Family Members as Interpreters: Review of Emory Guidance IRB Webinars- 1/12/2017

Topics to be covered Why the Guidance was Created Belmont Report principle of Justice What does the law say? Title VI of Civil Rights Act CLAS Standards Emory Healthcare policies Children’s Healthcare of Atlanta policies Implications for research IRB Guidance

Why the IRB Created this Guidance No IRB policy previously addressed the issue Guidance developed after receiving questions from investigators Consulted interpreters, ethicists and IRB members who are also researchers Goal: support the protection of human subjects without overburdening research community

The Belmont Report Respect for Persons, Beneficence, Justice Justice: participants shouldn’t be excluded unless there is a compelling reason Research quality is enhanced when conducted across a range of beneficiaries Excluding those with limited English proficiency may reduce generalizability

What does the law say? US law doesn’t say anything about using family members as interpreters US Corporation for National and Community Service policy guidance: recipients of federal financial assistance should provide services for patients who have limited English proficiency (LEP). “a responsibility to ensure meaningful access to their programs and activities…”

Title VI of Civil Rights Act 1964 Prohibition against exclusion from participation in, denial of benefits of, and discrimination under federally assisted programs on ground of race, color, or national origin

CLAS Standards The National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care HHS Office of Minority Health Principal Standard Provide effective, equitable, understandable and respectful quality care and services that are responsive to diverse cultural health beliefs and practices, preferred languages, health literacy and other communication needs.

Emory Healthcare Policies for Treatment Follows Title VI and CLAS Standards Provides free access to the following: Document translation for medical documents Video remote interpreting for American Sign Language Telephonic Interpretation for over 200 languages On-site interpretation during normal business hours; some languages require 24 hour advance notice

Children’s Healthcare of Atlanta Policies for Treatment Follows Title VI and CLAS Standards Family members may not be interpreters when medical procedures are involved Provides access to the following: Spanish and other foreign language interpreters Phone interpreters Sign language interpreter Written translations Cultural resource support

Implications for Research Higher stakes in research Subject has to understand: the project is research may be no direct benefit any other information that may affect decision to participate

Downsides to prohibiting family member interpretation Potential sample bias Delays due to being second priority for interpreter resources Additional cost for studies that do not have access to free interpreter services Risks raised by using phone interpretation since subjects don’t interact the same way as with in-person interpretation

Consensus Despite the downsides, family members should not be used as interpreters.

IRB Guidance The IRB requires a qualified interpreter during consent and re-consent of subjects and when describing any medical procedures and tests during the conduct of a study. Minors are not allowed to serve as translators under any circumstance.

IRB Guidance Study team members who are proficient in the language of the subject may be used as interpreters. Team must document that they are truly capable of interpreting for subjects. It is expected that the team member is truly proficient and culturally aware. Family members and friends cannot serve as interpreters for these discussions.

IRB Guidance The IRB may allow adult family members to serve as interpreters for minimal risk, socio-behavioral or non-clinical health studies. Unrelated interpreter would only be required for consent discussion- not data collection Study team should explain the plan to use adult family members in the initial study submission

IRB Guidance Exp: Socio-behavioral/public health study where study documents are fully translated. A qualified interpreter could handle the consent discussion An adult family member or other non- professional interpreter may help with administrative and logistical conversations during study visits

IRB Guidance The IRB may allow for the use of adult family members as interpreters in acute settings There must be a potential benefit for subjects participating in the study Study team must make the case that time limitations preclude the use of a professional interpreter The plan must be laid out in the study’s initial submission

Questions

Contact the IRB Contact the QA and Education Team! Name Email Phone Maria Davila, MD, CCRC, CIP maria.davila@emory.edu (404) 712-0724 Shara Karlebach, WHNP-BC, CIP swilli7@emory.edu (404) 712-0727 Jessica Baker, BS jessica.baker@emory.edu (404) 712-9698 Clarissa Dupree, BS cdupree@emory.edu (404) 727-8864