irb review n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
IRB Review PowerPoint Presentation
Download Presentation
IRB Review

Loading in 2 Seconds...

play fullscreen
1 / 70

IRB Review - PowerPoint PPT Presentation


  • 102 Views
  • Uploaded on

IRB Review. Mechanics: Looking under the hood IRB Administrators 2012 PRIDE Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session Traveling to and fro (basic, beyond and in between) Exploring the IRB Meeting Agenda Quorum Approval Criteria Minutes

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'IRB Review' - helena


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
irb review

IRB Review

Mechanics: Looking under the hood

IRB Administrators 2012PRIDE

Lucindia Shouse, MS, CIP

May 31, 2012

road map
Road Map

Question-and-Answer Session

  • Traveling to and fro (basic, beyond and in between)
  • Exploring the IRB Meeting
    • Agenda
    • Quorum
    • Approval Criteria
    • Minutes
    • Communication
irb meetings are to occur at intervals appropriate for which of the following
IRB meetings are to occur at intervals appropriate for which of the following:
  • Quantity, complexity, and frequency of required actions
  • Adequate IRB oversight of the progress of approved research
  • Both of the above
scheduling
Scheduling
  • Scheduled meetings of the IRB are to occur
    • At intervals appropriate for the quantity, complexity, and frequency of required actions
    • To permit adequate IRB oversight of the progress of research it has approved
  • Other meetings may be scheduled as needed in accordance with facility SOPs

VHA Handbook 1200.05, Paragraph 13.b

slide5

Members attending in person must have received all relevant materials prior to the meeting and must be able to participate actively and equally in all discussions

  • True
  • False
agenda materials
Agenda Materials

All members including those participating by conference call or videoconferencemust have received all relevant materials

VHA Handbook 1200.05, Paragraph 13.c.

discussion
Discussion

What about last minute agenda items?

  • Best effort
  • SharePoint
  • Sufficient discussion by members attending
  • Other Ideas?
quorum
Quorum
  • Majority of all voting members
    • Not majority of voting members present
    • Not majority of voting members present after members are recused
  • Maintained throughout the meeting

VHA Handbook 1200.05, Paragraph 13.jjj.

a member has declared a conflict of interest this member cannot
A member has declared a conflict of interest. This member cannot:
  • Contribute to the quorum
  • Be present for the discussion
  • Be present for the vote
  • All of the above
conflict of interest
Conflict of Interest
  • A member with a COI cannot
    • Contribute to a quorum
    • Be present for the discussion exceptto answer questions
    • Be present for the vote
  • This member must be recused

VHA Handbook 1200.05, Paragraph 3.jjj.

slide11
For the purposes of quorum, a VA representative must be present if an affiliate IRB or another VA facility’s IRB is an IRB of record
  • Yes
  • No
va representative
VA Representative

One of the officially-designated VA representatives must be present to constitute a quorum for the review of VA research

VHA Handbook 1200.05, Paragraph 13.(2)

veteran representative
Veteran Representative
  • VA IRBs should make every effort to include a Veteran or Veteran representative as part of the fulfillment of the requirement of relevant diversity of experience and expertise
  • Strongly encouraged, but not required

VHA Handbook 1200.05, Paragraph 12.a.

consultants
Consultants

A consultant or ad hoc advisor with expertise in special areas

  • May be invited to assist in the review of issues which require expertise beyond, or in addition to, that available on the IRB
  • May not vote with the IRB

VHA Handbook 1200.05, Paragraph 12.i.

slide17

The quorum is 11 and 11 voting members are present. A voting member leaves the meeting room. Issues requiring a vote may be discussed but no vote may be taken.

  • True
  • False
voting member
Voting Member

Quorum must be restored before any discussion of, or action on, issues requiring a vote may occur

VHA Handbook 1200.05, Paragraph 13a.(1)

slide19
The quorum is 11 and 12 voting members are attending. The non-scientist leaves the room. Is the quorum still maintained?
  • Yes
  • No
non scientific member
Non-scientific Member

For the quorum to be maintained at least one voting member, whose primary concerns are in non-scientific areas, must be present

VHA Handbook 1200.05, Paragraph 13.a.

