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Prospective Clinical Trials Involving the Consent Process: Consent

Consent Forms

This section should include all IRB approved/stamped consent forms stored in reverse chronological order with the current approved version first.

Signed and completed consent forms and notes documenting the consent process for study subjects may be kept with their study record or in a separate binder.  A copy of the signed consent form should be given to the participant and added to the medical record.

Note:  any changes to the consent form must be submitted to and approved by the IRB prior to use except when necessary to eliminate apparent immediate hazards to the subject.

Consent forms for subjects who enrolled (signed consent form) but are found to be ineligible or later withdraw from the study must be kept.  A note to file explaining the ineligibility or withdrawal should be created and kept with the consent form.

Consenting Non-English Speakers

Per regulation, the informed consent process must be done in a language that is understandable to the subject. Based on our patient population, the Institutional Review Board (IRB) requires that most consent forms (CF) and subject research materials be fully translated into Spanish.     

In addition, researchers should plan in advance so that an interpreter is available as needed for the consent process and ongoing interactions with the subject. 

To ensure the accuracy of interpretation, unless a provider is a native fluent speaker of the patient’s language, an interpreter must be arranged for by contacting Interpreter and Translation Services.

The criterion for requiring translations of consent forms and other research materials is based on the native language of the expected study population. If the expected study population has a >5% native language other than English (which is the case of the Spanish speaking population in Springfield), then studies must have the consent document and research materials translated into that language. This criterion is generally waived if it involves a pilot study of <10 patients with no expectation of benefit or a study that has an expected enrollment period of <42 days.

Effective October 1, 2010, industry funded studies will be assessed a $750 fee for consent form translations when required per IRB guidelines.  (see link to Translation & Use of Interpreters form for full description)

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