This is an Eval Central archive copy, find the original at evalacademy.com.

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. Quality improvement projects where participant information is used to inform improvements but kept confidential may not require consent, 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 or population, 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. It is important that each consenting participant is 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 Eval Academy 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 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 rise 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 within the project to show that participants were fully informed prior to participation. As described in Part 1 (link), 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 oral consent
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. The ARECCI guidelines and screening tool are an excellent resource to get project leads to question 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.

Consent can be a huge part of an evaluator’s role, but it isn’t always scary. If you still have questions reach out to us – we’d love to chat about this more!

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