Informed consent is one of the central pillars of research ethics. The contents of which reach beyond the document itself and require a knowledge of how we recruit, our participant's rights and how we support them and finally, how we manage the data we collect.
This checklist aims to guide you through these things and help you implement a process that meets data privacy laws and helps you build trust through transparency.
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Before you ask
Data management and housekeeping
Understanding how data moves through your processes helps to identify risks around how you handle personally identifiable information. We created a workshop you can run with your researchers to map out these processes while aligning them on best practices.
Many apps and devices back-up data captured automatically to their own clouds. It's important to be mindful of this, especially when dealing with PII and sensitive data.
One of the outcomes from our free Data Management Workshop is that your researchers understand their processes, reflect and make adjustments if necessary.
The relevance of different types of data can have different shelf lives. Consider the recordings from a usability test, over research into deeper cultural perspectives. Think about how long that data is practically useful for and adjust your retention policies accordingly.
Some cloud providers prevent full deletion of files from their servers, instead simply moving files to a trash folder. Double check that you can actually delete things.
Obtaining consent from children
Consider how the child was approached to take part in the study and any potential coercion which might arise - this can also occur in how you are presented to the children through perceived alliances with adults they already know.
If participation has been negotiated through adults it is best not to assume that children have been fully informed about your research. Allow for time to explain the purpose and invite questions at the beginning of your session.
Use this as a basis for a discussion about the research, whether you plan to record or not and that they can decide not to take part or answer particular questions if they don’t want to. Always invite questions.
Some children may be sensitive to being recorded. Give them an opportunity to say what they think and ask questions. If you are working with a group of children and one child in the group objects, it is best to not record for the entire group.
Where possible, provide options for activities that may differ from the study which the child can choose to do instead. Welcome children who choose to rejoin or take part later in the study.
Writing the consent form
Try to make the language in the form as simple as possible, avoiding design and legal jargon and invite questions where possible.
Part of understanding the consequences an individual might encounter is to understand the motivation of the research and actors involved in it. Knowing this allows people to make a more informed decision about whether to take part or not.
Most people probably haven't taken part in a research study before, and will likely feel anxious about what to expect. Knowing this upfront can help to remove those anxieties.
Being recorded often makes people nervous and can change the entire dynamic of the session. Let them know upfront what you would like to record and why, before offering them a meaningful choice about whether you record or not.
Knowing what those recordings will be used for can help people to understand if they are comfortable with it or not.
Knowing who else will see the research data before it is de-identified or anonymised (while the participant is potentially exposed) can help reassure them that their information is being safeguarded appropriately.
Using checkboxes is effective in giving the participant meaningful choice about how their data is used. It does not coerce into taking part (eg: agree to all of the above) and enables them to take part if they are not comfortable with being recorded.
If the participant has questions it should be clear (and easy) for them to know who to ask, how they can ask and that it is okay to ask.
It should be clear (and easy) for the participant to be able to withdraw from the study at any point in time.
The process for how to withdraw from the research should be made clear, typically this will be to email a researcher.
Your participants have the right to request all of the information you have about them relating to a specific topic. Think about how you would pull all of that together and provide it to them. Here is some more information from the ICO in the UK on handling access requests.
Participants have the right to withdraw consent. All research should indicate the point at which data will have been anonymised and amalgamated and in certain circumstances cannot then be excluded. Some projects provide a date after which consent cannot be withdrawn.
Participants have the right to request their data is deleted. Ensure that you have the appropriate measures in place to erase information and that information can be deleted. For more information see Participants right to erasure.
Make sure that you actually need to collect and process any special category data before doing so. Is there another way to achieve your purpose without this data?
Special category data is any personal data revealing: racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data (where used for identification purposes), data concerning health, data concerning a person’s sex life, or data concerning a person’s sexual orientation.
When you ask
After you ask
This might involve saving the state of the consent form and allowing the participant to simply change their selected options. Using Consent Kit allows the participant to do this, and notifies the researcher by email if it happens.
See the guidance from the ICO on handling data subject access requests. Using Consent Kit enables you to generate a report of all interactions with the participant, the consent they gave and links to any data recorded during the research.
You can kick start the withdrawal process from within Consent Kit. Deleting their data will notify the researcher(s) responsible for that participant of all follow up actions required, such as deleting any remaining recordings.
Linking consent to recordings lets you see which information you need to pull into a report in the event of a subject access request, or can tell you what you need to delete should the participant want to withdraw from the research.
You can set your data retention policy globally in Consent Kit. This will start a countdown for each recording linked, based on the agreed retention policy in the consent form the participant signed.
Assigning a new team member to be the owner of a project in Consent Kit will make them the recipient of any notifications regarding deleting data or withdrawing participants from research automatically.