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The informed consent process starts with the recruitment of subjects. According to TENK, people participating in research have the right to participate voluntarily but also to refuse to participate. It is particularly important to ensure that participation is voluntary if the research participant is in a customer, employee, service or student relationship or in another dependent relationship with the research organisation, or if a person other than the participant decides on their behalf on their participation in the research. Typically, such situations involve, for example, a school or prison environment, or a workplace, where data are collected from a person in the role of an employee, or where data are collected from children.

Research permit from an organisation does not mean that consent has been given on behalf of the persons involved. It is also a fundamental right of subjects to know that they are being studied, especially in situations where the researcher is also in a role other than that of researcher in relation to the subject, for example as a supervisor or teacher of the subject.

The research participant must not feel that participation is compulsory or feel afraid of negative consequences if they refuse to participate in the research: so they should not be pressured nor tempted to participate.  

Recruitment should be done in a neutral way, for example by advertising the upcoming study on email lists, bulletin boards or social media. It is important that the person interested in the study contacts the researchers themselves. It is not advisable to contact recruits directly in person.

• The information must be written in such a language and in such a way that the subject can easily understand what it means for him or her to be the subject of the study. The template should be adapted in such a way that the target group of subjects in the study can easily understand its content.
• Subjects should also have the opportunity to ask questions and discuss the study orally with the researchers. Therefore, the informed consent processes cannot be outsourced to other persons or organizations except for compelling reasons. This guidance does not apply to register research.
• The content of the information sheet must be the same as in the research plan, although it can and should be more accessible in terms of terminology and language.
• Subjects must be informed and consent must be obtained before data are collected from them.
• Data collection should not start before the subjects have had sufficient time to familiarize themselves with the information sheet, the privacy notice and the content of the consent form and have given their documented consent.

The informed consent procedure must ensure that the following rights of the research subject are respected:

• The right to participate voluntarily and also to refuse to participate.
• The right to suspend participation in the study, temporarily or indefinitely, at any time without negative consequences.
• The right to withdraw consent to participate.
• The right to receive an intelligible and truthful account of the objectives of the study and of the potential harms and risks of participation.
• The right to know that he/she is being studied, in particular in situations where the researcher also plays a role other than that of the researcher in relation to the subject (manager, teacher, colleague, social worker, etc.).

1. Minors as participants

Ethical principles are always followed when researching people, regardless of the age of the subject. Children must be given a say in matters that concern them in a way that is appropriate to their development.

As a general rule, informed consent is sought from the guardians of children under 15 years of age. It is up to the 15-year-old and older to decide whether or not to participate, and the guardian cannot refuse to allow the child to take part in the study. Even then, however, the guardians must be informed about the study in which their child is taking part.

Sometimes a child’s participation in research is justified without separate consent of the parent or carer. In such cases, the study must always be reviewed by the Ethics Committee.

If necessary, use the JYU's simplified research notification, privacy notice and consent template (has been updated at October 2022).

TENK: Ethical principles for research involving minors

• Minors must be informed about the research in a way that they are able to understand.
• If the minor is 15 or older, their own consent is sufficient for participation in the research. The parent or carer should be informed of the research also in these situations, if the research design or research questions permit it.
• The participation of minors under the age of 15 is primarily decided by the parent or carer. For survey-based research involving a large number of respondents, it is sufficient to inform the parent or carer of the research so that they can refuse their child’s participation in the research if they so desire. The number of respondents is large if the survey targets at least 400 people. Informing the parent or carer is also sufficient in research that does not involve the processing of the personal data of the minor participant (for example observation without recording devices and processing of personal data).
• Even if participation in the research requires the approval of the parent or carer or a legal representative, minors primarily give their own consent to participating in the research.
• Researchers must always respect the autonomy of minor research participants and the principle of voluntary participation, irrespective of whether the consent of the parent or carer has been obtained for the research.
• If participating in the research is not in the minor’s best interests and the minor does not wish to participate in the research, the researcher must discontinue the minor’s participation. 

The researcher can submit a child welfare notification, if the researcher observes or becomes aware of factors that indicate a necessity to investigate the need for child welfare.37 If the researcher decides to report to social services under the Child Welfare Act, it is important that they carefully consider the ethical questions involved, such as whether the parties involved should be informed.

See: JYU Child Protection Policy (Templates and policies).

2. Persons with reduced capacity for self-determination

Anyone’s capacity may be reduced temporarily or more permanently. Ethical principles must be observed also when conducting research with a research participant whose capacity is limited, e.g. due to illness or age. However, for example physical impairments, sensory impairments or advanced age do not in themselves limit the right of autonomy or thus the right to decide whether or not to participate in research.

However, people who, owing to a mental health disorder, a developmental disorder or other similar reason, do not have the capacity to give their consent to research are defined as being unable to consent in the Medical Research Act (984/2021). According to the same act, written consent may be given by a close relative or other person closely connected with the person or by their legal representative. The study must also be directly related to the medical condition or disability of the person being studied.
 

TENK: Ethical principles for research involving people with limited capacity

• People with limited capacity must be informed about the research in a way that they are able to understand.
• Even if their participation in the research requires the approval of a legal representative, the person with limited capacity primarily gives their consent to participate in the research themselves.
• Researchers must always respect the autonomy of research participants with limited capacity and the principle of voluntary participation, irrespective of whether the consent of the legal representative has been obtained for the research.
• If participating in the research is not in the best interests of a person with limited capacity and if they do not wish to participate in the research, the researcher must discontinue the person’s participation. 

If necessary, use the JYU's simplified research notification, privacy notice and consent template (has been updated at October 2022). (Templates and policies).

Exceptions to informed consent, deception, research on disclosed data, social media data, register research.

Informed consent is a key ethical principle in research, which can only be deviated from for compelling reasons.
The researcher should request an ethical review from the Ethics Committee if his or her research deviates from the principle of informed consent.

1.When ethical review is mandatory

Deviation from the principle of informed consent for participation in research occurs where the participation is not voluntary or the participants are not given sufficient or correct information about the research (if for example the nature of the research demands this kind of research design). 

This refers, for example, to research where the research question requires a research design based on deception. Such a research design must be reliably justified in such a way that the research question, which is of significant information value, cannot otherwise be answered.

When a study deviates from informed consent, care must be taken to ensure that:

• subjects are duly informed about the processing of personal data when the research design so permits
• the study is justified and cannot be carried out with an informed consent of the subjects
• the collection of the data does not pose a risk or harm to the subjects
• the subjects are informed of the actual content and purpose of the study as soon as this is feasible from a research point of view.

2. When ethical review is not mandatory

• The research is based only on public information, archive data or registry and documentary data, without the data security risks associated with data that is combined from several sources.
• Careful consideration must be given to public information, as the public nature of, for example, social media material is not unambiguous. 
   

The Ethics Committee will verify that you have drawn up an appropriate plan for informing your research subjects of the study. At least the information listed above must be included in the information sheet delivered to your subjects.
Will research subjects be provided with sufficiently clear information about the study, their participation and the processing of personal data?

Reward/gift for the participants: an assessment of whether the amount of the premium jeopardises the voluntary participation (attractively high). Similarly, it will be assessed whether the costs of participating in the investigation will be incurred which may prevent participation.
Please note that fees paid to research subjects are now taxable income: follow the JYU guidelines.