Consent Part 2: Do I Need To Get Consent? How Do I Do That?
October 2021
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I previously wrote about what consent is and the options you have for obtaining it. Check out that article here. Here I’ll explore more detail about how to assess when you need to obtain consent.
Is Consent Always Needed?
Consent to participate in an evaluation project may not be required if the risks posed to an individual are normal, or no more than routine care. A good rule of thumb is that “the level of consent should match the level of risk.” A thorough ethical review may help if you’re unsure what this means. When participant information is used to inform improvements but kept confidential consent may not be required, whereas interviewing members of a vulnerable population may require a comprehensive consent process.
Some questions to consider when assessing the risk of participation may include:
What are the impacts of a breach of confidentiality?
Is the topic sensitive in nature? Does it address a stigmatized behaviour, religious, culture or legal issues?
What is being asked of the participant? Does it cause any burden?
Is there risk of causing psychological distress?
There are a few more considerations and principles to cover:
1. Capacity
Capacity is the ability to understand and appreciate the information being provided. Those with diminished capacity may still (and are encouraged to) be involved in the consenting process. Each consenting participant must be fully aware and capable of providing consent. Commonly, this means being over the age of 18, free from the influence of drugs or alcohol, and free from any mental or physical illness that may impair decision-making or understanding. Check out our article where one of the Three Hive team encountered problems with capacity and how she dealt with it.
Importantly, capacity may change over time, and there are projects where you may need to assess capacity, and consent, multiple times.
2. Coercion
It is possible that the invited participants feel obligated to participate. Falagas found that only 47% of participants truly understood the voluntary nature of participation. This is alarming and suggests that reasons for participation may stem from fear of being denied services or a power imbalance between the project lead and the invitee. Asking yourself about perceived or real power imbalances or conflicts of interest between participants and project leadership is a good place to start.
3. Revisiting Consent
Importantly, consent can change; it must be obtained and maintained. In projects that have a longitudinal time component, consent should be revisited at each touchpoint throughout a project. Reminders can be given about what has been previously consented to, the nature of remaining participation, changes in capacity can be assessed, the right to withdraw may be presented. and/or a new opportunity to ask questions may be offered.
4. Evidence of Consent
Evidence of consent is an important part of the process. Evidence may be important should adverse events occur to show that participants were fully informed before participation. As described in Part 1, each form of consent has a means of providing evidence.
Evidence of consent may be:
a (signed) consent form
a documented process or script for obtaining verbalconsent
a recording of verbal consent
field notes from the data collector about the consent process
through the actions of the participant (i.e., implied consent)
There is limited information available to guide the consent process in evaluation work. We’ve got a couple of resources available: Questions to make sure your evaluation is ethical (infographic) and Putting an ethical lens on your evaluation planning may help you think about the need for consent and the ethical issues surrounding consent (e.g., power imbalances, conflicts of interest, information sharing, or the confidentiality associated with participation).
Ultimately, thoughtful consideration of the consent process is an important project design step. If consent is required, documentation of the consenting process allows for evidence that the consent process has been planned and will be applied systematically.