Question

​​​​​​A 10-year-old Hispanic boy is admitted for bone marrow transplantation as treatment for acute myelogenous leukemia. The doctor wants to enroll the patient in a clinical trial for a new pain medication, but both the par- ents speak only Spanish. The consent form is in English, and the physician has a limited knowledge of Spanish. What is the physician’s best option for obtaining consent from this pa- tient?

4. (A)  Explain the study to the whole family in Spanish, to the best of the physician’s abil- ity

5. (B)  Have a Spanish-speaking employee of the hospital translate for the patient

6. (C)  Have the parents sign the English form af- ter discussing the study via an interpreter

7. (D)  Obtain a translated consent form and dis- cuss the study via an interpreter

8. (E)  The boy speaks English, so the parents’ consent will not be required

Answer 1

The correct answer is D. Obtaining informed consent from the patient means that the pa- tient understands the risks, benefits, and al- ternatives to the study, and that the doctor re- lays to the patient pertinent matters about the plan of care. For the non-English-speaking patient, the consent is translated into the ap- propriate language and discussed with him/her through an interpreter. This allows the patient (or in this case, his parents) freedom to read and process the consent and to discuss it later. Whereas this option may not be possible for every language or reasonable for every study, it is appropriate in this non-emergent situation.

Answer A is incorrect. With limited knowl- edge of Spanish, the doctor will unlikely be able to address all the important issues delin- eated in the consent form.

Answer B is incorrect. Having someone other than an interpreter translate will be invading patient privacy, incomplete, and not perfectly accurate/reliable.

Answer C is incorrect. In a non-emergent set- ting, the best approach is to allow the patient/ family to view a translated copy of the consent and consider all their options in an unbiased manner. The use of an interpreter, however, would be invaluable in an emergent setting.

Answer E is incorrect. The patient is too young to give consent (<18 years).