Ethical reviews on non-medical research in the field of the human sciences
The Regional Ethics Committee of Tampere University Hospital provides ethical reviews of medical research conducted on humans, human embryos and foetuses in the Pirkanmaa, Kanta-Häme, Päijät-Häme and South Ostrobothnia Hospital Districts.
If you require a statement from the ethics committee, please go through sections 1-3 carefully.
- Ethical guidelines
- Documents to be submitted when requesting a statement
- Does my study require an ethical review
1.1. Respecting the autonomy of research subjects
Participation in research should be voluntary and based on informed consent. An exception from the principle of voluntary consent can be made when research is conducted on published and public information and archived materials. Research concerning official registries and documents and carried out without the consent of research subjects is governed by legislation.
Research subjects can give consent orally or in writing, or their behaviour can otherwise be interpreted to mean that they have given consent to participate. For example, assenting to a polite request for an interview or responding to a questionnaire or request for a written response indicates that the subject has consented to be studied.
In institutional settings (prisons, child protection institutions, hospitals, homes for the elderly, etc.), it is important to make sure that consent is given voluntarily by each and every subject. In evaluating the matter, attention must also be paid to the nature of the study, i.e. the degree to which personal matters are dealt with (need to protect privacy). If the research intervenes in personal integrity, it is particularly important to ensure the genuineness of consent. On the whole, researchers should always take into account the constitutional rights guaranteed to each individual.
If research intervenes in the physical integrity of subjects, consent must always be given in writing or in some other certifiable way, unless this is contrary to the interests of subjects. For example, a person with AIDS may not want his or her name registered on a written consent.
Consent can be specific or general. General consent applies to research use in general. General consent can include conditions regarding the form in which data are recorded and archived, and conditions set for the use of data in secondary research.
If information obtained from subjects is combined with information in official registers, subjects must be given detailed information on the registers that will be used.
Specific consent concerns the use of information in a particular study. Specific consent with regard to the use of data may be justified on the grounds that data cannot be anonymised and that archiving the data with identifiers for secondary research would in all likelihood be harmful to subjects.
Subjects have the right to withdraw from a study at any stage, but this does not mean, however, that their prior input (interviews, etc.) cannot be used in the study.
Autonomy and Research Involving Minors
According to section 6 paragraph 3 of the Constitution of Finland, children must be treated equally and as individuals and must be allowed to influence matters pertaining to themselves to a degree corresponding to their level of development. The same right is also ensured in Article 12 of the UN Convention on the Rights of the Child. On the other hand, according to section 4 paragraph 1 of the Child Custody and Right of Access Act (361/1983), a guardian has the right to decide on a child’s personal matters. Balancing this right and the above-mentioned principles in the Constitution and the UN Convention on the Rights of the Child is not always easy.
Consequently, the National Advisory Board on Research Integrity has called for legislation to be clarified in this respect. First, according to the above-mentioned principles, children should be able to influence matters pertaining to themselves to a degree corresponding to their level of development. Second, there are situations where there may be differences in values and interests between a guardian and a minor, and requesting the guardian’s consent may endanger the collection of comprehensive research data on the conditions and behaviour of minors, thus restricting the freedom of science, which is guaranteed by the Constitution. Third, there are studies which do not include risks and where requesting consent from the guardian would be difficult.
Autonomy and Age Limits
Many studies that are conducted in schools and institutions of early childhood education and care can be carried out as part of the normal work of the institution or school. It is not necessary to request a guardian’s permission if the director of an institution of early childhood education and care or the head teacher of a school has evaluated that the study would produce useful information for the institution or school and can be carried out as part of the normal activities of the institution or school. For example, observations, broad questionnaires and open interviews which do not collect directly identifying information (names, IDs, addresses) for research purposes can be carried out without the consent of parents or some other guardian. In other cases they must be informed of the study.
When studying minors outside an institution of early childhood education and care or school, researchers must themselves evaluate when it is necessary to ask for a guardian’s separate consent or inform a guardian of the study so that the guardian can forbid the child from participating in the study. A study involving children under the age of 15 can be conducted without a guardian’s separate consent or informing a guardian if this is justified from the viewpoint of
- the age and development level of subjects,
- the subject and research method or
- the need for information.
