Informed consent is more than a form; it’s a process. What does it involve?

The Big Picture

• The informed consent process ensures that research participants can make voluntary and knowledgeable decisions about whether to take part in a research study.
  
• Informed consent must be accessible and understandable to the potential research participant. Accessibility and comprehension can be achieved in a variety of ways.
  
• Genomics research requires careful explanation about how the participant’s genomic information will be used during and after the study, as well as any implications that arise from the sequencing of their DNA.

To many, the term informed consent is mistakenly viewed as the same as getting a research participant's signature on the consent form. FDA believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with:

• adequate information to allow for an informed decision about participation in the clinical investigation.

• facilitating the potential participant's understanding of the information.

• an appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.

• obtaining the potential participant's voluntary agreement to participate.

• continuing to provide information as the clinical investigation progresses or as the subject or situation requires.

To be effective, the process must provide sufficient opportunity for the participant to consider whether to participate. (21 CFR 50.20.) FDA considers this to include allowing sufficient time for participants to consider the information and providing time and opportunity for the participant to ask questions and have those questions answered. The investigator (or other study staff who are conducting the informed consent interview) and the participant should exchange information and discuss the contents of the informed consent document. This process must occur under circumstances that minimize the possibility of coercion or undue influence. (21 CFR 50.20.)

What is Informed Consent?

As new medical products are being developed, no one knows for sure how well they will work, or what risks they will find. Clinical trials are used to answer questions such as:

• Are new medical products safe enough to outweigh the risks related to the underlying condition?,

• How should the product be used? (for example, the best dose, frequency, or any special precautions necessary to avoid problems),

• How effective is the medical product at relieving symptoms, treating or curing a condition.

The main purpose of clinical trials is to “study” new medical products in people. It is important for people who are considering participation in a clinical trial to understand their role, as a “subject of research” and not as a patient.

While research subjects may get personal treatment benefit from participating in a clinical trial, they must understand that they:

• may not benefit from the clinical trial,

• may be exposed to unknown risks,

• are entering into a study that may be very different from the standard medical practices that they currently know

To make an informed decision about whether to participate or not in a clinical trial, people need to be informed about:

• what will be done to them,

• how the protocol (plan of research) works,

• what risks or discomforts they may experience,

• participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work.

A central part of the informed consent process is the informed consent document. The Food and Drug Administration (FDA) does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be included.

Before enrolling in a clinical trial, the following information must be given to each potential research subject:

• A statement explaining that the study involves research.

• An explanation of the purposes of the research.

• The expected length of time for participation.

• A description of all the procedures that will be completed during enrollment on the clinical trial.

• Information about all experimental procedures the will be completed during the clinical trial.

• A description of any predictable risks.

• Any possible discomforts (e.g., injections, frequency of blood test etc.) that could occur as a result of the research.

• Any possible benefits that may be expected from the research.

• Information about any alternative procedures or treatment (if any) that might benefit the research subject.

• A statement describing:

  • the confidentiality of information collected during the clinical trial,

  • how records that identify the subject will be kept

  • the possibility that the FDA may inspect the records.

• For research involving more than minimal risk information including

• an explanation as to whether any compensation or medical treatments are available if injury occurs,

• what they consist of, or

• where more information may be found.

• questions about the research,

• research subjects' rights,

• injury related to the clinical trial.

• Research subject participation is voluntary,

• Research subjects have the right to refuse treatment and will not losing any benefits for which they are entitled,

• Research subjects may choose to stop participation in the clinical trial at any time without losing benefits for which they are entitled.

• Contact information will be provided for answers to :

• A statement that:

When Appropriate, one or more of the following elements of information must also be provided in the informed consent document:

• A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).

• Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).

• Added costs to the research subject that may result from participating in the trial.

• The consequence of leaving a trial before it is completed (e.g. if the research and procedures require a slow and organized end of participation).

• A statement that important findings discovered during the clinical trial will be provided to the research subject.

• The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

• read the consent document,

• ask questions about anything they do not understand.

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, friend or advocate.

An investigator should only get consent from a potential research subject if:

• enough time was given to the research subject to consider whether or not to participate

• the investigator has not persuaded or influenced the potential research subject.

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

• the research subject is made to ignore or appear to ignore any of the research subject's legal rights,

• releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary. You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully. Ask questions about any information you don’t understand or find confusing.

Legally, children are not able to give true informed consent until they turn 18. So, before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree. Unlike informed consent, assent is not always required by law, though IRBs may require it.

To take part in the assent process, your child must be mature enough to understand the trial and what they are required to do. Some children as young as 7 years old may be able to take part. But this age varies depending on the child and the group running the trial.

