Informed Consent Form Templates
(language used throughout form should be at the level of a local student of class 6th/8th)
Notes to Researchers:
- Please note that these are templates developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.
- The informed consent form consists of two parts: the information sheet and the consent certificate.
- Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.
- These templates include examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.
- In these templates:
- square brackets indicate where specific information is to be inserted
- bold lettering indicates sections or wording which should be included
- standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.
By Carrie Winstanley
Social science studies (including your dissertation), are about individuals, communities and societies. Even though you’re not carrying out a case study, questionnaire or interview when doing your research for your dissertation, you’re bound to be looking at an issue that involves people – and before starting off you need to sort out any ethical matters connected with your research.
You have to make sure that the interests and rights of anyone affected by your work are safeguarded and you must ensure that you keep to the following:
Obeying the legislation on human rights and data protection
Maintaining good quality research (data collection, storage analysis, dissemination of information)
Gaining the informed consent of your subjects
Thinking through the consequences of your work
Most undergraduate dissertations are fairly straightforward because the sample group you’re researching is usually fairly small and the context is known to the supervisor and the student. This scenario (of knowing your subjects and there being minimal risk and concern) is recommended because it makes the whole process manageable and more feasible in the timescale that you’re given for your dissertation.
If your research causes you to fall into any of the following categories, you need to ask your supervisor for advice on what you should do:
Your study involves vulnerable participants and/or those unable to give informed consent (such as children or people with learning difficulties or disabilities).
Some of your subjects may be feeling under pressure to take part (friends, colleagues, family members).
Your research means discussing issues that may upset people or cause stress, such as health matters, personal experiences or something the person knows to be illegal such as drug use.
Your study involves communicating with a ‘gatekeeper’ in order for you to have access to the subjects (for example, you need to obtain the agreement of the teacher and the parents to access the children in her class).
Your participants may be taking part without their knowledge (for example, carrying out observation of children in a playground).
You may be at risk when carrying out observations or interviews.
Dissertation ethics: Check your compliance with university regulations
Universities have specific regulations about getting ethical clearance for any part of a study that may breach ethical guidelines. You’re going to have to comply with particular permissions if you’re carrying out observations or interviews.
Your university may ask you to complete a form to get ethical clearance for your research. This is the norm for higher level studies and research projects but less common for undergraduate dissertations. If you do need to fill in a form addressing ethical concerns, the questions you’re likely to be asked are:
Aim of study.
Background (naming some of the literature and other studies in a similar area).
Research methodologies and methods.
Potential problems for subjects (such as discussing sensitive issues).
Potential problems for the researcher (such as travel following interviews carried out in the evening).
Methods of recruiting subjects (including declaration of inducements – that is, whether or not you paid them).
Evidence of having informed consent.
Data protection (including the security of your data storage and anonymity of subjects).
Look through the list and have an answer in mind for each question in case ethical concerns and obligations come up during supervision.
Dissertation ethics: Know what’s appropriate
A group of first year undergraduate students were interested in looking at teenagers’ views about how sexual content is used to boost sales of magazines. The students put together an interview schedule for a focus group but didn’t run the questions by a tutor first. Using university headed notepaper so that the questions looked official the students presented the group of 13- and 14-year-olds with the questions.
The first question asked: ‘Have you had sex?’ and the questions moved onto others including ‘Do you think that all your friends are sexually active?’ and ‘How does it feel to be the only one in your group of friends who’s still a virgin?’ Clearly these questions wouldn’t have been approved by the tutor, but the students were genuinely surprised when the university staff expressed their shock.
Dissertation ethics: Gain informed consent
You must have the consent of people taking part in your research. In most cases you’re required to have written consent and your course tutor or department may well have a standard form for you to use. Consent forms are designed to comply with Government requirements, which exist to protect vulnerable people from any poor research practices. One example of this is the Criminal Records Bureau (CRB) check that you’re going to need if your research involves children.
Your responsibility to your subjects doesn’t end once you’ve collected the data. It’s up to you to be frank and honest when interpreting your subjects’ words and actions. You’re not allowed to twist words or alter what people have said or done.
Dissertation ethics: Respect other people’s ideas and views
When you’re doing interviews and carrying out questionnaires it’s important to keep your thoughts to yourself. Hiding your feelings can be hard, but if you disagree violently with someone you can end up stopping the person from expressing his views for fear of ‘getting something wrong’.
