, or March 15, 2010

20
Timeline Example Convened IRB - Minor Conditions
  • Convened IRB meets on March 15, 2009 and approves
    the protocol with minor conditions
  • Investigator completes changes on March 20, 2009
  • IRB Chair verifies conditions are met on March
    25, 2009
  • Continuing review and re-approval of research
    must occur on or before the date when IRB
    approval expires, or March 15, 2010

21
Timeline Example - Expedited IRB
  • IRB chair reviews protocol on March 15, 2009 and
    request more information from Principal
    Investigator
  • Investigator makes additional changes and
    resubmits protocol on March 20, 2009
  • IRB Chair reviews final changes and approves
    protocol on March 25, 2009
  • Continuing review and re-approval of research
    must occur on or before the date when IRB
    approval expires, or March 25, 2010

22
Timeline Example - 30 Day Rule
  • IRB approval of a protocol is set to expire on
    March 25, 2010
  • The IRB reviews and approves the protocol at a
    convened meeting on March 15, 2010
  • Continuing review and re-approval of research
    must occur on or before the date when IRB
    approval expires, or March 25, 2011

23
Key Points
  • Continuing review must be meaningful,
    substantive, and timely
  • Investigators must submit required information
  • Understand timeline for when continuing review
    and approval must occur
  • Prevent expiration of IRB approval
  • Understand what to do if IRB approval expires

24
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