Ethical review on non-medical research in the field of the human sciences
The Ethics Committee of the Tampere Region was established in 2010 to oversee the ethical reviews of proposed non-medical research in the field of human sciences at Tampere University, Tampere University of Applied Sciences, VTT Technical Research Centre of Finland Ltd. (Tampere) and the UKK Institute.
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 Ethical principles of research with human participants and ethical review in the human sciences in Finland issued by the Finnish National Board on Research Integrity (TENK) in 2019.
The Regional Ethics Committee of Tampere University Hospital (TAYS) carries our ethical reviews of proposed medical research involving human subjects, human embryos or foetuses as set out in the Medical Research Act.
In Finland, researchers in all disciplines are required to adhere to the following general ethical principles:
- 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.
- 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.
- Research must be conducted in a way that does not cause significant risks, damage or harm to research participants, communities or other subjects.
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.
2. Enforcement of ethical principles
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.
People participating in research have the following rights:
- 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.
- 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.
- 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.
- 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.
- 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.
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.
- 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.
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.
3. Research involving minors and/or people who lack capacity to consent
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.
- Minors must be informed of research in a way that they are able to understand.
- 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.
- 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).
- 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.
- 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.
- 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.
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.
- People with a limited capacity must be informed of the research study in a way that they are able to understand.
- 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.
- 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, researchers must withdraw the person from the study.
4. Processing of personal data for research purposes
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
- 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;
- 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;
- 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;
- 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.
The following factors must especially 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 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.
- 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.
- 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.
- 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.
Protecting privacy in research publications
Factors to be considered when publishing research findings:
- 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.
- 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.
- 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.
- 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.
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.
5. Openness of research data
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.
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:
- the research is justified and could be carried out if the subjects were informed of the study and asked to provide consent,
- The collection of data involves no risk to the subjects,
- If possible, the subjects will be informed afterwards of the nature and purpose of the study,
- The privacy of research subjects and data protection issues are duly considered when collecting, processing and reporting data.
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:
- 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.
- 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).
- 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)
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.
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 the responsible conduct of research (RCR). 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 responding to allegations of research misconduct. Read more: Responsible conduct of research and procedures for handling allegations of misconduct in Finland (2012).
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
Members of the Ethics Committee from 1 January 2020 to 31 December 2022
Chair: Docent, Senior Researcher Kirsti Uusi-Rasi
Vice chair: professor Hanna Toiviainen
Secretary: Senior specialist Heikki Eilo
Members of the Ethics Committee representing Tampere University:
University Lecturer Kristina Rolin
University Lecturer Aino Ahtinen
University Lecturer Hanna Vilkka
University Lecturer Noora Ellonen
Professor Laura Huttunen
Professor Pekka Louhiala
Professor Johanna Kujala
University Lecturer Anneli Kylliäinen
University Lecturer Niina Lilja
University Lecturer Liisa Mustanoja
Professor Asko Lehmuskallio
University Instructor Sami Serola
Associate Professor Hanna Toiviainen
Professor Kaisa Väänänen
Professor Päivi Åstedt-Kurki
The Ethics Committee also comprises representatives of the following higher education institutions and research organisations (deputy members in parenthesis):
Tampere University of Applied Sciences: Senior Adviser Liisa Marttila, TAMK (deputy member yliopettaja Arja Halkoaho)
VTT Technical Research Centre of Finland (Tampere): Senior Scientist Veikko Ikonen (deputy member Principal Scientist Eija Kaasinen and tutkija Päivi Heikkilä)
UKK Institute: Senior Researcher Minna Aittasalo (deputy member Senior Researcher Pauliina Husu)
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.
- Meeting schedule of the Ethics Committee and minutes
- Statements issued by the Ethics Committee
The Ethics Committee generally convenes once a month on a Monday.
In Autumn there is one meeting:
-Monday 13 December 2021 (submit requests for statement by 29 November 2021)
Meeting schedule of the Ethics Committee and deadlines for submitting a request for statement in spring 2022:
Monday 24 January 2022 (submit requests for statement by 10 January 2022)
Monday 21 February 2022 (submit requests for statement by 7 February 2022)
Monday 21 March 2022 (submit requests for statement by 7 March 2022)
Monday 25 April 2022 (submit requests for statement by 11 April 2022)
Monday 23 May 2022 (submit requests for statement by 9 May 2022)
Monday 13 June 2022 (submit requests for statement by 1 June 2022)
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. Please send your request for statement in PDF format to the secretary of the Ethics Committee by email (heikki.eilo [at] tuni.fi).
