Research protocols that are not regulated under Finland’s Medical Research Act (488/1999) fall within the scope of the guidelines governing the ethical review of research involving human subjects. These guidelines apply not only to humanities and social sciences but also to scientific and technological research involving human subjects, artistic research and in some cases to non-invasive health and medical research. The guidelines provided below are based on the <a href="https://tenk.fi/sites/default/files/2021-01/Ethical_review_in_human_sciences_2020.pdf">Ethical principles of research with human participants and ethical review in the human sciences in Finland (PDF)</a>&nbsp;issued by the Finnish National Board on Research Integrity (TENK) in 2019.

The Ethics Committee of the Wellbeing Services County of Pirkanmaa carries our ethical reviews of proposed medical research involving human subjects, human embryos or foetuses as set out in the Medical Research Act.

&nbsp;

In Finland, researchers in all disciplines are required to adhere to the following general ethical principles:

<ol>
	<li>Researchers must respect the dignity and autonomy of human research participants. The rights laid down in the Finnish Constitution (1999/731, Sections 6–23) are held by everybody. These include the right to life, personal liberty and integrity, freedom of movement, freedom of religion, freedom of expression, protection of property and the right to privacy. 
	&nbsp;</li>
	<li>Researchers must respects material and immaterial cultural heritage and biodiversity. In accordance with Section 17 of the Finnish Constitution, the Sami, as an indigenous people, as well as the Roma and other groups have the right to maintain and develop their own language and culture. 
	&nbsp;</li>
	<li>Research must be conducted in a way that does not cause significant risks, damage or harm to research participants, communities or other subjects.</li>
</ol>

In Finland all scientific research must comply with the guidelines on responsible conduct of research (RCR Guidelines) drawn up by TENK.

Section 16 of the Finnish Constitution safeguards the freedom of science and arts. This freedom must be used responsibly.

<h3>2. Enforcement of ethical principles</h3>

Research settings and topics may evoke different reactions among research subjects. While research protocols may induce similar emotional responses and psychological stress that people experience in their daily life, it is important that researchers look into the communities, cultures and backgrounds of their research subjects in advance to avoid causing any unnecessary harm to them or their communities.

The following principles especially apply to situations where the participant interacts with the researcher (eg as an interviewee), provides information, is being observed or is otherwise involved in the study. Informed consent to participate in research is a central ethical principle for all research involving human subjects.

Please note that informed consent to participate in research differs from the concept of consent that is used as a legal basis for processing personal data. If consent is used as a legal basis for processing personal data, this consent must meet the requirements set out in the EU’s General Data Protection Regulation (GDPR). According to the privacy policy of Tampere University, public task should primarily be identified as the lawful basis for processing personal data.

People participating in research have the following rights: 

<ol>
	<li>to participate voluntarily and to refuse to participate. It is particularly important to ensure that participation is voluntary if the participant is in a customer/employment/service/student relationship or other similar dependent relationship with the research organisation or if another person decides on the participation on his or her behalf. The research participant must not feel that participation is compulsory or fear negative consequences if they refuse to participate. You must document your subjects’ consent which they provide verbally, in writing, electronically or by other means. 
	&nbsp;</li>
	<li>to withdraw from the study at any time without suffering negative consequences. Withdrawal refers to the participant’s right to withdraw from the study or an individual phase of the study permanently or temporarily. Withdrawal will not prevent the use of data collected on the subject up to the time of withdrawal. Subjects will not be expected to disclose a reason for their withdrawal. In some circumstances, the researcher may withdraw a subject from the study on his or her behalf. 
	&nbsp;</li>
	<li>to withdraw their consent to participate in a study at any time. It must be as easy to withdraw consent as it is to give it. 
	&nbsp;</li>
	<li>to receive information on the content of the study, the processing of personal data, the practical implementation of the study (such as what participation in the research actually means), and the expected period of processing and retaining research data. Whenever possible, information must be provided in a language that the participant is able to understand either in writing or in electronic format. Research participants must be given enough time to consider their decision whether or not to participate, and any questions they have regarding the research must be answered. 
	&nbsp;</li>
	<li>to receive an understandable and truthful description of the research goals and potential hazards and risks associated with participating in the study. The expected impact and benefits of the study must be realistically described. 
	&nbsp; 
	Please note that research subjects do not usually receive financial compensation for their participation. Researchers may, however, provide their research subjects with a reasonable non-monetary reward to thank them for their participation (such as film ticket, product or similar). Research subjects may also receive reimbursement, for example, for reasonable travel and meal expenses that they incur in the course of their participation in the research.&nbsp; 
	&nbsp;</li>
	<li>to know that they are the subject of research, especially in situations where the researcher is not explicitly acting as a researcher but, for example, as a supervisor or teacher. Researchers must also disclose their affiliations to their research subjects.&nbsp; 
	&nbsp; 
	Despite their duty of confidentiality, researchers have a legal obligation to report to the relevant authorities any planned serious criminal offences that they become aware of during the course of research and that may still be prevented. There is no obligation under the Criminal Code of Finland to report a crime that has already been committed. Read more: Criminal Code of Finland (563/1998) Chapter 15, Section 10.</li>
</ol>