Don’t be a robot though – you can express mild surprise if someone says something really strange (you may find some subjects are after a reaction so you sometimes need to oblige), but try not to let other people’s views faze you. After all, you’re asking for the person’s opinion, so you need to let him express his opinion without feeling stupid.
Strike the right balance between modesty and arrogance. Don’t be so self-deprecating that people think that your research is a waste of time: ‘Oh, it’s just a little project, it’s not that interesting, it’s not a big deal’. Also avoid sounding self-important as this is equally off-putting: ‘Yes, I’m dealing with some really vital issues here – I want to expose the problems and find a solution to these continual low standards.’
Dissertation ethics: Keep your subjects’ anonymity
When you’re writing about the people in your research project you need to disguise the person’s real identity, making sure that the person can’t be identified and traced. Some of your subjects may say that you don’t need to hide their identity, but although that can seem like a good idea at the time, you don’t yet know where you research is going to take you and you may later regret choosing that option.
A parent, (not just the institution where the child is living, studying, or staying), must agree on behalf of a child.
Speak to your dissertation tutor about the legal aspects of your work. Generally a ‘child’ is 16 years old or under, but if someone is 17 and still studying in school, for example, you need to follow different guidelines than if you were asking your college peers who are over 18, or a 17-year-old with a full-time job.
The onus is on you to check the legality of what want to pursue. Consult your tutor if in doubt.
Changing the names of your research subjects when you’re writing about them is a good idea, but you need to do this with care and make it clear that you’ve changed the person’s names to preserve their privacy by simply saying: ‘In this dissertation, the names of subjects have been changed to preserve their anonymity’.
Give some thought to what the alternative names are going to be. Changing ‘Kelly’ to ‘Kerry’ or ‘Ian’ to ‘Iain’ isn’t going to do a good job of hiding anything much, and also be sure that you don’t change genders by mistake.
Although it can be a good idea to find a name that reflects the cultural background of your research subjects, if this is relevant to the study – take care here that you don’t slip into stereotype.
Researchers often refer to their subjects as ‘Child X’ or ‘Mrs Y’ and this does the job perfectly well. Some readers are not keen on dissertations that use this method because it seems very impersonal and makes for a jerky read.
Plus, if the examiner is marking a large number of dissertations that use the same convention, like other examiners, she may tend to forget which ‘Child A’ is which because there’s no personality linked to a person labelled by an initial letter of the alphabet (except for ‘Mr T’ of course).
Your rule of thumb is to use recognisable names that aren’t too outlandish and that are distinct from one another (don’t call your three subjects ‘Emily’, ‘Emma’ and ‘Emmie’ for example). Remember to be consistent throughout your dissertation.
Keep the real and ‘code’ names of your subjects in your dissertation notebook so that you don’t get confused.
Also remember to hide the names of schools, hospitals, specific departments or organisations you’ve been allowed to review where there are any potentially sensitive issues. Don’t try to anonymise organisations such as governments or government departments, even if you’re being critical.
In your appendices and additional material you have to make sure that you anonymise any letter headings, delete logos from policy documents and change names or delete them from personal reports. It’s a fairly common error in dissertations to find that students give away their subjects’ identities in the additional material – probably because students leave dealing with the appendices and additional material until the last moment.
When you’ve finished writing up your dissertation, do a Word ‘Find’ search through the text, looking for the real names of your subjects in case you’ve slipped up somewhere.
Dissertation ethics: Acknowledge the people who help you
Your acknowledgements are more about courtesy than being a fixed requirement in your dissertation, but it’s good manners to acknowledge people who’ve helped you by being subjects in your research, or by making it easy for you find your subjects.
For example, if you’ve interviewed budget holders about how they forecast their annual spend and your gatekeeper contact at the department was a research officer or someone in human resources, be sure to thank your contact as well as the subjects you interviewed.
You can make your acknowledgements without revealing the person’s identity. Use the person’s job title and if they evenutally see a copy of your dissertation they’re going to know who they are and recognise and appreciate your gratitude. All you need to say is: ‘With sincere thanks to all those people who helped me by giving up their valuable time and sharing their considered views’.