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Revised Informed Consent Template and Suggested Language Library

 

 

The IRB has revised the MUSC informed consent template to provide expanded guidance and instructions for writing the consent form.  Many of the instructions included are based on the comments that the IRB frequently issues to researchers.  When followed properly, the use of the revised template and suggested language should minimize the number of revisions needed to the consent form. 

Examples of the guidance included in the new template:

  • More explicit formatting instructions
  • Language for combined consent for minors and adults
  • Resources for use of non-technical language at an 8th-grade reading level
  • Clarification of which language is suggested versus required
  • Expanded instructions detailing the expectations for the content of each section

The revised informed consent template is available on the IRB Forms page

 

NOW AVAILABLE!

SUGGESTED LANGUAGE LIBRARY for PROCEDURES and RISKS SECTIONS

This language has been drafted to describe common specific procedures and the risks of those procedures.  The use of this language will ensure that research procedures are described clearly and in lay terminology in a consistent manner.  Please feel free to copy and paste into the informed consent as applicable. 

**This page is a work in progress!  If you do not see suggested language for a specific procedure or risk, please contact the IRB with suggestions.

The webpage for the suggested language is available for use and is located on the IRB Forms page Standard Consent Language (http://academicdepartments.musc.edu/research/ori/irb/suggested_consent_language/)

 

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  • Applications that the IRB Determines are Not Ready for Review
  • 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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