What is Informed Consent?

Philip Cleave
December 17, 2021
Participant signing their consent to take part in study

Whether as a result of our participation in a research study, or as a health or social care patient. No matter what walk of life we’ve come from, most of us at some time or another will have had to provide our consent, to legitimise our participation in an activity or to undergo medical treatment.

More than anything, this is to ensure adequate protection’s in place for the patient or individual involved in the study.

Informed consent definition

Informed consent refers to the permission granted by an individual in full knowledge of the possible consequences communicated to them. Typically, this is provided by a patient or research participant, to a doctor or researcher. And it concerns the potential benefits and risks of their treatment or research involvement.

Principles of informed consent

The principles of informed consent essentially state that a patient or research participant should have sufficient information, in order to make a free and informed decision about how they choose to progress next.

There are four main principles of informed consent to satisfy, in order to fully recognise that consent.

Decision making capacity

The person asked for their consent must have sufficient decision-making capacity to come to their decision. This is important, as decision making is not an absolute science. What we mean by this, is that while an individual may have the capacity to make some decisions, this may not apply to everything facing them.

Subsequently, you can examine an individual’s decision-making capability, by assessing their ability to comprehend the following components of their decision-making capacity:

  • Are they able to understand the options outlined to them?
  • Do they have the ability to understand the consequences of choosing any of the options offered?
  • Can they evaluate the personal cost and benefit of each of the consequences and then relate them to their own set of values and priorities?

An individual would need to be capable of rationalising all these options in order to have sufficient decision-making capability. If not, you could assign a ‘surrogate decision-maker’ whether another family member or a court-appointed guardian to do this on their behalf.

Decision-making capacity doesn’t necessarily mean you will always make the best decision. It simply means you can understand and relate to the options, their implications, and provide a rational reason as to why you would decide on a particular option over the alternatives.


Whether you’re looking to participate in a research study or undergo medical treatment or tests. When we talk about disclosure, it essentially refers to information that is provided for the participant.

While it’s not necessary to outline every single detail of a research study, medical procedure or test, it needs to be sufficient enough for the average individual to make an intelligent and informed decision. This information should outline the risks and likelihood (or probability) of each of the risks and the benefits, and likelihood (or probability) of benefit. If an individual has any questions, you should fully explain them, in a language and terminology that they can easily understand.

Documentation of consent

While many routine tests and procedures such as blood tests and X-rays, imply consent, others require documentation of consent.

For many invasive tests or treatments with significant risk, patients are provided with a written consent form and verbal explanation. Participation in detailed research studies requires something similar. Minimum requirements for informed consent are that participants fully understand what the research is and what they are consenting to.


Competency is a legal term. It’s used to denote a person’s decision making capacity and their accountability for making those decisions. Although, it’s a term often used loosely to indicate whether a person has the required decision-making capacity, it’s important to be aware of as technically a court of law can declare a person as incompetent.

It’s important to note, that besides being competent, an individual must be able to grant their consent voluntarily, without coercion or duress.

Why is informed consent important?

Whatever you’re participating in, whether research or medical based, informed consent is crucial.

It’s vital for promoting the rights of participants and ensuring fair treatment and respect. Without this you risk not only losing individual rights, but unethical behaviour, which in some situations could be extremely dangerous.

The importance of informed consent can he highlighted further by looking at its relevance in different settings.

Informed consent in research

When we talk about research, we’re referring to an extensive area consisting of two major methods, primary and secondary research. While there’s no need to worry about consent with secondary research, as you’re just gathering information from existing studies, many of the activities involved in primary research will require you to gather informed consent.

From new product testing undertaken by a focus group to human participation in an observational study. Depending on the type and complexity of research, there may be numerous risks involved. In such a scenario, it’s standard practice to fully inform research participants of the risks, benefits, and procedures involved. This can also apply to interviews and surveys, where participants are identified.

In order to consider any participant’s consent as “informed,” your research study or survey needs to disclose any facts that could influence someone’s decision about whether to participate in the study.

Informed consent in healthcare

When it comes to medicine, professional in that industry must frequently make key decisions.

Doctors must reach a diagnosis, then decide on the most appropriate treatment to fit a patient’s needs. In turn, patients must evaluate what they hear and decide whether to pursue a specific course of treatment, seek a second opinion or refuse a suggested procedure. If the patient provides their informed consent, there is now a clear pathway to treatment.

Essentially, informed consent is in place to protect the patient. The consent form is a legal document that ensures ongoing communication between a patient and their health care provider. This consent is obtainable as part of a larger healthcare questionnaire. For example, as part of a healthcare screening exercise and depending on the answers provided, you could ask for your respondents consent to agree to follow a particular dietary or exercise regime moving forward.

Obtaining informed consent

Having discussed what constitutes informed consent, it’s useful to look at the online data capture process for obtaining that consent.

Here’s a couple of options to consider for your survey, which provide greater clarity when it comes to survey data collection in the area of consent.

For both these scenarios you could start your survey with a separate, unnumbered page, that makes it obvious that it’s devoted to collecting consent.

Besides other components to include on this page which we will discuss next, the actual process of obtaining that consent, could be as simple as asking respondents to checkbox one of the following two statements.

Alternatively, you could make it even more obvious by asking the following radio button consent question with two possible answers.

I consent to providing my information in this survey?

With box question types, only those who answered ‘Yes’ can continue onwards into the main body of the survey. With those that answered ‘No’ disqualified from completing the rest of the survey.

The survey consent form: what to include

When it comes to your survey consent form or page, you should outline all the important details to potential respondents. This ensures everyone understands exactly what’s involved in being a respondent. Subsequently, helping to avoid any issues after your data has been collected.

What’s your survey about?

While the survey’s subject may seem obvious to you, it’s less likely to be for participants, who are yet to view a single question.

So, try to provide a short summary of your survey topic, outlining its purpose and any affiliated institutions or organisations. It’s valuable to detail your survey’s length, in terms of the number of questions, or projected time to complete. It’s also useful to outline what will happen once a respondent has completed all the questions.

What do you expect from your respondents?

It’s always a good idea for respondents to know what you expect from them, before they take your survey. For example, if you know that your survey works best in landscape mode on mobile devices, or you think the user experience will be better on a desktop, share that information with respondents.

Outline the risks and benefits

While online surveys aren’t usually risky, they can form part of a larger study that includes physical activity or tests. Be clear about the design of your project, outlining any risks that might face participants.

This is also a great place to communicate any benefits. This should include any survey incentives you’re offering.

Confidentiality and anonymity

Depending on your survey’s questions, if it contains any you feel people may find uncomfortable answering, make sure you clarify how you’re going to handle confidentiality or anonymity. This will ensure they feel more comfortable and less likely to walk away, which could negatively impact your response rate.

How will you use participants data?

Finally, your survey consent information should leave no questions regarding your plans about the survey data you collect.

When you’re able to keep responses completely confidential, make that clear. In contrast, if there will be any identifying information associated with a respondent’s answers you should disclose that up front too.

You should also include some information about survey security. Essentially, detailing any IT security and data protection processes you have in place to protect participants.

If you can do all of this, more respondents are likely to complete your survey. You’ll also be more likely to get the result you were hoping for.

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