If a study is to be conducted without a guardian’s separate consent or informing a guardian, an ethical review must be requested for studies involving subjects under the age of 15.
Researchers must always respect a minor’s autonomy and the principle of voluntary participation, regardless of whether a guardian’s consent has been obtained or not.
Information for Subjects
The information that must be provided to research subject depends on the nature of data collection methods. In studies based on observation, interviews or questionnaires, subjects must be told what the study is about and what participating in the study means in concrete terms and how long it will take.
Information regarding a study should include at least the following:
- the researcher’s contact information,
- research topic,
- the method of collecting data and the estimated time required,
- the purpose for which data will be collected, how it will be archived for secondary use, and
- the voluntary nature of participation.
Subjects may ask for additional information regarding the study and researchers should prepare for this in advance. Additional information can concern, for example,
- a study’s scientific or doctrinal orientation,
- how confidential data will be protected and where data will be archived after the study, and
- how and when the results of the study will be published.
In experimental studies, sufficient information must be provided concerning the design of the experiment. Experimental designs vary considerably from one field to another. Determining the adequacy of information is always up to the researcher according to the guidelines in the particular field.
If a study intervenes in the physical integrity of subjects, the information given to subjects must comply with the guidelines issued on the basis of the Act on Medical Research as far as these apply.
Regardless of how data are collected, requests by the subjects for additional information must be answered truthfully. Research personnel should be trained to answer questions. In some studies, such as studies based on participant observation, the research relation deepens over time, and it is natural to provide increasingly detailed information on the objectives and content of the study along the way.
Exceptions from Informed Consent: An Ethical Review Must Be Requested from the Ethics Committee
If a study deviates from the principle of informed consent, an ethical review from the research ethics committee is always required.
An exception from the principle of informed consent can be made if advance information would distort the results of the study. As a matter of principle, studies on the use of power should be allowed without consent of those in power. There are also groups and subcultures that researchers cannot approach without using an assumed identity for the sake of their own safety.
Data collection can deviate from the principle of informed consent in a number of ways:
- Research subjects may be given all the relevant information but participation is not voluntary (e.g. a study based on participant observation of military conscripts or the observation of work processes where the organization’s management has given permission for the research).
- Research subjects may be given insufficient or misleading information about the role of the researcher. For example, the researcher may not identify him/herself as a researcher but does not give misleading information (e.g. observational data collected from an emergency room or riding with a police squad) or the researcher may work under a covert role (e.g. to mislead research subjects in a field study of discrimination).
- The researcher identifies him/herself but gives misleading information about the content of the study.
Observing subjects in a public place does not require their consent or an ethical review from the ethics committee. Technical recording equipment can be used in a public place provided the principles regarding privacy and data protection are observed in the use, storage and archiving of data.
1.2. Avoiding harm
An important task of historical and social research is to produce information on the improper functioning of social institutions and problems regarding the use of power.
Possible harm resulting from research can stem from the collection of data, the storage of data and consequences following the publication of studies.
Avoiding Mental Harm
Avoiding mental harm includes treating subjects with respect and reporting findings in a respectful way in research publications.
How sensitive a subject matter is and what the limits of privacy are depend primarily on the research subjects themselves. If the subjects know what matters will be dealt with on the basis of the information that is supplied to them, by giving consent they have demonstrated their willingness to participate in the study while being aware of the study’s scope and methods. If subjects participate in a study by writing about their experiences or answering a questionnaire, they regulate their own participation by avoiding matters and questions that they consider damaging or harmful.
People experience things in different ways. The same research questions or topics can arouse different reactions in different people. Research situations can and may include the same kind of mental strain and feelings (disappointment, joy, sadness, hate, shame, frustration, etc.) as in everyday life in dealing with different aspects of human life.
If a study includes interaction with subjects (participant observation, experimental study, interviews), subjects must be treated politely and with respect for their human dignity.