quorum question
Quorum Question
  • The quorum is 8 and 11 voting members attend the meeting. For one vote:
    • 3 are recused
    • 8 are present
    • The vote is 5 in favor, 3 opposed
quorum question1
Quorum Question
  • Quorum was maintained
  • A majority of the voting members attending voted in favor
approval criteria
Approval Criteria
  • Must be met before IRB can grant approval(expedited review, convened initial review or continuing review)
  • Must be met, when relevant, before IRB can grant approval of an amendment

VHA Handbook 1200.05, Paragraph 17

approval criteria1
Approval Criteria
  • Minimization of Risks
  • Risks and Benefits
  • Equitable Selection of Subjects
  • Informed Consent
  • Safety Monitoring

VHA Handbook 1200.05, Paragraph 17

approval criteria2
Approval Criteria
  • Privacy and Confidentiality
  • Information Security
  • Vulnerable Subjects
  • Conflict of Interest
  • Investigator Qualifications

VHA Handbook 1200.05, Paragraph 17

approval criteria3
Approval Criteria

HIPAA Authorization

  • The IRB must determine the following are consistent with each other
    • Protocol
    • Informed consent
    • HIPAA authorization

VHA Handbook 1200.05, Paragraph 17

approval criteria4
Approval Criteria
  • IRB Members and Staff need to know them
  • Mechanisms
    • Checklists
    • Handouts
    • Posters
    • Other ideas?
minutes
Minutes

Draft minutes of IRB meetings must be written and available for review within 3 weeks of the meeting date

VHA Handbook 1200.05, Paragraph 28

minutes1
Minutes
  • Final minutes cannot be altered by anyone, including other authorities or committees
  • However, corrections can be made and documented in subsequent meeting minutes

VHA Handbook 1200.05, Paragraph 28

minutes must provide a summary of the discussion of controverted issues and their resolution
Minutes must provide a summary of the discussion of controvertedissues and their resolution
  • True
  • False
minutes2
Minutes

Controverted issue

  • Highly debated between IRB members
  • Resolved by the IRB
  • Must be documented in the minutes including
    • Rationale or resolution

VHA Handbook 1200.05, Paragraph 28.n.

slide35
The IRB must determine that risks to human subjects are minimized. Which of the following are risks to subjects or others?
  • Physical
  • Legal
  • Social
  • Economic
  • Psychological
  • All of the above
slide36
Risk

Minutes must document

  • Level of risk
  • Rationale for determination of level of risk

VHA Handbook 1200.05, Paragraph 28.j.

social security numbers
Social Security Numbers

Minutes must provide a summary of discussion when real SSNs, scrambled SSNs, or the last four digits of SSNs will be used

  • Include security measures

VHA Handbook 1200.05, Paragraph 28.q.

waiver of informed consent
Waiver of Informed Consent

Minutes must document protocol-specific findings justifying determinations:

  • Waiver or alteration of informed consent
    • The minutes must specifically document that the IRB determined that all criteria for waiver or alteration of the informed consent process were met

VHA Handbook 1200.05, Paragraph 28.g.

vulnerable subjects
Vulnerable Subjects

The IRB must document

  • Why individuals or populations are vulnerable
  • That adequate safeguards are in place for those likely to be vulnerable including those who
    • Are susceptible to coercion or undue influence
    • Lack comprehension
    • Have increased susceptibility to harm
    • At risk for economic, social or legal consequences

VHA Handbook 1200.05, Paragraph 45.b.

a crado waiver is required for research involving which of the following
A CRADO Waiver is required for research involving which of the following:
  • Children
  • Prisoners
  • Category D or X Drugs in Pregnant Women
  • All of above
vulnerable subjects1
Vulnerable Subjects

In addition to a CRADO waiver, the IRB minutes must document and justify protocol-specific findings for

  • Children
  • Prisoners
  • Pregnant Women

VHA Handbook 1200.05, Paragraphs 28.g.(2) and 46-48

vulnerable subjects2
Vulnerable Subjects

Persons who lack decision-making capacity

  • Are not to be subjects in research simply because they are readily available

VHA Handbook 1200.05, Paragraph 49

who has the responsibility to make sure the protocol and informed consent form address usual care
Who has the responsibility to make sure the protocol and informed consent form address usual care?
  • IRB
  • Investigator
  • Neither of the above
  • Both of the above
usual care
Usual Care
  • The investigator is responsible for differentiating usual care from research
  • The IRB must ensure usual care is clearly differentiated

