Human Sciences Ethics Committee of Satakunta University of Applied Sciences

The starting point of research involving human participants is the participants’ trust in researchers and science. Trust can only be retained if the human dignity and rights of the people participating in the research are respected. Research situations can and may, however, include mental strain and emotional experiences similar to situations of everyday life. The participant’s Informed consent to participate in research is a central ethical principle. 

The rights of the research participant 

• Voluntary participation and the right to refuse to participate. It is particularly important to ensure that participation is voluntary if the research participant is in a customer, employee, service, student or other relationship with the research organisation, or if a person other than the participant decides on their behalf on their participation in the research. The research participant must not feel that participation is compulsory or feel afraid of negative consequences. 

The participant’s consent to participate in the research must be documented either orally, in writing, electronically or by other means. 

• The right to discontinue participation at any time without suffering any negative consequences. This refers to the participant’s right to withdraw from the research or an individual phase of the research permanently or for a temporary period without giving any particular reason for doing this. The data collected up to that point may continue to be used in the research. The researcher may also suspend the subject’s participation in the research, if necessary. 

• The right to withdraw the consent to participate. 

• The participant has the right to obtain information on the content of the research, the processing of personal data and how the research will be conducted in practice. Whenever possible, information should be given in a language that the participant understands, in writing or in electronic form. The research participant must be given sufficient time to consider their decision whether or not to participate. 

• The participant should be given understandable and truthful information about the aims of the research and any potential harm and risks associated with participation. The information concerning the possible effects and potential benefits should be given in a realistic way. 

• The participant must be made aware that they are participating in research, especially in situations in which the researcher is in a role other than that of a researcher in relation to the participant, for example, the participant’s superior or teacher. The researcher should also inform the research participant of other relevant affiliations. 

(TENK 2019, pp. 51-52) 

A child should be able to influence matters concerning themselves to the extent commensurate with their level of development. Generally, their parent or carer is informed of the research. Sometimes a child’s participation in research is justified without the separate consent of the parent or carer (Convention on the Rights of the Child). (TENK 2019, p.52) 

Ethical principles for research involving minors: 

• A minor must be informed about the research in a way that they can 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 permits 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. Informing the parent or carer is sufficient in research that does not involve the processing of the personal data of the minor participant. 

• 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 participate in the research. 

• The researcher must always respect the right to 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. 

(TENK 2019, p.53) 

A person’s capacity may be reduced for example due to illness or aging. Physical impairments, sensory impairments or advanced age do not, however, in themselves limit the right of autonomy or the right to decide whether or not to give their consent to participate in research. (TENK 2019, p.53) 

“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, 2010, p.53.) 

Ethical principles for research involving people with limited capacity 

• People with limited capacity must be informed about the research in a way that they can understand. 

• Even if 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. 

• The researcher must always respect the right to autonomy of research participants with limited capacity and the principle of voluntary participation. 

• 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. 

The guideline by TENK (2019) defines the process as follows: “The central principles for processing research data containing personal data are that this must be planned, responsible and in accordance with the law. Planning must include appropriate consideration of the risks associated with the processing of research data to the research participants and others. The duty of responsibility applies to the entire lifespan of the research data and the study. The researcher must comply with the legislation in force and with the research-related data protection guidelines issued by their own organisation. Decisions made regarding the processing of personal data must be justified and clearly documented. Decisions made must be able to be checked subsequently by the authorities or the data protection officer of the organisation.” (2019, p.54.) 

The following factors must particularly be observed when processing personal data: 

• There must be a legal basis for processing personal data. The processing of special categories of personal data requires a separate legal basis. 

• When processing personal data, the roles of different bodies must be defined so that research data can be processed appropriately. The data controller for the research data must be clearly indicated when planning research. If there is a joint data controller, the responsibilities of each data controller must be individually defined. 

• The purpose for which personal data will be used must be determined in the research plan. In addition, the only personal data necessary for the purpose of the research may be collected. 

• As a rule, personal data must be removed from research data when it is no longer necessary to carry out the research. If personal data is to be stored solely to link the data, the identifiers and information needed to link the data must be stored so that they are protected and separate from the data to be analysed. Only people who have a legitimate basis for processing the research data should be permitted to access it. 

• Research participants are to be informed of their rights and the processing of their personal data in a truthful and comprehensible way. This is to be done no later than when their personal data is collected. The information on the processing of personal data and the rights of the participants must be made available to participants throughout the research process. 

More information on Informing research participants from TENK 2019 and the website of the Finnish Social Science Data Archivelaunch ( Tietoarkistolaunch ). 

Factors to be taken into account particularly when publishing research are as follows: 

• The privacy of people who have participated in the research and are mentioned in the publication is protected. Decisions are to be made on a case-by-case basis taking freedom of expression into account. 

• When publishing people’s names, the copyright of people who have taken part in the research must be evaluated. For example, a personal interview may be accompanied by the name of the interviewee and other information with the consent of the person in question. 

