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Before undergoing a life-changing medical procedure, it's a patient's right to understand the risks involved, so they can adequately prepare for the outcomes. This is important because you could face the full weight of the law if a medical procedure on an uninformed patient goes south.

What is Informed Consent? 

Informed consent is an ethical practice in medical research where the health practitioner explains the risks and benefits of a procedure before requesting the patient’s consent. More than providing adequate information about the treatment procedure, you must give the patient enough time to make an informed choice. The whole idea here is to ensure that the patient is fully aware of the medical treatment and can make a voluntary and informed decision on whether or not to go ahead with it. 

This type of consent is mainly required for complex medical procedures like surgeries and chemotherapy. Your doctor or healthcare provider might also request your permission for advanced medical tests like a biopsy, HIV testing, vaccinations, and administering anesthesia. Specifically, you should expect your doctor to give a proper diagnosis of the condition, explain the purpose of your treatment, and discuss the risks and benefits of any alternatives. 

Read: Consent Letter: Writing Guide, Types, [+12 Consent Samples]

Purpose and Importance of Informed Consent

The purpose of informed consent is to protect both the patient and the healthcare practitioners involved in a treatment procedure. 

For the patient, it ensures that they have a full understanding of possible side effects, risks, and benefits of a course of treatment or informs a patient of what other treatments may be available. It also allows them to fully participate in their own medical care. With this, the patient can make an informed decision or seek a second opinion on the available treatment plan. 

Use for Free: Teletherapy Consent Form Template

On the doctor’s path, informed consent serves as legal protection. A doctor could lose their license if they carry out a treatment process on a patient who is ill-informed of the risks and side effects. In all, informed consent creates a trust-based relationship between the medical practitioner and the patient. When all parties are armed with the right knowledge, they can make the most objective decisions in their favor. 

Other reasons you should prioritize informed consent include:

  1. It protects the patients from any form of assault or battery in the course of a treatment procedure. 
  2. It validates the medical treatment. 
  3. Informed consent provides sufficient information that helps the patient make the best decision for their health.

Types of Informed Consent

There are three common ways to collect informed consent from your patient before a medical procedure. You can request written consent, use an online form or ask for oral consent. Expectedly, all of these methods have their pros and cons and work best in certain contexts. Let’s discuss them in detail. 

For Researchers: Participant Consent Form Template

1. Signed/Written Consent

Signed consent is a written agreement between the patient and the medical practitioner. It contains a statement or declaration confirming that the patient is fully aware of any side effects and risks involved, and agrees to participate in the treatment plan. 

Typically, a written or signed consent follows a conversation between the doctor and the patient. During this conversation, the doctor records the informed-consent process to serve as a piece of formal evidence. This note will be attached to the written consent and signed by both the patient and the physician. If the patient isn’t old enough to give formal consent, their guardian can do this on their behalf. 

2. Online Consent

Health practitioners can use an online consent form to collect formal authorization for medical procedures from patients. Unlike written agreements, online consent forms are more convenient and easily accessible. This means that the doctor and the patient do not have to be in the same environment before an agreement is reached. 

On the online consent form, the doctor can list all the risks, side effects, and benefits of the treatment procedure. The form also has a digital signature field for collecting the patient’s signature after they must have read the terms and conditions. If the patient has any questions, they can contact the medical practitioner for clarifications. 

Free to Use: Immunization Consent Form Template

Why You Should Use an Online Consent Form 

  • It is cheaper and faster to collect data with an online consent form. Patients can easily fill information into different form fields and submit it at their convenience. 
  • You can customize an online consent form to suit your specific needs.
  • It’s easy to collect and process information using an online consent form. 
How to Create an Online Consent Form with Formplus 

Step 1: Sign into your Formplus account to access your dashboard here

"formplus-signin"

Step 2: On your dashboard, click on the “create new form” button. This will give you access to the form builder. 

"dashboard"

Step 3: The Formplus builder has several field options including text fields, number fields, and advanced options like the digital signature field. 

"signature-fields"

Step 4: Drag and drop preferred field options from the inputs section into your form. Next, use the edit “pencil” icon beside each field to add your questions, statements, and options. 

Step 5: Click on the “save” icon to save all the changes you’ve made, and automatically access the form customization section. In form customization, you can change the look and feel of your form using different options and features. 

Step 6: Copy the form link and share it with respondents. 

"formplus-link-share"

3. Oral (Recorded) Consent 

Also known as verbal consent, oral consent is the fastest method of collecting formal authorization from a patient before a medical procedure. In this case, the doctor or health practitioner reads/explains a verbal version of a consent form (i.e. an information sheet), and subjects give their verbal consent in place of written consent to participate. 

Giving verbal consent is as simple as saying “I agree” after the doctor explains the treatment plan. Of course, you’re not required to acquiesce immediately after discussing the procedure with your doctor; you are free to take some time to reflect and seek a second opinion. If you have any questions, you can ask the doctor or request to read through the information sheet.

If you choose to collect verbal consent from your patient, be sure to keep a recording as a piece of evidence. Without this, verbal consent is weak and cannot serve as tangible proof in court. 

Read: Experimental Research Designs: Types, Examples & Methods

When is Informed Consent Required? 

Whenever a doctor or health practitioner wants to carry out a complex medical procedure or treatment plan, they need informed consent from the patient involved or their guardian. This is a necessity that mitigates any risks for the doctor and the patient. 