VHA Handbook 1200.05, Paragraphs 10.g. and 17.b.(1)

scientific review
Scientific Review
  • The IRB is not required to perform a comprehensive scientific review
  • The IRB is responsible for being sufficiently familiar with the science to perform its review
    • Weighing potential risks and benefits

VHA Handbook 1200.05, Paragraph 15.b.

irb approval
IRB Approval

The research must not be initiated until the investigator has been notified in writing by the ACOS for R&D that all applicable approvals have been obtained and the study may be initiated

VHA Handbook 1200.05, Paragraph 25.a.(2)

the investigator may continue the study after receiving written approval from the irb
The investigator may continue the study after receiving written approval from the IRB
  • True
  • False
continuing irb approval
Continuing IRB Approval
  • The IRB must notify the investigator, the R&D Committee, and the local research office of its determination to approve, disapprove or require changes
  • The notification must be signed by the IRB Chair, another voting member of the IRB, or a member of the IRB staff

VHA Handbook 1200.05, Paragraph 25.d

slide51
There is a requirement for the IRB staff to send the investigator a copy of the IRB-approved informed consent form
  • True
  • False
informed consent form
Informed Consent Form
  • IRB correspondence must clearly indicate which version of the consent form has been approved
  • IRB approval date must be documented on each page
    • Use of a stamp
    • Preprinted box

VHA Handbook 1200.05, Paragraphs 25.b. and 33.b.

irb approval date convened irb review
IRB Approval DateConvened IRB Review

The convened IRB approves a study contingent on minor modifications. The IRB Chair uses expedited review procedures to verify the minor conditions were met.

irb approval date convened board review
IRB Approval DateConvened Board Review

The date of approval for purpose of determining the date of continuing review is the date the study was approved by the convened IRB contingent on minor conditions being addressed

VHA Handbook 1200.05, Paragraph 24.a.(2)

slide56
The date of continuing review is based on the date the IRB Chair, or experienced IRB member gives IRB approval
  • True
  • False
irb approval date expedited review
IRB Approval DateExpedited Review

The date of continuing review of the research study is based on the date the IRB Chair, or experienced IRB voting member(s), gives IRB approval to the research study

VHA Handbook 1200.05, Paragraph 24.b.

slide58

The IRB may only use expedited review for continuing review for research which was previously approved under the expedited review procedure?

  • True
  • False
expedited continuing review
ExpeditedContinuing Review

The IRB may use expedited review for continuing review in the following circumstances:

  • Permanently closed to enrollment, all subjects have completed all research interventions, and all research remains active only for long term follow-up; or
  • No subjects enrolled and no additional risks identified or
  • Remaining research activities limited to data analysis

VHA Handbook 1200.05, Paragraph 20

slide60

A project has been reviewed and approved by another VA facility’s IRB. Your local IRB can perform expedited review since the project has already been approved by a VA IRB.

  • True
  • False
review by another irb
Review by another IRB

Whether a project can be reviewed using the expedited review procedures is dependent on the following:

  • Research fits into a category eligible for expedited review and
  • Research is found by the IRB reviewer(s) to involve no more than minimal risk

VHA Handbook 1200.05, Paragraph 18.a.(1)

exemption
Exemption
  • The investigator must submit the proposed research study and request for exemption to the IRB
  • The IRB chair, or an experienced IRB voting member designated by the Chair, must make the determination of whether or not to grant the Exemption

VHA Handbook 1200.05, Paragraph 16.a.

rco audits
RCO Audits

The IRB may require

  • More frequent audits
  • More focused audits on one or more aspects
    • Vulnerable populations
    • Level of risk
    • Issues of noncompliance

VHA Handbook 1200.05, Paragraph 29

all irb records including protocol files and meeting minutes must be maintained for
All IRB records including protocol files and meeting minutes must be maintained for:
  • For 1 year
  • For 3 years
  • Per current FDA regulations
  • For the foreseeable future
records retention
Records Retention

Required records, including investigator research records must be retained until disposition instructions are

  • Approved by the National Archives and Records Administration
  • Published in VHA’s Records Control Schedule

VHA Handbook 1200.05, Paragraph 26.h.

references
References

VHA Handbook 1200.05

“Requirements for the Protection of Human Subjects in Research”

Published May 2, 2012

Common Rule

38 CFR 16

contact information
Contact Information

Lucindia Shouse, MS, CIP

Program Analyst

Dept of Veterans Administration

Office of Research & Development/PRIDE

Email: Lucindia.Shouse@va.gov