Information Sheets and Consent Forms
Potential recruits to your research study must be given sufficient information to allow them to decide whether or not they want to take part. An Information Sheet can take many forms though one of the most user friendly is the question and answer format. The information sheet should contain information that answers each question and tells participants about the study and what it involves.
The Information Sheet for participants and the consent/assent form are vital and must be completed carefully following the guidelines given below. The Information Sheet(s) and consent form should always be included with your application for ethical approval in order that the reviewing panel can see how you are presenting the project to potential participants.
You must provide separate Information Sheets where the differences between participants or different sections of the research require it (e.g. an Information Sheet for a child and a separate one for his/her parents/guardians, or an Information Sheet for those filling in a questionnaire and a different one for participants being interviewed).
The writer should include:
- simple words, sentences and paragraphs (take care to use language that is appropriate for the participant group)
- requests rather than commands
- the active voice (e.g. we will book) rather than the passive voice (e.g. appointments will be booked)
- a personal approach (e.g. we, you, your baby) rather than the impersonal (e.g. student, subject, they, those, he or she).
- A tick or initial box beside each statement
Jargon and acronyms should be avoided or accompanied by a clear explanation in everyday language. The whole Information Sheet should be understandable to the participant group e.g. a lay person, age approrpiate or appropriate for people with a learning disability.
Things to include:
- Title of the Study (this should be in lay language)
- You should begin by making it clear that this is a study in which the volunteer is being requested to participate and that such participation is entirely voluntary.
- Explain - in straightforward, lay language - the nature and aims of the research project and describe any possible benefits.
- Where the project is being funded by a body/organisation other than the University of Wolverhampton, (such as a charity, organisation, research council or by a private company), identify who the funder is.
- As part of ensuring informed consent is obtained, your anticipated plans for dissemination/publication should be described.
- Who you are recruiting (who should, and who should not, take part).
- What will happen if the participant agrees to take part (when, where, etc) and how long their involvement will last for. If extensive/complicated schedule of procedures a flow chart of what will happen and when is visually helpful. Pictures of equipment help too e.g. what Scanners look like or monitors
- Any risks (e.g. the limits to confidentiality, the circumstances where they may be a need for disclosure of information to a third party, possibility for distress) or inconveniences/discomfort that may be reasonably anticipated.
- Possible benefits (it is good practice to offer participants a copy of the final report and in such cases you should indicate how participants can access this). Any other benefits stated must be honest and realistic.
- State the arrangements for ensuring anonymity and confidentiality and how far these can be realistically guaranteed (if there are possible limits to this). If you are giving participants a choice of full anonymity, partial identification or full identification, this should be made clear. To ensure compliance with the UK Data Protection Act 1998 participants must be informed of what information will be held about them and who will have access to it (this relates to information that is identifiable or could potentially be linked back to an individual).
- Explain that the participant can withdraw themselves from participation at any time and that they can also withdraw their data (including any limitations e.g. after anonymisation or statistical analysis). If limitations apply you should state a date beyond which withdrawal of data is no longer possible.
- Give the name, telephone number, university email address and Departmental/Faculty postal address of who to contact to obtain further details about the study (this should usually be the researcher) and who to contact in an emergency. Please be aware that the use of a researcher’s personal contact details may cause problems.
- State what compensation arrangements are available in the event of injury. In the case of drug company - sponsored research, the Information Sheet should state that the company concerned has agreed to compensate participants who may be harmed without them having to prove negligence.
- When an outside agency is being used to transcribe data, you must inform participants of this.
- Where necessary, explain research procedures such as randomised control trial, anonymisation etc. in non-technical terms.
- Some researchers may find it helpful to include all information about a study in one letter to potential participants. In such cases the researcher must ensure that the required components for an Information Sheet are present within the letter.
- If the study is self-completion questionnaire based but is not seeking sensitive personal information it should still be stated on the Information Sheet that submission of a completed questionnaire implies consent to participate
- For questionnaire studies using online data collection methods, such as Survey Monkey, where it is possible for the researcher to access data from partially completed questionnaires (where the individual has navigated away from the questionnaire web page prior to reaching the end of the questionnaire and pressing the ‘submit’ button) the wording used regarding the consent process must be carefully considered, making it clear what data will be accessible to the researcher, what data will be used towards the study, and what the procedures are in terms of data withdrawal.
- For studies using online data collection methods, ensure it is clear to participants what sort of data the website administrators/owners will have access to.
- Where recruitment documents are to be translated into the participant’s own language, you will not be required to submit copies of the translated documents for review, only the English language versions. However it is the responsibility of the researcher to ensure that appropriate and accurate translations of the English language documents which are then approved, are used throughout the study once it formally commences. The researcher must provide assurances to the reviewers that the translated version will be an accurate translation of the one approved/submitted as part of the application.
- Explicit consent for data processing is required when collecting information classified as ‘sensitive personal data’* which is identifiable or could potentially be traced back to an individual. (‘Explicit consent’ is normally considered to be specific, written consent). As such, participants will need to give explicit consent for researchers to process sensitive data and permission for this should be sought on the consent form. In the case of self-completion questionnaires where no consent form is to be used the following statement should be included in the body of the questionnaire:
‘I consent to the processing of my personal information for the purposes of this research study. I understand that such information will be treated as strictly confidential and handled in accordance with the provisions of the Data Protection Act 1998.’
*The Data Protection Act, 1998 classifies sensitive personal data as consisting of information as to ‘(a) the racial or ethnic origin of the data subject, (b) his† political opinions, (c) his religious beliefs or other beliefs of a similar nature, (d) whether he is a member of a trade union (within the meaning of the Trade Union and Labour Relations (Consolidation) Act 1992), (e) his physical or mental health or condition, (f) his sexual life, (g) the commission or alleged commission by him of any offence, or (h) any proceedings for any offence committed or alleged to have been committed by him, the disposal of such proceedings or the sentence of any court in such proceedings’. (http://www.legislation.hmso.gov.uk/acts/acts1998/19980029.htm ). † ‘His’ should also be taken to include ‘her’.