Personalization of the products and services in all spheres of life has prompted us to reevaluate the way we treat privacy. It has also raised awareness about the importance of informed, explicit consent. If you want to protect both your business and your customers, it is of utmost importance that you understand what constitutes a valid consent form.
In this article, we will go through the basic requirements of a medical consent form and show you how to create this document in less than 15 minutes.
The Definition of Consent
Explicit consent constitutes an agreement or disagreement with a precisely presented option, such as a medical procedure, participation in specific activities or disclosure of personal information.
In order to be valid, consent must meet four conditions:
- capacity – the person must be capable of making informed decisions
- it has to be voluntary – made by the person themselves, free of other people’s influence
- unambiguity – the choice must be clearly stated
- it has to be informed – the person must be presented all of the information about the activity/procedure (we will go into detail about this later on)
Take a look at this example of a consent from – we will use it to walk you through the elements that constitute a reliable document.
Our consent form is crafted for medical research purposes, per recommendations by World Health Organization (WHO), because this type of informed consent usually requires special attention to details. Once you master this, you can adjust or simplify your consent form for commercial or business purposes.
The Elements of Informed Consent Form
There are eight mandatory elements to an informed consent form.
1. A statement that the study involves research
Your consent form should start off with the acknowledgment that the study involves research. Further elaboration includes stating the purpose of the study, and the expected duration of participation.
Describe the research procedures in detail, specifying which ones are experimental.
2. Foreseeable risks and discomforts
State the foreseeable physical, psychological or social risks of participation in the activity.
Include the estimated possibility of the unwanted outcomes, and make sure to point out all of these outcomes clearly.
Describe the benefits of this research, for the individual and society. For example, testing a certain medicine could give a person access to cutting-edge treatment. If proved effective, the treatment could cure a particular disease and help millions of people.
Most consent forms come with a disclaimer which states that benefits are not guaranteed or promised.
4. Disclosure of alternative procedures/treatments
If there is an alternative procedure or treatment to the offer in the consent form, the document should state it explicitly.
If there are none, the consent form can indicate that there are no known alternatives or that not participating is the second option.
5. Confidentiality of data
Describe in detail how the assembled personal information will be managed. State the extent of confidentiality, who will have access to data, why, and how this data will be analyzed and used.
6. Compensation and treatment for an injury
Some studies carry the risk of injuries and other damages – in these cases, the consent form should explain the specifics of compensatory actions.
Explain what is included in compensation, how it will be financially covered, and where further information can be obtained.
In case the participants have any questions about the research, their rights, or if they want to file a complaint, you should provide the contact information.
8. Voluntary Participation
A statement that the subject’s participation is voluntary, and that refusal to participate will not lead to any losses or sanctions. The consent form should also allow the subject to withdraw from the research/procedure at any time.
Apart from the eight mandatory elements of informed consent, in certain situations your consent form will need the statements about the following things:
- Currently unforeseeable risks
- Circumstances in which the investigator may terminate the participation
- Possible consequences of the subject’s voluntary withdrawal
- The number of participants
- Additional costs of the participation
- Availability of the information about developing findings during the research
After you inform the potential participants about the details of your research, you can move on to the final section of your consent form - certificate of consent.
You don't have to include the "decline" option in your consent form unless you want to keep the records of the acceptance rate among the surveyed people. Finally, ask for name and contact information after the person consents to the participation.
Keep in mind that a good consent form has to adhere to all the relevant legal requirements, such as Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR) and your state’s regulation. This document can be modified to reflect the nature of your products and services, but all of these elements still must be included.
With LeadQuizzes 3 Beta monthly plan, you have access to our content builder, where you can create customized consent forms for your research or business, and make sure you follow all the legal and ethical guidelines!