shades of gray: When is IRB approval required?

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Presentation transcript:

shades of gray: When is IRB approval required? 11/21/2012 Kevin L. Nellis, MS, CIP Executive Director, Human Research Protections and Quality Assurance Downstate Medical Center shades of gray: When is IRB approval required?

Objectives Understand which activities require IRB approval under the Common Rule (45 CFR 46) Understand resources for making this determination

Is IRB Review Required for Human Research? (Under the Common Rule) 1) Is it research? If “NO” to either question, consult “IRB Decision Aid” or call IRB @ X8480 2) Does it Involve Research Participants (Human Subjects)? YES Submit IRB Application

Is it Research? (Under the Common Rule) A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Systematic Investigation In general, a systematic investigation is an activity that is planned, orderly, methodical, and uses data collection and analysis to answer a question CAUTION: Pilot studies, feasibility studies, and other preliminary studies are considered a systematic investigation, for example: Convening a focus group to help researchers develop a questionnaire Pilot testing a questionnaire

Generalizable Knowledge Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study) that may be applied to populations outside of the specific study population.

Does it Involve Research Participants (Human Subjects) Does it Involve Research Participants (Human Subjects)? (Under the Common Rule) Living individuals about whom an investigator conducting research, obtains either… Data through intervention or interaction with the individual, or Individually identifiable private information

For Additional Help Call (718) 613-8480 IRB Website: http://research.downstate.edu/index.html 50 Shades of Gray Presentation Downstate IRB Decision Aid OHRP Decision Charts

Summary The devil is always in the details when determining whether IRB approval is required Consult the IRB for help (718) 613- 8480 or IRB@downstate.edu