<h3>3. Research involving minors and/or people who lack capacity to consent&nbsp;</h3>

Minors

Ethical principles must always be complied with when conducting research with human participants, irrespective of the age of the participant. Children must have the opportunity to influence matters concerning them to an extent corresponding to their stage of development. Parents or carers must generally be informed if their child participates in a research study. Sometimes a child’s participation is justified without obtaining separate consent from the parent or carer.

<ol>
	<li>Minors must be informed of research in a way that they are able to understand. 
	&nbsp;</li>
	<li>Minors who are 15 years of older are considered able to provide informed consent without parental consent. Parents or carers should, nevertheless, be informed of the study as long as the research protocol or research questions permit it. 
	&nbsp;</li>
	<li>Consent for the participation of minors under the age of 15 is primarily provided by parents or carers. For survey-based research involving a large number of respondents, it is sufficient to inform the parent or carer of the research so they have the option to refuse their child’s participation. Informing the parent or carer is also sufficient in research that does not involve the processing of personal data (such as observation without collecting personally identifiable information). 
	&nbsp;</li>
</ol>

<ol>
	<li>Even though participation in a research study requires parental/guardian consent, it is still necessary to obtain a minor’s consent to ensure their voluntary participation in the study. 
	&nbsp;</li>
	<li>Researchers must always respect the autonomy of minor research subjects and the principle of voluntary participation, irrespective of whether they have received parental/guardian consent. 
	&nbsp;</li>
	<li>If participating in a research study is not in the minor’s best interests and the minor does not wish to participate in the research, researchers must withdraw the minor from the study.</li>
</ol>

Researchers have the option to submit a child welfare notification, if they observe or become aware of factors that indicate a necessity to investigate the need for child welfare services. If you decide to contact social services under the Child Welfare Act, it is important that you carefully consider the ethical questions involved, such as whether the parties involved should be informed.

People who lack the capacity to provide informed consent

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, for example, due to illness or age. However, physical or sensory impairments or advanced age do not as such limit the right of autonomy or affect a person’s right to decide whether or not to participate in a research study.

However, people who lack the capacity to provide informed consent owing to a mental health disorder, a developmental disorder or other similar reason, are defined as being unable to consent in the Medical Research Act (488/1999). According to this act, written consent may be provided on their behalf by a close relative, other person closely connected to the person or a legal representative.

<ol>
	<li>People with a limited capacity must be informed of the research study in a way that they are able to understand. 
	&nbsp;</li>
	<li>Even if their participation requires the approval of a legal representative, it is still necessary to obtain consent from the person in question to ensure his or her voluntary participation in the study. 
	&nbsp;</li>
	<li>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. 
	&nbsp;</li>
	<li>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, researchers must withdraw the person from the study.</li>
</ol>

<h3>4. Processing of personal data for research purposes</h3>

Personal data and privacy policy

When personal data is processed for research purposes, processing activities must be carried out systematically, responsibility and lawfully. Processing activities must be carefully planned and the potential risks to the research subjects and others must be thoroughly assessed. The duty of responsibility applies to the entire lifespan of the research data and the study. As a researcher, you must comply with applicable legislation and the applicable privacy policies of your own institution. Decisions about the processing of personal data must be justified and clearly documented. You must make the documentation available to the relevant authorities or the data protection officer of your institution, in necessary.

