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IRB Minutes

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Title: IRB Minutes


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

2
VHA Handbook 1200.05Sets the Floor, not the
Ceiling
  • Follow state and local laws when more stringent
  • Follow any additional accreditation requirements
  • Local VA policies may be more robust

3
Draft Minutes
  • Must be written and available for review within 3
    weeks of the meeting date
  • Approval of minor conditions by the Chair or
    designated IRB voting member must be documented
    in the minutes of the first IRB meeting that
    takes place after the date of the approval of the
    minor conditions

4
Draft Minutes
  • Approval by voting members at subsequent IRB
    meeting
  • Must be signed by the IRB Chair, or a qualified
    voting member of the IRB designated by the Chair
  • Final minutes cannot be altered
  • May document training members received
  • May include adjournment time

5
Document Attendance
  • Members (voting and non-voting)
  • Alternate members
  • Document who attended through videoconferencing
    or teleconferencing
  • Clearly indicate they received all relevant
    material prior to the meeting and were able to
    actively participate in all discussions

6
Document Attendance
  • IRB minutes should demonstrate that IRB meetings
    were convened with members who represent
    regulatory/legal requirements and general
    perspective of participants (AAHRPP Accreditation
    Element II.1.A.)
  • NOTE IRB members cannot participate in the
    meeting discussions or voting by email

7
IRB Member With a Conflict of Interest
  • Conflict of interest relative to the proposal can
    be potential, actual, or perceived
  • Conflicted members recuse themselves and leave
    room (terminate call/videoconference)
  • Not counted towards quorum
  • Document member is not present during the
    deliberations or voting on the proposal, and that
    the quorum was maintained

8
IRB Member With a Conflict of Interest
  • Conflicted IRB members are documented in the
    minutes as absent with an indication that a
    conflict of interest was the reason for the
    absence (AAHRPP Accreditation Element II.1.D.)

9
Document Quorum
  • Quorum majority of IRB members present
    38.107(b)
  • Quorum must be present for each vote
  • Non-Scientist must be present
  • NOTE Quorum could be indicated in the minutes by
    tracking attendance. It does not have to be
    indicated with each vote.
  • No IRB regulatory actions can take place if
    quorum is lost

10
Document IRB Actions
  • Approval of minutes of prior meeting
  • Approval of research
  • Requiring modifications in research (e.g.,
    approve study contingent on specific minor
    conditions)
  • Deferring approval of study contingent on
    substantive modifications
  • Disapproval of research

11
Document IRB Actions (continued)
  • Suspension or termination of previously approved
    research
  • Details requiring observation of consent process
  • Administrative actions (e.g., voting on
    non-regulatory actions, etc)
  • Other actions based on local policy

12
Document Vote Properly
  • Document the vote on actions including the number
    of voting members voting
  • For
  • Against
  • Abstaining
  • In order for the research to be approved, it
    shall receive the approval of a majority of those
    members present at the meeting 38.108(b)

13
Format to Consider for Documenting IRB Vote When
Alternate Votes
  • Total Voting 15
  • Vote For-9, Against-3, Abstain-3
  • Smith serving as alternate for Jones
  • Approved

14
Format to Consider for Documenting IRB Vote with
Conflict of Interest
  • Total Voting 14 (1 recused)
  • Vote For-7, Against-4, Abstain-3
  • Note Smith not present due to COI terminated
    videoconference connection
  • Not approved
  • NOTE A recusal means they are not voting

15
IRB Determinations and Justifications
  • Document determinations required by VA and other
    Federal requirements
  • Waiver or alteration of informed consent
  • Waiver of documentation of informed consent
  • Research involving vulnerable populations
  • Waiver of HIPAA authorization
  • Document protocol-specific findings justifying
    those IRB determinations

16
Research Involving Pregnant Women
  • Document review of additional safeguards in IRB
    minutes
  • Should document in IRB minutes or protocol file
  • Criteria of 45 CFR 46.204 are met
  • Adequate provision made to monitor the risks of
    subject and fetus
  • Status of waiver from CRADO, if applicable

17
Research Involving Prisoners
  • Document review of additional safeguards in IRB
    minutes
  • May wish to document status of waiver from Chief
    Research and Development Officer (CRADO)
  • Should document that each the conditions of 45
    CFR 46.301 46.306 are met in IRB minutes or
    protocol file

18
Research Involving Children
  • Document review of additional safeguards
  • Should inform investigator of requirement to
    obtain CRADO waiver
  • Reflect discussions regarding
  • Level of risk
  • Informed consent and assent forms
  • Investigators qualifications to conduct research
    involving children

