Writing for the Participants of International Clinical Trials: Law, Ethics, and Culture

Purpose: Regulatory authorities and health care practitioners participating in international clinical trials are often discussed in the technical writing literature. However, the most vulnerable audience—the participants—is left out of the conversation. The purpose of this article is to examine the influence of legal and cultural contexts on participant-directed informed consent documentation. Such examination will help technical communicators make informed consent documentation more user-centered.

Method: Using excerpts from informed consents that I translated into Russian, examples from my six years as a localization specialist, and an overview of contradictory U.S., Russian, and international laws, I analyze the legal, ethical, and cultural considerations for informed consent documentation in international clinical trials.

Results: The results of this analysis show that international regulations often differ from U.S. and Russian laws. In addition, the culture and way of life in the country where a clinical trial originates (e.g., the United States) might differ from those in the country where the trials are conducted (e.g., Russia). These differences influence the comprehension of information in informed consent documentation and a patient's decision to take part in a clinical trial. Technical communicators are often responsible for the difficult task of reconciling the contradictory issues raised in international clinical trial legislation, differences in legal systems of particular countries, and tensions between law and culture.

Conclusion: I offer strategies that technical communicators can adapt to work in the best interests of their audience and to present user-centered information in informed consent documentation.