Holmes et al: Research Methods for the Biosciences 3e
Guidance on writing participant information sheets
There is a substantial body of legislation that describes what is considered to be appropriate approaches to take when conducting research involving humans. The following suggests subheadings and content for you to include in a participant information sheet. This guidance does not reiterate this information but suggests ways to provide the relevant information about your study to your potential participants to enable them to give informed consent (see section 4.8).
The information sheet is best written as an invitation in simple, clear, non-technical English. Paragraphs with subheadings break the text into more easily identifiable sections. You should consider the needs of your participants and use appropriate level and style of language, font shape and size, diagrams and figures. You need to provide sufficient detail for the participant to be able to make an informed choice however you do not want to be too verbose or the potential participant will not read all the information. Aim at making this participant information sheet no more than two sides of A4.
If you start your information sheet with the title of your study it concisely indicates to your potential participants what you are investigating.
The invitation is to ask the potential participant to consider the study and to reassure them that their questions will be answered. For example:
I would like you to consider taking part in my research. Before you decide please read this sheet as this explains why the research is being done and what you will be asked to do. I am happy to answer any questions you have.
What is the purpose of the study?
It is important that your participants fully understand the purpose of your study.
Why have I been invited?
You should explain briefly why the participant has been invited to take part in the study and how many others will be in the study. In this section you may need to outline exclusion criteria which are necessary either on health and safety grounds or to ensure your participants are in the required statistical population. For example you may wish to study a particular age group, participants in good health, a particular gender or ethnic group. Exclusion criteria are often required but you need to ensure that these are not discriminatory but reflect the focus of your study (see section 4.8.3).
What will happen to me if I take part and what is expected of me?
Describe exactly what your participant will be expected to do. To achieve a full explanation it often helps if you try to put yourself in the subject?s shoes. You need to explain essential requirements such as the need to read this information sheet, sign a consent form,attend appointments, complete questionnaires and comply with any lifestyle or dietary restrictions. You need to outline how you will collect any tissue samples and what will be involved in taking any personal measurements. You should include an indication of how long the participant will be involved in each aspect of the research and inform the participant if your study will involve video/audio-taping or photography.
What are the possible benefits, disadvantages and risks of taking part?
In undergraduate research benefits and risks to a participant tend to be minimal. Whatever the benefits, disadvantages and risks these do need to be outlined so that the participant can make an informed decision about their engagement with the research. For example
?We cannot promise the study will help you but the information we get from this study will help improve our understanding of?.?
To meet ethical standards the disadvantages and risks must be kept to a minimum.
Who is organising the research?
Here you need to refer to yourself as the lead researcher and any other members of the research team that a participant may encounter. You also need to present your research in its wider context such as the department, university, research group or company to which you are affiliated. Participants can decide on taking part in a study depending on who is providing the funding. You therefore need to include this information especially if that funding is supporting you personally with a bursary or salary.
Will my taking part in this study be kept confidential?
There are usually a number of points in a research study when you need to consider how you maintain the anonymity or confidentiality of your participants? identity. These include when:
- you first recruit the participants
- you collect any human tissue samples
- you collect any other measurements
- you collect data from surveys, questionnaires, interviews, focus groups etc.
- the samples and data are used and stored
- the results are reported
- the samples and data are destroyed
Therefore in this section you need to tell the participant what measures are in place to ensure their anonymity or the confidentiality of the research. You may use a participant number for labelling all data and any samples you collect. This has implications for the withdrawal of participants from the study and therefore needs further explanation (see below). In the details proved here you also need to include information on who has access to the materials and under what conditions and how and when the data and all records and samples will be destroyed. When results are disseminated consideration must be given as to how you the researcher will ensure that the participant cannot be identified in the report unless they have given their express permission.
Usually you seek narrow consent from your participants where the data and samples are used for this one study. If this is not the case and you are seeking broad consent this must be made very clear to the participants along with the terms of that broad consent.
What will happen to the results of the research study?
Participants should be advised at this stage whether they will be given individual results from the analysis of their own personal data and samples or given access to the final report. For each of these scenarios you need to outline if and how this will be achieved. In undergraduate work it is not common practise to return personal results to participant: as you are still learning how to undertake research and are more prone to making mistakes, you are not usually qualified to give advice and support in relation to the results. Therefore for most undergraduate studies this section explains that this is the case and then outlines how the overall study results can be obtained by the participant if they wish.
Who has reviewed the study?
Projects involving human participants are invariably considered by an independent ethics committee or are subject to similar independent scrutiny. For example:
This study has been reviewed and approved by the ______________Research Ethics Committee.
Do I have to take part?
You should explain that taking part in the research is entirely voluntary.
What will happen if I don?t want to carry on with the study?
Explain what the subject can and can?t expect if s/he withdraws. If you have assigned a participant number to introduce a higher level of confidentiality then you need to consider whether you will be able to identify data and samples from this participant. A common approach taken is to use a participant number but to have a separate record of the participant?s name alongside this number in a separate and very secure location. For undergraduate studies we use the consent form for this purpose and these are held by the student?s supervisor and are not accessible by the student undertaking the research.
What if there is a problem?
You should inform participants how complaints will be handled and provide contact details of the person who will deal with any complaint. This may be the researcher, who can try to solve the problem in the first instance. However, a participant may not wish to complain to the researcher if s/he is the object of the complaint, and may wish to make a more formal complaint. Your institution will usually have a research complaints procedure.
Further information and contact details
You should give the participant an appropriate contact point (someone in the research team).
You should also provide a contact number if a subject had any concerns during the study, if this is different. You should consider your own personal safety and not provide exploitable personal details.