Patient-Related Issues

The Wednesday AccrualNet Blog Post (8-22-12): Lost in Translation

Last Updated: Sep 13, 2012

Originally posted by: Annette Galassi, AccrualNet Team Member, on the former Accrualnet site on August 23, 2012.


I’ve recently returned from Ethiopia, where I spent time on the oncology unit of a large public hospital. Although almost all of the health professionals spoke English, Amharic was their primary language and the language spoken by patients. I loved Ethiopia but found it difficult to not always understanding what was being said and unsettling to not know if I was really being understood.


Being in this position gave me a new appreciation for the challenges faced by our patients with limited English proficiency (LEP) - those individuals who do not speak English as their primary language and have a limited ability to read, speak, write or understand English. These patients must navigate a complex health care system and routinely interact with members of the health care team who do not speak their native language. If they are approached about joining a clinical trial, they may receive information about it from providers who have difficulty explaining concepts in “plain English” or through an interpreter. They are faced with a long, complex consent form that is barely comprehensible to those of us who are fluent in English.


What resources are available to help us make this process less daunting for our patients with LEP? One is the Office of Human Research Protections (OHRP) approved Short Form. This is a written consent document (stating that the elements of informed consent required have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required and the participant must be given copies of both the short form document and the summary. The witness should be fluent in both English and the patient’s language and the English language consent document can serve as the summary. For additional information visit the OHRP web site.


What strategies, resources, or tools do you use for the informed consent process with participants with LEP? Do you use translation services for your consent documents? If so, how do you cover the associated costs?

Candace Maynard's Image

Originally posted by: Gina Pokrashevsky, Project Coordinator, ENACCT on the former AccrualNet site on August 28, 2012.

As a part of ENACCT’s National Cancer Clinical Trials Pilot Breakthrough Collaborative, the five participating community oncology practices were also interested in strategies for improving access to trials for LEP and low health literacy patients. Using questions from the sites, ENACCT surveyed the national experts serving as coaches for the project. Some sample responses are included below.

Q: What hasn’t worked?
A: Trying to translate every consent form

Q: What has worked?
A: We use the short form, translated to Spanish. We make sure there is a family member that speaks English to be able to report symptoms, etc. and communicate with the research team. They may be used to discuss the treatment options and consent with the patient up until the point that the patient will be signing a consent. Then we use a certified translator – the hospital provides Spanish translators on site. For other languages, we use the AT&T translation line.
A: Phone interpreters, navigators (in culture), community partners and NexTalk.

Q: What other clinical trial tools do you have for your patients who do not speak English?
A: Clinical trial fact sheets, study specific sell sheets.

Q: What IRB issues/concerns do you have and how have you addressed them?
A: Initially there was concern over use but we have developed such a robust cancer care process for these patients that it is part of the institutional culture. MD champions were critical.

Q: What other suggestions can you make for the challenges of respectfully working with non-English speaking, or low health literacy individuals?
A: Our practice is to take as much time as possible to ensure understanding. We rarely talk with a patient, consent and start on the same day. We try to always have the discussion, send the patient home with the ICF, then talk again when the patient returns. We always include the family and encourage patients to have someone with them who will take notes.
A: In culture staff is critical or cultural competency/promotora training for staff.

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