Informed Consent Protocol

1. Informed consent, also known as valid consent, means giving sufficient information about the research and ensuring that there is no explicit or implicit coercion so that prospective participants can make an informed and free decision on their involvement. The change in data protection law means that individuals still need to provide their consent to participate in research, but that researchers do not always need the individual’s consent to process their data as part of that research (this could include repurposing data, or sharing data with other parties). The primary objective in all cases is to be open with the participant about the realities, and potential risks, of their involvement.

2. Researchers should take the steps necessary to ensure that all participants in the research:(a) understand the process in which they are to be engaged, including why their participation is necessary and;(b) understand the purpose of the research and how and to whom its research findings will be reported.

3. Researchers should make clear to participants what their rights are regarding their withdrawal of consent, as well as the right not to answer particular questions. Researchers should indicate the point at which withdrawal will no longer be possible because data will have been anonymised and/or amalgamated and cannot be excluded. If data are to be archived and shared participants should, where possible, give specific consent to this. For further information see the protocol on Data Protection, Anonymisation and Sharing Research Data.

4. Typically information to participants should be provided in written form, time should be allowed for the participants to consider their choices, and an informed consent form should be signed. However, research is a dynamic process and consent, similarly, is not simply resolved through the formal signing of a consent document at the start of research. Instead it is continually open to revision and questioning, and should be revisited regularly as the project evolves. Researchers should aim to foster relationships in which ongoing regard for participants’ consent is sustained, even after the study itself has been completed.

5. There should be no coercion of research participants to take part in the research. Adult research participants, however, may be given small monetary reimbursement for their time and expenses involved. For further information see the protocol Reimbursement for Participants.

6. It is recognised that there are occasions when the use of covert research methods is necessary and justifiable. However deception (i.e. research without consent) should only be used as a last resort.

7. An information sheet should help a person to make an informed choice regarding whether or not to participate in a research project. Potential participants may take more care when reading a concise information sheet and, thereby, be better informed than if s/he has to read an information sheet that runs into several pages. It should contain information which is clear and accessible to potential participants about:

The people conducting the research, their institutional affiliations and the funding body if relevant.
The purpose of the research.
What participation will involve, including the right to withdraw.
How the information provided will be used (and where it might be repurposed and shared if known).
How confidentiality and anonymity will be preserved.
The risks and benefits of participation.

8. The information sheet should normally be given to potential participants in advance of their participation, giving them sufficient time to reflect on the information provided, ask questions, and come to a decision about participation. Ideally it should not be provided at the same time as the informed consent form to enable sufficient time for decision making.

9. It is good practice to reiterate verbally the contents of the information sheet before participants sign consent forms. This is important because some participants may have undisclosed literacy problems. In addition, such a discussion would help clarify any misunderstandings, for example over limits to withdrawal of data and the rights of researchers to repurpose and share data. In situations where the provision of written information prior to the commencement of the research is inappropriate researchers should always give the information listed above verbally allowing potential participants to take sufficient time for discussion and consideration before making a decision about participation. Potential participants should always be given the opportunity to ask questions about the research before signing the consent form.

10. Written informed consent should be obtained from participants where possible. In cases where consent is to be obtained verbally this should be recorded. In all cases the purpose is to verify that participants:

have understood the information provided on the information sheet (or its verbal equivalent);
have been able to discuss this information with the researcher;
are participating voluntarily;
recognise that they are free to withdraw (up to the point at which their data is anonymised and amalgamated);
recognise that they can decline to answer particular questions without negative consequences;
understand how their personal data will be protected; and
understand that their data might be used in other research and might be shared with other researchers (with as much specific details as possible).

11. Where written or verbal consent is not to be recorded a full statement justifying this should be submitted to the Ethics Committee for review and approved.

12. Note that in longitudinal research it may be necessary to explain the need for (and limitations of) enduring consent. This is where there is no time limit on consent given and participants do not need to be re-contacted should any of their personal data be reused for further research. This may also be important for data that is placed in an archive. Principles of preserving confidentiality apply. It may also be necessary to re- negotiate consent during the lifetime of the research.

13. Where participants are not legally responsible, their legal representatives or guardians should be consulted as well as the individual. Additional safeguards also need to be put in place if participants are vulnerable due to their age, health and any other factors. It must be clear that participants fully understand the research and what they are being asked to do.

14. Further guidance is available on the Research Ethics webpages website.

15. All participant-facing material is reviewed by the Faculty or School Research Ethics Committee during the ethical review process.

Template participant Information Sheets and Consent Forms are available on the University Research Ethics templates page.