A researcher must make sure that the principle of voluntary participation is also observed in situations where there is interaction with subjects. A subject’s annoyance, embarrassment, fearfulness or physical fatigue can be sufficient grounds for the researcher to discontinue the study as far as the subject is concerned, even if the subject does not expressly refuse to continue. It is essential to ensure that subjects are participating voluntarily when studying people in institutional settings (hospitals, prisons, child protection institutions, homes for the elderly, etc.). Unnecessary mental strain can be avoided by testing in advance how much time subjects’ participation will take.
Avoiding Financial and Social Harm
Financial and social harm to subjects is more likely if a study does not observe the ethical principles concerning privacy and data protection. According to the principles, systematic care must be shown in handling and storing confidential information. Furthermore, the duty of confidentiality must be observed regarding subjects’ private matters (see ethical principles regarding privacy and data protection).
Research publications can have harmful consequences for subjects. The risk of harm is greatest if results are presented judgmentally, in a prejudiced way or disrespectfully. Harm can also be caused by publishing results giving a negative picture that are not based on comprehensive data or the systematic analysis of data.
Researchers should avoid any damage or harm to subjects that may be caused by research publications. However, this principle should not prevent the publication of research findings that may not be pleasing to subjects in all respects. A researcher’s task is to produce new information without having to fear the reaction of authorities or other research subjects. Particularly research concerning the use of power and the functioning of social institutions must not be restricted on the grounds that results can have negative effects for subjects. The best way to ensure freedom of research is to conduct research carefully and systematically and to publish results with proper arguments and shedding light on different perspectives in a balanced manner. Researchers and editors are responsible for compliance with ethical principles in research publications.
Studies Containing Risks of Harm: An Ethical Review Must Be Requested from the Ethics Committee
Studies entailing possible risks that cannot be evaluated by research subjects themselves, and studies with potential to cause harm beyond the limits of normal life, must be evaluated in advance. This includes studies that
- intervene in the physical integrity of subjects or
- in which subjects undergo exceptionally strong stimuli and evaluating possible harm requires special expertise (for example, studies containing violence or pornography).
In addition, studies in which the researcher is aware that there is a risk of causing long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life or studies that can signify a security risk to subjects (for example, studies concerning family violence) must be evaluated in advance.
1.3. Privacy and data protection
The protection of privacy is a right protected by the Constitution of Finland. It is also an established and important principle in research ethics. Data protection forms the most important area of privacy protection regarding the collection and processing of research data and the publication of results.
- Research ethics principles concerning the protection of privacy fall into three categories: protecting research data and confidentiality,
- storing or disposing of research data and
- research publications.
The goal is to find a balance between confidentiality and the openness of science and research.
Principles concerning the protection of privacy do not apply to materials that are in the public domain or to published data which can concern individuals and their activities in the fields of politics, business, official activities and culture. Guidelines concerning privacy and principles concerning data protection must be observed with regard to court sessions and court decisions, however.
The Personal Data Act (523/1999) contains provisions on the processing of personal data. According to section 3, personal data means ‘any information on a private individual and any information on his/her personal characteristics or personal circumstances, where these are identifiable as concerning him/her or the members or his/her family or household’. With regard to identifiability, the most significant thing is whether a particular individual can be identified from data easily and without unreasonable costs. Identifiers in research data have traditionally been divided into direct and indirect identifiers. Direct identifiers are name, address, date of birth and a person’s voice and picture. Indirect identifiers are, for example, place of residence, neighbourhood, education, job and family composition.
According to the main principle in the Act, personal data can be processed with the consent of the subject. A basic principle regarding the collection and storage of personal data is the need for personal data in the study. Personal data may not be collected and stored unnecessarily. If research data can be reasonably analysed without direct identifiers and there are no research grounds for storing identifiers, only data from which identifiers have been removed may be produced for research purposes and stored for secondary research. (See FSD’s guidelines for anonymising data.)
Data with identifiers can be collected and used when this is appropriate from the viewpoint of that particular research. With the consent of the subject, data can also be stored for secondary research with identifiers. Research in the humanities and social and behavioural sciences may require the processing and storage of identifiers. This may be based on the need to analyse data, later contacts with subjects or the historical and cultural significance of data. All contemporary data may also have historical and cultural significance.
