Informed Consent Form Translation
On the way to market, clinical trials are a crucial part of determining a treatment’s benefits, safety and efficacy. While subjects should not be exposed to unreasonable risks, clinical research by definition involves some uncertainty. For that reason, regulatory agencies such as the US Food and Drug Administration (FDA) require all subjects who participate in clinical trials to first be informed about those risks and to freely provide their consent, in whatever language they speak. That’s where the translators come in.
What Is Informed Consent?
The FDA mandates an informed consent process for clinical trial subjects and potential subjects. The goal is to help them understand all of the implications of participating in the clinical trial, so that they may make their own informed decision. Subjects are provided complete information about the clinical trial in writing. In addition, they are given the opportunity to ask questions and receive answers about the trial. If the subject accepts the possible risks and benefits, he or she signs an informed consent form and begins the enrollment process.
The FDA’s Informed Consent Requirements
As part of the informed consent process, the US Food and Drug Administration (FDA) requires patients understand certain information related to the clinical trial. This includes:
- What the trial is studying and the purpose of the research,
- The researchers’ names and credentials,
- A full account of the research procedures involved in the study,
- What is expected of a participating subject,
- Distinguishing which procedures are experimental and which are standard,
- The expected duration of the subject’s participation in the trial,
- How the study handles confidentiality,
- Potential risks,
- Potential benefits,
- Alternative treatments independent of the study,
- Any type of compensation to be received,
- That subjects have the right to leave the clinical trial at any stage and
- That researchers also have the right to end the study at any time.
The Need to Translate Informed Consent Forms
Whether a clinical trial is conducted at home or abroad, considering the implications of participation requires that informed consent forms, as well as other pertinent information about a clinical trial, are provided in a language the subject understands. Translated informed consent forms need to accurately represent the original, be readily understandable by the subject population and stand up to regulatory scrutiny. Not so easy in translation. Serious expertise is required.
Experts in Informed Consent Form Translation
Like other types of clinical trial translation, translating informed consent forms requires specialized expertise at every step of the way. For more than 20 years, Responsive Translation has been providing compliance-intensive translation services with our ISO 9001 and ISO 13485 certified processes and triple-check quality assurance.
As a strategic partner, we work closely with clients to meet regulatory and Institutional Review Board requirements. We can advise whether steps like back translation are necessary.
Responsive Translation only uses highly-qualified and experienced native-speaking medical translators, medical translation editors and clinical subject matter experts. We provide certificates of translation accuracy, which most Institutional Review Boards require to approve a translated informed consent form.
To discuss your specific translation requirements, or for more information about Responsive Translation’s range of clinical trial translation services, please contact us at +1-212-355-4455 or firstname.lastname@example.org.