How to create a consent form

Consent forms are crucial for business communication and legal compliance.

A well-defined objective is the basis of this sort of document, whether it’s for medical procedures, data processing, event participation, or other activities.

To create a consent form, you need to list the consenting parties and specify the activities or data covered by the consent. 

It should also state the parties’ rights and responsibilities and include dates, contact information, and other necessary details.

This article will take you through the consent form creation process in more detail and includes a step-by-step guide.

What to include in a consent form

To ensure informed consent, a consent form must include the following:

  • A statement of activity
  • The purpose of the activity
  • Procedures
  • Risks to the participant
  • Benefits to the participant
  • Cost of participation
  • Confidentiality
  • Voluntary participation
  • The right to withdraw or terminate participation
  • Ongoing contact information
  • Signatures
  • Version, date, and page numbering

How to write a consent form: A step-by-step guide

Follow these steps to write an effective consent form.

Step 1: Title and introduction

Let’s use a dental consent form as our example document here.

Start with a descriptive title — for example, “Informed Consent Form for Dental Extraction” (this applies even if you use a dental consent form template).

Explain the form’s purpose and briefly describe the activity or study in the introduction. 

Step 2: Description of the activity

Explain the activity or study, including its duration, requirements, and procedures.

Use simple language so participants can understand.

Anybody undergoing a dental extraction will find it reassuring to understand the process in detail and will be able to make a more informed decision based on this understanding.

Step 3: Risks and benefits

Just as you would have to consider contract risk management when signing a contract, consent form signees also need to understand potential risks.

Be honest and transparent about the pros and cons to help them reach a decision. 

A dental extraction, or any other medical procedure for that matter, carries a degree of risk that the signee must be made aware of.

The benefits of such procedures often outweigh these risks and invariably aim to improve quality of life, but the potential dangers must be made clear.

Step 4: Confidentiality and data handling

Explain how you will handle and protect participant data and personal information. Build trust by assuring confidentiality.

You don’t need to go as far as including a confidentiality agreement, but participants must be confident their data will be handled appropriately.

Step 5: Voluntary participation and withdrawal

Make it clear that participation is voluntary.

Ensure that people know they can quit at any time without incurring a penalty. 

Step 6: Consent statement

Create a clear statement expressing the participant’s informed consent.

For example, “I have read and understood this consent form and willingly agree to participate.”

In our specific example of dental extraction, it would be prudent to ask patients to agree to statements like, “I am aware of risks, potential complications, and possible side effects” and, “I have been instructed about how to prepare for treatment.”

Step 7: Signature and date

Include spaces for participant signatures and consent dates.

If the participant is a minor or cannot sign, specify who can give consent.

Step 8: Contact information

Provide important contact information.

This includes the name of the person or organization responsible for the activity or study and allows participants to reach out with any questions or concerns.

Step 9: Language and format

Use simple language, and avoid jargon or technical terms.

Use legible fonts and formatting to improve readability.

It’s also best to keep the use of passive voice to a minimum; address the patient directly instead of referring to them in the third person.

Step 10: Review and approval

Before using the consent form, have supervisors, ethics committees, or legal advisors review it to ensure compliance with regulations and ethical standards.

Step 11: Version control

To track updates and changes, give the consent form a version number or date.

Step 12: Provide a copy

After signing the consent form, give the participant a copy for their records.

Introducing PandaDoc’s consent form templates

Get started today with PandaDoc’s consent form templates.

These are simple and effective.

Select a template, customize it, and use it to obtain informed consent for your activities, studies, or medical procedures.

Our consent form templates include:

Medical/Psychology Informed Consent Form Template: Use our comprehensive medical procedure consent form to inform patients before medical procedures.

Research Study Consent Form Template: For researchers, our research study consent form template helps you get informed consent from participants by clearly explaining the purpose, procedures, and risks.

Telehealth Consent Form Template: This template ensures patients understand remote consultations and can willingly consent as telehealth services grow.

Counseling Consent Form Template: Mental health professionals can use this template to inform clients about therapy and obtain informed consent.

Parental Passport Consent Form Template: This template helps organizations planning international trips involving minors to get parental or guardian consent.

Produce the best examples of consent forms with PandaDoc’s help

PandaDoc provides a wide range of templates.

We have consent forms for medical procedures, research studies, and more. Customize our templates to fit your company’s needs. 

Add or remove sections, edit content, and customize forms easily. You can also save time and effort by using our pre-designed templates.

Fill in your activity or study details and you’re ready to go!