Guidelines for Students and Staff undertaking Research Involving Human Participants
Any student or staff member who is considering undertaking research that involves collecting data from human participants must first get formal clearance for their project. This includes student dissertations, essays, portfolios and other assessed work, and staff and postdoctoral research.
- What type of research does this include?
- Why is ethical clearance necessary?
- What should I do?
- What other clearance is required before I start?
- How do I obtain informed consent?
What type of research does this include?
Any research involving direct interaction with other people, or that uses data that have been collected from individuals. Typical forms that this might take include:
- Observations of people’s behaviour
- Canvassing opinion through questionnaires or evaluation forms
- Focus groups
- Visitor survey data (whether collected by you, or another organisation)
- Personal records, including medical data
Why is ethical clearance necessary?
Researchers are often focused on the aims and outcomes of their work, but it is also important that the way in which you go about collecting your data is ethically sound. Underlying this is the idea that your research should minimise the risk of harm to those who take part in it, while being fully compliant with UK law. In addition, by gaining proper ethical clearance you will have protection from the UCL legal team should any problems arise during the course of your work.
Ethical approval is not just a matter of ticking a few boxes; you will also receive tailored advice that will help you develop a robust methodology and avoid some of the potential pitfalls of this type of research.
What should I do?
Students should first discuss their proposed research with their course co-ordinator or dissertation supervisor, in order to develop a clear idea of their research aims and methods. When ready, you should fill out one of the following forms:
- Human Participant Research Application for coursework
- Human Participant Research Application for dissertations
- Human Participant Research Application for Staff or postdoctoral researchers
Coursework forms should be sent to your course co-ordinator for approval. Dissertation and staff forms should be forwarded to the Research Ethics Coordinator and Chair of the Institute of Archaeology Ethics Committee, currently Rachael Sparks at IoA.firstname.lastname@example.org. Your application will be assessed, to see if your work requires any additional ethical approval from UCL or external organisations. You will then be advised on how best to proceed
What other clearance is required before I start?
You may also be required to gain additional approval before starting your research.
Any research at UCL that makes use of living human participants, or the collection and/or study of data derived from living human participants requires approval from the UCL Research Ethics Committee or the National Research Ethics Service, unless it falls into one of their exemption categories.
If you are planning to record information that would allow your research subjects to be identified, then you will need to inform the UCL Data Protection Officer of your plans.
You may also need to gain the permission from other organisations in order to recruit research subjects or collect data from them. For example, if you intend to observe visitors to a museum, you should formally request that museum’s permission to do this. They may have their own requirements for how this research should be conducted. Some organisations may require you to have formal UCL ethical approval in place before allowing you access.
may also have to submit a Risk Assessment Form if your research is likely to
have any associated health and safety issues. Examples where this might be
required could include having your subjects do experimental flint knapping,
conducting your research abroad, conducting interviews in private residences,
or collecting data in any other dangerous circumstances or environments.
Completed forms should be submitted to Sandra Bond, the Institute's Departmental Safety Officer, who can also offer further advice on the subject.
Finally, you will need to gain the informed consent of your research subjects before you begin collecting information from them.
How do I obtain informed consent?
Anyone taking on the role of your research subject should be fully aware of the nature and purpose of your research, what their role in it will be, and how the data they provide will be subsequently used. This is called informed consent. Consent must be actively provided, rather than assumed or implicit, and participants should have the right to withdraw at any time.
To ensure active and willing consent, make sure you recruit people ethically. That means not pressurising people to take part by exploiting friendships, business or employer/employee relationships. It is acceptable to provide limited incentives to encourage participation, such as entry into a prize draw, providing the value of the prizes is not excessive. Cash prizes should be avoided. Participants can however be offered reasonable compensation for the costs of participating, such as travel and lunch expenses.
The best way of ensuring informed consent is to provide potential subjects with an information sheet, that outlines everything the subject needs to know about your work and their involvement in it. This should be written in clear English, and designed to suit your target audience. For advice on how to design a good information sheet for your participants, see the UCL Graduate School Ethics pages.
In some cases, it may be more appropriate to provide this information verbally (e.g.: if your subject cannot read).
After providing sufficient information to inform the subject, they are then asked to provide their consent. This may involve:
- Both information and consent form should be on UCL letterhead.
- Giving verbal consent, where a signature is impractical.
- Selecting a check box to say they agree to take part at the start of an online survey or questionnaire.
In the case of paper questionnaires and surveys, consent is usually assumed to have been given, as the participant has actively chosen to complete the survey.
Potential subjects need to be able to understand what they are being asked to do, which means that they should be fluent in the language being used to obtain consent, and capable of understanding the content. Children over the age of 16 can sign their own consent form if deemed able to do so. For children under 16, informed consent is provided by their parent or legal guardian, while the child themselves should also provide assent to the study.
Please note that the above listed Participant Information Sheet and Consent form templates replace those previously available on this site in order to comply with the new General Data Protection Regulation (GDPR) that came into force on 25 May 2018. Both templates are also available through the UCL ethics registration process Procedures page, and Legal Services research activities pages.
If your research recruits NHS patients, their tissue or data, the study will need approval from the Health Research Authority – HRA (formerly NHS REC or IRAS) and/or the Medicines and Healthcare Products Regulatory Authority. Please contact the UCL and UCLH Joint Research Office for further information, as you will need to use different Patient Information Sheets and Consent Form templates.
The GDPR is raising the bar to a higher standard for consent: whereas consent under current data protection law has always required a clear, affirmative action, the GDPR clarifies that pre-ticked opt-in boxes are not indications of valid consent. The GDPR is also explicit that organisations must make it easy for people to exercise their right to withdraw consent, and the requirement for clear and plain language when explaining consent is now strongly emphasised.