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ANNOUNCEMENT REGARDING Non-English Speaking Subjects - What is a Short Form Consent?

 

To meet the federal requirements, the informed consent document should be in a language understandable to the subject (or authorized representative), and a copy of the consent document must be given to each subject. When the study subject population includes non-English speaking people the IRB requires a translated consent document to be prepared and submitted to the IRB with an assurance that the translation is accurate.

If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. If investigators enroll subjects without an IRB approved written translation, a “short form” written consent document in a language the subject understands should be used to document that the required elements of informed consent were presented orally. 

What is a short form? The short form is a modified consent form written in a language understandable to the subject (or legally authorized representative) that outlines the basic requirements for informed consent.

 Where is the short form located?

The short form consent is available on the IRB website http://academicdepartments.musc.edu/research/ori/irb/forms.html 

One form is available in English and one has already been translated to Spanish by an ATA certified translator.

 

How do I use the short form consent? The short form consent process requires the assistance of a translator and the presence of a witness.  A guidance document provides detailed information on the requirements for the person obtaining consent, the translator and the witness.

 

What happens after the short form is used?

Within 30 days, the PI must submit an amendment to the IRB with a fully translated informed consent to be used to re-consent the subject and to consent future non-English speaking subjects.

 

Does the IRB have a detailed policy about enrolling Non-English Speaking Subjects?

Yes. HRPP 7.5 provides a thorough outline of the necessary requirements and is located on the IRB website at http://academicdepartments.musc.edu/research/ori/irb/HRPP/HRPP%20Guide%20Section%207.5

 

 

What about HIPAA?

There is now a fully translated Spanish HIPAA Authorization available for all investigators to use.  It is located on the IRB website http://academicdepartments.musc.edu/research/ori/irb/forms.html 

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    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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