Informed Consent

When does the Informed Consent process End?

• When the subject is given a copy of the informed consent

• When the subject signs the informed consent

• When the subject completes all study activities

• When the study closes out

The current version of iConsent automatically provides the subject with a copy of their completed consent so it is not needed to provide them with a copy following the encounter.

• True

• False

How many days do you have to update the subjects Epic chart?

• 1

• 3

• 5

• 7

During a consent review it's revealed that the subject did not date their signature, utilizing the event tracking note in Epic you can confirm the exact date and time the consent took place. How should you document the missing date for the subject?

• Write in the date for subject using Epic 

• Write in the date for subject using Epic and attach Epic note

• Write in the date for subject using Epic and attach Epic note and signify that you were the one writing in the date on their behalf 

• Oh my goodness please don’t write in anything for the subject this is not allowed 

Which of the following best describes a qualified bilingual/multilingual staff member in a covered entity's workforce?

• Fluent in English and another language, with knowledge of specialized vocabulary.

• Basic in English and another language, without specialized vocabulary.

• Multilingual but lacking specific communication skills.

• Proficient in English and multiple languages, regardless of specialized vocabulary.

If the IRB requires re-consenting, all patients must be reconsented within 60 days from IRB notification of approval.

• True

• False

Subjects who are transferred from another site to don't need re-consented.

• True

• False

Which of the following statements regarding informed consent for participation in research involving children is true?

• If both parents are present, only one signature is needed for the child's participation.

• The IRB doesn't decide if one or both parents' signatures are needed because its always both parents.

• Verbal assent is required for ages 7-12, and written assent for ages 13-17.

• If a child declines participation, the process stops until parental or legal guardian consent is obtained.

Which of the following statements accurately describes the waiver of consent process?

• The IRB always requires full consent for all studies, regardless of risk level.

• Waiver of consent is only granted for studies with significant risk to participants.

• The IRB may approve the Principal Investigator to modify or waive the consent process for minimal risk studies or procedures.

• Waiver of consent is only applicable for studies involving vulnerable populations.

Following signing a consent form, Epic experiences a technical interruption and a delay in the delivery of a signed electronic consent to study staff and the subjects EMR. Since the document was seen completed, study activities can still take place while waiting for Epic to update 

• True

• False