How to inform research subjects and ask for their consent
Many research projects involve research subjects, i.e. people participating as subjects in experiments, interviews, surveys, etc., or people whose personal data or biological samples are processed for research purposes. Before research subjects are involved in a project, they must give informed consent. Below is a guide, including templates that may be used, for researchers at Stockholm University on how to inform research subjects and ask for their consent.
The requirement to obtain informed consent from research subjects is a fundamental research-ethical principle included in many central guidelines and recommendations concerning good research practice (for examples, see Codex). The main purpose of obtaining informed consent is to protect research subjects and respect their right to self-determination. This, in turn, is crucial in order to safeguard public trust in research. Some types of research also entail legal requirements on obtaining consent, e.g. related to mandatory ethical review (more information here ) and restrictions on processing sensitive personal data (see below).
Consent may serve different functions or concern different aspects of research. The most common of these are:
- Consent to participation. This is the general research-ethical requirement ensuring that participation in research is informed and voluntary. For participating in clinical trials, special requirements apply (more information here).
- Consent as a legal basis for personal data processing. Processing of personal data must rely on a legal basis. Consent from those whose data are processed is one possible legal basis, but it is normally only recommended in cases where the research involves processing of sensitive personal data that takes place outside of Sweden (more information below).
- Consent to the processing of biological samples. When research involves the taking and saving of biological samples, research subjects are asked to consent to this.
Often more than one of these kinds of consent is needed. If so, it is advisable to separate them in the consent form (see the suggested Consent form below).
In order to be fully valid for all the functions described above, a consent has to fulfil a number of requirements (the details of fulfilment may vary with the circumstances):
- Consent has to be voluntary. Potential research subjects must not be coerced or unduly influenced in any way. If there is some form of dependency relation between the person consenting and the researcher, the voluntariness may be questioned. Researchers must therefore consider this aspect when evaluating whether the research is ethically justifiable.
- Consent has to be informed. The information given to the research subjects must make it clear what participation would mean for them (e.g. if there will be physical interventions which may cause bodily injuries, or if sensitive data will be processed risking privacy infringements, etc.). Such information should provide a good basis for taking a stand on whether or not to participate. The potential research subject should be given the opportunity to ask questions and have them answered. Detailed suggestions concerning how to inform research subjects are given in the document Information sheet below.
- Consent must be specific. A valid consent cannot concern participation in research or processing of personal data or biological samples in general. The consent needs to be limited to specific studies or projects, in order to make it clear enough to the research subject what he/she is asked to consent to.
- Consent must be given in the form of an explicit and unambiguous declaration or act. Research subjects must clearly express their willingness to participate in the research project, e.g. by signing a consent form (this is the preferred method: see the suggested Consent form below), ticking a box in a questionnaire, or by stating the consent at the beginning of a recorded interview.
- Research subjects must be able to withdraw their consent, and it must not be more difficult to withdraw it than it was to give it in the first place. The practical implication of such consent withdrawal must be stated in the information provided to the research subject.
- Consent must be documented. Signed consent forms must be collected by the researcher and saved as long as necessary. The research subject is to keep the information sheet and a copy of the consent form. A copy of each version of the information sheet and the consent form shall be saved and archived after the research project has been terminated. Consents that have been obtained through other means than signed forms still need to be properly documented.
In some cases it is not feasible or reasonable to ask research subjects to consent – for instance when research subjects cannot be identified beforehand or when such identification would demand excessive effort. In these cases, researchers nonetheless have an ethical obligation to provide information to potential research subjects to the extent possible, e.g. by posting information on their department’s website, publishing information in newspapers, etc. There may also be cases where providing information to research subjects would be detrimental to the purposes of the research project, or cause risks to research subjects or researchers. Any deviation from the general requirements of information and consent must be compatible with legal and ethical obligations, and it may occur only if it is impossible to achieve the aim of the research by any other means which do not involve such a deviation. The considerations motivating any deviation from informing research subjects and asking for consent must be documented.
Some persons lack the capacity to consent; they may be too young or have limited decisional capacity due to temporary or permanent injuries, illnesses or impairments. As a general rule, such persons should not be included in research, but sometimes there are good reasons for them to be included. For example, their participation may be essential to the purpose of the research or they (or others in their situation) may benefit from the research. If they are adults, consultation must be made with next of kin as well as with limited guardians (god man) or guardians (förvaltare) if this falls within his/her mandate. As far as possible, the potential research subject should also be informed. If any of these persons (including the potential research subject himself/herself) opposes participation, the potential research subject must not be included in the research.
If the potential research subjects are minors, the Ethical Review Act (Etikprövningslagen) sets different requirements depending on their age. If the subjects are under 15 years of age, all custodians (vårdnadshavare) must be asked to give consent on their behalf. Furthermore, they shall be informed about the research and have the right to decline to participate (even if custodians consent). If they are between the ages of 15 and 18, they shall be asked to consent themselves, unless they are unable to understand what the research involves for them (in which case the same rules apply as for those below 15 years of age).
When processing personal data for research purposes, you need to:
- Ensure that all your projects involving personal data processing are added to your department's record of processing activities.
- Determine the purpose of the processing of personal data, and the legal basis for doing this. The preferred legal basis for research projects is that the processing is necessary for the performance of a task carried out in the public interest (GDPR Article 6.1 e). Information about legal bases can be found here.
- Determine if there is a clear risk that you will process sensitive personal data (more information here). If so, you need to apply for ethical review (more information here). If any part of the processing takes place outside of Sweden you may have to use consent (GDPR Article 6.1 a) as the legal basis for the processing.
- Evaluate whether you need to carry out a data protection impact assessment (DPIA). This has to be done if the processing of personal data is likely to result in a high risk to the rights and freedoms of the research subjects (see detailed instructions here ).
- Make sure that you will be able to handle your research material in a secure way (see more information here (in Swedish) ). When possible, personal data should be stored in pseudonymised form (see below), in order to increase data protection. It is advisable to set up a data management plan for the handling of your research data (more information here).
- Prepare for archiving your research information (project plans, ethical review documentation, information sheets, consent forms, financial and other administrative documents, etc.). Information about archiving of research data can be found here .
- Protect the privacy of the research subjects, e.g. by making sure that the data are pseudonymised or anonymised to the extent possible without disproportionally compromising the purpose of the research, the possibility of reviewing the research, or the usefulness of the data for future research. Pseudonymisation means that personal identifiers are replaced in a way that allows for identification only with the help of additional information that is stored separately from the data. Note that pseudonymised data are still personal data. Anonymisation means that all identifying links to the research subjects are irreversibly destroyed (and “backwards identification” is not possible).
- Make sure that the process and documents for informing research subjects and asking for their consent live up to the requirements of GDPR and national regulations concerning personal data processing (see further information above and suggestions below).
Templates that may be used by researchers to inform research subjects and ask for their consent can be found via the links below. Note that these documents must be adapted to the specific circumstances of the research project in question.
If you have questions about how to inform research subjects and obtain valid consent, or about research ethics in general, please contact the ethics support function at the Office för Research, Engagement and Innovation Services. You may also find useful information on our web pages.
Information about how to handle, share and archive research data at Stockholm University can be found here.
Information specifically about the processing of personal data at Stockholm University can be found here. For legal issues, contact the Office of the President.
September 18, 2020
Source: Office för Research, Engagement and Innovation Services