Why are consent forms important in your healthcare practice?
Documenting informed consent from your patients is a critical component of compliance at your practice, as it protects both patients and providers alike. Consent forms empower patients with information to make informed decisions about their medical care, outlining potential benefits, risks, contraindications, and side effects. For healthcare providers, robust consent forms are more than a layer of legal protection, they also lay a foundation for clear communication, transparency, and trust.
To ensure the consent forms at your practice are thorough, you’ll need to focus on two areas: the substance of the forms themselves and the processes in which you obtain and document a patient’s informed consent. In this article, we'll review both.
Want to download and customize your own consent forms? Check out our Consent Forms Shop, which also includes policies and procedures.
What should your consent forms include?
The more meticulous you are in crafting your consent forms, the more protection they should allot. While it is possible to download basic consent forms online, it’s imperative you have a trusted legal team review these documents to ensure they are up-to-date and include pertinent language. Most boilerplate documents downloaded for free online are, well, free for a reason.
A list of topics your consent form should address include:
Explanation of the procedure or medication, including what it is, how it works, and a summary of ingredients (if applicable).
Recommendations such as alternatives, when to discontinue use, how and when to inform other healthcare providers, how individual responses may vary, and follow up care.
Conditions under which a patient should not use the medication or procedure. Examples may include pregnancy, existing health concerns, risks dependent upon age, family history, or use of other medications.
What a patient should tell their healthcare provider before undergoing treatment, including other medications they’re taking and existing medical conditions.
Possible side effects (including common, uncommon and rare) of the treatment.
Patient acknowledgement and signature.
Many consent forms will include a list of potential benefits. While there is no hard and fast rule that benefits should not be included, practice owners must be extremely careful when including such language. Medical and nursing boards across the country are cracking down on what could be construed as false or misleading advertisements. Affirmative language about the benefits of treatment must be accompanied by citations to applicable scientific studies and/or disclaimers that results will vary. Using language that states treatment “may” have a certain result is far better than stating that it “will”. Steer clear of any such guarantees.
What are best practices for obtaining and documenting informed consent?
Having a thorough consent form in place is just the first step. Next, make sure you have the procedures in place at your practice to obtain informed consent for patients and keep it on file.
Here are some best practices to keep in mind.
How can you best ensure a patient understands and consents to the procedure?
Make sure your consent forms are not packed with only medical and legal jargon. Explain confusing terms, give patients adequate time to review the forms, and make sure to answer any potential questions a patient may have.
How often should you obtain a returning patient’s informed consent?
It’s best to have patients sign a new consent form any time they are undergoing a new procedure, product type, or medication. Have recurring patients sign new consent forms for repeat procedures at least once a year or if and when anything changes in their health history.
Are your consent forms up-to-date?
In the rapidly evolving landscape of healthcare, it’s crucial to continuously update your consent forms with emerging information. If the FDA issues updates for new potential risks or side effects, or if there are any changes to a medication or compound, you need to update your consent forms and obtain new patient signatures.
Are your consent forms aligned to state regulation?
When it comes to healthcare practices, regulations vary on a state-to-state basis. Ensure your forms comply with all of your state’s regulations regarding both the procedure itself as well as patient consent.
What are best practices for documenting and storing a patient’s informed consent?
First - and this should go without saying - make sure you do actually receive a patient’s signature on a consent form before moving forward with a procedure. It might seem obvious, but sometimes a signature can be overlooked in the process of handing patient paperwork and discussing the procedure.
Once you have obtained a patient’s informed consent, ensure any method you take to store a signed consent form is safe, private, and in compliance with HIIPAA guidelines.
What other types of forms does my practice need beyond informed consent?
In addition to consent forms for patients, your practice should also have documentation outlining various policies, procedures, and processes. Consult with a legal team to create your practice’s policy and procedure forms, photo release forms, intake forms, safety or cleaning forms, standard operating procedures, and more.
Not only do these forms protect your practice and providers from potential legal action, they enhance your overall operations and patient experience. Think of them both as legal armor as well as a foundation to grow and thrive in your practice.
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