Protecting Research Data and Confidentiality
The protection of data with identifiers must be carefully planned. The protection of subjects’ privacy may not be jeopardized by the careless storage of data or unprotected electronic data transfers.
Data security solutions for data with identifiers include decisions regarding where paper materials containing identifiers will be stored, at what stage unnecessary data will be destroyed or how their storage and archiving will be arranged for secondary research. Decisions must also be made regarding how electronic data containing identifiers will be protected (back-up copies, user names, processing if necessary on computers not linked to a network), and to what extent identifiers will be deleted or stored in connection with the data to be analysed.
If necessary, researchers or other research personnel handling data with identifiers can be required to sign a pledge of confidentiality. The research director or the principal investigator is responsible for written pledges. The confidentiality of data containing identifiers also applies to anyone using data, even if written pledges are not used.
If subjects’ personal data are not needed for data analysis, and there are no research grounds for storing them, paper materials containing identifiers must be destroyed, and identifiers must be removed from electronic files or else recoded, categorised or otherwise masked. Identifiers that are stored for the purpose of further contacts with subjects must be protected and stored separately from analysed data.
If research data have been collected from official documents and registers without asking for subjects’ consent, both identifiers and sensitive information must be destroyed as soon as they are unnecessary for conducting the research.
The confidentiality of research data relies on restrictions on the processing, use and storage of data. Research data may not be used of handed over for other uses besides research. It is particularly unacceptable to reveal information on research data or hand over data in such a way that it could influence the evaluation, treatment or position of individual subjects. Research data may not be handed over to the media or for commercial purposes.
Protecting privacy as a constitutional right protects citizens particularly against measures taken by public authorities. A researcher’s task is to produce scientific information to help understand social problems or society and culture in general. This task does not include revealing information about individual subjects to authorities. For example, information concerning crimes is considered to be sensitive information that is subject to and restricted by the researcher’s obligation of confidentiality. Information regarding individual subjects in research data may not be revealed to tax authorities, social welfare authorities or the police.
An exception to the obligation of confidentiality is every citizen’s obligation to report an imminent serious offence that can still be prevented. The deciding factor is the possibility to prevent an offence. A researcher does not have an obligation to reveal information regarding crimes that have already been committed, unless revealing information helps to prevent an imminent serious crime.
According to section 25 of the Child Welfare Act (417/2007), the obligation to confidentiality can be inapplicable if in the course of work a researcher discovers that ‘there is a child for whom it is necessary to investigate the need for child welfare on account of the child’s need for care, circumstances endangering the child’s development, or the child’s behaviour’. The primary starting point in a researcher’s work is to ensure confidentiality and remain in the role of researcher. In studying children and young people one must respect their own opinion if they are mature enough to form an opinion. If a researcher decides on the basis of the Child Welfare Act to make a report, it is good practice to inform the subjects in questions of this intention.
Storing or Destroying Research Data
Research in the humanities and social and behavioural sciences is not always repeatable, but the scientific community should have the possibility, if necessary, to verify research findings from the data analysed in a study. Openness is a key characteristic of science and also a precondition for testing the validity of scientific information, critically evaluating information and advancing science.
Data that are carefully archived for secondary research reduce the need to collect research data containing identifiers. Archiving also reduces the research pressure on small population groups. It is particularly important to archive for secondary research data that have cultural, historical and/or scientific value.
When necessary, the protection of privacy should be ensured through anonymisation measures and through the regulation of access to data for secondary research.
If it is necessary to remove identifiers from data stored for secondary use, the goal of the anonymisation measures undertaken should be that secondary users of data cannot immediately identify individual subjects. In addition to direct identifiers (name, address, ID), indirect identifiers (workplace, school, place of residence, age, profession, etc.) can be removed from archived data or be recoded, categorised or otherwise masked.
The protection of subjects’ privacy should be ensured by setting strict conditions on the secondary use of data. Data can only be used for research purposes. In addition, secondary users of data should be requested to sign an agreement on the conditions set for secondary research and if needed also a pledge of confidentiality.
If the data containing identifiers are sensitive, and cannot be anonymised, and research subjects have not been asked to give permission to store the data, the datasets should be destroyed after the study has been completed. If data are of scientific value or historically unique, a request for permission to archive data can be submitted to the National Archives.