As with the informed consent process, the assent process is meant to be an ongoing conversation between your child, your family, and the research team. This team may include doctors, nurses, social workers, and other health care providers.

During the assent process:

• You give informed permission for your child to join the clinical trial.
• The research team explains the trial to your child in language they can understand, including what it means to take part and what they can expect.
• The research team may use written forms, videos, graphics, and other visual aids to help explain the trial.
• Your child is encouraged to talk with your family and ask questions of the research team.

It may take several sessions before the research team feels that your child has a clear understanding of what the trial involves. At that point, your child is asked to show assent or dissent.

Both Parents Need to Give Permission

Usually, both parents will need to give permission for your child to take part in the trial, unless one parent:

• Has died
• Is unknown
• Is incompetent
• Is not reasonably available
• Has sole legal custody of the child

When Assent Is Not Required

Assent must be obtained from children unless:

• Your child is not capable of assenting.
• Your child might benefit from the treatment or procedure being studied in the trial.
• The treatment or procedure that may benefit your child is only available in clinical trials.

Even if assent is not required, your child will still benefit from going through the assent process. Doing so can help them feel more in control and engaged in the trial. It shows that they have a say in what happens to them and that their questions and input are valued.

Informed consent is a process through which you learn details about the trial before deciding whether to take part. This process includes learning about the trial’s purpose and possible risks and benefits. It is a critical part of ensuring patient safety in research.

During the informed consent process, the research team, which is made up of doctors and nurses, first explains the trial to you. The team explains the trial's:

• Purpose
• Procedures
• Risks and benefits

They will also discuss your rights, including your right to:

• Make a decision about taking part
• Leave the study at any time

Before agreeing to take part in a trial, you have the right to:

• Learn about all your treatment options
• Learn all that is involved in the trial, including all details about treatment, tests, and possible risks and benefits
• Discuss the trial with the principal investigator and other members of the research team
• Both hear and read the information in language you can understand

After discussing the study with you, the research team will give you an informed consent form to read. The form includes written details about the information that was discussed with you and describes the privacy of your medical records. If you agree to take part in the study, you sign the form. But, even after you sign the consent form, you can leave the study at any time. You can always ask questions. And, as new information becomes available, the research team will inform you.

In research, informed consent is a process — often more than a one-time endeavor. It is interactions between a research team and a potential research participant or their legal representative. During these interactions, members of the research team provide potential research participants with a description of the study, including benefits and risks of participation, that will help them make informed decisions about whether to begin or continue participating in a research project.

The three key features that must be met during this process are:

• providing key information.
• confirming the participant understands the information.
• ensuring any decision to participate is voluntary and not coerced.

One common component of informed consent is the “consent form,” which participants sign to indicate their willingness to take part. The consent form summarizes the research project and its benefits and risks, and it explains the individual's rights as a research participant. Usually, the researchers and the potential participant discuss the study and contents of the consent form, and researchers answer any questions the participants may have. These conversations can be an ongoing process depending on the nature of the research study, rather than a one-time informational session.

Institutional Review Boards (IRBs) can waive the requirement for a signed form in a few circumstances, for instance when there is minimal risk to participation such as responding to a survey.

IRBs are groups of five or more people with various backgrounds who are appropriately authorized to review and monitor research involving human participants. They ensure the rights and welfare of participants are respected.

The IRB may allow for a legally authorized representative to provide informed consent on behalf of an adult who lacks capacity to do so themselves. Similarly, parents or guardians must also provide permission for their child’s participation, and children must be informed about their participation in a developmentally appropriate manner and indicate their agreement to participate through a process known as “assent.”

When developing an informed consent process and consent form, researchers should use appropriate language, videos or other educational materials that fall within cultural expectations of potential research participants. Authors of written materials should strive to use simple but accurate language that describes the concepts.

The amount of time each participant needs to understand and to consent to research participation varies, but researchers should ensure that participants are given adequate time and know that they do not have to make an immediate decision. This enhances the voluntariness of the consent process.

To ensure that participants have sufficient understanding of the study to provide their consent, researchers can ask participants to explain their understanding of the research project so the researchers can correct any misconceptions.

Certain genomic concepts can be challenging to convey. With advances in genome sequencing technology, increased data sharing and concerns around genomic privacy, the genomics field recognizes the need for flexible approaches to communicate the informed consent process and the consent form with prospective research participants. Additionally, in 2018, regulators added the requirement for participants to be informed if their biospecimens will undergo whole-genome sequencing.

Genomics research often requires large numbers of diverse participants across large geographic areas. To overcome the challenge of reaching many people across long distances, researchers may carry out some or all of the informed consent process remotely by phone, videoconference or web-based methods.