According to Healthline, informed consent is required for any of these medical procedures: 

  1. Most surgeries
  2. Blood transfusions
  3. Anesthesia
  4. X-Rays
  5. Chemotherapy
  6. Advanced medical tests, like a biopsy
  7. Most vaccinations
  8. Blood tests, like HIV testing 

Informed Consent in Research 

When conducting qualitative and quantitative research, the investigator might require informed consent from participants. Research participants need to know the objective of your research and how you would use their data before providing any required information. 

You can create an informed consent form for research on Formplus. In the form's intro page, you can include important information about your data collection process, data privacy terms, and other important details that participants need to know. 

Informed Consent in Clinical Trials 

Clinical trials often require voluntary participants who serve as a "sounding board" to validate a new procedure or treatment. Before admitting people into your clinical trials program, you should receive informed consent from all of them. 

Informed consent is the process of providing participants important information pertaining to the clinical trial, including what procedures they will undergo and possible risks and benefits. Participants have a right to know what they're potentially getting into, and they are free to back out at this point. 

Informed consent is also a good way to establish a trustworthy relationship between the researcher and participants throughout the process. Once your research participants know what to expect from the entire procedure, you'd experience fewer complaints and pushbacks during the trials. 

How to Obtain Informed Consent

A common question that comes up among researchers and medical practitioners is, "when is the right time to obtain informed consent?" 

Generally, your patient should provide informed consent before the commencement of any medical procedure or clinical trials. You can use any of the three methods earlier highlighted to collect formal authorization—that is, written authorization, online form, and verbal consent.  

Follow these steps to obtain informed consent from your patient or research participants: 

Step 1: The investigator or medical practitioner must explain every aspect of the treatment method or study. Here, you should provide information on the purpose, procedures, risks, benefits, alternatives to participation for the procedure. At this stage, the patient is free to ask any questions. 

Step 2: The researcher will provide an information sheet containing all the information about the procedure, side effects and risks. The patient can request some time to study the document and seek second opinions. 

Step 3: After studying the sheet, the patient can give verbal consent for the process. After this, you can go ahead to collect written consent via a simple document or online form. If the patient isn't old enough to consent, a legally authorized representative can do this on their behalf. 

What are the Requirements for Informed Consent? 

According to the U.S Federal Regulations, valid informed consent for research or medical treatment must include the following: 

  1. Full disclosure of information
  2. Competency of the patient or surrogate to make an informed decision
  3. Voluntary decision-making 

If a treatment procedure poses minimal risks to the participants, then the investigator might wave informed consent. 

Examples of Informed Consent

You can use these templates as a guide for informed consent as a researcher or medical practitioner. 

On Formplus, you'd also find several consent form templates ready for use. You can also tweak them to suit your organization's needs. 

1. Botox Consent Form Template 

Use this Botox consent form to mitigate the risks of this complex procedure for the patient and the clinic. "botox-consent-form"

You can customize this template to suit your needs in the form builder. It also has an e-signature field where clients can upload their digital signatures

Try the Botox Consent for Free


2. Body Contouring Consent Form 

Before commencing a body contouring surgery, you can use the Formplus body contouring form to collect the personal information of the patient, and their digital signatures for formal authorization. You can share this form via email invitation or embed it on your website.

Try the Body Contouring Form for Free


3. Medical Authorization Form 

The Formplus medical authorization form allows schools to collect formal consent from parents and guardians, in the case of a medical emergency involving their wards. In this form, you can collect information like the name of the student, age, existing medical records, and the like.

Try the Medical Authorization Form for Free

4. Participant Consent Form 

Are you conducting a systematic investigation? Use the Formplus participant consent form to obtain formal authorization from the people who want to take part in your study. "participant-consent-form"

In our form builder, you can tweak this template to suit your specific research needs.

Use the Participant Consent Form for Free


5. Organ Donation Form 

Before carrying out an organ transplant on a patient, you can use the Formplus organ donation form to get formal consent from all the parties involved. With this form, donors can fill out their contact details, current health status, medical history, details about the organ, give online consent, and so on.

Use the Organ Donation Consent Form for Free


Difference Between Implied and Informed Consent 

The major difference between implied consent and informed consent is the expression of acquiescence. 

In informed consent, the patient expressly agrees to partake in the medical procedure or research. He enters into a formal and documented agreement with the clinic or healthcare practitioner, and this agreement can stand as a piece of evidence in a court of law. With implied consent, the patient’s behavior communicates whether or not they want to take part in a treatment procedure. 

Let’s look at an example. Suppose you attend a dinner event at a restaurant. Upon arrival, a waiter comes to you with a tray of drinks. This action communicates that you can pick a glass of wine from the tray. Although the waiter didn’t say a word, his actions provide implied consent. 

Other Types of Consent

Unanimous Consent 

This is a type of consent given by all the parties involved in an agreement. For example, all the members of a subgroup in your research population can provide formal authorization for your study. 

Substituted Consent 

This type of consent allows a decision-maker to attempt to establish the decision an incompetent person would have made if they were competent. 

Implications of Lack of Consent In Research 

From all we've shared so far, you should have a fair idea of the implications of skipping the informed consent process in medical treatment, research or clinical trials. 

For one, conducting a complex medical procedure without the patient's informed consent puts the doctor at legal risk. If something goes wrong during the process, you can get sued and lose your practicing license. Also, it causes misinformation for the research participants or clients, which can affect the quality of information they provide during the research process. 

Create Online Consent Forms for Free





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