Terms and definitions

<ul>
	<li>Personal data means any information relating to an identified or identifiable natural person. Research data contains personal data if it can be directly or indirectly used to identify a person or persons, taking into account the means that are reasonably likely to be used to do this;</li>
	<li>Special categories of personal data refer to personal data that reveals an individual’s racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership as well as to the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual orientation;</li>
	<li>processing means any operation or set of operations performed on personal data, including, for example, collection, storage, dissemination, use or adaptation of research data that contains personal data;</li>
	<li>Data controller refers to the person, organisation or other party that determines the purpose and means of personal data processing. The data controller is responsible for compliance with the data protection principles. The data controller may be, for example, a research organisation or an individual researcher. There may also be one or more data controllers, or multiple organisations and researchers may serve as joint controllers.</li>
</ul>

The following factors must especially be observed when processing personal data:

<ol>
	<li>There must be a legal basis for processing personal data. The processing of special categories of personal data requires a separate legal basis.</li>
	<li>When processing personal data, the responsibilities of different stakeholders must be defined so that research data can be processed appropriately. When planning research, the data controller must be clearly identified. In the case of joint controllers, the responsibilities of each data controller must be separately defined.</li>
	<li>When planning research, the purpose for which personal data will be processed must be determined in sufficient detail. The purpose may be, for example, clearly described scientific research. The research protocol must be designed so as to ensure that no unnecessary personal data is collected on the subjects.</li>
	<li>As a rule, personal data must be erased when it is no longer necessary in order to carry out the research (eg the addresses and personal identity numbers of research participants when they are no longer needed to link the data). If personal data is to be stored solely in order to link the data, personally identifiable information must be appropriately protected and separately stored from the data to be analysed. Access to research data must be limited to people who have a legitimate basis for processing the data.</li>
	<li>Research participants must be informed of their rights and the processing of their personal data in truthful and comprehensible language. Research participants must be provided with this information in a manner that is practical and natural in view of the research and those involved. Information must be provided no later than when personal data is collected. Research participants may not be expected to personally obtain information about the processing of their personal data and look into their rights. Privacy information must be made available to participants throughout the research process. When personal data is collected in a way other than directly from the participant (such as in connection with registry research) the necessity and content of the data and the time of informing the research participants must be determined separately in accordance with applicable legislation.</li>
</ol>

Protecting privacy in research publications

Factors to be considered when publishing research findings:

<ol>
	<li>The privacy of people who have participated in a research study and are mentioned in the publication must be respected. Related decisions must be made on a case-by-case basis while taking freedom of expression into account. 
	&nbsp;</li>
	<li>When considering whether to publish people’s names, the copyright of people who have taken part in the research must be respected. In addition, with the consent of people who have provided information or been interviewed, a research publication may include their names and other background information when the research is based on, for example, personal interviews or oral history. 
	&nbsp;</li>
	<li>Do not promise complete anonymity to your research subjects and people who have provided information if anonymity cannot be guaranteed. For example, providing anonymity for your subjects in research publications may not necessarily prevent their identification by those who are familiar with the activities of the community or organisation that has been the subject of your study. 
	&nbsp;</li>
	<li>When writing about a private individual who has passed away, you must aim for respectful expression. You must respect the privacy of the person’s relatives and others close to him or her.</li>
</ol>

It is not generally appropriate to publish data in a way that allows research subjects to be identified. This does not apply to public figures who exercise, or have exercised, significant power and whose privacy is narrower than that of private individuals. Critical evaluation of the actions of public figures is an important part of the freedom of science enshrined in the Finnish Constitution. In addition, the EU’s General Data Protection Regulation (GDPR) that came into force in 2018 contains special provisions regarding the freedom of expression and the freedom of information. However, the necessity to publish personal data must carefully considered on a case-by-case basis based on its importance to society. Even public figures have the right to privacy that must be respected.

