Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

When a non-English speaking subject joins a trial and the consent forms are in English, what must be done?

1. Translate the forms in-house

2. Request the sponsor for a translated version of the consent

3. Ask the daughter to translate the documents

4. Proceed without signed consent

The correct answer is: Request the sponsor for a translated version of the consent

The selected answer highlights the importance of ensuring proper communication and informed consent in clinical trials, particularly when non-English speaking subjects are involved. When the consent forms are only available in English, it is crucial to obtain a translated version to facilitate understanding. This is not just about providing information; it’s a regulatory and ethical requirement to ensure that participants can fully comprehend the study details, including risks, benefits, and their rights. Requesting the sponsor for a translated version ensures that the translation is done by professionals who understand the context of the trial and can accurately convey the information in the participant's language. This minimizes the risk of misinterpretation and upholds the integrity of the consent process. In contrast, translations done in-house may not always adhere to official standards, and relying on a relative, like a daughter, to translate could introduce biases and inaccuracies. Proceeding without signed consent is a violation of ethical standards and regulations, undermining the entire framework of conducting clinical research responsibly. Thus, obtaining the translated consent form from the sponsor is the most appropriate and compliant action.