Protecting Privacy in Research Publications
Unlike research data, research publications are in the public domain. The need to protect privacy in publications must be evaluated on a case-by-case basis.
For most studies, there is no need to present subjects in an identifiable way in published findings. The results of quantitative research are reported statistically, which means that there is no risk of identification even when the publication is based on data containing identifiers.
In the case of qualitative data, the risk of identification must always be evaluated before any samples/quotations from the data are published: what indirect identifiers (workplace, school, place of residence, age, profession, etc.) will be left in the sample as such, what will be masked and what will be omitted altogether.
In studying organisations or other social actors (institutions, associations, work communities, public bodies, etc.), the identifiability of the organisation and its individual representatives must be evaluated separately in each case. Subjects generally participate in a study as individual representatives of their social or professional role. Anonymity in research publications does not necessarily prevent identification among those who are familiar with the unit or organisation in question, however. Subjects should not be promised complete anonymity unless it can reasonably be guaranteed. Research publications should strive to treat individual subjects and the research target in a respectful manner. Critical findings regarding the research target should be explained analytically, avoiding a labelling attitude.
In research, particularly in the humanities but also in the social sciences, it may be justifiable for research purposes and also ethically to present subjects by name in research publications. For example, a study based on interviews with experts can be published without removing the names of subjects or other identifiers. Agreement about this must be reached with research subjects in advance.
If research concerns archived materials, the identifiability or non-identifiability of subjects in research publications depends on the conditions the distributing archive has set on the use of the data.
Ethical review in the human sciences
Tampere University is committed to adhering to the Finnish Advisory Board on Research Integrity guidelines entitled Responsible conduct of research and procedures for handling allegations of Misconduct in Finland (2012) and to other ethical guidelines in the field of the human sciences. The human sciences include all fields and disciplines which involve methodology used in social sciences or behavioural sciences.
The Ethics Committee of the Tampere region was set up in 2010 and it includes members from Tampere University, Tampere University of Applied Sciences, the UKK Institute and the VTT Technical Research Centre of Finland. The Ethics Committee provides statements to researchers working at the above-mentioned organisations.
The purpose of the Ethics Committee is to provide ethical reviews of non-medical research in the human sciences conducted at universities, higher education institutions and research institutes in the region, and to promote increasingly ethical research through its decisions and activities.
The Ethics Committee collaborates with the Regional Ethics Committee of Tampere University Hospital. These committees have divided duties between them.
Promoting ethical research and making the Ethics Committee’s work more transparent requires openness. The Ethics Committee therefore publishes the following information about every study submitted for ethical review (unless publishing this information contradicts any agreements on confidentiality):
- The applicant’s reasons for requesting an ethical review and his/her evaluation of the ethicality of the research
- The researcher’s summary of the research plan
- The Ethics Committee’s decision.
Ethics Committee of the Tampere region
The Ethics Committee of the Tampere region was set up in 2010 to provide ethical reviews on non-medical research in the human sciences conducted at universities, higher education institutions and research institutes in the area and to promote increasingly ethical research through its decisions and activities.
Ethics Committee’s secretary is Heikki Eilo, Head of Administration (University Services) at Tampere University.
If you have any questions about the Ethics Committee or want to discuss the necessity of an ethical review, please contact the secretary. Before you do so, please read the section ‘Ethical Review’ carefully as it contains the latest information about the topic and guidelines for review.
Contact information: email@example.com, +358 40 190 1389
The request for ethical review
The request for ethical review must be one PDF document consisting of all the information listed below. This document must be submitted to the Ethics Committee’s secretary by e-mail. In addition, the cover note must be printed, signed and submitted to the secretary as a hard copy.
Please submit your request at least two weeks before the meeting at which you wish to have your study discussed.
Please ensure the language of the request is clear and understandable. The request must contain the following information (please number each item and present them in the following order):
Nb. The committee does not grant research permission for the study, but it should be obtained form the organisation in question before the reseach process has been launched. The ethicall committee gives a statement on the ethical aspects relating to the statement request/research plan.
