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Does the project constitute research?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45CFR46.102(d)

Does the UMCIRB have jurisdiction over the project? Any ECU faculty, staff, or student conducting human subject research or any project constituting human subject research conducted at PCMH must have UMCIRB approval

Does the project involve human subjects?

Human subject means a living individual about whom an investigator whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. 45CFR46.102(f)

What is the level of risk?

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  45 CFR 46.102(i) Definition for prisoners differs and is located at 45 CFR 46.303(d).

         The review process depends upon the level of risk

     No more than minimal risk    More than minimal risk

Deadline & meeting information on the UMCIRB website

      EXEMPT                            EXPEDITED                     FULL COMMITTEE

      6 specific          9 specific

        criteria            criteria

   Exempt formFull / expedited formFull / expedited form + protocol

IRB Chair approves   IRB Chair approves  Full committee approval

March 17, 2009

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