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?