When you send the Ethics Committee a request to review your proposed research protocol, you need to combine the documents listed below into a single PDF file and email this file as an email attachment to the secretary of the Ethics Committee.
You do not need to send a written cover letter any more to the secretary, but add it in the first document of the above mentioned pdf file.
Ethics Committee of the Tampere Region/Heikki Eilo
Main building C 141
FI-33014 Tampere University, Finland
Please be aware that your request for statement must be turned in at least 2 weeks before the intended meeting of the Ethics Committee, so that there is enough time to include it in the agenda.
Students and doctoral researchers must co-submit the request with their supervisor.
Please note! 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 study.
The statement provided by the Ethics Committee does not constitute a binding administrative decision. Researchers are ultimately responsible for their own research. The data controller of the study holds primary responsibility for any data protection issues. However, the Ethics Committee serves an important function as an ethical review may be required, for example, by funding agencies and scientific journals.
The Ethics Committee will not review studies that have already been completed or have already started (especially if the empirical section of the study is already underway).
Neglecting to request an ethical review for a proposed research protocol that requires such a review (see the guidelines above) may constitute a violation of good scientific practice.
If a funding agency or publisher requires an ethical review but such a review has not been carried out because the ethical review policy that is in place in Finland does not require it, the Ethics Committee may provide you with a document that describes the Finnish policy.
1. Content of the request for statement
The request for statement that you send to the Ethics Committee must include numbered sections in the following order. Write your request in clear and understandable language.
1. Cover letter that includes the following information:
- Contact information of the principal investigator
- Grounds for submitting the request for statement (here you must specify why your proposed study requires an ethical review, see the section 4.2. herein for more details).
- Possible reason to maintain confidentiality. The Ethics Committee is committed to promoting the openness of ethical reviews but will keep the information confidential if, for example, confidentiality is required in the contracts signed with your financier. This confidentiality obligation will apply to the information that is generally published on the Committee’s website (namely the grounds for requesting a statement, your assessment of the ethical considerations, the research abstract and the decision made by the Ethics Committee) – other information and documents reviewed by the Ethics Committee are not public.
2. The research proposal (with the pages numbered). The abstract must be written in Finnish if the language of the study is English. The research plan is drafted for the purpose of ethics evaluation by the committee. The maximun length of research plan is 10 pages. The research plan must be drafted according to the following instruction:
Please note! Your research proposal must clearly indicate whether your study is part of a broader research programme or otherwise linked to other research projects (such as dissertation research). The field of research must be identified at the beginning of your research proposal.
3. An assessment of the ethical considerations by the principal investigator (here you can provide more detailed information to elaborate on the grounds for requesting an ethical review). You should assess the ethical risks and potential harm that are associated with participating in your study and exceed what people may expect to experience in their everyday life. The ethical assessment should be carried out in accordance with the principles set out in the Ethical principles of research with human participants and ethical review in the human sciences in Finland issued by the Finnish National Board on Research Integrity (TENK, 2019).
This assessment should not focus on the RCR Guidelines of the Finnish National Board of Research Integrity (TENK) as these guidelines discuss research ethics and violations of scientific integrity on a more general level.
4. Risk assessment
You can contact the University´s Research Data Services if you need help with drawing up a risk assessment (researchdata [at] tuni.fi). Please also see the section 6b, privacy notice. You can also consult with our Research Data Services when repairing a privacy notice. If you are unfamiliar with these documents, please consult with Research Data Services before submitting your request statement to the Ethics Committee.
A concise assessment of the risks associated with the processing of personal data must always be carried out before starting to process personal data. In this section of your request for statement, you need to assess the risks related to data protection and privacy. See more instructions on the website of the Data Protection Ombudsman.
Please be aware that the concise risk assessment concerns the processing of all personal data, not only special category data.
5. Impact assessment
If the results of a concise risk assessment indicate that participation in your study will pose significant risks to research subjects from the perspective of privacy, you must carry out an impact assessment pertaining to the processing of personal data. Please see more information on website of the Office of the Data Protection Ombudsman.
Please note! You must always carry out an impact assessment, if the processing of personal data may result in significant risks to your research subjects. This information may be extremely relevant for your subjects. In addition, there are specific scenarios identified in the GDPR where an impact assessment must always be conducted. Please go to the website of the Office of the Data Protection Ombudsman to learn more (section titled Impact assessment in the case of the processing scenarios specified in the General Data Protection Regulation).
