What is consent, really?
Chances are you’ve heard the term “Consent” used outside the medical field.
Maybe you checked a box on an online form agreeing to their “Terms”. Or perhaps you’ve parked next to signs saying “Park at your own risk”. Some of you may have even used Gym equipment “at your own risk.”
Whether we like it or not, we provide multiple forms of consent everyday.
Sounds simple enough, right? What’s the big deal?
Well, odds suggest that box you checked permits the website to sell your browsing data. Or even worse, it probably allows them to spam you with weekly emails you NEVER asked for.
The “park at your own risk” sign could be there because recently there have been a series of burglaries or hit-and-runs that suggest there might a better place to park your car.
What proof do you have that gym equipment is safe to use? Do you know if their machines have been prone to breaking, causing injury?
In its simplest definition– consent means to grant permission to someone or something.
Considering that, it’s downright SCARY how easily we hand out “permission” in today’s society...
Perhaps you're wondering, how can we consent to things without realizing it? Is that even consenting? Unfortunately, from a legal standpoint, there are four varying degrees of consent:
Implied Consent: This type of consent is given implicitly when someone puts themselves in a situation that has a set of outcomes or risks that are part of engaging in the activity
Example: Someone getting hit while playing hockey or in a boxing match.
Expressed Consent: This level requires that consent/agreement is unmistakably stated either verbally, in writing, or by a non-verbal gesture such as nodding one’s head.
Example: You check a box or sign a form agreeing to something.
Unanimous Consent: Applies to groups or organizations where each group member is required to provide their individual expressed consent.
Example: You agree to risks associated with a specific work environment.
Informed Consent: Informed consent is when the subject is made keenly aware of the potential risks and benefits involved, responsibilities, and deemed competent to provide consent.
Example: Signing an agreement for treatment after consulting with your doctor.
After reading so far, consent appears pretty loose, doesn’t it. How often do you fully understand the risks before providing your consent?
Even if you never plan on participating in a paid study, having a deep understanding of the different types of consent is critical in today's world. If you do plan on participating in a study, prepare to give your informed consent.
Informed Consent in Research
Informed Consent, being the highest degree of consent, is not as simple as checking a box or providing a verbal yes. There are four additional components involved in providing informed consent:
1. The subject is provided all information regarding the procedure– including the expected risks, benefits, and the likelihood that they will occur.
2. The subject must have the capacity (or ability) to make the decision– meaning they must be over the age of 18 or an emancipated minor, and not incapacitated either by the influence of drugs, alcohol, mental, or physical circumstances.
3. The Subject must be able to comprehend the information– signing something without comprehending the implications undermines consent. A medical professional must ensure every volunteer truly understands the information they are being provided.
4. You must voluntarily grant consent, without coercion or duress– meaning there can be no coercion involved when collecting your consent.
Avoiding the pitfalls of informed consent. Why is it important?
It’s easy to idealize high standards without truly practicing them, especially given the incentive in today’s healthcare. I'm in no way suggesting researchers are untrustworthy. But they are human and like you and I can get busy or become tunnel-visioned on their responsibilities and goals.
While it takes two parties to provide informed consent, in this information age, it only takes one to be informed.
As a participant, you should use this step as an opportunity to educate yourself about a certain condition or treatment. After all, in today’s litigious society, ignorance is no defense.
Here's a templated checklist you might read through before even sending in your application.
- What is the study’s purpose or goal?
- How long will the study last?
- What am I required to do as a participant?
- What does my doctor think?
- What is the treatment?
- How will it be administered?
- Will they use a placebo?
- Will I be told if I get the placebo?
- Will the sponsor know if I get the placebo?
- What level of approval does the treatment have?
- How experienced are the physician and study staff?
- What will the sponsor do to keep me safe?
- Will I have access to the results of the study?
- Is my participation in the study publicly listed?
Although, this list is just a starting point. Be sure to consider the specific questions and circumstances and inform yourself before providing any consent.
Conclusion
Regrettably, no article can sufficiently portray the important role consent plays in today's world. At the very least, I hope that this article challenged you to think about how you currently spend your consent.
It is your "purchasing power" in a world of risks. And in a society that is used to us consenting to nearly everything, remember that factor alone makes your decision more valuable and higher in demand.