Research Ethics

What are you doing?

Research proposal: A research proposal is a document that outlines the design of a study which would answer a formulated and specific research question. The proposal would outline your research question, and the methodology you would use to answer this. Do you need formal ethical approval for this? NO but you should have a section on the proposal that discusses how ethical issues would be considered.

Review of the literature: This is classed as secondary research. Reviewing the literature includes a variety of different methodologies including a narrative literature review, scoping review, rapid evidence review, and systematic reviews. Do you need formal ethical approval for this? NO but you should consider publishing a review protocol (which is your research proposal) on a platform such as Open Science Framework. Ethical issues should be considered through critical appraisal of the studies included in your review using a checklist such as Critical Appraisal Skills Programme (CASP) or the Mixed-Methods Appraisal Tool (MMAT) and providing a reflection on your own ethical practices when writing an academic piece.

Analysis of existing data: This is classed as secondary research. Existing data is information that exists without you having to ask anyone to do anything and it can be analysed or explored to answer a question. For example, this could include published data sets from the Office for National Statistics or could include the analysis of social media posts. Firstly, you need to answer the question: is the data in the public domain (note: social media posts are not classed as publicly available as you need to have an account to access them, module evaluation data is not in the public domain)?

Yes: Do you need formal ethical approval for this? NO but you should consider ethical issues which may be relevant to this data set in your methods.

No: Do you need formal ethical approval for this? YES you need ethical approval and should go through LEAS

Gathering your own data: This is classed as primary research. Gathering your own data could include doing surveys, interviews, focus groups, or experiments, and is where you are gaining new data from people (participants). Do you need formal ethical approval for this? YES you need ethical approval and should go through LEAS

Ethical considerations for the different methods

Review of published literature:

Did they get ethical approval and where was this from?
Do they talk about consent, withdrawal, distress of participants, or confidentiality?
Consider how you represent the data from the original studies in your synthesis. Is it an accurate representation of what they were saying, avoiding trying to make it fit the answer to your question?
Consider how you present the data from original studies in your synthesis. Are you ensuring you are avoiding plagiarism?

Analysis of existing data in public domain:

Where is the data coming from? Who were the participants?
How were the data gathered? Did the participants consent and are there any issues in confidentiality in terms of sharing/using the data?
Who is publishing the data? Any conflicts of interest?
What analysis are you doing? How are you avoiding manipulation of the data?
Consider how you use and represent the data. Is it an accurate representation of the original data set?

Analysis of existing data not in public domain:

A full application through LEAS is needed and in particular, you would need to answer the following:
Where is the data coming from?
Who were the participants?
Did they consent to sharing the data?
Are there any issues with confidentiality?
How are you getting access to the data - how is it being shared with you?
Do you require any approvals, permissions, or training to work with the data?
Do you need a data sharing/processing agreement?
As part of LEAS, you will need to complete a Data Protection Impact Assessment and consider if you need any formal agreements in place to access and use the data you have gained.
What analysis are you doing? How are you avoiding manipulation of the data? Are there any limits on what you can do with it?
Consider how you use and represent the data. Is it an accurate representation of the original data set?

Research proposal and gathering your own data:

Do you need to get additional approval? Yes, if you are planning on using NHS staff, premises or patients, using Ministry of Justice (HMPPS) or Ministry of Defence information. You must explore this before submitting an application through LEAS. Any doubts, email sponsor@lincoln.ac.uk
Informed consent: How are you going to get informed consent from your participants? Are they able to give this (age and capacity)? You will need to give them a Participant Information Sheet with all of the information on (template on LEAS) and ask them to complete a consent form (template on LEAS)
Withdrawal: Can your participants withdraw from the study? If so, when and how? Can they withdraw after they have completed the study? If so, how and when? If not, why not (for example, if they have completed an anonymous survey, they will not be able to withdraw once they have submitted it). You must tell people the limits to their withdrawal (for example, 2 weeks after an interview as after this time, it will be collated with other interview data and under analysis).
Confidentiality: Is the data confidential? If it is anonymous, then confidentiality is more probable. If it is not anonymous, will your pseudo-anonymise the participants (give them a participant number or fake name)? When may you have to breach confidentiality (such as a safeguarding concern) and how would you do this? When you write up your results, will you identify anyone? Could this be done by accident (based on a combination of identifiable data such as a specific age, gender, disability, ethnicity, place of work, or job role)? How will you attempt to avoid this? Do you need to link participants in a pre- and post- survey? How will you do this, especially if it is anonymous?
Data protection and storage: Where are you going to store your research data (Microsoft 365 accounts are the University standard approved systems)? Where will it be stored after the study has finished? How long for? Is this the same procedure for research data and contact details or other identifiable information? (these should be stored separately to avoid identification of participants and identifiable data should be deleted as soon as it is no longer needed. Research data are usually kept for 5 years). How will you ensure you are compliant with General Data Protection Regulations (GDPR)? Are you transferring data between organisations (including for transcription and any use of AI)? Have you got the data sharing agreements in place for this?
Psychological distress and risks: Is there a risk to participants when taking part in this research? Could any topics be triggering (trigger warning needed on adverts and information sheets)? How will you manage any distress shown by participants? Where can you signpost them to for support (this should be included on information sheet and debrief sheet)? Are there any other risks to participants? Is there any deception involved in the study? Why and when will you tell them? What could be the impact of this?
Risks to researchers: Are there any potential risks to you as a researcher? How will you get support for this?
Benefits: Are there any benefits to the participants for taking part in the research? Are there any payments or any other incentives to them and how will this be managed? Are there any ethical issues relating to paying/incentivising your participants?
Dissemination: How are you planning on disseminating your findings? Where, when and how? Will you tell participants (you need to consider storing their data for longer if they consent to this, and you can't tell them if they answered anonymously)?
International research/recruitment of participants: Is your sample actively recruiting participants from a country outside of the United Kingdom? Does the country have their own ethical review process and have you engaged with that? If not, why not?
Human tissue: Does your research involve working with or collecting human tissue (saliva, blood, cells etc.)? There are additional ethical considerations and potential training that is needed. Please email htog@lincoln.ac.uk
Animals: Does your research involve animals? You need specific animal ethical approval to consider the impact of the research on the animals. Please contact ethics@lincoln.ac.uk for any advice.
Vulnerable populations: Does your research involve any vulnerable populations such as children (under 16), people without mental capacity under the Mental Capacity Act, or any other vulnerable adult populations? If so, you need to consider how you will gain informed and voluntary consent and where this will come from?
Security sensitive research: Does your research involve any data or activities which could pose a security risk? You should consider how this would be managed and if any external approvals are needed?
You will need to upload your research materials including any surveys, interview/focus group questions, recruitment adverts, stimuli, and approval letters/partner agreements, alongside your participant information sheets and consent forms.

Links and sources for support

LEAS - https://ethicsapply.lincoln.ac.uk/
Open Science Framework - https://osf.io/
NIHR - https://www.nihr.ac.uk/