Institutional Review Board Gretchen Gimpel Peacock, IRB Chair Thorana Nelson, IRB Vice Chair True M'

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Institutional Review BoardGretchen Gimpel
Peacock, IRB ChairThorana Nelson, IRB Vice
ChairTrue M. Fox, Administrator

• For the Protection of
• Human Participants
• in Research

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IRB Reviews Research Conducted with Human
Participants

• Purpose to determine if the rights and welfare
  of human participants are adequately protected.
• Documents must be provided that contain enough
  information to allow valid judgments about the
  science and ethics of research

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How do you know if youre doing research?

• A systematic investigation designed to develop or
  contribute to generalizable knowledge or to
  contribute to the general body of knowledge.

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How do you know if you are using human
participants?

• Living individuals about whom an
  investigatorconducting research obtains
• Data through intervention or
• interaction with the individual, or
• B. Identifiable private information

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What does the IRB look for in a research project?

• Risks minimized (coercion?)
• Risk vs. Benefits ratio
• Equitable participant selection
• Informed Consent process appropriate
• Privacy, confidentiality, safety - maximized
• Safeguards for vulnerable subjects
• Research design - scientifically sound

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Who submits application to the IRB?

• Principal investigator (PI)
• PI must be faculty member
• or researcher internal to USU
• Cannot be grad student or post-doc
• Must submit prior to study
• implementation
• includes pilot studies
• Exempt research and research using
• previously collected data must be submitted

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What are the deadlines?

• Full-board review meetings
• held quarterly
• however, additional meetings scheduled
• as needed
• Meeting dates listed on web at
• www.usu.edu/research/irb/deadlines.cfm
• Exempt/expedited proposals
• reviewed in the order received
• generally takes 3-6 weeks

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What do I need to submit?

• Online application
• www.usu.edu/research/irb/submission.cfm
• Assurance document
• PI and any research personnel in contact with
  human participants must have completed IRB CITI
  training
• www.citiprogram.org
• Informed consent, assent, and / or cover letter
• Proposal or description of proposed research
  design
• Copies of instruments, surveys, questionnaires
• Advertising used for recruitment

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What happens after that?

• PI Contacted by e-mail
• Changes to consents typical
• Once final approval granted, research may begin
• Continuing Review
• yearly status update

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What else do I need to know?

• You must contact the IRB whenever any changes in
• methods/objectives
• population used
• adverse events
• Form at
• www.usu.edu/research/irb/forms.cfm

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Classroom Research Assignments

• Can use streamlined form
• http//www.usu.edu/research/irb/forms/ClassApplica
  -tion.pdf
• If research
• Not with vulnerable populations
• Minimal risk (e.g., anonymous survey)
• Submit application as early as possible in
  semester

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Online Resources

• USU IRB website
• www.usu.edu/research/irb/
• Office of HS Protections
• http//www.hhs.gov/ohrp
• Office of Research Integrity
  http//ori.dhhs.gov

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Institutional Review Board
Contact Gretchen Gimpel Peacock, Chair
797-0721 gretchen.peacock_at_usu.edu True M.
Fox, Administrator 797-0567 true.fox_at_usu.edu