The committee does not give statements about research that has already been completed or that has already begun (particularly when the empirical part of the research is already being carried out).
The statement request must be submitted by email to the secretary of the committee Heikki Eilo (firstname.lastname@example.org)
1. Cover note, including the following:
- Contact details for the person in charge of the research
- Reasons for submitting the request
- Possible grounds for confidentiality
The Ethics Committee wishes to promote openness in ethical reviews but allows concealment, for example, in cases where the sponsor's agreements so require. Confidentiality concerns the information published on the Ethics Committee’s website (i.e. reasons for submitting the request, applicant’s evaluation of the ethicality of the study, summary of the research plan and the Ethics Committee's decision); other information and documents submitted to the Ethics Committee are not public.
2. Research plan (paginated) and a summary. Please note that if the study is conducted in English, the summary must be submitted in Finnish. The summary must be written so that the researcher and possible partners agree to publish it on the Ethics Committee's website under 'Decisions' unless the summary is confidential (see section 24[1:21] of the Act on the Openness of Government Activities). The research plan must be clearly defined. NB: The research plan must clearly indicate if the study is part of a larger research programme or if it involves other research projects (e.g. doctoral dissertation work).
3. Evaluation of the ethicality of the study by the person in charge of research. In ethical assessment one should take into consideration especially the ethical principles stated in the so-called HYMY guidelines (2009) issued by TENK, which concern ethical preassessment. The TENK guidelines on so-called responsible conduct of research (2012) concern responsible conduct of research on a general level and the processing of violations of responsible conduct of research, so one should not refer primarily to those guidelines in ethical assessment.
4. Announcement to research subjects If the study deviates from the principle of informed consent, please present reasons in the section where you evaluate the ethicality of study.
5 Notice of consent for research subjects to sign (form A). The notice of consent is required in addition to the announcement if data are analysed with identifiers and include sensitive information. Model notices of consent:
6. Other materials provided to research subjects (interview schedule, diaries, questionnaires, etc.)
7. Data management plan (i.e. plan for handling, storing and archiving data). Nb. Large research projects involving several parties should include a mention of how the parties have agreed on the use of the material and how copyrights have been defined. This would apply to requests for statement dealt with from the year 2017 onwards.
8. Description of the file from the Data Protection Ombudsman: if the study involves collecting information with identifiers: description of scientific research data file
NB! The part concerning the rights of the registered person is always assessed case by case, according to e.g. whether personal data is processed or not.
When seeking consent from a minor's parent or other guardian, consent forms must also be submitted with the request. If a research subject is unable to provide his/her consent, for example, for a reason related to mental health or intellectual or developmental disability, consent must be obtained from the subject's guardian or legal representative. This consent form must also be included in the request.
In addition, the applicant must ensure that the following information is clear from the request:
- People and organisations participating
- Summary of the study
- Data collection (target groups and methods)
- Research permits and consents
- Consent to use the data for some other use than research (e.g. in teaching)
- Voluntary participation and the right to withdraw from the study
- Risks and benefits
- Safety of the equipment used in the study
- Confidentiality of information
- Recording and storing data
- Insurance policies
- Feedback provided to research subjects
- Letters to research subjects (see models)
- Consent forms (see models)
- Questionnaire and evaluation forms and interview schedule
Please note that the request must include a table of contents with appropriate page numbers. The table of contents must comply with the guidelines and structure provided above in items one to eight. The information presented in the bulleted list above can be included in the research plan and letter to research subjects.
Letter to research subjects
The letter to research subjects must include the information listed in items one to seven below. Please pay attention to the following:
- The clarity and intelligibility of writing
- The language of the study; in multinational studies, the letter to subjects and the consent form must be submitted to the Ethics Committee in Finnish
- The logic and information value of the letter to subjects
- The intelligibility of the letter provided to research subjects; subjects must be able to understand the letter and ethical questions related to the study.
Take a look at the guidelines on informing Research Participants
Informing research participants, please see Content of information to participants and write the participant information sheet as instructed in points 1-8 in above link. The ethics committee emphasizes that the announcement to research objects should be clear and intelligible. Disciplinary jargon should be avoided. The announcement should clearly indicate what the participants of the study agree to.
