About the IRB Approval Process.
What research needs approval?
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- If I am just talking with people about ...I'm not doing anything to them--there are no experiments, no clinical trials, do I need human subjects approval?
- If my research qualifies as "exempt" under the federal regulations, must I submit an application for approval?
- If I am using data compiled by other third parties, e.g. governmental agency or another researcher, do I need approval?
- What are some common things that may disqualify research as "exempt" research?
- If my research is not exempt, must I obtain written signed consent, even if there is minimal risk?
- What do I do with the signed consent forms?
- Suppose I want to make a minor change in the study--add or remove a new question or new task, put an ad in the newspaper to recruit more subjects, do I need to do anything?
- When do I need to file a continuing review form?
- What else do I need to submit with my application?
- The forms seem to apply to Indianapolis, are long and may not be applicable to my given situation. Is all this detail necessary?
- If the Indianapolis Office is currently processing the studies for both campuses, how will they determine what studies need to be addressed first?
- What has the University done to help alleviate the backlog and address delays?
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