The following list of likely areas you will need to explore is not comprehensive, but will provide a prompt for your planning and reflection.
What benefits could arise from your research?
Have you considered benefits to the participants, for example impact of participation or research outcomes?
Have you considered the benefits to the research organisations, project partners and funders involved?
You could look at:
- wider groups or populations
- scientific knowledge
- the research team
How will the ethics aspects of the project be monitored throughout the research lifecycle?
How will unforeseen or adverse events in the course of research be managed? For example, do you have procedures to deal with any disclosures from participants?
Have you considered harm and risk to:
- the participants, eg harm, deception, impact of participation or of outcomes
- the collected data, eg storage, considerations of privacy, quality
- the research organisations, project partners and funders involved
- wider groups or populations
- the research team?
How can potential risks be addressed?
Details and recruitment of participants
What types of people will be recruited? For example, students, children, people with learning disabilities or the elderly.
You should consider:
- how the competence of participants to give informed consent will be determined
- how, where, and by whom will participants be identified, approached and recruited
- if any unequal relationships will exist between anyone involved in the recruitment and the potential participants
- if it is necessary to check the background of members of the research team who will be in contact with participants, for example through the Disclosure and Barring Service
- if there is a need for participants to be de-briefed and who should the debrief.
You should consider the role of consent. You’ll need to think about:
- what information participants will be given about the research
- the best way to ensure they can make an informed decision about whether or not to take part
- if you are providing all the information participants need
- if re-using data, that the consent from the primary data collection covers further analysis that is planned
- how participants can opt out and withdraw their data
- how will you gain further consent, if your research changes.
Is participation voluntary? If not, can you justify that? Could anyone feel pressured to take part?
Have you considered anonymity, and confidentiality?
Have you considered all perceived conflicts of interest in undertaking this research, for example, financial reward for outcomes?
Research outside the UK
Are you conducting research outside the UK? Are there any additional issues that need to be considered as a result – for example, local customs, local ‘gatekeepers’, political sensitivities, legal and ethics requirements in other countries or benefit sharing?
Your legal obligations
Have you considered what legislation your project will need to abide by, eg Data Protection Act, Freedom of Information Act, Human Rights Act, Mental Capacity Act?
You will need to think about:
- how you will protect your data at the research site and away from the research site
- storing your collected data
- how you will dispose of data, and after how long
- making plans for data archiving and arrangements to support wide access to the data
- your legal obligations if you will be collecting information through a third party
- ethics within your plans for dissemination, impact and knowledge exchange
- a research ethics protocol approved by your research organisation that would be appropriate to use
- which research ethics committee is most appropriate to review your research
- the time you need to secure an ethics review.