19
Research Involving Individuals Who Lack
Decision-Making Capacity
  • Document review of additional safeguards
  • Document IRB deliberations and the criteria used
    to approve inclusion of individuals who lack
    decision-making capacity in the IRB minutes or
    IRB protocol file
  • Document findings related to the use of surrogate
    consent in IRB minutes

20
Subjects Susceptible to Coercion or Undue
Influence
  • Document that safeguards are adequate to protect
    the rights and welfare of subjects who are likely
    to be susceptible to coercion or undue influences

21
Risk and Rationale
  • Document the IRBs determination of the level of
    risk (e.g., whether or not the research
    constitutes minimal risk)
  • Document the rationale for the IRBs
    determination of the level of risk

22
Informed Consent Requirements
  • Document the IRBs determination that all
    appropriate elements were included in the
    informed consent form, and are included in the
    informed consent process
  • Document findings when IRB does not include or
    alters some or all of the elements of informed
    consent

23
Frequency of Continuing Review
  • IRB must document which protocols require
    continuing review more often than annually, as
    appropriate to the degree of risk
    38.103(b)(4)38.109(e)
  • Document the IRBs determination of the frequency
    of continuing review of each study

24
Document Basis for Requiring Changes or
Disapproval
  • Examples
  • PI must broaden recruitment pool geographically
    to maintain diversity of subjects
  • IRB disapproves research because of investigators
    misconduct inquiry however, he may resubmit,
    once inquiry is resolved

25
Provide Summary of Controverted Issues and
Resolution
  • Example
  • IRB debates over whether an Opt-in recruitment
    methodology should be required as opposed to the
    Opt-out methodology proposed by the investigator
  •  IRB requires the investigator to submit
    additional justification as to why an Opt-in
    methodology should be approved for this
    particular study

26
Provide Statements of Significant New Findings
  • Example This study demonstrated that anti-HIV
    drugs inhibit emerging virus linked to prostate
    cancer and chronic fatigue syndrome in Veterans.
    The study indicates that four drugs used to treat
    HIV infection can inhibit a retrovirus recently
    linked to prostate cancer and chronic fatigue
    syndrome

27
Non-Veteran Subjects
  • Provide a summary of the justification for
    including non-Veterans as subjects in the IRB
    minutes
  • IRB must appropriately document in the IRB
    minutes or IRB protocol file its determinations
    regarding participation of non-Veterans in the
    study

28
Real Social Security Numbers
  • Summarize discussion when real Social Security
    Numbers (SSNs), scrambled SSNs, or the last four
    digits of SSNs will be used in the study
  • Include discussion of security measures
  • NOTE Does not apply if the only use of SSNs is
    on the informed consent form or the HIPAA
    authorization

29
Waiver of HIPAA Authorization
  • Documentation of the IRBs findings for waiver of
    HIPAA authorization may be in the IRB minutes or
    the IRB protocol file
  • If IRB does not document the waiver of
    authorization as required, the waiver is not valid

30
FDA-Regulated Studies
  • May document that a physician is present
  • May document that an IND/IDE has been validated
    or one is not required
  • IRB must categorize a device study as either
    significant risk (SR) or non-significant risk
    (NSR) and document its determination in the IRB
    minutes

31
Expedited Review Procedures
  • IRB must notify IRB members of research studies
    approved
  • IRB approval must be documented in the IRB
    minutes or IRB protocol files

32
Other Items for Consideration for IRB Minutes
  • May document discussion regarding flagging of
    medical records
  • Provide summary of Protocol Deviations, Adverse
    Events, Unanticipated Problems Involving Risks to
    Subjects or Others, Audits, Reports to ORO, OHRP,
    FDA
  • Document discussion of IRB business

33
IRB Records Include
  • IRB SOPs as described in 38 CFR 16.103(b)(4) and
    (5)
  • IRB Roster and Member Resumes
  • Minutes of IRB meetings
  • Federal Wide Assurance (FWA)
  • Memorandum of Understanding (MOU)

34
IRB Study File Includes
  • All research proposals and amendments reviewed
  • Scientific evaluations, if any, that accompany
    the proposals
  • Approved informed consent documents
  • Progress reports submitted by investigators
  • Reports of injuries to subjects

35
IRB Study File Includes
  • Records of continuing review activities
  • Copies of all correspondence between the IRB and
    the investigators

36
IRB Records
  • Must be readily available
  • Space needs to be sufficient to provide secure
    storage of records
  • Investigator must maintain research records that
    the protocol is being implemented as approved
  • Store according to VA and Federal records
    retention requirements

37
Key Points
  • Accurately reflect activities, discussions, and
    determinations in IRB minutes
  • Record deliberations, actions, and votes for each
    protocol in IRB minutes
  • Maintain IRB minutes and Records in compliance
    with VHA Handbook 1200.05, Common Rule, state
    requirements, and local VA policy

38
QUESTIONS
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