• Research participants and people who have provided information for the research must not be promised complete anonymity if this cannot be guaranteed. 

• The researcher must aim for respectful expression when writing about private individuals who have passed away. The need for privacy of the deceased’s relatives and others closest to them should be appropriately observed. 

“Preserving the data gathered in research to make it available to other researchers is one way of ensuring open science. The degree of openness is determined based on the data in question, taking into account both freedom of science and freedom of expression, and the protection of personal data and privacy. Alongside completely open data, there may also be data that is open to researchers only. Sometimes the data cannot be made openly available at all for legal or ethical reasons. In such cases, the information describing the data may be open.” (TENK, 2019, p.57.) 

The opening of the data must be considered at the planning stage of the research and the research participants must be informed about this at the data collection stage. When data contains personal data, the data controller is responsible for the secure storage and possible opening of the data in compliance with legislation. The opening of the research data will reduce the need to collect the same type of data unnecessarily. 

The data collection plan and the intended research method are examined from the perspective of avoiding risk and harm. 

The documents drawn up for informing research participants and obtaining their consent are checked. 

The review focuses on weighing the potential harm and damage caused to participants, their families or the researcher themselves in relation to the intended scientific value of the research. 

The ethical principles for research that involves human participants described above serve as a starting point for the review. 

The researcher is responsible for ensuring that their research is ethical, and the data controller for the research is responsible for decisions regarding data protection. 

All research plans should address ethical risks and the intended methods for avoiding harm and damage, irrespective of whether or not the research undergoes ethical review. 

If the human sciences ethics committee considers that the plan under review falls within the scope of the Medical Research Act (488/1999), it returns the plan to the researcher. (TENK, 2019, p.59) 

An ethical review is carried out before data is collected. An ethical review statement cannot be issued afterwards. 

The researcher is always responsible for the ethical and moral solutions in their research, and submitting the research for ethical review never transfers this responsibility to the ethics committee. 

Theses supervisors are responsible for ensuring that their supervisees are familiar with ethical principles, but the writer of the thesis is responsible for their work being ethical. If ethical review is necessary, it is recommended that the student request it jointly with their supervisor. 

The funding body or publisher may require an ethical review for a research, even if the research design in question would not require it in Finland and no review was requested before data collection. In this case, the ethical committee may provide a description of the ethical review practice in Finland. (TENK 2019, p.59-60) 

The ethical review particularly assesses: 

• the potential risks and harm to research participants, their families and potentially also the researcher themselves as well as their likelihood in relation to the plans drawn up to avoid them 

• sufficiently clear information to research participants on the content of the research, their participation in the research and the processing of their personal data 

• the data management plan, also containing a description of the processing of personal data throughout the lifespan of the research 

• the appropriateness of the research participant’s written or electronic consent to participate 

• the way in which the consent of participants is requested and documented if written or electronic consent is not used 

• the significance of the new information that the research aims to obtain in relation to potential harms and risks. (TENK 2019, p.60) 

The participation in the research deviates from the principle of informed consent. 

This means that 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). (TENK 2019, p.61) 

When the research deviates from the principle of informed consent, it must be ensured that 

• research participants are appropriately informed of the processing of their personal data where the research design so permits 

• the research is justified and could not be carried out if participants were asked to consent to participate in the research 

• data collection does not cause damage or harm to participants 

• the real content and purpose of the study are explained to participants as soon as this is possible in view of the research. (TENK 2019, p.63) 

The research involves intervention in the physical integrity of the research participants. 

Examples of this could be measuring physical condition, taking physiological samples, eating dietary products or restricting physical freedom, e.g. using technology, so that research participants have no opportunity to stop their participation in the research of their own free will within a reasonable period of time. When research intervenes in physical integrity, it is necessary to check whether this is a case that must be evaluated under the Medical Research Act or research that falls within the remit of a human sciences ethics committee. 

The research focuses on minors under the age of 15 without separate consent from a parent or carer or without informing a parent or carer in a way that would enable them to prevent the child’s participation in the research. 

In this case, it must be ensured that the research does not cause harm to the participant and that the minors asked to participate in the research are capable of understanding the topic of the research and what the research requires of them in concrete terms. In addition, at least one of the following criteria must be met: 

• The research focuses on issues of which sufficient research information cannot be obtained if the participation of children requires the consent of the parent or carer (e.g. domestic violence, social problems and similar). 

• The research focuses on issues that minor participants themselves do not want their parents or carers to know about (e.g. drug or alcohol use, sexual orientation and similar). 

The research participants will be subject to exceptionally strong stimuli. 

Examples of this could be data containing violence or pornography which the participants will be shown as part of the research design. Exceptionally strong stimuli may also be involved in research designs in which the participants are deliberately presented with ideas and data that are completely incompatible with their values. 

