The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the concept of informed consent and specific aspects associated thereto.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance.

General Requirements

The scope of the guidance covers, inter alia, the general requirements to be followed with respect to informed consent. For instance, with respect to the language to be used, the authority additionally emphasizes that it should be understandable to potential participants or their authorized representatives. For the purpose of this requirement, “understandable” means the information presented to the prospective subject is in a language and at a level the subject can comprehend (including an explanation of scientific and medical terms).

When it takes to the language to be used, the authority explicitly prohibits the use of exculpatory language requiring a subject or an authorized representative to waive any of the rights they have under the applicable law or release the parties responsible for the study from liability for negligence. According to the guidance, the authority considers exculpatory language to be language that has general effect or freeing or appearing to free an individual or an entity from malpractice, negligence, blame, fault, or guilt.

In order to assist the parties involved in following the above rule, the document also provides several examples of the language that should not be used and would be considered a violation of the above rule, namely:

“I waive any possibility of compensation, including any right to sue for injuries that I may receive as a result of being in its study”; or

“If you suffer an injury as a result of being in this study, neither the institution nor the investigator can assume financial responsibility or liability for the expenses of treatment for such injury”

Instead, the parties responsible for clinical investigations are encouraged to include language that explicitly confirms the rights of study participants in case of any issues or injuries. It is also important to mention that study participants could be asked to bear the costs associated with the treatment for a potential injury, however, they would still be entitled to bring an action against the party responsible for such an investigation.

Basic Elements: Overview

The document also provides an overview of the basic elements of informed consent and highlights the key points associated thereto. In accordance with the applicable regulation, there are eight basic elements to be included in the informed consent provided to potential study participants.

The guidance further describes in detail each of these elements and provides additional clarifications to be taken into consideration by the parties involved in order to ensure compliance with the respective requirements.

Description of Clinical Investigation

The applicable regulation provides that informed consent should contain a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and an identification of any procedures that are experimental. 

In accordance with the guidance, it is important to ensure that potential subjects understand that the clinical investigation they will participate in is primarily intended for research purposes. Preliminary data, which might include bench research, animal studies, pilot studies, and literature, exists, but the main purpose of participation is to contribute to research, such as evaluating the test article’s actual safety and effectiveness.

When discussing informed consent elements, the FDA recommends first discussing the standard medical care a patient might receive if not participating in the research. Subsequently, potential subjects should receive information about the research, allowing them to differentiate between standard care and the research. The description of the clinical investigation should highlight any tests or procedures mandated by the research that wouldn’t be part of standard care. All experimental procedures must be identified, and procedures strictly tied to the research should be clearly explained.

The clinical investigation’s description must elaborate on the test article being studied and, if applicable, the control. This description should provide relevant details on both the test article and the control, including information on FDA approval status and their specific permitted uses. It is also vitally important to address the potential risks and benefits associated with both.

The consent process should also cover what is expected of the study subject in line with the research protocol, detailing aspects such as the number of clinic visits, and any applicable medical or dietary limitations. If detailing every procedure might overload the consent form, the FDA suggests providing general procedures in the main form and detailing study procedures in an addendum.

In accordance with the document, the informed consent process must specify the anticipated duration of a subject’s involvement in the clinical investigation. This ensures their active participation and any subsequent long-term follow-up, detailing the specific procedures to be executed during such follow-ups, potentially utilizing illustrative charts for clarity.

In summary, the present FDA guidance provides an overview of the regulatory requirements for the language to be used for informed consent and outlines applicable limitations. The document also describes in detail the approach to be applied when communicating vitally important information about the study to potential participants. 

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