Regulatory/IRB
True or False: The translated short form contains study-specific/protocol-specific information, such as risks.
In addition to Team Lead, Regulatory, and Sponsor, what other department should be included as soon as a Non-English Speaking patient is identified?
QA
In what electronic system is the consent process documented?
EPIC
(SOURCE: POWERPOINT SLIDE 4)
What should be given to the participant after the end of the consent process?
A signed copy of all documents
(SOURCE: GUIDANCE DOCUMENT)
Who is involved in the consenting process either in person or via the language line?
Certified Interpreter
(SOURCE: GUIDANCE DOCUMENT)
Which IRB does not have translated short forms readily available?
QUORUM
Instead of an approval letter, what does WIRB provide for short forms?
Certificate of Translation/Certificate of Accuracy
What serves as the summary for the translation?
English Long Form consent
(SOURCE: GUIDANCE DOCUMENT)
If an interpreter is used via the language line, how is their "signature" obtained on the consent?
Interpreter’s reference number is written down.
According to the Translation Tip Sheet, who is responsible for contacting the sponsor via email to see if they will pay for the translation?
CRN/CRC
(SOURCE: TRANSLATION TIP SHEET)
Which IRB allows for up to TWO short forms per language, before the long form is required to be translated?
Fox Chase Cancer
After a patient signs a WIRB short form, how long do they have until they need to sign the translated long form?
60 business days
What document does not need to be translated, however must be presented and signed during the consenting process?
HIPAA
(SOURCE: GUIDANCE DOCUMENT)
True or False: Per WIRB, all patient materials do not have to be translated, but can be given to a Non-English speaking patient if an interpreter is present.
FALSE
(SOURCE: EMAIL FROM WIRB 7/24/19)
True or False: The language line is only available 9am-5pm.
False (24/7)
(SOURCE: FCCC WEBSITE>LANGUAGE SERVCIES & INTERPRETERS)
Per NCI guidelines, if the consenting process for Non-English speaking patients is not documented correctly, what does this result in?
Major Deviation
What form does the interpreter sign if they refuse to sign the consent form?
Interpreter’s Statement
True or False: The risk section should be summarized to the patient.
FALSE •The risk section must be read word for word
(SOURCE: POWERPOINT Slide 5 & GUIDANCE DOCUMENT)
Where can you find all of the guidance and tip sheets regarding Non-English speaking patients?
SharePoint --> QA/Compliance
(SOURCE: POWERPOINT SLIDE 13)
What two signature lines are on the interpreter’s statement?
Interpreter and Patient
(SOURCE: GUIDANCE DOCUMENT)
After a modification is created in eIRB, what step needs to occur BEFORE the short form can be given to the patient?
PI Sign-Off
If a patient is deemed ineligible and not returning to FCCC after signing a WIRB short form, do they still need to sign the translated long form?
*Per WIRB email dated 5/2/2019.
What fully translated consent form language is typically available for CIRB studies?
Spanish
-Translation Tip Sheet, Page 2.
True or False: If a CRN/CRC or Physician are fluent in the patient’s primary language, they may act as the interpreter.
FALSE
(SOURCE: GUIDANCE DOCUMENT)
What three signatures are required on the long translated consent?
Patient
Physician
Interpreter *
*if refuse - Interpreter statement
(SOURCE: POWERPOINT SLIDE 8)