- Give participants a clear explanation of the aims, overall purpose, methods and implications of the research.
- Explain that participation is voluntary.
- Remind participants that they have a right to withdraw their consent at any time without any consequences.
- Explain the degree of benefit, risks, burden or discomfort involved in participation. Give an estimate of the time and effort expected of participants. EUR: Potential Risks and Discomforts
- Explain precautions to ensure participants’ safety and provide information on insurance, if there is any.
- Explain who is funding the research and for what purpose.
- Disclose who will benefit from the research.
- Give a firm commitment to protecting respondents’ anonymity and privacy (provided that this can genuinely be guaranteed).
- Make a clear commitment to treating personal and sensitive information confidentially.
- Reassure participants that there are security procedures for analysing any data gathered.
- Explain clearly who will have access to any data that participants provide.
- Consider any unintended/unexpected/incidental findings and explain how you intend to deal with such findings.
- Explain briefly where research findings will be published.
- Offer to provide respondents with further information about research if they ask for it.
- Give the name and contact details of the contact person who can answer any queries participants may have.
- Clarify possible uses to which data may be put in future (if this is envisaged) and clarify whether participants will be asked for consent again if this is the case. Cover any issues relating to the copyright of data and other materials used in the research.
Questions
Is your informed consent form clear? The following example questions may be a helpful tool to check your form:
- Do you know why we are asking you to take part in this study? Do you know what the study is about?
- If you decide not to take part in this research study, do you know what your options are? Do you know that you do not have to take part in this research study if you do not wish to? Do you have any questions?
- If you decide to take part in the study, do you know how much time will the interview take? Where will it take place? Do you know that we will be sending you transport to pick you up from your home? Do you know how much time will the discussion with other people take? If you agree to take part, do you know if you can stop participating? Do you know that you may not respond to the questions that you do not wish to respond to? Etc. Do you have any more questions?
- Can you tell me if you have understood correctly the benefits that you will have if you take part in the study? Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be reimbursed? Do you have any other questions?
- Do you know that you do not have to take part in this study if you do not wish to? You can say no if you wish to? Do you know that you can ask me questions later if you wish to? Do you know that I have given the contact details of the person who can give you more information about the study? Etc.