Module 2
Page 4 of 11

User recruitment, consent and ethics

When planning your user research, there are several key things you need to consider.

Ethics

Designing healthcare related products can require a formalised and stringent ethics approval process. Healthcare products and services can involve decisions, experiences and interactions that are highly sensitive, with far more significant risks compared to other industries. It necessarily involves people who might need extra support and compassion.

When designing a study, the participant’s health, safety and interests must be protected throughout. Any intrusive methodology (such as a home visit) must be justified with respect to the research questions. This will be scrutinised during any ethics approval process.

The history of medical research testing is fraught with instances of involving people in ways which transgress their dignity and rights, further reinforcing the need for a contemporary robust process for ethics. This process can take time and resources, so it is vital to consider the ethics of a research project from the start.

NHS ethics process

Every research project must have the ethics of involving participants in mind. In some cases, it will need ethical approval from an external ethics board or, in the UK, the NHS ethics process. NHS ethics approval is a highly involved process which can take up to six months (at times more) so must be built into project schedules.

A number of resources are available online to establish if your project will require NHS ethics, and if so, which approval board is most appropriate. Some projects which are lower in risk might be eligible for the Proportionate Review Service, which allows a shortened time for approval. In most cases (including Proportionate Review), NHS ethics approval must be processed through the IRAS submission system, a portal through which all applications are completed.

More details on the NHS ethics review process can be found here.

The ethics submission will generally demand a justification for every stage of the project, from recruitment through to dissemination. All study details included in the ethics submission must then be adhered to in the actual project, so upfront planning is crucial to avoid having to apply for approval of any amendments.

Recruiting users

Recruitment refers to the process of bringing on board people who are willing to participate in your research. It is a crucial stage which needs to be carefully thought out, just as much as the other aspects of research planning. The strength of your research will largely be determined by having a representative group of users to work with. Ensuring that this happens takes time and consideration.

Some key principles:

  • Consider who will be the most appropriate and representative people to work with, and how many individuals would be ideal to involve in your research
  • Consider the appropriate incentive, language, and way of framing the project to support recruitment and ensure a representative sample
  • Aim to recruit as representative a sample of users as possible
  • Be aware of biases in the recruitment approach and explicit with any limitations in the final sample

You can learn from recruitment as well: about the kinds of people who come forward, where people find out about the study, the language that they use, why they decide to take part and so on. This might come in handy later when thinking about how to communicate about your project and who to communicate with.

Planning recruitment

You will need to:

  • Create a recruitment brief outlining characteristics of ideal candidates
  • Find potential participants
  • Screen participants to understand which of the characteristics you’re looking for are true
  • Communicate with participants and gain consent
  • Provide incentives e.g. vouchers
  • Plan and schedule testing

Creating a recruitment brief

If using a recruiter, you’ll need to create a recruitment brief. Even if you aren’t, you could still use the same process to draw up the criteria that you’ll use internally to recruit research participants.

Step-by-step
  1. Identify the characteristics you need in participants: e.g. familiarity with mobile phones, age, geographical location, health status etc. Avoid making assumptions based on demographics (e.g. that older people will be less able to use technology) and focus on knowledge or experience rather than demographics as much as possible.
  2. Categorise these by level of importance into primary, secondary or tertiary characteristics. If a characteristic isn’t essential, it is useful for a recruiter to know this, so that they can adapt if necessary to the available candidates.
  3. Looking at the required characteristics, decide which recruitment path you think would be most appropriate (see below).
  4. If using a recruiter, add the above characteristics into a document that also clearly states the objectives, schedule and any other relevant parameters they’ll need to know.

Recruitment methods

There are a range of routes for recruitment that you can use, depending on the requirements of your research:

Recruitment specialists (specifically health/medical focus)

  • Pros
  • If well managed can save internal time spent on recruitment.
  • Can access new networks in a very targeted way.
  • Enables access to individuals (from patients to healthcare practitioners) who might otherwise be difficult to reach.
  • Adds professionalism to recruitment efforts to help in still trust with participants.
  • Cons
  • Can be expensive and become a key external dependency for the project.

Social media (Harnessing pre-existing forums, groups for networks)

  • Pros
  • Can be cheaper.
  • Can tap into specific networks but also allow users themselves to boost the call out.
  • Cons
  • More internal time to manage.
  • Can introduce self-selection bias (only the very keen or very engaged are likely to respond).
  • Excludes non-users of social media.

Flyers, leaflets (in spaces where the target audience spends time)

  • Pros
  • Can reach those who do not use social media etc.
  • Can reach a new but targeted audience.
  • Cons
  • Time consuming and expensive to produce and distribute.
  • As with social media, can introduce self-selection bias that favours those who are already very engaged.

Gatekeepers or partners (eg doctors, local councils, charities)

  • Pros
  • Provides legitimacy, ready made networks.
  • Enables snowballing, in which one person recruited can recommend others in their networks, facilitating the recruitment of existing networks.
  • Cons
  • Dependency on others’ timescales and available resources. Informal processes can be slow and provide fewer guarantees for finding the right individuals within project timings.

Informed consent means that participants are able to make an informed choice about whether to take part because they have been given clear and accessible information on:

  • the project background
  • what will be expected of them in terms of their involvement (time, travel, activities)
  • how their data will be used (especially confidentiality and anonymity)
  • how they will be compensated for their time (what they will receive in the way of incentives)

You must get informed consent from participants before you start working with them. Research cannot begin without consent having been given. This is good, ethical practice, and will also be a requirement for getting ethics approval if you are going down that route.

An information sheet and consent form must be created for participants to sign. The information sheet sets out the key details of the project, the research and the nature of their involvement. The consent form records their details, sets out what the participant is agreeing to, and collects their signature. These must be as inclusive as possible in terms of the language, length, and formatting. Signed forms must be collected before the research starts.

Participants must have enough time to review and ask questions before signing consent (minimum 3 days, ideally 2 weeks). At the start of the first interaction with participants (e.g. research interview) we reiterate the terms of consent to make sure that they are clear and give participants a final chance to ask questions and discuss in person.

On the Dementia Citizens project, when testing a digital consent process for our apps, we found people didn’t always read through consent information: the conventional language was lengthy, with jargon, and repetition. So we made the process clearer, more interactive and accessible.

Read about the consent process for people with dementia here.

Engaging users

We have used a range of mechanisms to both support engagement and an ethical basis for involvement:

  • Regular data feedback
  • Dedicated website to update research participants
  • End-of-study report to be shared with participants
  • Thank you card
  • Thank you email
  • Summary of research findings