ADOBE ACROBAT
Understand informed consent forms.
Whether you’re running a research study, getting a waiver, or going through an institutional review board, explore the guidelines and processes around clinical research and treatment.
Informed consent basics.
- Informed consent is necessary when a patient is deciding with the help of their doctor about treatment.
- This type of consent is also required for any medical research trial or study using human subjects.
- With electronic signatures, including digital signatures, and forms, patients and research participants can get faster and more accessible treatment.
What is informed consent?
Informed consent is a part of medical ethics and law that states that a patient should have all the necessary information before making a decision about their medical care. This is because navigating healthcare systems can be a complicated and often opaque process for patients, making informed consent one of the pillars of medical ethics.
This consent isn’t limited to medical care in a hospital. If a patient is joining a clinical trial, informed consent is necessary, especially when you’re working with an institutional review board (IRB) who will approve or deny funding. Informed consent can also be referred to as express consent, but that is not the same as implied consent, which refers to consent granted by actions or behaviors within a particular situation.
3 fundamentals of informed consent.
Informed consent has three main principles.
1. Decision capacity and competency
In order for someone to give informed consent, they must have the decision-making capacity, meaning that they must be both conscious and of sound mind to make an informed decision and be able to understand what the informed consent document is asking.
2. Documentation of consent
At the very minimum, informed consent requires the signature of the person consenting to whatever treatment or procedure is on offer. If the person in question is a minor, legally authorized representatives or a parent(s) or guardian must give consent. Often, there is an additional component when children are participating in a trial called child assent, where children are asked to give their consent, but legal requirements vary.
3. Disclosure
For informed consent to occur, the doctor or treatment provider must provide enough information about the procedure so the patient can reasonably consent. While this disclosure doesn’t include every detail, it must have enough so the patient is making an informed decision.
Key elements of consent forms.
When designing an informed consent form, you should always consult with an attorney because you likely need to include many important details and required elements within the form itself. While this article doesn’t include an exhaustive list, below are some steps for building an informed consent form for a research trial with five important components to include.
Statement about the project
The first section describes the overall purpose of the research project, what the goals are, how long it will take, and what the expectations of the participants will be. For example, if this were a drug trial, it would clearly identify itself as such, outline the various effects of the drug in question, and also point out how participants will interact with the trial. Think of this as an information sheet for the participant and keep things easy to read.
Research summary
This section summarizes the research backing the trial, who the principal investigators are (the researchers), and what will be studied within the trial. It includes the purpose of the research, how long it will take, and the procedures that will occur within the scope of the trial.
Reasonable risks
In this section, possible side effects and potential risks and discomforts of the trial are specified. This is a critical part of the informed consent form, as this is where the signee gains information to help decide if the benefits outweigh the risks.
Reasonable benefits
This section describes what can be expected to come from the research and the direct benefits that the patient might experience from the drug trial or research.
Alternative procedures or additional treatments
If there are parts of the trial that are reliant upon treatment with other medications or therapies, these are outlined as well, so the patient can consent to them. Finally, the form ends with a signature field, which is where Adobe Acrobat comes in.
How electronic signatures, including digital signatures, make consent forms easier for everyone.
You can configure Adobe Acrobat to support compliance with FDA 21 CFR Part 11, which establishes the Food and Drug Administration’s (FDA) regulations on electronic records and signatures.
Learn how electronic signatures, including digital signatures can jump-start digitizing your paperwork and make life easier.