6. Subject information sheet (see the section ‘Informing prospective research subjects of your study: information sheet’ herein for more details).
a. If you intend to deviate from the principle of informed consent, the reasons for this choice must be presented in the section where you assess the ethical considerations of your study.
b. Privacy notice If you will be processing personal data (NB! The concept of personal data is extensive) in connection with your study. You must also draw up a privacy notice if your data is likely to include personal data, even if the collection of personal data is not the primary purpose of your study. The privacy notice must be attached to the subject information sheet. The privacy notice may include some of the same details as the subject information sheet. See the link below for information that a privacy notice must include.
Please also see the EU’s General Data Protection Regulation, Articles 13 and 14.
7. The consent form to be signed by your research subjects or other statement detailing the process of obtaining and documenting participants’ consent. The Ethics Committee recommends researchers to use written consent forms if their study intervenes in the physical integrity of their subjects (if the study falls outside the scope of the Medical Research Act) and if the research data will not be anonymised before analysis and the data contains sensitive information (special category data defined in the GDPR).
If you request permission from parents or guardians for their child’s participation in your study, the consent form must be appended to the request for statement. If research subjects are unable to provide informed consent due to a mental disorder, disability or other similar reason, you must request consent from their guardians or legal representatives. This consent form must also be appended to the request for statement.
8. Other material provided to research subjects (interview framework, diaries, questionnaires, etc.).
9. Data management plan (plan for processing, storing and archiving research data). Please note! If your project involves multiple partners, your data management plan must specify how the partners have agreed to use the data and indicate how copyrights have been defined. See the instructions provided by the Finnish Social Science Data Archive.
Although copyright and contract questions are discussed in the data management plan, please be aware that the Ethics Committee is not authorised to make decisions about copyrights or contracts and will not assess their validity. The Ethics Committee will only assess whether the proposed study is ethically acceptable and whether it may harm research subjects or violate their right to autonomy and privacy.
10. After the EU’s General Data Protection Regulation (GDPR) came into force, it is no longer necessary to prepare research data files that were formerly required. However, you must prepare a GDPR-compliant record of processing activities. You do not have to send this document to the Ethics Committee but you must have it ready. The Ethics Committee may request to see your privacy notice to look into potential data protection issues associated with your study. Template for recording processing activities provided by the Office of the Data Protection Ombudsman.
PLEASE NOTE! Your request for statement must include a table of contents with the above sections from 1 to 9.
The committee may require resubmission of the request for statement/research plan, if there are clear and significant ethical issues concerning the information sheet for research participants, the consent form, the data management plan, the planned data protection practices, the ethical assessment carried out by the researcher and/or the planned research methods. The decision whether to require resubmission will be made on a case by case basis following an overall assessment of the research plan. Resubmission is generally required if there are multiple issues that must be addressed.
When you are drawing up a request for statement, make sure that the following information is included:
- persons and organisations involved in the study
- research abstract
- data collection (target groups and methods)
- institutional permission to carry out the study
- consent to use data for other purposes (such as teaching)
- voluntary participation and the right to withdraw at any time
- risks and benefits associated with the study
- information about what participation in the study means in concrete terms (eg the time it will take)
- safety of devices used in connection with the study
- storage and retention of research data
- feedback to be provided to your research subjects
- subject information sheet prepared according to the template
- consent forms prepared according to the template
- questionnaires and interview framework
The request for statement must include a table of contents with page numbers so that the required details are easy to find. The table of contents must be include the same sections as the request for statement (sections 1-9 above). The information included in the bulleted list above may be included in your research proposal and your subject information sheet.
Informing prospective research subjects of your study: information sheet
The information sheet provided to your research subjects must be clear and understandable. Avoid scientific jargon. The sheet must clearly describe what it means to participate in the study!
See the EU’s General Data Protection Regulation, Articles 13 and 14.
The information sheet provided to your research subjects must include the following details:
- Contact information
- The research topic and goals. Indicate whether the study is expected to harm or benefit research subjects and why. Describe how the study will be implemented and what participation will actually mean (eg how much time subjects should set aside for their participation)
- Methods for collecting research data
- Voluntary participation. Mention whether research subjects will receive compensation or not. Point out that research subjects have the right to withdraw from the study at any time without giving any reason and without suffering negative consequences. You should also state that the data collected on the subjects to the point of withdrawal will remain part of the study database and may not be removed.