<h3>5. Openness of research data</h3>

Open science is a precondition for the critical evaluation of research findings and for scientific progress. Storing research data to make it available to other researchers is one way of ensuring open science. The degree of openness is determined on the basis of the data in question, taking into account the freedom of science, the freedom of expression and the protection of personal data and privacy. Alongside completely open data, there may also be data that is only accessible to researchers. Sometimes data cannot be made openly available for legal or ethical reasons. In such cases, only metadata may be freely accessible.

The provision of open access to research data must be considered already at the planning stages of your research study. Your research subjects must be informed at the data collection stage that the research data will be openly available. If the data contains or has originally contained personal data, the data controller will be responsible for ensuring compliance with applicable legislation when making data openly available. When collecting, storing and opening research data, reliable services must be used throughout the lifespan of the study to safeguard the privacy of your research subjects.

Opening research data to other researchers reduces the need to gather the same type of data unnecessarily. This reduces research pressure on small population groups, for example. The risk of damage to unique objects, old documents and other objects can also be reduced if it is possible to examine these, for example, in a digital format. It is a good idea to check at the planning phase whether data applicable to your study already exists before gathering or obtaining new data.

Ethical principles

a. Studies that involve intervening in the physical integrity of research participants

Intervening in physical integrity for research purposes may include, for example, 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.

b. Studies where the principle of informed consent does not apply

The Ethics Committee will assess whether it is ethically acceptable to carry out a study that does not follow the principle of informed consent. Such a study may be accepted if the following requirements are met: &nbsp;

<ol>
	<li>the research is justified and could be carried out if the subjects were informed of the study and asked to provide consent,</li>
	<li>The collection of data involves no risk to the subjects,</li>
	<li>If possible, the subjects will be informed afterwards of the nature and purpose of the study,</li>
	<li>The privacy of research subjects and data protection issues are duly considered when collecting, processing and reporting data.</li>
</ol>

c. Research subjects are minors under the age of 15 and the study is conducted without parental/guardian consent and without offering parents or guardians the opportunity to refuse the child’s participation

A study involving minors under the age of 15 may be conducted without parental/guardian consent and without informing them of the study, if the study involves no risks to the subjects and the research protocol is justified as it fulfils one or more of the following requirements:&nbsp;&nbsp;

<ol>
	<li>The subjects’ age and stage of development: the minors who will take part in the study understand what the research is about and what participation requires of them.</li>
	<li>Research topic and methods: the research topic is not sensitive and asking for parental/guardian consent would be complicated (eg studies exploring youth clubs, extracurricular clubs or similar).</li>
	<li>The need for information: The topic is such that comprehensive data cannot be collected if parental/guardian consent is requested (such as domestic violence, social problems or similar) or such that minors may not want their parents to know about their participation in the study (eg substance abuse, sexual orientation or similar)</li>
</ol>

d. Studies that expose research participants to exceptionally strong stimuli 

e. Studies that may cause long-term mental distress (trauma, depression, insomnia) that goes beyond the risks usually encountered in daily life 

f. Studies that may entail a security risk to the participants (eg studies on domestic violence) or their family members 

The potential hazards and risks associated with the proposed research protocol must be carefully described in the request for statement, so that the Ethics Committee will be able to assess the ethical dimensions of the study and weigh the potential risks against the expected benefits. The studies must be planned and conducted so that possible risks to subjects are minimised.

The Ethics Committee will weigh the expected benefits of the study against potential harm or discomfort that the participants may incur and consider the measures to be taken during and after the study to minimise the risks (physical or mental) or prevent them altogether (data protection). The Ethics Committee will also take the free will and autonomy of research subjects into account as research subjects are, to a degree, able to assess the risks of participating in research studies by themselves. &nbsp;

When experimental research protocols are reviewed, the Ethics Committee may, upon your explicit request, consult the ethical guidelines that apply to the discipline in question. Your request for statement must indicate how the Ethics Committee will be able to access these guidelines.

