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Office of Research Integrity

Institutional Review Board for Human Research (IRB) Front Page

ANNOUNCEMENT REGARDING Applications that the IRB Determines are Not Ready for Review

When the IRB receives an application that is prepared in such a way that the proposed research procedures are unclear or large components of the application are missing, reviewers will be unable to provide meaningful comments and guidance.  In such cases, the application will be withdrawn in eIRB, and recommendations for additional resources and guidance will be provided to the PI.  Below are some examples of scenarios in which the IRB may determine that an application is not ready for review: 

  •  Missing or inadequately prepared essential documents, including:
    • protocol
    • consent form/s
    • questionnaire/s or focus group materials when the main component of the study is the administration of that material
    • documentation needed to determine the engagement level of any off-campus study sites
    • drug or device documentation 
  • Inconsistent or unclear description of procedures such that the reviewers are uncertain of what is being proposed
  • Project described does not seem to constitute research with human subjects as written
  • Recurrent errors throughout the application and attachments to the extent that a detailed review and revision of the entire application is needed Information presented in the SmartForm is not in agreement with the information provided in the protocol, ICF and other supporting documents

When an application is withdrawn in this manner, the recommendation from the IRB is to:

  • Seek help from the free on-campus research support services at the SUCCESS center. 
  • Talk with Principal Investigator’s Mentor to receive guidance on how to provide a complete application.
  • Set up a meeting with the IRB Administrator and Chair

 *Please refer to the SUCCESS center website at

http://academicdepartments.musc.edu/sctr/programs/success_center/index.htm

 to request regulatory services. 

  • Before a study is submitted to the IRB, departmental approvals must be obtained. The eIRB system automatically routes the study to the approving individuals along with a notification email...
  • Expedited Review-Retrospective Studies...
  • From the FAQ Page

    Q9.1 Why am I not able to log into the eIRB?

    A9.1.

    • Please make sure when entering your username you are entering your MUSC NetID name. Then enter your password.
    • If you continue to have log in issues, you may need to be registered in the eIRB system. This may be the case for someone who has just been assigned a NetID and has not yet been added into the eIRB system. If this is the case, the 1st time a new user logs into the system, a registration screen will be displayed. Fully complete the requested information. Note: Non-faculty member study PIs will require a mentor to be able to be listed in eIRB with PI rights. To ensure this, check the box that indicates you are a student, as this is the mechanism to grant you this PI access right. After the registration form is complete and the user clicks ok, an email is sent to the MUSC eIRB administrator. The site administrator will complete the registration (about a 24 hour turn-around timeframe), assign the user roles appropriate to the user’s research activities and activate the account. The user will receive an email notification of account activation. This process can take up to 24 hours; however, if registration is required sooner, contact the eIRB systems administrator.
    • If you continue to have log in issues, you may need to contact OCIO at 792-9700 to ensure your Net ID is working properly.

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