Informed consent is a basic human right. Therefore, risks must be made clear to participants of clinical trials or those undergoing surgical procedures. To ensure these basic rights are protected, the US Food and Drug Administration (FDA) mandates the use of informed consent forms (ICFs).
An ICF must include a range of information to minimize liability – and it must be written in a language that the subject understands. If the subject does not understand English well enough to give informed consent, the Institutional Review Board (IRB) mandates that the form must be translated by a medical translation professional. It is critical that the subject has a clear understanding of the risks and responsibilities of participating in a clinical trial.
Carrying out a procedure or clinical study without obtaining informed consent can expose medical professionals to a host of ethical challenges, malpractice suits or even charges of assault.
Defining informed consent
Informed consent is the process between a patient and a medical professional that provides the patient with the information necessary to determine the risks of undergoing a specific procedure or test. The informed consent process includes follow-up discussions to clarify ambiguities and ask questions, and should give patients ample time to make thoughtful decisions.
After the subject reviews the relevant information, he or she must sign the ICF. In cases where there is a reasonable expectation that non-English speakers will participate in a trial, the clinical investigator must submit the translated informed consent documents to the IRB before starting the consent procedure. After signing, the entire process comes under review again by the IRB, which is charged by the FDA to “protect the rights and welfare of subjects participating in clinical investigations.”
Elements an ICF must include
The following eight ICF components are required by the FDA – and must be written in the participant’s mother tongue or an officially acceptable translation – to earn IRB approval:
1. Description of Clinical Investigation – Subjects must be provided with an explanation of the research being conducted, its purpose, length of trial, and how it will be carried out (including any experimental procedures).
2. Risks and Discomforts – The subject must be informed of any foreseeable risks, danger or discomfort, including the severity of pain from a surgical procedure, recovery time, or even standard tests.
3. Benefits – The subject must receive a full description of how the experimental treatment could benefit them and/or others. The description should be clear, realistic and not overly optimistic.
4. Alternative Procedures or Treatments – The subject must be made aware of other options to treat their medical problem/s. The risks and benefits of those options must be fully explained.
5. Confidentiality – Subjects must be informed about who will have access to confidential medical records (e.g. the study sponsor), the degree of confidentiality they can expect, and under what circumstances the records would be turned over to a third party. In all cases, the FDA may inspect medical records (permission from the subject is not necessary).
6. Compensation and Medical Treatment in the Event of Injury – When there is more than minimal risk, subjects must be clear on what compensation and medical treatment, if any, may be obtained in the event of injury. Circumstances under which no compensation or treatment is available must be clearly expressed.
7. Contacts – Information must be provided regarding who to contact for further inquiries or complaints. The contact person should not be a member of the clinical team carrying out the trial so that the subject feels comfortable making a complaint or inquiry.
8. Voluntary Participation – Subjects must be made aware that they will not suffer any penalty or lose benefits they are entitled to by withdrawing from the study at any time. In addition, if withdrawal entails special procedures, those must be outlined in detail. It is important to note, however, that any data collected about a subject prior to their withdrawal is still fair game for inclusion in the study.
Other elements, when appropriate, should inform the subject of unforeseeable risks, circumstances under which the study leader may terminate participation, additional costs, and new, relevant research.
Exculpatory language is not permissible anywhere on an ICF form. This kind of language allows the individual to waive their legal rights, releasing the research sponsor (or its agents) from liability for malpractice or negligence (e.g. compensation for research-related injury).
The responsibility of ensuring informed consent
Responsibility for ensuring informed consent falls to three parties – the IRB, the clinical investigator, and the research sponsor. The three-pronged system ensures that the patient is protected from coercion or pressure to participate against his or her will. For example:
- A manufacturer wants to produce a new drug or medical device. They decide to sponsor a research project involving human subjects. They become responsible for “assuring the FDA that a study will be conducted in compliance with the informed consent and IRB regulations.”
- The sponsor hires a clinical investigator (and staff) and makes them sign specific forms (e.g. FDA-1572) or agreements promising to have the study reviewed by an IRB. From that point forward, the clinical investigator usually acts as the main point of communication between the IRB and the research sponsor.
- The IRB reviews all the materials to be signed by the research subjects, including officially translated versions of the ICF, before the consent process begins. Once everything is IRB-approved, it becomes the clinical investigator’s direct responsibility to collect ICFs from every research subject.
Translating for non-English speaking subjects
Ethically, scientific research should be carried out independent of considerations about the predominant language in a particular area. People who speak other languages should be neither targeted nor excluded. In order for foreign language speakers to make an informed decision, translation requirements dictate that all of the relevant consent forms must be delivered at the subject’s level of understanding (without medical jargon) in a language they speak fluently. For studies that pose more than minimal risk to subjects, ICF translations must be performed by a professional medical translator or a qualified Language Services Provider (LSP) that relies on medical translation professionals.
When to use a qualified LSP
A qualified translator must be retained if:
- A subject does not understand English but is literate in other languages. In this case, a written ICF must be provided in a language that the participant understands and a translator must be provided who is fluent in English and the participant’s spoken language.
- A subject does not understand English and is illiterate in other languages. In this case, an oral explanation must be given in the subject’s language. A witness must be present, and a short form in the subject’s language and a detailed long form on the oral presentation are required.
The essence of personal autonomy
Medical trials go to the very heart of personal autonomy. The law ensures that no one should ever be subject to medical experimentation without full understanding of the risks, benefits, alternatives, and procedures.
The FDA provides clear directions for ensuring that the necessary information is presented in an understandable manner. To minimize liability, clinical trials must adhere to the FDA’s guidelines as closely as possible, including ensuring that informed consent forms are handled by medical translation professionals.