IRB Minutes

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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)

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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

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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

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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

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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

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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

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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

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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.)

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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)

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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

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IRB Study File Includes

• Records of continuing review activities
• Copies of all correspondence between the IRB and
  the investigators

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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

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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

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QUESTIONS