Clinical Data Interchange Standards Consortium (CDISC)
August 22, 2024
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Informed consent form is a process in which competent participants, after receiving and comprehending all research-related information, can voluntarily express their intention to participate in a clinical trial. While clinical trials identify the safety and efficacy of the investigational product,1 the primary goal of IC is to safeguard the patients or participants being recruited in these trials and ensure that they have received the information they need to know about what they are getting themselves into.
A language-based approach to creating and interpreting informed consent forms
The patient information sheet attached with the informed consent form (ICF) suggests that the principal investigator informed the individual in every detail about their involvement in the research procedures.2 In simpler terms, the main purpose of the ICF is to inform the prospective participants in a clinical trial that they are “subjects of research” rather than actual patients. Additionally, to take the voluntary decision, the information contained in the ICF must be understandable to the prospective participant or the representative.3 Therefore, the language of ICF plays a major role in the consent process.
As per 21 CFR 50.20, ‘no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative’.3
The consent procedure must correspond to the specific organization regulations for clinical trials as well as the patient’s right to autonomy. Both the investigator overseeing the clinical research and the volunteers are protected by laws and consent rules. An Institutional Review Board (IRB) often keeps an eye on how ethical guidelines are followed during the planning and execution of studies.4
One of the most significant advancements in the area of ethics about biomedical research involving human beings in the last five to six decades has been the acknowledgment of the moral right of research subjects to make their own choice, to self-determine, or to decide on the study’s involvement. These three elements are the key to the ICF.5
The collaborative nature of the ICFs is another crucial aspect, which enables participants and the investigator to agree on multiple reasonable options while taking into account the participant’s particular preferences and priorities and the best available specific evidence.4
The language of ICFs is bringing a new debate about whether it should be universally understandable, as it is quite difficult for participants from different regions and without prior knowledge of clinical trials or research to comprehend the information or rules. However, even english speakers struggle to grasp the language of ICFs; imagine how difficult it would be for persons with limited English proficiency.
The impact of language about key information and financial implications was determined in a research investigation in which the participants respond, with higher frequency to understand the compensation for injury process specific to the trial in tailored ICFs compare with the standard one. The findings of this study suggested that refining ICFs to clarify the key information to the participants in the context of comparative effectiveness trials is beneficial to improving study comprehension more easily.7
In addition, according to both the United States (US) Food and Drug Administration (FDA) and the US Department of Health and Human Services (DHHS), it is mandatory to translate the ICFs for all participants with limited English proficiency. The ICF must meet the requirement of these both agencies according to the following guidelines: 6,8
Per DHHS:
In clinical trials conducted under the FDA guidelines, the ICF must comply with 21 CFR 50.20 and comprise the information needed by each of the eight fundamental aspects of 21 CFR 50.25(a) and each of the six aspects of 21 CFR 50.25(b) that apply to the investigation. However, the IRBs have the last say on whether the information in the ICF is enough.8 Moreover, the information in the ICFs must be given a lay language that can be easily comprehended by the participant with no prior knowledge and should be given in writing for the majority of the time.
Communication in healthcare settings demands specialized advanced communication skills, as well as an increased awareness of oneself and others. When the participant and investigator speak different languages, the informed consent procedure becomes more complicated since the informed consent. Discussion must be completed either in the patient’s native language or through an interpreter.
As we discussed above, the language of the ICF must be easy or lay to understand; this also applies while interpreting the information to the participants. The discussion or interpretation of the information of the ICF between the investigator in charge and the participants must be in simpler terms instead of speaking complicated medical terms. To make communication more effective, there are a few things that can be done, which includes:9
These things are essential to have clear and effective communication between the healthcare provider and the participant during the interpretation of the ICF information or rules.
Clear, concise, and easy communication between the investigator and the participants empowers the participant’s comprehension of information and their ability to make informed decisions about their enrollment and involvement in the clinical research, knowing the potential risks and benefits involved.
Furthermore, ICF is consistent with ethical values which promotes transparency, honesty, and respect for participants’ decisions. It guarantees that the participants’ well-being takes first place above society’s concerns. Besides, to maintain conformity with ethical and legal norms, regulatory authorities such as FDA require researchers to seek informed consent from the participants. Noncompliance from the investigator’s end might have substantial implications, such as invalidation of the study’s findings or legal consequences.
Participants’ recruitment and retention are two major bottlenecks that significantly increase clinical trial delays. They are crucial for the clinical trial’s scientific validity as well as for financial considerations. Therefore, problems with recruiting and retaining participants should be addressed and reduced. During recruitment via ICFs, it is important to appropriately address concerns, including participant expectations, situational vulnerability, and understanding the objective of participation.
Moreover, participants with less education require more explanation time and in-depth conversations to satisfy their concerns regarding the information in the consent process. Hence, the investigator must be more empathetic and diligent with the participants while interpreting the information. They should also anticipate several questions from the participants’ end and address each of their questions positively and in detail to ensure their safety as well as privacy. The quality and quantity of communication between the investigator and the participant matter for a participant to make an informed decision.10
The ICFs should be inclusive of all gender-neutral language, as many transgender individuals have said they were discouraged from participating. Because they were addressed with improper pronouns or because the investigators didn’t know how to refer to gender-affirming operations accurately. The major rationale for utilizing gender-neutral language is to establish a welcome gesture for people of all gender identities and sexual orientations.11
Therefore, based on the above discussion, it is evident that language and communication play an important role in participants’ informed decision-making. Also, a well-written, succinct, and gender-neutral ICF ensures early recruitment and retention. By providing the study participants with easy-to-understand, lay-friendly instructions. Moreover, these forms ensure the standard ethical considerations and legal norms set by the regulatory bodies are complied with by the researchers. Therefore, an ICF is the fundamental building block for conducting an ethical and accountable clinical trial.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.