An informed consent form is a written document that describes a research study to a volunteer, who then decides whether to take part. It records the study details, the risks and the benefits in one place, and it carries the participant's signature. Use the free template below to create one online, or download the PDF and print it.
Last Updated: October 2026. This guide is reviewed and updated regularly to reflect current law. If you notice an error or outdated information, please contact us.
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An informed consent form for a research study is signed by a volunteer who has read about the study and agreed to take part. Researchers use it to explain what the study is about and what the volunteer will be asked to do. A completed form records:
Clinical researches are a stepping stone to life-saving medical discoveries. The success of such trials leads to the advancement of medical care. Upon successful clinical research studies, the doctors discover more accessible and less harmful alternatives to existing treatment and develop vaccines or drugs with safer aftereffects.
At certain stages of the research study, researchers require volunteers to be human subjects to test and evaluate the actual effect of the supposed treatment. According to FDA regulations, anyone willing to participate in the exempt research studies must undergo an informed consent process.
Signing an informed consent document is required in various situations and is widely used in medical settings such as providing treatment, operations, invasive procedures, or conducting a clinical investigation.
Informed consent for exempt research study enrollment requires a researcher to educate the participant about the goals, duration period, possible risks, and benefits of participation. Part of the required consent elements, such as explanation, can be conducted verbally through the conversation with a participant, but the essential details must be duplicated in informed consent documents.
The consent must be given knowingly and voluntarily upon evaluating all possible threats and consequences. Only after the participant fully comprehends the terms and purpose of the study and the personal health risks that may happen during trials can they sign a written consent document.
Informed consent is a multi-stage process that leads to the final stage of signing consent forms. Failing to perform each stage of the informed consent process properly may cause legal ramifications. The researcher must educate the potential participant with adequate information to comprehend the possible consequences of the given or refused consent and make an educated decision.
Four main elements of informed consent are required to conduct the consent process properly: patient’s competency (ability to grant permission), legibility, information about the research, and consent documentation.
The informed consent forms with a purpose for enrollment in research trials must contain the following sections:
In specific cases, a researcher may specify additional elements in the informed consent forms, including unforeseeable risks management or involuntary termination. It is strongly advised to make a written document as specific as possible and list all things that may arise during the research projects.
This short glossary explains the words you will see most often on a research consent form.
The peculiarity of clinical trial informed consent is that it doesn’t end after signing the consent document. The participant can ask researchers for clarifications regarding the studies during and after the completion of trials.
Besides, participants have a right to withdraw their consent due to health risks or other reasons during the research. However, the participant may also face the ramifications upon premature termination. These ramifications are usually described in the informed consent forms.
On the other side, the researcher may also eliminate the participant before the study’s completion due to any plausible reason, such as a change of eligibility criteria or the participant’s failure to comply with the prescribed procedures.
Follow the steps below to complete the informed consent form for a research study. Open the template, then work from the top of the document down to the signature lines, one part at a time.
An informed consent document is a legal form that must include all elements required by federal regulations. You can use the informed consent form template available on our website. Be sure to stick to these steps while completing the form.
The screenshots under each step show the FormsPal Informed Consent template filled with sample entries in blue, so you can see where each answer goes. The names, addresses, dates and amounts are examples only.
Date and Participant
Find the opening paragraph on page 1. Enter the date of the consent and the name of the participant.
Study Information
Next, the document must specify the extensive details regarding the research study. It includes the information of the affiliation, institution, and contact details of the researcher that conducts the study.
Fill in the study name, the study number or affiliation, and the researcher’s name, address, phone and email. Add a short purpose, the approximate number of people involved and who funds the study.
Study Dates
Informed consent forms must clarify the period during which the research is conducted. Include the days when the research begins and ends.
At the top of page 2, write the approximate begin and end dates.
Study Hours
Also, the document must usually tell the approximate period the participant is expected to spend on the study, calculated in hours, days, or weeks.
Still in the Study Dates and Hours part, enter the total hours, days and weeks.
Participant Criteria and Purpose of the Study
On page 2, find the Participant Criteria heading. In this section, the researcher must describe the criteria to evaluate the eligibility of human subjects.
The study participants have the right to be informed regarding the goals and purposes of the study. Then write a short purpose under the Purpose of the Study heading.
Risks and Benefits of Involvement
Clarify the potential threats to a person’s health condition. It is not mandatory to describe the risks in full detail. Still, it is necessary to tell the volunteer about any possible irreversible changes to a participant’s health for them to make a proper conscious and educated choice.
Stating the benefits of the study can stimulate participants to be obedient and diligent during the research period. That is why stating them in the document is essential.
Write the risks first and the benefits next, still on page 2.
Compensation, Costs and Confidentiality
If the study is funded (by sponsors or governments), it can apply the stimuli in reward payment for participation. The amount of money given to the participants must be documented if applicable.
For some clinical tests or research studies, the participant must pay money for medication or treatment. If any cost is applied, you need to state it in the document.
On page 3, tick the compensation option and write in the amount if one applies. Tick whether there is no cost or list the costs. Then tick the confidentiality paragraph if it applies to the study.
The researcher can ask participants to sign a non-disclosure statement to prevent them from leaking any information about the study, its methods, or any other details about the research process.
No Confidentiality Obligations
If the study carries no confidentiality terms, tick the No confidentiality obligations box at the end of that part instead of the paragraph box above it.
Name, Signature and Date
Participants who consent to participate in the trials must provide their full names and sign the written form.
Under the closing line on page 3, print the last, first and middle name, sign on the Signature line and write the date.
These short answers cover questions people often ask about an informed consent form for a research study. If you still have a question about your own study, ask the researcher or the institution that runs it.
When the clinical trials’ prospective participants are the patients who have no decision-making capacity, their legal representative can grant permission to participate in alternative treatments or research studies on behalf of the person who is unable to do so. These may be incompetent patients or patients in an unconscious state.
If the research subject is a minor, the volunteer must have parental permission to enroll and the child’s consent or agreement. Unless the parent holds full custody over the child or the other parent is deceased or incapable, permission from both parents is required.
IRB stands for institutional review board. It is a group at a hospital, university or research center that reviews the plan for a study. If your form names an IRB, you can contact it with questions about the study.
Yes. You have two ways to do it:
Ask the researcher or the study team about anything on the form that you do not understand. Do this before you sign.
General information, not legal or tax advice.
