Informed consent from a human research perspective

Informed consent is an important topic to get right - particularly if you are conducting human research. If you get it wrong, you leave yourself open to legal proceedings by those that feel your actions have been negligent. 

Here, we look to explain the principles behind informed consent as well as giving an informed consent definition. In doing so, we aim to help you stay on the right side of the law as well as emphasising why informed consent is so important. 

What is informed consent? 

Informed consent is the agreement from an individual to a healthcare provider regarding medical treatment. A healthcare provider has a responsibility of care to explain treatment fully. Additionally, a healthcare provider must be confident that the patient understands the procedure well enough so they can deny treatment if they want. 

With regards to human research, if you are carrying out a trial, a patient must understand that they can agree to your research or not. They must also have been fully briefed on that research, what it entails and what any outcomes could be. 

To cover yourself when asking someone to give informed consent, it is commonplace to ask them to sign a consent form. This is almost like a contract and, if designed correctly, it should legally cover you when you carry out your research. If you are ever unsure as to whether your consent forms or contracts are robust, ask the experts. 

What are the 4 principles of informed consent? 

For informed consent to be given properly, you or a healthcare practitioner must abide by four principles to ensure that a patient is fully acquainted with the situation. The four principles of informed consent are:

1. The patient must be able to make a decision

This means, that before carrying out any human research on your subject, that person must have the mental capacity to make a decision. Those that are of lesser understanding, who cannot understand the possible effects of a medical treatment, will need to have consent from a legal guardian. This could mean that a person is not of legal age or is not of sound mind to make such an important decision. 

2. There must be an explanation of information before a decision is made

For a person to be able to make a decision regarding their treatment or admittance into human research, all information must be fully explained. If you are conducting clinical research, this means that you must outline and detail everything that will happen as a result of the procedure. You must also explain the procedure itself. Additionally, you are required to explain all the possible outcomes and side effects of your trial. If you miss anything, informed consent cannot be given in full faith. 

3. The patient must understand the medical information given

It is imperative that once you have explained everything there is to know about a medical treatment or medical trial that the patient actually understands what has been said. In particular, they must understand the medical information relayed. This is so you can be sure they fully comprehend what the outcomes could be. 

4. The patient must understand their decision is voluntary. 

Under no circumstances can legal informed consent be given, if a patient does so involuntarily. They must have the freedom of will to say yes or no to the course of treatment or research that they are offered. If they are put under any duress at all, legal informed consent cannot be given. 

With regard to human research and clinical trials in particular, these four principles of informed consent can be summarised as follows:

• The patient must be fully briefed on the purpose and procedure for the research
• The patient must be given all relevant information about the research. This must include any advantages or disadvantages that could be a result of the trial. 
• The patient has to understand all the information given to them. 
• The patient must have the freedom to say yes or no to their participation. 

Why is it important? 

Informed consent is one of the founding pillars of the medical profession. Without it, patients are at risk of being subjected to medical treatments or human research without their consent. 

It is critical, too, to acknowledge the importance of the word informed. Patients must have all the information they need to make an informed decision. If all the information isn’t given, patients may be agreeing to a course of action that they do not fully comprehend. 

Making it a legal requirement to provide all the information to patients helps prevent negligent behaviour. Additionally, it helps stop those in the world who would seek to take advantage of patients. If the legal requirement to have informed consent didn’t exist, they could do so. Informed consent was established to protect the most vulnerable in society. 

With respect to human research, informed consent is important to both the patient as well as the medical researchers. Firstly, it stops careless professionals having a cavalier attitude towards their patients and research. Secondly, it means that patients understand fully what they are letting themselves in for. Thirdly, and perhaps most importantly, it helps make results reliable so that they can be used. 

Overall takeaways for informed consent

Informed consent from a human research perspective is imperative to get right, right from the start. Without it, any research conducted or data gathered can be called into question. Even if the trials or research produced medically helpful results, they can feasibly be voided if they were not gathered in a lawful way. 

Bearing that in mind, if you are considering conducting research, make sure you spend the time getting the legalities correct. If you do not, you could call into question any findings that you make as well as leaving yourself liable to legal actions by your patients. Have the right contracts and consent form in place to ensure that you don’t leave yourself open to any risk.