The Protection of Human Subjects: The IRB

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The Protection of Human SubjectsThe IRB

• Karyn Popham for
• Susan R. Tortolero, PhD
• July 5, 2001Introduction to Epidemiology Class

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IRB

• IRB is the abbreviation for the generic term
  Institutional Review Boardthe institutional
  infrastructure for guaranteeing the protection of
  human subjects in research.

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The IRB at UT HSC Houston

• At the University of Texas Health Science Center
  at Houston, the official name of the IRB is the
• Committee for the Protection of Human Subjects

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CPHS Approval

• Before any research involving human
  subjectshowever indirectlycan begin, it must
  receive formal approval from the Committee for
  the Protection of Human Subjects.

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CPHS Approval

• Failure to obtain this prior approval can result
  in disciplinary action up to and including (for
  students) summary dismissal from the University.

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The Protection of Human Subjects

• It is important for students to understand not
  only the process as it applies to students here
  at the University, but also
• the rules which will govern them for the rest of
  their careers
• the reasons these rules exist

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The Protection of Human Subjects

• Training in these issues is required of all
  researchers and research staff, and soon will be
  required of all students.
• The training will provide an overview of both the
  historical context and the specific rules
  regarding the protection of human subjects.

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Training and Certification

• Training is available on-line, over the Internet.
  There are currently three options available to
  students

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Option 1 NIH

• The NIH itself has just unveiled its on-line
  training
• http//cme.nci.nih.gov/

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Option 2 UCLA

• UCLA has an on-line training which you may stop
  and return to at a later timehttp//training.ar
  c.ucla.edu

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Option 2 UCLA, cont.

• The UCLA site requires you to Register online
  before you take the test.
• Enter your full name and use your UT email
  address as the contact address.
• Under the Site category, select "Other"
• Under the School/College category select "Other
  (NON UCLA affiliated)"
• Remember your User name and Password the
  UCLA site allows you to pause and continue your
  session at a later date.

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Option 3 U. Minnesota

• The University of Minnesota has an on-line
  training which you must take in one sitting, but
  many people find it substantially shorter than
  the UCLA versionhttp//www.research.umn.edu/con
  sent

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Option 3 U Minn., cont.

• In the University of Minnesota site select the
  "Social and Behavioral Science Module"
• You can review the Orientation session or go
  straight to the test.
• After each section a quiz will be given.
• At the completion of the test, provide your name
  and email address use your full name and UT
  email address.
• The University of Minnesota site does not allow
  you to stop and continue at a later time.

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Which Site?

• With the release of the NIH on-line training,
  that is probably the best place to start.
• As each site has its own examples and questions,
  each can contribute to your understanding of the
  IRB process and rules.
• It is perfectly acceptable to obtain training
  (and certification) from all three sources.

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Why Take the Training?

• At some point (probably rather soon), you will be
  required by the University to take this training
  and obtain the certification.
• Doing so now will allow you to take the training
  at a time most convenient for you and with fewer
  people competing for access to the site.