Ask the expert: Bring all the right forms to the IRB

Staff Development Weekly: Insight on Evidence-Based Practice in Education, June 5, 2009

This week, Marquetta Flaugher, ARNP-BC, DSN, discusses the forms needed by an institutional review board (IRB) considering a proposal for a nursing research project.

Q: How can I be sure staff nurses are prepared for what needs to be presented to the IRB for a research project?

A: Presenting a research idea to the IRB committee involves a lot of documentation, as the committee needs to understand exactly what is being proposed before it can weigh considerations and effects.

There are many different forms that may be needed by the IRB, including all of the following:

  • Proposal with cover sheet
  • Study personnel education sheet
  • Investigator disclosure (conflict of interest
  • Informed consent
  • Application for new approval
  • Report of sentinel adverse events/safety supplement
  • Report of protocol exceptions
  • Change of principal or coinvestigator
  • Continuing review
  • Closure of study
  • Industry sponsored forms (used in testing pharmaceuticals or equipment)

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