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Initial Submission Standards
Effective July 1, 2019 the IRB office will begin returning, without review, new study submissions and human subject determination request applications that are incomplete or do not meet minimum submissions standards.  An Initial Submission Checklist is available to assist with submitting a complete application to the IRB.  Submitting a complete application will help avoid delays from the time of submission to the time of receiving IRB approval.  MEDICAL RESIDENTS please have your research project reviewed by your assigned Ph.D. advisor before submitting to the IRB.


REASONS applications will be sent back:
•    Missing study protocol
•    Missing ancillary committee review (i.e. Protocol Review Committee)
•    Missing McLaren required CITI training (for the PI and/or Academic Advisor)
•    Missing consent documents
•    Major inconsistencies within or between documents (e.g., application or consent form does not match protocol)
•    Important attachments are missing that are needed for the review (e.g. recruitment materials, data collection tools, questionnaires, etc.)


Research policies, forms, and templates can be found at https://www.mclaren.org/main/research


If you have questions or concerns about your submission, please contact the Research Integrity department before you submit your study at 248-484-4950 or at hrpp@mclaren.org.

 

All prospective interventional studies will need to be reviewed and approved by the MHC Protocol Review Committee (PRC) prior to submitting your eProtocol application to the IRB.  This includes medical residents/fellows.  Send your request for review to mcri@mclaren.org, subject line PRC Review. 

 

 

 

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