Translation of Informed Consent Forms: An Introduction

Clinical trials are undoubtedly important. Without them, little scientific or medical progress would be possible. But even more important than the trials themselves, is the welfare of the human participants. They are an integral part of the clinical trial process. Their rights and wellness should always be a priority. One way to ensure all participants are fairly treated, is through the proper translation of informed consent forms. 

What is an Informed Consent Form?

An informed consent form is a requirement, not an option. A human can not partake in the research process during a clinical trial without signing one. These forms obtain a participant’s consent to participate and inform them of their rights. A participant should expect to find the following information on an informed consent form in a clearly described and understandable way.

  • A summary of the procedure or study.
  • The purpose of it.
  • The duration and schedule.
  • Expected procedures.
  • Potential benefits and risks.
  • Alternatives to participating.
  • The rights and responsibilities of those involved (the participant, study administrators, sponsors, etc.).

The requirements of an informed consent form ensure that a subject’s participation is voluntary. Informing participants about all aspects of the trial required both ethically and legally. 

Informed consent forms consist of two parts. One part is the information sheet that includes the aspects outlined above. The second part is the certificate of consent. Participants receive a copy of their informed consent form and information sheet. 

Where Does Translation Come In to Play?

Ensuring all research participants are properly informed of what a medical study entails is vital, or else you risk violating a participant’s rights. Being prepared to overcome language barriers can be necessary to ensure no violations occur. A language barrier or poor translation efforts can derail a clinical trial. A barrier can also harm a participant. Particularly if they do not understand what they are agreeing to.   

The proper translation of informed consent forms is a more pressing need than ever before due to the increase in medical research conducted in developing countries. These locales are often chosen as the site of clinical trials because they offer reduced costs. As well as access to affected populations who may benefit from the trial. For some, these trials are the only access to medical care they have. 

What is at Risk?

These trials can lead to new treatments, vaccines, and medications. But they can also violate the ethical rights of the at-risk populations found in developing countries. These violations can occur in first world countries too. Particularly, in locations like the United States where different cultures and languages frequently mix. Working with a seasoned translation expert can help avoid these violations and contribute to the success of a clinical trial.

It is not appropriate to exclude a participant due to their inability to read or understand a particular language. Doing so violates the governing principles of human subject research. Respect for persons, beneficence, and justice. Researchers must communicate directly with a subject or provide a trustworthy alternative to ensure they understand their rights, risks, and what their participation will entail.