Friday, June 06, 2008

English As A Second Language

An interesting issue came up today as I sat before our Investigational Review Board (IRB) on behalf of a colleague who was trying to get a multi-center, prospective, randomized NIH-sponsored trial approved. The trial uses a medical device in one arm (the subject of randomization). The issue at hand involved the insistence (by trial design) that the patient participants should be fluent in English.

Immediately, the reviewers of the protocol were concerned that excluding patients based on their language of origin might suggest enrollees were discriminated upon based on their ability to speak English. This was, after all, an NIH-sponsored trial. It is true that, historically, women and minorities have been underrepresented in national trial designs – the desire to adequately represent these groups seems appropriate. But I found it difficult not to require enrollees to be fluent in English for such a complicated trial involving over 2 years of follow-up – it is, after all, our national language. More importantly, I argued, the very reason we were sitting before the IRB was because the investigation was felt to pose “less than minimal risk” for our patients. If a problem arose during the course of the trial, and a non-English-speaking patient calls our center, would they be able to communicate their concerns? More importantly, would we have the capabilities to communicate with them? Would this potentially increase the risk to the patient if communication were compromised? In to how many languages should our consents be translated? Spanish? Hindi? Urdu? Mandarin? Russian? Polish? The list seems endless.

Are we discriminating against a sect of the population that is non-English-speaking by not offering them these trials or just playing it safe by excluding those not fluent in our language?

The answer seems obvious to me, but then, I speak English. Any one else have thoughts on this? Suggestions?

4 comments:

Ian Furst http://www.waittimes.blogspot.com said...

If you dont' have the funds or resources to have a translator on the trial then it seems reasonable. I remember seeing a family that came from another country under a charity program and was asked to participate in a study. It raised the question of whether they felt pressure to participate in the study in order to retain funding. Obviously it was not the intent but it was the perception by the patient that creates the ethical issues. What is the perception of a non-english speaking patient who is explained anything about the trial in english? Will they feel a greater obligation to agree due to self-conciousness?

DrRich said...

Wes,

I chaired a busy academic IRB for almost 10 years, and this question often came up. My view was that the purpose of the IRB was to assure that the rights and welfare of the research subjects were appropriately honored. By "rights" of the research subject, I always focused primarily on the right to be fully and completely informed as to the nuances of the research, specifically, on the obligations the patient was accepting, and on the risks the patient was agreeing to. Unless the patient completely understands their obligations under the research, and all the possible risks their participation in the research entails, then they will be unable to make a fully informed and autonomous decision as to whether or not to participate. In my mind, this consideration far outweighs the consideration of the patient's ostensible "right" to be invited to participate.

Accordingly, the more complicated or the more potentially risky the research study, the more important it was to assure that direct investigator-to-subject communication could take place, that is, the more reasonable it was to limit research subjects to English language speakers. In my experience, these kinds of studies (the more complex ones with at least some risk involved) were the only studies where the investigators commonly asked for the study to be so limited. If an investigator asked to limit a simple, risk-free study to English speakers (which always seemed to me to be for the convenience of the researchers rather than for potential safety or autonomy of the research subject), we would ask them to make a reasonable attempt to find translators for at least Spanish-speaking patients (since such translators were widely available and would often volunteer to help for free).

To summarize, I always placed the issue of patient safety and patient autonomy ahead of the issue of diversity. This was not politically correct even in the 1990s, and today may constitute heretical thinking that may mandate a visit by the inquisitors.

Rich

DrWes said...

Rich-

Thank you. I suspect we're taking your approach - perhaps not PC, but hey, I think the priorities, in this case, are aligned correctly...

Rogue Medic said...

If you have predominantly English speaking researchers using translators to provide information to people, who are not predominantly English speaking, don't you introduce another variable into a study that obtains validity from its ability to control for as many variables as possible?

Is there a culturally different approach to the same information? Is there a problem with compliance or with inclusion of herbal "remedies" that the researchers have not been made aware of?

I think that the treatment of non-English speaking patients does affect the study and should be addressed in the discussion.