Please note that if a researcher’s proposed study should undergo an ethical review but he or she neglects to request such a review, the failure may constitute a violation of research integrity (RI). The same goes for a failure to comply with the instructions provided in the Ethics Committee’s statement. If necessary, the suspected violation may be investigated following the procedure for handling alleged violations of research integrity. Read more: <a href="https://tenk.fi/sites/default/files/2023-05/RI_Guidelines_2023.pdf">The Finnish Code of Conduct for Research Integrity and Procedures for Handling Alleged Violations of Research Integrity in Finland 2023 (PDF)</a>.

Proposed research protocols requiring ethical review

The Ethics Committee of the Tampere Region oversees the ethical reviews of proposed non-medical research to be carried out in the region’s universities, higher education institutions and research organisations. In addition, the Committee issues statements and engages in activities that help regulate the standards of ethical conduct for scientific researchers in and around Tampere.The Ethics Committee collaborates with the Regional Ethics Committee of Tampere University Hospital. There is clear division of responsibilities between the two committees.The development of research ethics and the transparency of the Committee’s proceedings requires open access to information. The following details of studies that undergo an ethical review will be published on the Committee’s website:• Decision made by the Ethics Committee<h2>Members of the Ethics Committee 1 January 2023–31 December 2025</h2>Chair: Docent, Senior Researcher Kirsti Uusi-RasiVice chair: TBASecretary: Senior specialist Heikki EiloMembers of the Ethics Committee representing Tampere University:<ul><li>Senior Research Fellow Annika Blomberg, MAB</li><li>Tenure Track Professor Marita Husso, SOC</li><li>Academy Research Fellow Mari Korpela, SOC</li><li>University Lecturer Anneli Kylliäinen, SOC</li><li>University Lecturer Katja Lehtisaari, ITC</li><li>Professor Niina Lilja, ITC</li><li>Professor Pekka Louhiala, SOC</li><li>Tenure Track Professor Leena Mikkola, ITC</li><li>University Lecturer Liisa Mustanoja, ITC</li><li>Associate Professor Elina Mäkinen, MAB</li><li>Senior Research Fellow Jussi Okkonen, ITC</li><li>University Lecturer Kristina Rolin, SOC</li><li>University Instructor Sami Serola, ITC</li><li>Professor Hanna Toiviainen, EDU</li><li>University Lecturer Jari Varsaluoma, ITC</li><li>University Lecturer Hanna Vilkka, EDU</li></ul>The Ethics Committee also comprises representatives of the following stakeholder organisations (deputy members in parenthesis):<ul><li>Senior Researcher Minna Aittasalo (deputy member Senior Research Pauliina Husu), UKK Institute</li><li>Principal Lecturer Arja Halkoaho (deputy member Senior Advised Liisa Marttila), Tampere University of Applied Sciences (TAMK)</li><li>Manager Veikko Ikonen (deputy members Senior Scientist Päivi Heikkilä and Research Scientist), VTT Technical Research Centre of Finland Oy (Tampere)</li></ul>Head of Administration Heikki Eilo (heikki.eilo [at] tuni.fi, tel. +358 40 1901389, city centre campus, Main building room C128). Please direct all enquiries about the Ethics Committee and ethical reviews to Heikki Eilo. Before sending an enquiry, please make sure you read the relevant guidance pages and check the frequently asked questions. You may be able to quickly find an answer to your question.<ul><li>Meeting schedule of the Ethics Committee and minutes</li><li>Statements issued by the Ethics Committee</li></ul><h2>Ethics Committee meetings</h2>The Ethics Committee generally convenes once a month on a Monday.Meeting schedule of the Ethics Committee and deadlines for submitting a request for statement in spring 2024, there is one committee meeting left:<ul><li>Monday 17 June 2024 (submit requests for statement by 3  June 2024)</li></ul>Meeting schedule of the Ethics Committee and deadlines for submitting a request for statement in autumn 2024<ul><li>Monday 28 August (submit requests for statement by 12 August)</li><li>Monday 23 September (submit requests for statement by 9 September)</li><li>Monday 21 October (submit requests for statement by 7 October)</li><li>Monday 18 November (submit requests for statement by 4 November)</li><li>Monday 16 December (submit requests for statement by 2 December)</li></ul>The meetings will begin at 9:30. The venue will be the meeting room Kahveri located in the Main building on the city centre campus. In addition, it is possible to participate via Teams.Please send your request for statement in PDF format to the secretary of the Ethics Committee by email (heikki.eilo [at] tuni.fi (heikki[dot]eilo[at]tuni[dot]fi)).

