By Charlotte Crowder, MPH, ELS, Freelance Medical Writer and Editor
Use these tips to help medical writers create plain language, ethically sound informed consent documents with easy-to-read formats for participants in investigative clinical trials.
Ethical Premises of Informed Consent
Medical research depends on the voluntary participation of research subjects, and the informed consent process is based upon ethical principles outlined in the Nuremberg Code1 and the Declaration of Helsinki2 to protect those subjects.
The chief components of an ideal informed consent process include the following.
- Written information for prospective subjects about the research study
- Face-to-face discussion between the prospective subject and clinical staff
- Ample time for the prospective subject to consider participation in the research study
Although no substitute for the in-depth conversations that study personnel should be having with prospective subjects, the informed consent document should be viewed as a major decision-making tool in a subject’s choice regarding whether to participate in a trial.
Subjects’ anxiety or desperation may impede comprehension and give them false hopes regarding potential study outcomes. Use wording to ensure that trials are clearly and objectively presented as research to answer a medical question. Investigational products must be represented as such and not misconstrued as approved treatment. This careful attention is necessary to prevent what is known as the therapeutic misconception, when clinical studies involving investigational products are seen by subjects, and sometimes even by clinical investigators, as offering therapy beneficial to participants.3 Use neutral terms such as subjects or participants to refer to those who voluntarily take part in studies at any clinical phase. Although they may indeed be someone’s patients, they are not patients in the context of the study.
Key Information. The International Conference on Harmonisation outlines the specific items required in an informed consent document. The focus of the written material should be on the key information a prospective participant needs to decide whether or not to take part in the trial.4
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