The University of Maryland, College Park Institutional Review Board

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The University of Maryland, College
ParkInstitutional Review Board

• The IRB

March 7th, 2007
Roslyn Edson
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Use of Humans in Research
HISTORY
Ethically Questionable Biomedical Studies (e.g. the Tuskegee study)
Ethical Codes The Nuremberg Principles Declaration of Helsinki The Belmont Report
The Common Rule (45 CFR 46) The Federal Wide Assurance
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Definition of a Human Subject

• A human subject means a living individual about
  whom an investigator conducting research obtains
• data through intervention or interaction with
  the individual
• identifiable private information

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Basic Ethical Principles

• Respect for Persons
• individuals treated as autonomous agents
• persons with diminished autonomy protected
• Beneficence
• do no harm
• maximize benefits/minimize risks
• Justice
• the benefits and risks of research must be
  distributed fairly (e.g. the selection of
  subjects must be equitable)

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I Read the News Today, Oh Boy !

• Healthy Volunteer Dies in Hopkins Asthma Study.
  June 01
• Fathers Complaints Shuts Down Research at VCU.
  Jan. 00

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The Federal Regulations for the Protection of
Human Subjects

• The Common Rule (45 C.F.R. 46) is the regulation
  pertaining to the use of human subjects for
  research funded by 16 Federal agencies.
• This regulation requires that approval by an
  Institutional Review Board be obtained before
  research involving the use of human subjects can
  be initiated. This applies to research funded or
  supported by these 16 Federal agencies.

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The Federal Wide AssuranceFWA 00005856

• Assures protections for human subjects
• Designates the UMCP IRB (IRB00000474)
• All activities, regardless of the source of
  funding, will be guided by the Belmont Report
• Applies The Common Rule (45 CFR 46) to all human
  subjects research, regardless of source of
  support
• Applies the Subparts (B,C D) of 45 CFR 46 to
  all human subjects research, regardless of source
  of support

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UM System Policy on Human Subjects in Research

• All UM System research activities which involve
  human subjects, regardless of the level of risk,
  require review and approval, prior to the
  initiation of the activity.
• An IRB shall have jurisdiction over all reviews
  and approvals.

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UM System Policy

• Policy applies to all research activities
  performed on the premises of the UM System or its
  constituent institutions or elsewhere by faculty,
  students, or employees under UM System auspices
• An IRB will have the authority to determine
  whether or not any activity is covered by the
  policy or whether it requires review.

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Definition of Research

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

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Level of Research Review

• Exempt (IRB Manager or IRB Co-chair)
• Some surveys, educational tests, and interviews
• Some research involving existing data
• Some research on educational practices
• Doe not apply if the data is person-identifiable
  and the disclosure of the data outside the
  research could be damaging to the subject
• Expedited Review (IRB Chair or other designated
  IRB members)
• not more than minimal risk (e.g. risk is to
  that encountered in everyday life or routine
  medical or psychological exam) and
• Activities involve only procedures listed in
  expedited review categories (63 FR 60364-60367,
  November 9, 1998)
• Full Board Review
• gt than minimal risk
• Clinical trials

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Human Subjects Research Review
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What should be included in a consent form ?
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Elements of an ICF

• Institutional research statement
• Age statement
• Purpose
• Procedures
• Confidentiality

• Risks
• Benefits
• Freedom to withdraw statement
• Contact info for the investigator and the IRB
• Signature and date line

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Upcoming Changes

• electronic IRB submission and approval system
  (currently in pilot phase)
• Mandatory online IRB training for all
  investigators (faculty, staff and students)
• A second IRB to handle the increasing volume of
  IRB applications that require full Board review

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For Further Information and Inquiries

• IRB Staff
• Roslyn Edson, IRB Manager x 50678
• Roxanne Freedman, IRB Coordinator x 54212
• Pankaja Dakhane, Graduate Assistant
• IRB Co-Chairs
• James Hagberg
• J. Dennis OConnor
• IRB Acting Co-Chair
• - Robert Brown
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• http//www.umresearch.umd.edu/IRB