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What the ethics? Negotiating ethics submissions

Submitting an ethics application is a daunting process. There are so many things to consider, and this is multiplied when working with a participant population which may be vulnerable. So, what do you need to consider when applying for ethical approval for your research? I am going to talk you through some points you need to consider!

Having just submitted my own ethics application for focus groups and an online survey, I feel I can now save you some time and talk about the sources I have found helpful and what needs to be included for you to (hopefully!) get the green light to carry out your research.

I first need to specify that the advice here will be for carrying out research with people living with dementia who have the capacity to consent. If you are planning research with people who may be unable to give written or verbal consent or will be going through NHS ethics, I will provide some signposting to research and support, but I will not be able to advise much further sadly. This blog will also be most relevant to those conducting qualitative research. I will begin with what you need to consider generally before going on to considerations that need to be made specifically for research with people living with dementia.

What to do before you even begin

Forms, forms, and more forms!

Now that you’ve found out all the admin details you will need, it’s time to fill out many, many forms! It is worth considering that if you are applying for ethics for multiple elements, e.g., an online survey and focus groups, many of the forms will have to be submitted for each part of the proposed research. For example, Online Survey Risk Assessment and Focus Group Risk Assessment.

The main forms you can expect to submit are:

What you need for each form

I will now talk through the details you are likely to need to include for each form/document. Templates will likely be available, which you can adapt to your own research, which makes the process quicker. You will however need to think about any additional points that you want to include on these generic forms.

Participant information sheet

For this form, you will need to cover:

Informed consent form

Informed consent forms usually follow a template, but you may want to add optional/additional elements such as:

I agree that information I provide can be quoted anonymously in research outputs. _____ I agree that anonymous data from this study can be used for other, future research projects that may be unrelated to the aims of this study _____________

Risk assessment

The template for your organisation/university may differ to the one used by mine (Loughborough University), but it is likely that you will need to think of all the activities that your research will involve, the activity’s associated risks, who might be harmed, measures to control the risk and then rate the likelihood and severity of the risk to calculate a ‘risk rating’.

Examples of things you need to think about for risk assessment:

Activity: Hazard: Who might be harmed and how Observations in-person Fire Anybody within the vicinity Gathering informed consent Organisational hazard, loss of reputation if not properly completed. The organisation/university, damage integrity, lead to complaints/disciplinary actions Activities involving being outside Exposure to wet and/or cold weather Researcher may get ill, suffer sun burn or heat stroke Any research activity that involves interaction between individuals Risk of negative response / attack/ unpredictable behaviour from the individuals. The researcher may be subject to attack or verbal abuse COVID-19 pandemic Risk of contracting or transmitting coronavirus by not washing hands adequately Ensure water, soap and drying facilitations at premises. Researchers are trained on how to wash hands properly. Hand sanitiser for when not possible to wash hands.

Sample questions/topic guide

If you are conducting research involving online surveys, interviews or focus groups you will need to provide an idea of the questions/topics you will discuss for them. For this, you need to think about what demographic information you need to collect – e.g., age, gender identity, race, occupation. There may also be demographic information specific to dementia which you need to collect. For example, asking if the participant knows anyone living with dementia, is or has been a carer for someone with dementia, or whether they are diagnosed with dementia themselves. You need to think about how personal these questions are.

In terms of surveys, you want to reduce drop out of participants part way through the survey as much as possible. Techniques for doing this include limiting ‘free response’ boxes and replacing them with Likert scale questions with an optional follow-up for participants to explain their answer. For example:

  1. To what extent do you agree with the statement “X, Y, Z”? *Required
    • Strongly agree
    • Agree
    • Disagree
    • Strongly disagree

Top Tip - Make it so all questions are mandatory but provide participants with a ‘prefer not to answer’ option. This way you will know that they didn’t want to answer, not that they just missed the question accidently.It is also important to only ask questions on things you absolutely need to know as part of the research aims so participants are not overloaded with surveys which are unnecessarily long. Try to make the survey visually clear and easy to follow – but this part can come after the ethics submission. For the ethics submission, it is only needed that you give the committee enough idea of what you will be doing, and tweaks can be made afterwards. It is also important to show that you have incorporated signposting into the survey design (e.g., a link to support groups, organisations, and charities).

For focus groups, it is important to include a topic guide (i.e., questions and prompts around the topic(s) you plan to discuss). You will also need to include information about how you will introduce the focus group to the participants (e.g., housekeeping information about fire alarm procedures, rules such as ‘listen to others’ and ‘don’t speak over each other’, repeat how long the focus group is expected to take, remind participants you are interested in their opinions/beliefs, recap of their ethical rights – right to withdraw, confidentiality, right to refuse to answer or leave the room at any time, gain permission to record and detail when you will take a break). Remember that signposting will also be needed at the end of the focus group, this can be achieved in the follow-up email to participants so that online links are easier to access than if a paper copy were given.

Details of research document

In this document you may want to include extra details you feel are relevant to the proposed research which will allow the ethics committee more insight into your plans and show you have thought through the research. These details include:

Ethics and dementia research

The advice I have described so far has been general, but I would now like to consider what extra things we may need to take into account when conducting research with people living with dementia. Some of the points I will describe are related to in-person research/interviews/focus groups:

Dementia and informed consent

This is a large area of concern in dementia research, but if you are aware of relevant legislation, and have checks in place, you will be fine. Legislation that you need to be aware of is The Mental Capacity Act (2005) [1], which is good to read up on. In terms of consent, I have found the process model of consent [2] useful. This involves monitoring and reviewing consent throughout the duration of the research project, asking family members or informal carers if this is something the participant living with dementia is likely to want to participate in as well as asking for consent from the participant living with dementia, and looking out for signs of them no longer wanting to be part of the research (these signs could be non-verbal and behavioural cues as well as verbal language [3]). In terms of my own research, I am only allowing participants to self-select to take part. This is so that individuals can elect to take part (recruited from the online survey and through other means if necessary, such as the DEEP network [4] and social media). This does however exclude people with more advanced dementia who may be less able to communicate.


Felicity Slocombe

Author

Felicity Slocombe [12]is a first year PhD Student from Loughborough University. Felicity’s research focuses on identity and dementia and how identity can be managed interactionally – how we can help support identity of people living with dementia through our conversations. Driven by a family connection to dementia, and writing each month on a range of topics from her work, and that of her wider group ACTInG (Applied Cognition Technology and Interaction Group), and sharing news from her training and events.

Follow @fliss_slocombe [13]