Consent and Participant Information Guidance

A consent form should normally be used to record the consent process and a participant's agreement to take part in your study.

The consent form should be produced on headed paper or equivalent if recording consent electronically.

Ensure that the study title and the study IRAS ID is clearly displayed. You may also wish to include a study identification number.

You may wish to include spaces for site or centre ID and/or participant ID.

If you are producing a number of consent forms for your study (e.g. for different types of participant, or to be used in different UK nations), ensure that each consent form is clearly identified.

When producing your consent form you should consider what is appropriate for your type of study and the participants who will be involved.

For many studies the following paragraphs will be sufficient to accurately record agreement to take part. You may not need to include all, think about what you are asking potential participants to give their consent to (remember one size doesn't fit all - only include what is appropriate for your research):

• I confirm that I have read the information sheet dated.................... (version............) for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.
• I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected.
• (If appropriate) I understand that relevant sections of my medical notes and data collected during the study, may be looked at by individuals from [company name], from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records.
• (If appropriate) I understand that the information collected about me will be used to support other research in the future, and may be shared anonymously with other researchers.
• (If appropriate) I agree to my General Practitioner being informed of my participation in the study.
• (If appropriate) I understand that the information held and maintained by the Health and Social Care Information Centre (or amend as appropriate) and other central UK NHS bodies may be used to help contact me or provide information about my health status.
• I agree to take part in the above study.

You should provide a box after each item on your form for potential participants to initial, tick or provide the answers 'yes' or 'no', to indicate their specific agreement with each statement.

If you are producing consent forms to be used by legal representatives, ensure that the language used addresses them appropriately. Make it clear you are asking them for consent on behalf of, or advice with respect to a child / young person or adult lacking capacity.

Some example templates are available from our 'Examples & Templates' page.

For some studies you may choose to provide an itemised or tiered consent form covering specific issues, especially where additional elements are optional for the participant. This is not obligatory but may include:

• Additional invasive tests or samples required for study purposes only;
• Consent to use of audio/video-taping, with possible use of verbatim quotation or use of photographs;
• Transfer of data/samples to countries outside of the European Economic Area (EEA) with less data protection;
• Agreement to receive individual feedback from testing.

Only offer potential participants options if you are confident that you can deliver all combinations of accepted or rejected options.

The signatories on the consent form should be those who are involved in the consent process, e.g. the participant, the researcher or the participant's legal representative / consultee.

You must ensure that the signatory is appropriate for the circumstances (e.g. recording consent given on behalf of an adult not able to consent for themselves to a non-CTIMP in Scotland should ask for the signature of a Welfare Attorney / Welfare Guardian / nearest relative etc).

Consent forms for a participant's legal representative should address them directly and should be written appropriately. The consent form must be clear that they are being asked for consent on behalf of the research participant.

An independent witness is not routinely required except in cases where potential participants are not able to read or write, or who are visually impaired etc.

Informed consent must be recorded in writing, however electronic methods for documenting consent can be considered to be in writing. You will still need to provide a copy of the signed consent form to the participant and so you should consider whether this will be a physical or electronic copy.

As part of recording consent electronically you are likely to need to use electronic signatures. Electronic signatures can take a variety of forms and are classified in different ways. You should check what type of electronic signature is acceptable for your research.

When recruiting adults lacking capacity in England, Wales or Northern Ireland to a research study that is not defined as a Clinical Trial of an Investigational Medicinal Product (CTIMP), you will be asking a consultee to advise on whether to include the adult in your study or not. The advice they provide should be recorded on a Consultee Declaration Form.

An example of a Consultee Declaration form can be found in 'Examples & Templates'.

You must ensure that all consent forms carry appropriate version control(date, version number and IRAS ID). This will help you manage consent documentation throughout the life of your study, and will be referenced by others who review and/or approve specific study-related paperwork (e.g. Research Ethics Committees, NHS R&D Offices etc).