- Contact information
- Subject and objectives of the study. The description of the research should alsoo mention whether the research entails any benefits or drawbacks to the research subjects and give the reasons why that is.
- Data collection
- Voluntary nature of participation. There should be a mention in the information letter whether the research subjects are rewarded in some way (for example cinema ticket, fee etc.) or not.
- Maintaining confidentiality
- Combining register or record data to information supplied by subjects
- Maintaining privacy in publications
- Informing about archiving and further use of the data
Further information on informing research participants, for example on the voluntary nature of research participation.
N.b. The collected research material should be restored the minimun time of five (5) years, if not ordered otherwise (for instance by the financer of the research).
The Ethics Committee will provide the following information on each study on its website unless the researcher prohibits this:
- The applicant’s reasons for requesting an ethical review and his/her evaluation of the ethicality of the research
- The researcher’s summary of the research plan
- The Ethics Committee’s decision
Guidelines for ethical review
An ethical review examines, from the perspective of avoiding risk and harm, how the study will be conducted, what information will be given to subjects, and how data will be collected, processed and stored.
The review weighs the intended scientific value of the study against the possible negative effects that may be caused to the subjects participating in the study. The review always considers the ethical principles of the human sciences, namely the autonomy of research subjects, the avoidance of harm, and privacy and data protection.
In human science research, ethical considerations emphasise the encounter between the researcher and the subject, which can include unanticipated factors. The researcher is always responsible for the ethical and moral solutions in a study.
In the human sciences, the evaluation of scientific value and risks is not a utilitarian cost-benefit analysis but rather a question of the normative appraisal of inherently incommensurable values. Ethical review ensures that a study does not pose risks that could be avoided without weakening the scientific value of the study. When the scientific value has been weighed against the possible risks, one must decide whether risks in general are morally acceptable. Research which entails higher risks may be morally acceptable if the scientific value of the study is very high and the study does not cause harm to subjects (studies not based on informed consent), or the people participating in the study can evaluate possible harm themselves on the basis of the information supplied to them.
If a study observes the principles of autonomy and does not present a risk of causing mental harm beyond those encountered in normal life, this should be mentioned in the request for an ethical review. In this case, the Ethics Committee will primarily evaluate the information supplied to subjects as well as matters concerning privacy and data protection.
If the research design involves a risk that threatens subjects' autonomy, or if the study may cause such harm that special expertise is required to evaluate it, the Ethics Committee must also evaluate the proposed research methods in relation to the research questions and the value of the new information that the study will provide.
Information for Subjects
The Ethics Committee will check that the informing of research subjects is planned appropriately. Information regarding a study should include at least the following:
- the researcher’s contact information,
- the research topic,
- the data collection method and the estimated time required,
- the purpose for which data will be collected, used in secondary research and archived, and
- the voluntary nature of participation.
In experimental studies, sufficient information must be provided concerning the design of the experiment. Experimental designs vary considerably from one field to another; the ethics committees will determine whether the proposed level of information is adequate.
If a study involves an intervention in the physical integrity of subjects, the information given to subjects must comply with the guidelines issued on the basis of the Act on Medical Research to the extent to which they apply.
For more information on informing research subjects from the point of view of data management, please visit the Finnish Social Science Data Archive’s guidelines.
Privacy and Data Protection
An ethical review examines a study’s data management plan and ensures that technical data security solutions have been planned. The data management plan must describe
- how data containing identifiers will be protected or have identifiers removed,
- whether signing a pledge of confidentiality will be required of persons using or processing the personal data, and
- the plan for archiving the data for secondary research or alternatively destroying personal data after the study has been completed.
Ethics committees do not review the protection of privacy in research publications. Researchers and editors are responsible for complying with ethical principles in research publications.
A study must be submitted for ethical review if it falls under one of the following categories
a. The study involves an intervention in the physical integrity of subjects
The ethical guidelines for medical research can be applied in planning and reviewing studies that involve an intervention in the physical integrity of subjects. All studies that involve an intervention in the physical integrity of subjects are reviewed by the Ethics Committee of Pirkanmaa Hospital District.
