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.
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.
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. Definition for prisoners differs and is located at .
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
Exempt formFull / expedited formFull / expedited form + protocol
IRB Chair approves IRB Chair approves Full committee approval
March 17, 2009