Institutional Review Board

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Institutional Review Board

• Protecting Human Research Subjects

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Presentation Outline

• Structure
• Tips for Teachers
• Background Ethical Problems in Research
• Purpose
• Rules
• Process
• Examples
• Q A

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Structure

• IRBs required by Federal Law
• ALL Human Subjects Research MUST be approved by
  Gallaudets IRB
• IRB responsible to Fed. Govt., not Gallaudet
• IRB can be audited by Government
• IRB must contain professionals and community
  members

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Structure

• Gallaudets IRB is responsible for reviewing ALL
  research involving Gallaudet students, faculty,
  staff and teachers. We are also responsible for
  research involving recruitment of alumni through
  records held in the Alumni Office.

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Structure (Gallaudets IRB)

• The Gallaudet Institutional Review Board
  currently has 17 members, representing various
  components of the Gallaudet campus
• The Gallaudet IRB office is in Kendall Hall room
  101A
• The chair of the IRB is Dr. Carolyn Corbett
• The Institutional Review Board coordinator is Ms.
  Carlene Thumann-Prezioso who is located in Fowler
  Hall, Room 214

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Tips for Teachers

• Your own human subjects research needs to be
  submitted to the IRB
• Student human subjects research in your class
  needs to be submitted to the IRB (grad/undergrad,
  theses, dissert.)
• Other researchers cannot use your students as
  subjects unless approved by the Gally IRB
  (surveys, etc.)

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Tips for Teachers (Contd)

• Build enough time into class projects for IRB
  approval
• In most cases, the IRB requires some changes in
  projects
• The IRB chair or a member is available to lecture
  to your class on issues and procedures
• The IRB chair staff are available for
  consultations

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Background Ethical Problems

• Nuremberg Trial (1946)
• Milgram Study (1963)
• Tuskegee Study (1933, 1972)
• Belmont Report (1974)
• Respect for persons
• Beneficence
• Justice

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Purpose

• Carry out Objectives of Belmont Report Through
  Guaranteeing
• Informed Consent
• Voluntary Participation
• Risk/Benefit Analysis
• Minimization of Risk
• Justice in the subject selection

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Rules

• Risks (Psychological, Social, Economic, Physical)
  must be minimized
• Risks must be offset by benefits
• Subjects must be informed and voluntarily consent
• Special populations must be protected

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Rules Protected Groups

• Children younger than 18 years
• Prisoners
• Pregnant women
• Mentally ill
• Individuals with mental retardation

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Rules Classes of Research

• Exempt--Examples
• Anonymous Surveys
• Observation of Public behavior
• NO Videotaping
• Use of Public Records
• ONLY the IRB Decides if the Research is Exempt

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Classes of Research

• Expedited All Other Human Subjects Research that
  presents at least a minimal risk of harm (as
  determined by the IRB)
• if minimal risk is involved can be expedited.
• Full Board Review More than minimal harm or
  protected populations involved

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Processes

• Fill out form (Found under Gallaudet Research
  Institute on the Gallaudet website)
• Write Up Research Proposal, including
• Informed Consent Form
• Video Consent/Release (if applicable)
• Interview/Survey Questions (if applicable)
• Cover letter (if applicable)
• Brief Literature Review

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Processes (continued)

• Timelines
• 1 week if the IRB decides it does not need any
  modifications and is exempt
• 1-2 weeks if the IRB decides it does not need any
  modification and is expedited
• If the IRB suggests modifications the timeline
  varies
• For Full Board Review, from 2 weeks to 2 months
  depending on modifications

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Processes (continued)

• When the project is finished, the researcher must
  notify the IRB
• Projects that continue past 1 year must get a
  renewal
• Any modifications require approval
• Any adverse results must be immediately reported
  to IRB

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Common Examples

• Anonymous Surveys versus Confidential Surveys
• Questions that pose risks
• Videotaping
• Use of classmates or students (adults)
• Compensation for Subjects
• Deception

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There Has Never Been A Research Project At
Gallaudet University That Has Not Been Done Due
To Lack Of IRB Approval!
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Questions???

• Thank you for your attention.