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

2. 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

3. 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

4. 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

5. 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…”

6. 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

7. 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.

8. 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

9. 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

10. 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

11. 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

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

13. 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.

14. 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.

15. 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

16. 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

17. 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

18. Questions

19. Contact the IRB Contact the QA and Education Team! Name Email Phone
Maria Davila, MD, CCRC, CIP
(404)
Shara Karlebach, WHNP-BC, CIP
(404)
Jessica Baker, BS
(404)
Clarissa Dupree, BS
(404)