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• Make sure that the subject is aware that he or she can withdraw consent at any time without explanation and without any negative consequences.
• Make sure the subject understands what he or she is actually consenting to, so at this stage, this is still to be ensured for the most crucial elements of the information sheet.
• Use templates to make sure that all the necessary elements have been taken into account.
• Make sure that giving consent is not too complicated or burdensome. Note that withdrawing consent must be as easy as giving it.
• Remember that the participant must have the opportunity to ask the researcher additional questions.

It is not necessary to sign the consent form if it is difficult to do so in practice or if the subject is unable to sign it: for example, in the case of a young child or if the subject has reduced capacity of self-determination (formerly "incapacitated"). However, even in such a situation, consent must always be requested as a general rule.

• In survey software (e.g. REDCap, Webropol), a notice, privacy notice and consent content are added at the beginning of the questionnaire. The subject confirms that they have read the documents in question, after which they can answer the questionnaire.
• Consent can also be given, for example, during an interview or otherwise orally, after the subject has received the information and privacy notice.
• See: REDCap-instructions

Procedures:

• In the case of an electronic questionnaire or when oral consent is requested, the subject will also be provided with the information and data protection notice drawn up on the basis of the University's model, and with the consent form or equivalent information without signature lines, so that the subject can familiarise themselves with the contents of the documents before giving consent. 
• In the case of oral informed consent, care must be taken to document it, for example by recording it on audio or video tape or by having another person present.

Please note that consent can only be informed if the person has received all the information concerning the processing of personal data and the research (information sheet and privacy notice). These documents can also be made available to subjects by providing them with a link to the documents on the website. 

Informed consent for children, elderly persons or persons with limited capacity

It is essential that the principle of informed consent cannot be deviated from in this case eith

1. Informed consent of a minor

Ethical principles are always followed when researching people, regardless of the age of the subject. Children should have a say in matters that affect them according to their stage of development 

Participation in a study by a person under 15 years of age is primarily decided by the guardian, but even if the consent of the guardian or legal representative is required, the minor subject gives his or her consent to participate in the study in the first place. In addition to consent, the consent and assent of children and adolescents to participate in the study must be discussed with them.

If the minor is 15 years of age or older, his or her consent is sufficient to participate in the survey. Even in this case, the guardians must be informed of the study if the study design or questions allow it.

In some cases, the child's participation in the study is justified even without the explicit consent of the guardian. In such cases, the research must always be reviewed by the Ethics Committee. 

If necessary, make use of the JYU's simplified template combining notice, consent and privacy notice (updated 10/2022) 

Can be found in the Templates under the heading "CLEAR_EN-10_2022"

TENK: Ethical principles for research on 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.

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: The Child Protection Policy of the Ä¢¹½Ö±²¥.

2. Research involving people with limited capacity

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 (488/1999). 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.

TENK: Ethical principles for research on 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. 

Is there a deviation from the principle of informed consent?

What it means:
Participation in research is a deviation from the principle of informed consent when the participation of subjects is not voluntary or when subjects are not given sufficient or correct information about the research (for example, if the nature of the research requires such a research design).

What to do when you deviate from informed consent:

Your study must be reviewed by an ethics committee.

No review is required for research on public and published data, registers, documents and archival material.

NOTE! Ethical consent is not the same as consent required by data protection legislation.

The exceptions to the consent requirement in the data protection legislation do not apply to the ethical principles.

From an ethical point of view, consent to participate in research must be requested even if no personal data are processed at all.

Appropriateness of the participation form: 

• The appropriateness of the written, oral or electronic consent of the subject to participate, for example in a questionnaire. The consent must be executed in accordance with the TENK and JYU guidelines.

How consent is obtained from subjects:

• The way in which subjects' consent to participate in the study is obtained and documented, even when written or electronic consent is not used. Written consent is recommended. Any deviation from this must be justified and the implementation described. A signature is not required.

Whether the research deviates from informed consent:

• For research that deviates from the principle of informed consent, the Ethics Committee will assess whether it is ethically acceptable to conduct the research.
• A study can be considered ethically acceptable if the following conditions are met:

1. The study is justified and cannot be carried out by informing the subjects of the study and asking for their consent to participate. 
2. The collection of the data does not pose a risk to the subjects. 
3. Where possible, the content and purpose of the study will be explained to the subjects afterwards (case-by-case review).  
4. Adequate attention will be paid to the protection of the privacy of the subjects in the collection, processing and reporting of the data.