ETHICAL AND REGULATORY IRB ISSUES

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ETHICAL AND REGULATORY IRB ISSUES
Jimmie L. Valentine, Ph.D., FAIC, DABCP Professor
of Pediatrics and Pharmacology Chairman, UAMS IRB
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HOW DO I AVOID GOING TO THE IRB?
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Life is tough its tougher if you are stupid
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INSTITUTIONAL REVIEW BOARD (IRB)
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PURPOSE OF IRB

• To protect the rights and welfare of human
  subjects recruited to participate in research

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UAMS IRB

• Chair appointed by Vice Chancellor for Academic
  Affairs and Research Administration (VCAARA)
• Members recommended to and appointed by VCAARA

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UAMS IRB

• IRB OF RECORD FOR

• UAMS
• CAVHS
• ACHRI
• ADH
• NCTR

• CARTI
• ASH

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IRB COMMITTEES

• Composed of members from
• UAMS and affiliated institutions
• Lay (non-scientifically trained)
• Prisoner advocate

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IRB COMMITTEES

• Biomedical Committee
• Three committees 1st, 3rd, 4th
• Tuesday of each month
• Behavioral Committee
• 2nd Thursday of each month

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IRB COMMITTEES

• Future plans
• Add a 2nd week biomedical
• committee

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UAMS IRB WEB SITE
http//www.uams.edu/irb/IRB.asp

• Handbook
• Institutional Policies and Procedures
• Federal Regulations, Guidelines, and Reference
  Materials

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SUBMISSIONS TO IRB
All submissions are done electronically
using Automated Research Information
Administrator (ARIA)
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TYPES OF SUBMISSIONS

• New
• Expedited
• Exempt

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U.S. REGULATIONS AND GUIDELINES USED BY IRB

• Title 45 US CFR.46
• --The Common Rule
• --Additional subparts-vulnerable subjects
  protection

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U.S. REGULATIONS AND GUIDELINES USED BY IRB

• Focus of the Common Rule
• Research involving human subjects

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DEFINITION OF RESEARCH

• Systematic investigation, including research
  development, testing, and evaluation, designed to
  develop or contribute to generalizable knowledge

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SYSTEMATIC

• Systematic implies an organized activity

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INCLUDING

• including specifically encompasses research
  development, testing, and evaluation

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DESIGNED TO

• designed to the proposed activity must reflect
  the deliberate intention to have that activity
  develop or contribute to generalizable knowledge

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GENERALIZABLE

• generalizable knowledge is NOT information
  obtained using scientific technology and methods
  that will be applied to elucidating a societal
  issue example DNA evidence in a criminal case

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GENERALIZABLE(continued)

• generalizable knowledge is generally considered
  to be information that will be published in the
  open scientific and medical literature

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DEFINITION OF HUMAN SUBJECT

• A living individual about whom an investigator
  obtains
• Data through interaction or intervention
• Identifiable private information

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RULE OF THUMB FOR WHETHER IRB APPROVAL IS REQUIRED

• If you plan on doing any type of investigation in
  living humans you should think
• IRB approval may be needed

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Lack of IRB Approval Prior To Performing An
Investigation Is An Accident Waiting To Happen
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ETHICAL GUIDELINES

• The Belmont Report
• The Declaration of Helsinki
• These documents, among others, state that a human
  research subject has the right to understand what
  will be done to them the so called Informed
  Consent

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WHAT RESEARCH MAY BE EXEMPT FROM IRB REVIEW?45
CFR 46.101(b)

• research activities in which the only
  involvement of human subjects will be in one or
  more of the following categories are exempt from
  this policy

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EXEMPT REVIEW (continued)

• 1. Educational studies involving normal
  educational practices

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EXEMPT REVIEW (continued)

• 2. Educational tests, surveys, interviews,
  observations
• --except when results could be linked
• --except when results could be damaging
• --except when involving public officials

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EXEMPT REVIEWS (continued)

• 3. Research involving the collection or study
  of
• existing data, documents, records,
  pathological specimens, or diagnostic specimens
  when publicly available and not identifiable

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EXEMPT REVIEW (continued)

• 4. Research designed to evaluate public benefit
  or service programs
• 5. Taste, food quality, and consumer acceptance
  studies

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WHO DECIDES IF A RESEARCH PROJECT IS EXEMPT FROM
IRB REVIEW?

• Not you!!!!
• IRB Chairman or his designee

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WHAT RESEARCH MAY BE ELIGIBLE FOR EXPEDITED IRB
REVIEW?45 CFR 46.110

• No more than minimal risk
• Retrospective chart review
• Does not involve intervention or interaction with
  children
• Prisoners not involved

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WHO DECIDES IF A RESEARCH PROJECT CAN BE
EXPEDITED?

• IRB Chairman or his designee

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SUBMISSION OF NON-EXEMPT OR EXPEDITED PROTOCOLS
REQUIRED DOCUMENTS

• Protocol
• Consent Form (translation for non-English)
• Grant application
• Clinical methods (protocol)
• Advertisement(s)

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TYPES OF IRB ACTIONS ON SUBMITTED PROTOCOLS

• Approve
• Approve with minor contingencies
• Approve with major contingencies
• Table
• Disapprove (Decline)

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IRB ACTION -APPROVED-

• Continuing review periods
• Annual
• Quarterly
• Investigator can start study once
• approval letter is received

• Semi-annual

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IRB ACTION -APPROVED WITH MINOR
CONTINGENCIES-

• Can be approved by expedited
• review of IRB Chair following
• satisfactory response to ALL
• minor contingencies
• Study cannot start until ALL
• contingencies are met

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IRB ACTION -APPROVED WITH MAJOR
CONTINGENCIES-

• Cannot be approved by expedited
• review of IRB Chair - requires
• fully IRB Committee review
• Study cannot start until ALL
• contingencies are met

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IRB ACTION -TABLED-

• Serious problems found with the
• protocol and/or consent as submitted
• Requires a new protocol submission
• by the investigator

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IRB ACTION -DISAPPROVED
(DECLINED)-

• IRB Committee found reasons that
• patient safety could not be assured
• with the protocol
• Ethical considerations may have
• entered the decision

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HOW CAN IRB APPROVAL BE ACHIEVED?

• Follow the
• guidelines
• Ask for help