What To Include In Electronic Informed Consent Forms

Electronic informed consent forms are more commonly used nowadays. If you need to use this method of document or contract signing, you must know what to include in electronic informed consent forms. Read more about these elements below.

What Is It For?

Electronic informed consent forms certify that people know the risks they take when they agree to something. In certain industries, the law even requires these forms.

You will find that consent forms tend to be more common in two kinds of businesses:

• Healthcare organizations that conduct clinical trials
• Companies that offer high-risk activities, such as rollercoaster rides, zip lines, and adventure tours

Although a consent form in itself does not prevent accidents or save people, it can shield the company from potential lawsuits should something happen.

If you’re creating a consent form to protect your association, here are the best tips to implement.

Elements to Include in Electronic Informed Consent Forms

You might feel tempted to skip out on including some information in your consent form for the sake of space and simplicity. But, it is important to include all the elements you require from the person completing it and all the information you must make them aware of.

For example, your form should ask for general information such as the person’s name, date of birth or age, mailing address, email address, and, when appropriate, their medical history. You should also ask them to sign the form.

In addition to this, you must also communicate certain information to the person. Where appropriate, these include but are not limited to the following:

The Purpose of the Research or Study

In the medical industry, patients must know the purpose of the trial or study. You should impart information regarding the treatments, including any aspect that is still experimental.

Information About the Event or Procedure

This section should state what the person can expect during the event or procedure. It can also dictate the duration of the research or study and any conditions that may put an end to it.

Assurance of Voluntary Participation

You must inform the person that their participation is voluntary and that they can pull out of it at any time.

Risks

List down all of the risks associated with the study or research. This list should include all risks and not just the ones that apply to the person signing the consent form. If the procedure or event might pose a threat or risk to others, the form should indicate that.

It is important that the person signing the form understands all the potential risks or inconveniences involved in addition to the possible positive results.

Reimbursements or Costs

The form must indicate any reimbursements that the participant can expect or any costs they might incur. It should also detail the treatment or compensation available to them in the event that something goes wrong.

Confidentiality Statement

If applicable, the form must show any regulatory authorities, auditors, or monitors that will receive access to the information of the person signing the form.

Additional Legal Information

Depending on the purpose of the form and your industry, you may need to add legal or mandatory information. For clinical trials, for instance, the FDA has specific regulations regarding what informed consent forms must include.

Creating Informed Consent Forms: Best Tips and Practices

Here are some of the best tips and practices when constructing your electronic informed consent forms.

Make It User-Friendly

Paper forms tend to be very restrictive in terms of the number of pages and layouts, so they can be very boring. In contrast, electronic forms don’t have such limitations, allowing you to adjust them to fit a more user-friendly layout. For instance, you can break down the form into different sections to make it easier to read.

Auto-fill Responses

You can program some fields to be filled out automatically to streamline the process and save time. For example, you can auto-fill the date and time the person signs the form. If the person has an existing account, you can auto-populate the form with the personal information you have access to, such as name and email address.

Use Conditional Logic

You can program your form to show or hide questions based on the person’s responses to previous questions. For example, if your form asks the person if they have any children and they respond with a “yes,” your form can show an additional question that asks for their ages. If they answer “no,” you can hide the additional question since it’s irrelevant.

Use Contextual Support or Help Text

Help text can go a long way in providing guidance to the person filling out the form. Paper forms don’t allow you to provide contextual support due to space issues, but digital forms are more flexible. You can program instructions and explanations to pop up when the person hovers over or taps on a certain text.

Get to the Point

Make sure to keep your form short and sweet but still include all pertinent information and questions. If it’s not something you need to ask, don’t include it in the form. Every question should fulfill a purpose.

The 4 Principles of Informed Consent

The four principles of informed consent are:

• The patient must be competent enough to make a free choice. They must not be mentally handicapped.
• The patient must grant their consent freely and willingly.
• Content of the consent form must be completely understood and acknowledged.
• The patient must be able to rationally manipulate the information provided.

Final Advice

When creating electronic informed consent forms, your top priority and consideration should be the end user. See to it that your form is clear and easy to navigate so that the user understands everything. Additionally, you should ensure your form consists of all mandatory and pertinent elements. Make it a habit to review your form every now and then to identify any areas for improvement.

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