Making consent information a participant can decide from
Consent information does its job only when a prospective participant can decide from it. That takes a clear, accurate, truthful and complete explanation of the study, a document lean enough to read that still holds what the decision needs, plain wording in the participant's own language with formats for readers who do not read text well, and a fair balance of benefit and risk with no promise of benefit. Understanding cannot be guaranteed, and an ethics committee checks the documents and stands against promotional language.
What the decision needs
Informed consent is a fundamental right of trial participants. It is a process of learning about and discussing the details of a study before a patient decides whether to take part. It is also an ongoing conversation in which all questions should be clarified. The participant should receive everything needed to make an informed decision, which is what gives informed consent its name. It is very important to tell people the aim of the study, what will be done to them, how the protocol works and the risks they may experience, and that their participation is voluntary. The informed consent form is legally required. Consent forms are required for clinical trials and are found at every phase of clinical trials throughout the world.
Prospective participants have the right to know all the implications and consequences of taking part, and they need to be fully aware of every aspect of the study before giving informed consent. Ensuring that every document written for study participants is clear, accurate, truthful and complete is an important task of the ethics committee. A consent form must be appropriate to the complexity of the research and to the needs of the population studied, and every potential participant must be able to understand the risks and benefits of the research.
In the US, federal regulations require that potential participants be given the information they need to make an informed decision about taking part, and that researchers facilitate the understanding of what has been disclosed and promote the voluntary nature of the decision. The Office for Human Research Protections names the same three as the key features of the consent process. Given health literacy rates, conveying complete and accurate information consistent with those regulations at a level participants can understand is a challenge. The consent document is one crucial piece of the consent process. It describes the research goals, tests and procedures, costs, potential risks and benefits, treatment alternatives and legal disclaimers, and all of this content must be communicated in a way that helps a person comprehend it. In oncology research, where 20-letter words are commonplace and the readers are largely lay people already in a fragile state of mind, a plan for communicating effectively, consistently and above all understandably is essential.
The limits of understanding
The signed consent form is essentially a contract: the participant agrees to take part, understanding that they may or may not receive the investigational product, that they may instead receive a placebo or a comparator, and that this is the risk they take. Yet no one can be sure that a participant understands that risk. Patients have traditionally relied on a learned intermediary, usually their primary care physician, whom they trust with questions about their health. Despite Dr Google and the misinformation found by trawling the web, most patients go to their doctor and ask whether they should join a trial.
One of the first ten people in an immunotherapy trial, a patient with melanoma, saw on looking at her informed consent form how little she had understood: maybe the word melanoma, and she had put a question mark beside everything else. She holds that the phrase informed consent rarely delivers on its first part, and that as a consequence the second is very hard to achieve. She believes that this can change, because a world is needed in which information is clear and consent is truly possible. In another case, a patient consented to an intervention without fully understanding its implications, and it damaged his quality of life.
A lean, layered document
Although consent forms are required, medical writers have a responsibility to make them clear, concise and easy to understand, and the growth of multinational clinical trials and the importance of plain-language writing have put medical writers on the front line of this work.
Sponsors clearly need to improve their consent forms. Collaborating with patients and doctors on a consent form is very important, because the document should meet their needs and should not be only a legal document that someone signs without really understanding its content.
Federal regulations emphasise that consent documents should be brief and in lay language. In an age when infographics and media are increasingly popular, bloated, wordy documents impede understanding, and an overhaul of current practice is essential. Short, direct sentences in the active voice improve the readability and length of a consent form. Drawing on lean principles, focusing on the key message can help reduce redundancy and eliminate excessive verbiage. With skilfully written prompts, AI can produce brief, impactful text that still includes the mandatory elements. Simplified consent forms will go a long way in enhancing the reader's experience and engagement, and they let participants better understand the whys, whats and ifs of a study and put them in a better position to give consent or not.
Nearly all consent forms are legal documents. Like other legal documents in health care, such as privacy notices, they must meet the intent and the letter of the law and yet be written in plain language. One approach to meeting the needs of both patients and lawyers writes the document in two parts: an easy-to-understand part at the front, followed by the full legal text. Another uses the newspaper's layered format, which runs from the most general or most important information to the more detailed. Examples can be used to explain what many of the legal statements mean.
Plain language
Guidelines on developing an informed consent form urge writers to use standard plain language to give patients all the relevant information on risks and benefits that they need to make well-considered decisions about their treatment. Consent forms should be clear and complete, should point out the risks involved in a treatment, and should be developed following the recommendations of plain writing.
The availability of information on the web has made it possible for a patient to become more informed about whether to take part in a trial, so there is an obligation to provide information in a way that is understandable not only to a scientifically and medically trained reader but also to the lay public. A number of enterprises, such as the MRCT under Harvard University, develop plain-language terminology so that information is more comprehensible when a patient is confronted with it. Plain language loses some of the precision and specificity developed together with technical language, but information presented as if for readers of the British Medical Journal will not be understood, so understandability is traded against precision and nuance.
The participant's own language
The US regulation at 45 CFR 46 requires the information given to the participant or their representative to be in language they can understand. Making prospective participants fully aware of every aspect of a study in some cases requires the patient information documents to be translated into several languages.
In Spain, consent forms are almost always translated from English, and some have run to more than 10,000 words, although Spain's coordinating centre for research ethics committees has proposed a sample information sheet and consent form for sponsors to use. A radical solution would be not to translate them at all but to write them from scratch in Spanish, capped at around 2,500 words.
Formats beyond text
Informed consent is required to be presented in plain language, and ways to present information other than as text, such as videos and schematics, are being looked at. Formats other than text matter because some people do not comprehend text well, some are blind and some are illiterate in the language of the document, and translated versions of everything are attempted but are not always possible for less common languages. Society understands that it has historically fallen short in allowing the patient to be a partner in the decision, and improving how the data and consequences of a trial are communicated takes time, effort and the will to do it.
Fair balance of benefit and risk
Perhaps the most difficult hurdle in communicating the consequences of taking part is that the outcome of an experimental medicine is unknown, which is why it is being researched. Any benefit presented to patients is therefore very speculative, something bad may happen, and a cure or a benefit cannot be promised. Telling a desperate patient with an untreatable, progressive disease for which no standard of care is available that they may be cured could influence them to enrol in a trial that may not be in their best interests.
One view holds that fair balance is the best way to encourage participation ethically. When an application is submitted to a regulatory authority, the applicant is obliged to present both the data supporting its hypothesis and the data conflicting with it. Information presented in a fair, balanced way, without suppressing any of it, lets a person make a more unbiased choice: they can weigh the pluses and the minuses and decide what is best in their own situation, understanding that the risks and benefits are not known, because it is research.
One concern is that plain language could come across as marketing and so coerce a patient further into participating, given that their participation is mainly in the interest of the investigator or the sponsoring institution. Against that concern, the institution and the investigator are usually not the ones who write the informed consent. The sponsor usually provides it, and some clauses may be adjusted to local or institutional standards. The ethics committee usually assesses the language itself, and so stands as a barrier to promotional language and to misrepresentation of information.