Ethics Committee of the Tampere Region

Request for statement and required documents

The Ethics Committee does not grant institutional permissions to conduct a study but only issues statements of the ethical acceptability of a proposed study. You must separately apply for permission to conduct your study from your home institution before starting your research.

The Ethics Committee does not evaluate&nbsp; so called pure registry research (analysis is based only on the registry data). The review of the ethics committee is not required for reserch of public and published data, registry and documentary data and archive data. The review must be, however, done if the participants´personal data is collected from different sourcies (registries). However, if personal data is combined form multiple souces (from several registers) in the course of a study, the research plan must be reviewed by the Committee in the case the proposed research design is likely to pose risks to the rights and freedoms of data subjects or their safety (cf. research that requires an ethical review: research may pose risks to the safety of research participants, researchers or their family members.)

&nbsp;

The committee only deals in exceptionally cases statement requests in which masters´s theses is concerned (sensitivity of the topic). The matter must be contacted in advance by the secretary of the committee who will discuss the matter with chair, who will decide on the matter. The committee gives a statement on post graduate research.

The Ethics Committee will not accept assignments from individuals who are seeking admission to a doctoral programme.

The Ethics Committee will not issue a statement on research that has already been completed. Statements will not be backdated. A statement will not be issued if the research subjects have already been interviewed, even if the study has not yet been fully completed.

The Ethics Committee will not issue a statement if a grant proposal is pending. As a rule, the Ethics Committee only reviews proposed research projects that have already secured the necessary funding and human resources (such as a study that has received a positive funding decisions, a funded place in a doctoral programme, company funding or research that is carried out alongside gainful employment).

<ul>
	<li>Please note that the primary funding agencies (such as the EU, the Academy of Finland, Business Finland, foundations) do not expect proposed research to undergo an ethical review in advance. An ethical review is therefore not a requirement for receiving a grant. It would not be practicable as only a small share of grant proposals are accepted. &nbsp;</li>
	<li>Researchers are naturally expected to assess the ethical considerations of their research when they are drawing up grant proposals, but it is usually enough to state in the proposal that the study will be conducted in compliance with the principles of research ethics. If necessary, you can request an ethical review of the study (or a part thereof) from the Ethics Committee of the Tampere Region or the Regional Ethics Committee of Tampere University Hospital.</li>
	<li>You may request a statement from the Ethics Committee, if your research subjects, financiers or partners require such as review or if you are planning to publish your findings in a journal that requires such as review.</li>
</ul>

When the Ethics Committee refuses to provide a statement 

1. What is public?

The final statement is only public due to Finnish publicity law.

&nbsp;

2. Does the Ethics Committee only review research proposals submitted by the member organisations?

&nbsp;

The Committee will only review research proposals submitted by universities, higher education institutions and research organisations located in the Tampere region. The Committee may therefore review research plans of non-members as long as the institution responsible for the research is located within the region. Please direct related inquiries to the Ethics Committee.&nbsp;&nbsp;&nbsp;

The Ethics Committee will only review studies to be carried out by a company if one of the member organisations is responsible for the proposed research.&nbsp;

3. Will the Ethics Committee review the research protocols of multiple subprojects connected to the same study?

The Ethics Committee recommends researchers to submit separate statement requests for each subproject. If you consider it necessary to review an extensive study as a whole, you must provide a valid reason for this request and clearly mark all the documents so that is easy to assess the research protocols of each subproject and identify any ethical issues.

The Ethics Committee has made this decision because in the case of extensive studies it may be difficult, for example, to develop a clear picture of the roles and responsibilities pertaining to the protection of personal data. Carrying out an ethical review of planned subprojects when the entire research protocol is not yet clear is particularly challenging.

Ethics Committee of the Tampere Region

Ethical principles

Proposed research protocols requiring ethical review

Ethics Committee of the Tampere Region

Request for statement and required documents

When the Ethics Committee refuses to provide a statement

Frequently asked questions

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