By law, participants must be told a certain amount of information if their personal data is to be used for research. Information about the legal requirement, including a template privacy notice, is available at https://dataprotection.leeds.ac.uk/information-for-researchers.
In addition, the expectation is that researchers will obtain, and record, the informed consent of participants. In order to achieve this, participants must be given clear information about the study’s aims, the risks and benefits, and the nature of their involvement. Researchers must be satisfied that this information has been correctly understood, and participants must be given sufficient time to reflect on the information given.
A participant’s right to withdraw without giving a reason at any time must also be clearly explained and understood. In no circumstances should coercion, disproportionate payment or the expectation of any other inappropriate reward be used to influence consent.
There may be circumstances under which it would not be practicable to obtain participants’ fully informed consent in advance – examples might include projects involving the use of covert or participant observation or projects which depend upon participants being unaware, at least initially, of the true object of investigation. Under such circumstances, researchers should consider carefully the justification for a methodology which precludes the establishment of informed consent in advance and be prepared to explain this in their grant application or application for ethical approval, as appropriate. In any case, the expectation is that participants will consent to the use of their data in the research.
The consent form is key to allowing the storage and wider sharing of the data you collect. The more your data is re-used, the more impact it can have. It should be possible for participants to opt out of being contacted for follow up study.
Creating your informed consent documents
If you are going to be using a participant information sheet and consent form, examples of the forms you will be using need to be included with your application for ethical review.
- Template participant information sheet – revised March 2019
- Easy-read participant information sheet
- Template participant consent forms – revised March 2019
- Easy-read participant consent form
- Informed consent protocol – revised February 2019
- Verbal consent protocol – revised February 2019
- UK Data Service guidance on consent for data sharing
- Consent for questionnaires/ surveys (includes example introductory paragraph) – revised May 2019
Remember to take any funder requirements about research data management into account when planning your informed consent documents: http://library.leeds.ac.uk/research-data-policies.
You should mention that the project has ethics approval and provide your ethics reference and date of approval in all the participant-facing documentation. E.g.:
“This study has been reviewed and given a favourable opinion by _______________Research Ethics Committee on [date], ethics reference [ref]”
It’s important to explain to research participants how their personal data will be used, and what their rights are. Privacy Notices need to be concise, easily accessible to participants and easily understandable.
Reimbursement of research participants
Protocol on the Reimbursement of research participants
If the payment is to be made:
- In the course of undertaking research, particularly social science or medical research, to volunteers required to take part in tests, submit to measurements or be interviewed, OR
- Is in relation to the use of ‘lay’ people or ‘users’ in research invited to attend meetings to give their views on various matters to inform the research process and direction
- The payment is a small sum to cover out of pocket expenses and as compensation for time spent
Then the amount should not be subject to tax or NI.
Recruiting Microworkers as research participants
Working with potentially vulnerable participants
The Policy on safeguarding children, young persons and adults in vulnerable circumstances must be complied with. Note that paragraph 15 of the Policy states:
No research using (or otherwise engaging) children, young persons or adults in vulnerable circumstances may be carried out without the permission of the relevant faculty ethics committee and the head of the school concerned. The head of the school concerned shall be responsible for ensuring that a satisfactory written risk assessment is completed and that control measures specified therein are effected.
In most cases, researchers working with vulnerable people will need to secure Disclosure and Barring Service (DBS) clearance (https://www.gov.uk/government/organisations/disclosure-and-barring-service). The DBS offers organisations a means to check the criminal record of researchers to ensure that they do not have a history that would make them unsuitable for work involving children and vulnerable adults.
Guidance on recruiting from peers (ie family, friends, colleagues).
Other sources of information
- University policies
- ICO guidance on valid consent
- SRA Code of Practice for the safety of social researchers
- Using oral history recordings
- UK Data Archive guidance on consent in surveys
- UK Data Archive guidance on obtaining consent when the research participant is a child
- Internet research: UK Data Archive guidance on consent for internet research. See also https://ris.leeds.ac.uk/InternetBasedResearch
- MRC & Wellcome Trust guidance on feeding back health-related findings
- Gunning Fog index