Consent Part 1: What is Informed Consent
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As an evaluator, a big part of our role is to collect data. Sometimes that data comes from administrative databases that require data sharing agreements, but sometimes it comes from people, who need to consent to sharing their information (or data) with you. So let’s talk about what consent is (and isn’t).
I’ll share the punch line with you up front: consent doesn’t have to be a scary, overly burdensome process. If you keep some key principles in mind, obtaining the right consent can be pretty straightforward.
There are different types of consent, many of which don’t apply in an evaluation context: consent for medical procedures, legal consent, etc. It is this legal consent, and the “signed consent form” that most people think of when they think of consent.
Consent, broadly, is giving permission for, or agreeing to, something happening. Informed consent means individuals consent with full knowledge of the nature of participation, alternative options, and potential benefits, risks, or consequences to them (more on this below!). As the evaluator, you need to respect an individual’s choice to participate in your evaluation. For an individual to participate, they need to know what those pros and cons or benefits and risks are! Finally, assent is given on by a person unable to provide their own consent (e.g., children or adults with disabilities).
As an evaluator, it is best practice to consider the consent process through an ethical lens, and then to document that process and the decision-making rationale. The documentation serves to provide evidence of the process.
What is Informed Consent?
Informed consent requires that the participant be informed of:
all the known or suspected risks and benefits of participation
the complete nature of participation (that is, what are they being asked to do or share)
the withdrawal process (if there is one)
their rights to access their own information
benefits to the project
what will be done with the information
who will have access to their information and confidentiality will be maintained
compensation or expenses
However, writing this out in a consent form is not the end of informed consent. An important part of consent is that the participant is provided the opportunity to ask questions or clarify information. This dialogue is important to ensure the potential participant has all the information they need to make an informed decision, but also for the project lead to ensure that the participant properly understands the information.
A review of consent literature has shown that there are major opportunities for improving the consent process! Falagas et al found that only 54% of consenting participants understood the study’s aim, 47% understood the voluntary nature of participation, 44% understood the right/ability to withdraw, 50% understood the associated risks, and 57% understood the benefits to participating. These results highlight the importance of an open discussion where it is the aim of the evaluator not only to inform, but to ensure understanding. You are not collecting informed consent if your participant is not informed!
Methods of Obtaining Consent
1. Consent forms (aka written consent)
The purpose of a written consent form is to provide all the information regarding participation to the participant in a clear, systematic way. The written consent, whether signed or not, can provide evidence that there was, at minimum, a presentation of information to the participant.
Reminder: Having a consent form does not necessarily mean you have informed consent, and informed consent does not necessarily require a consent form.
A systematic review by Nishimura et al found that an enhanced consent form or an extended discussion around consent were the most effective methods at improving participant understanding. An enhanced consent form aims to simplify consent to optimize understanding. It can include increased font size, enhanced literacy level, or additional materials including leaflets. Microsoft Word has features that can help you assess readability and literacy levels or look into an app like Hemingway.
If a paper consent form is used, it is important to draft the consent with the target audience in mind. Health Canada recommends a reading level of grades 6 - 8 for the general population. Here’s a quick checklist for what to include in a consent form:
purpose for the data collection
description of the complete nature of participation, which may include time commitment
risks
benefits
assurance of the voluntary nature and the right to withdraw
use of information
confidentiality
contact person
any appropriate legal disclaimers, or reference to research grants or ethic approvals
Reading Level Tips: To reduce reading level, try to make sentences shorter by removing unnecessary words or breaking a long sentence into 2-3 separate sentences. Choose words with as few syllables as possible.
Try to avoid jargon and acronyms and assess the literacy level (aim for Grades 6 - 8).
It is common for the project lead to keep a copy of the consent, and also provide a duplicate copy for the participant to keep.
A word on signatures: A signature on a consent form has its roots in legal consent. A signature may act as evidence not only that the person acknowledges the information in the consent form but that they have, in fact, provided consent. However, unless you have funding, legal, or organizational policies around signatures, they are not necessary to obtain informed consent. In fact, if you are collecting data from vulnerable populations, there can be risk in keeping a record of a participant’s name, especially if it can be linked to their data. An ethical principle of evaluation is to collect the bare minimum data required, so consider carefully if you absolutely need a signature.
2. Verbal consent
Verbal consent can be an ethically sound method of obtaining consent. Scripting a consent process will ensure that each participant is given the same information about the project. Or, a consent form may be used as an aid or resource. As in a written consent, the language used in a verbal consent process should use lay language and keep the target audience in mind. A script or consent form can act as evidence that a consent process was documented and that each participant engaged in a conversation before giving or denying consent.
3. Implied consent
Implied consent is when a participant does not explicitly express consent but consents via action or behaviour. It can also be a valid option in appropriate circumstances.
In some evaluation projects, the project leads do not interact with participants. For example, a lead would like a survey handed out by front desk staff at a service centre to each customer. In this case, the project lead is not available to obtain consent and placing the onus of obtaining consent on the front desk staff may be inappropriate. Once a project has been deemed ethically sound, it is possible that a participant can give informed consent by action. For this to occur, the participant must have access to the same information as one would receive in a written or verbal consent process. This information may come as a detached written document or the information may be included at the start of any paper data collection (e.g., a survey).
Example Text: By completing this survey you are consenting to have your responses used in aggregate and shared back with program staff to be used in quality improvement.
There should be a statement that indicates that by moving forward with participation (e.g., by completing this survey), that the participant understands and accepts the nature of participation and provides consent. In this case, the completed participation, along with documentation of the consenting process, would act as evidence of consent. Because capacity to consent cannot be assessed in this way, ethical review of the project is recommended.
In all cases, the project leads should have a clear, documented process for how consent will be obtained, and how (if necessary) it will be reassessed throughout the project. If you are unsure if there are any policies around how you obtain consent, check in with your local health authorities, associations/colleges, or governmental acts that may have policies around consent.
If a consent process is used, the participant should be informed of the intended use of the data, including an intent to publish data. The intent to publish, however, does not necessitate requiring consent. Publishing data while maintaining confidentiality is ethically acceptable.
Stay tuned for Part 2 of this discussion that dives more into how to obtain consent and a list of principles to consider!
In the meantime, check out Eval Academy tools for some consent form templates we have for interviews and focus groups.