The research involves the risk of causing mental harm that exceeds the limits of normal daily life to the research participants or their family members or others closest to them. 

A risk may appear for example when the research is associated with traumatic experiences of research participants or their family members or others closest to them. Research situations can and may, however, include mental strain and emotional experiences similar to situations of everyday life. 

The research could pose a threat to the safety of the participant, the researcher or their family members or others closest to them. 

A threat to safety may arise, for example, in research into domestic violence or in research conducted in crisis situations or areas. (TENK 2019, pp. 61-65.) 

Note! If the research design involves any of the above and no ethical review has been made, it may be a violation of responsible conduct of research (RCR). 

An ethical review may be requested if the funding body, cooperation partner, research subject or publisher of the research requires it. It cannot be requested afterwards. 

Enquiries about the work of the committee and the possible need for an ethical review of research can be sent to the chair of the committee. However, it is a good idea to consult the contents of these pages first, as they contain the latest information on the topic. 

The committee does not issue opinions on theses for bachelor’s degrees, except in exceptional cases. While thesis supervisors are responsible for ensuring that their students are familiar with ethical principles, thesis students are responsible for the ethics of their work. However, the student and his/her supervisor can use the material on these pages to examine ethical issues in research. 

Statements issued are free of charge for the personnel, projects and the students of Master’s degree of SAMK . After receiving the request for a statement, the chair of the committee may ask the applicant to complete the request and instruct the applicant on the process. 

The ethical review statement issued can be either positive or conditionally positive (requiring changes. The statement may also be negative (requiring changes). If the researcher fails to comply with the guidance in the statement received, this may constitute a violation of responsible conduct of research (RCR). (TENK 2019, p.66) 

The request for an ethical review report is to be made using the electronic evaluation request form, including the required annexes. 

•  Please refer to the guidelines for the preparation of the ethical review request and the templates to be attached to it on SAMK’s Research Ethics website (e.g. templates for privacy notice and consent forms). The information is only in Finnish at the moment. English version is under construction 

• If necessary, contact the committee in good time before submitting the request for a statement. 

• Take research ethics issues into account already at the research design stage, e.g. allow sufficient time for the ethical review  process and possible applications for research authorisation before the actual research (data collection) can start. 

• Carefully and thoughtfully prepare a request for an ethical review, especially on large-scale research designs. The Committee recommends that requests for advice should be drafted by ‘sub-studies’ (e.g. projects). 

• Be aware that the Ethics Committee may ask for additions to the request for an ethical review and its annexes before issuing a favourable opinion. 

• Clearly draft and mark the addenda to the request for an ethical review to ensure unambiguously that the requested corrections have been made. 

The request for the ethical review statement should include at least the following documents (we are sorry, but the English form in under construction at the moment): 

1. Grounds for requesting an ethical review 

2. Research plan and its summary 

3. Contact details of the person responsible for the research 

4. Assessment of the ethical nature of the research by the person responsible for the research 

5. Information intended to be given to research participants and the possible consent form, as well as other data to be given to participants (e.g. questionnaire, interview outline) 

6. Data management plan 

7. Data protection statement for scientific research (if data containing identifiers is gathered from participants) (TENK 2019, p.66) 

The request for an ethical review should be drafted in such a way that it contains sections 1 to 7 in a single document. This document should be sent as an e-mail attachment to the chairman of the committee. 

The request form for an ethical review should be saved in pdf format and sent, together with the necessary annexes, by e-mail to the chairman of the committee. 

The e-mail address of the person submitting the request for an ethical review  will serve as an electronic signature. 

Timetable for processing requests for the ethical review : the committee will respond to requests for ethical review by the 10th of each month, i.e. August to December in autumn and January to May in spring, but no requests for ethical review will be processed in June and July. After the requests for ethical review are sent to the chairman, the committee meets after the 10th of the month to consider them and the chairman sends the completed opinion to the sender of the request for an ex-ante evaluation within approximately 1-3 weeks. 

After summer 2025, the Committee will respond to requests for opinions by the 3rd of the month (or the following working day if it falls on a weekend or public holiday), i.e. in autumn from September to December and in spring from January to May (no requests for opinions will be dealt with in June and August). After the requests for opinions have been sent to the chairman, the committee meets after the 3rd of the month to examine them and the chairman sends the committee’s opinion to the applicant for an ex-ante evaluation within 15 working days. 

Address for sending requests for the ethical review: Seppo Pamppunen, Chairman of The Human Sciences Committee of Satakunta University of Applied Sciences :  seppo.pamppunen@samk.fimail 

If the person who has requested an ethical review statement does not accept the changes proposed in the statement or the decision of the human sciences ethics committee, they may request a statement on the matter from TENK. The request for a statement, including the grounds for requesting a statement, must be submitted within two months of the ethics committee’s decision. Further information: tenk.fi/en (TENK 2019, p.66)