- Confidentiality of research data
- The processing of personal data and the possible combination of registry data with information provided by research subjects
- Privacy of research subjects in scientific publications
- Further use and archiving of the research data
You should also pay attention to the following points:
- Is your subject information sheet written in clear and understandable language?
- The language used to carry out the study: if a study involves international partners, the information sheet and consent form submitted to the Ethics Committee must be written in Finnish.
- Is your information sheet informative and logical?
- Is your information sheet informative and understandable to research subjects?
If your research involves minors as research subjects, you must provide them with information about your study in a clear language at a level that they can understand. If your study will intervene in the physical integrity of your research subjects, you must provide information to your subjects in accordance with the guidelines set out in the Medical Research Act.
Please go to the website of the Finnish Social Science Data Archive to find more information about data management, anonymisation and the information that must be provided to your research subjects.
The following details of your study will be published on the Committee’s website with your consent:
- the grounds for requesting a statement from the Ethics Committee and your assessment of the ethical considerations relating to your study
- abstract of the research proposal (provided by the researcher)
- the decision made by the Ethics Committee
2. Guidelines for the ethical review
In human sciences, the consideration of research ethics mainly focuses on the encounters between the researcher and his or her research subjects that may include unexpected elements. Researchers always hold sole responsibility for the ethical and moral choices they make while conducting research.
Ethical reviews will especially focus on the following elements of your proposed study: What are the risks and hazards (as described in your request for statement) that your study may potentially cause to your research subjects, their family members and to the researchers involved? Considering the measures taken to minimise risks, how likely are the risks? Will research subjects be provided with sufficiently clear information about the study, their participation and the processing of personal data? Is the data management plan sufficient, and does it include a description of the processing of personal data throughout the research lifecycle? Do you have an appropriate written or electronic consent form to be signed by your research subjects? If you will not be using a written or electronic consent form, how will you request research subjects to participate in your study and how will you document their consent? How would you weigh the importance of the expected findings against the potential hazards and risks associated with your study?
When research falls in the category of human sciences, the weighing of the expected benefits against potential risks is not as straightforward as a cost/benefit analysis but more like a normative assessment of different values. The purpose of the ethical review is to ensure that all the potential risks are eliminated, if possible, without compromising the scientific value of the study. The next step is to assess whether the risks that cannot be eliminated can be considered morally acceptable. The threshold for morally acceptable risk may be increased, if your study is expected to produce significant scientific value and will cause no harm to your research subjects (=studies where the requirement to obtain informed consent has been waived), or if your research subjects are considered able to assess the potential risks based on the information provided to them.
If your study will be carried out in compliance with the principle of respecting the autonomy of research subjects and is not expected to give rise to mental distress that goes beyond normal everyday life, you must clearly state so in your request for statement. Then the Ethics Committee will primarily focus on assessing the information provided to your prospective research subjects and reviewing data protection and privacy issues.
If your study involves a significant risk of violating the autonomy of your research subjects or may potentially harm your research subjects in ways that cannot be assessed without special expertise, the research methods to be employed in your study will be assessed in relation to your research questions and the importance of the new information that your study is expected to generate.
Informing your research subjects
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.
If you will be conducting experimental research, you will be expected to provide sufficiently detailed information about your proposed research protocol. The typical setting of experimental research varies greatly between disciplines. The Ethics Committee will assess whether the information is sufficient on a case-by-case basis.
If a study will intervene with the physical integrity of research subjects, they must be informed of the study in accordance with the applicable guidelines set out in the Medical Research Act.
Privacy and data protection
The Ethics Committee will review your data management plan and ensure that you are prepared to take appropriate technical data protection measures. Your data management plan must describe:
- the measures that will be taken to protect or erase personally identifiable information
- possible confidentiality agreements that must be signed before processing personally identifiable information
- the plan to retain research data for future research purposes or appropriately dispose of the data after the study has been concluded
The Ethics Committee will not assess the data protection policies of scientific publications in advance. Researchers and the editorial boards of journals are responsible for considering the ethical issues relating to research papers.
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 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.)
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).
- 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.
- 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.
- 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.
1. What is public?
The final statement is only public due to Finnish publicity law.
2. Does the Ethics Committee only review research proposals submitted by the member organisations?
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.
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.
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.