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Supporting Education and QI in Research (SEQuR)

4. What are some of the things that I have to consider before submitting an application to the IRB?

What type of IRB application do I need to complete? The same application is used for both minimal risk studies and greater than minimal risk studies IRB Application. If you are unsure about what category of research or what form to complete you should contact the administrative support for the MMC IRB at 207-396-8240.

 

What level of risk is this study, minimal risk or greater than minimal 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.  Anything else is considered greater than minimal risk.  If you are still unsure you should contact the administrative support for the MMC IRB at 207-396-8240.

 

Your study may meet the exemption criteria if you are not collecting patient identifiers while conducting a minimal risk study.  Please see more below.

 

Have the educational requirements been completed for all research staff? There are several educational pieces that need to be completed.  For more information on these please go to our website at www.mmcri.org/citi.

 

Are any of the research activities being conducted at a location that is not under the jurisdiction of the MMC IRB / Privacy Board?  MMC IRB approval of your research study does not include permission to perform any research related activities at these sites; additional IRB approval may be required.

 

One example would be when research related activities are done by an MMC employee at a site (Hospital/University) which has their own IRB in place. IRB review of the research at that site may be required.

 

Another example is when research activities are done at a private practice which does not have an IRB in place.  In this example MMC IRB requires a "letter of support / permission" written by the practice administrator or equivalent.

 

If the research activity will involve any Department (outside of your own) at MMC that will be necessary to support your research you must obtain review and sign off from each Department using the Internal Services Checklist before your application is submitted to the IRB.

 

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Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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