Studies involving an intervention in the physical integrity of subjects include the following:
- Studies which involve taking blood samples, DNA samples, biopsies or other similar samples
- Studies which involve physical strain (e.g. measuring noise tremor and the effects of electric impulses)
- Nutritional studies which use food products to affect health or the risk or symptoms of illnesses.
For more information about ethical principles applied to these types of studies, please visit the Guidelines of the Ethics Committee of Pirkanmaa Hospital District (only in Finnish).
b. The study deviates from the principle of informed consent
If a study deviates from the principle of informed consent, the Ethics Committee will evaluate whether conducting the study is ethically acceptable. Conducting the study is ethically acceptable if it meets the following conditions:
- The research is justified and it would not be possible to conduct the research if subjects were informed of the study and their consent was requested;
- Data collection does not involve risks to participants;
- If possible, research subjects will be informed afterwards of the nature and purpose of the research;
- Adequate attention is paid to the privacy of the research subjects and data protection issues.
c. The subjects are children under the age of 15, and the study is not part of the normal activities of a school or an institution of early childhood education and care, and the data are collected without parental consent and without providing the parents or guardians the opportunity to forbid the child from taking part in the study
A study involving children aged under 15 can be conducted without the consent of a parent or other guardian and without informing the parent or guardian if it does not involve risks to subjects and the research design is justified by one or more of the following:
- On the basis of subjects’ age and level of development: The minors who are intended subjects are able to understand the research topic and what participating in the study requires of them in concrete terms;
- On the basis of the research area and method: The research topic is not sensitive and asking for a parent's or guardian's consent is difficult in practice (e.g. studies of youth clubs or pupils’ voluntary clubs, etc.);
- On the basis of the need for information: The subject matter of the study will prevent the collection of comprehensive data if the parents' consent must be requested for the children's participation (domestic violence, social problems, etc.), or the research covers issues which minors may not want their parents to know about (use of intoxicating substances, sexual orientation, etc.).
d. The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise (e.g. studies containing violence or pornography)
e. The study may cause long-term mental harm (e.g. trauma, depression, sleeplessness) beyond the risks encountered in normal life
f. The study can entail a security risk to subjects (e.g. studies concerning domestic violence)
The researcher must describe possible negative effects and risks so that the Ethics Committee can evaluate whether the study is ethical by weighing the possible risks to subjects against the intended scientific value of the study. Studies must be conducted in a manner that minimises any negative effects and risks to subjects.
The intended scientific value will be weighed against the possible negative effects and against the measures that are taken to reduce the negative effects to subjects during or after the study (physical or mental harm) or to prevent them altogether (data protection). The evaluation must take into consideration the subjects’ free will and autonomy. After all, subjects are always able to evaluate, to some extent, the risks of participating in a study.
In evaluating experimental studies, the ethical guidelines of the particular field can be applied in a supplementary manner. If researchers wish to apply the ethical guidelines of their field, they must indicate this on their request for review and supply reference information for such guidelines.
Does my study require an ethical review?
Regardless of whether a research subject, funding agency or scientific journal requires an ethical review, researchers must submit their research plan for ethical review if a study contains any of the following features:
- The study involves an intervention in the physical integrity of subjects;
- The study deviates from the principle of informed consent (ethical review is not required if the research is based on public documents, registries or archived data);
- The subjects are children under the age of 15 and the study is not part of the normal activities of a school or an institution of early childhood education and care, and the data are collected without parental consent and without providing the parents or guardians the opportunity to forbid the child from taking part in the study;
- The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise (e.g. studies containing violence or pornography);
- The study may cause long-term mental harm (e.g. trauma, depression or sleeplessness) beyond the risks encountered in normal life;
- The study can represent a security risk to subjects (e.g. studies concerning domestic violence).
A researcher can request an ethical review should the research subject, the funding agency or a cooperation partner require it, or if the results are to be published in a scientific journal which requires an ethical review.
The guiding principle in any ethical review conducted by the Ethics Committee is the ethical guidelines provided by the Finnish Advisory Board on Research Integrity. Please read the guidelines carefully before submitting a request for an ethical review.
After reviewing an intended study, the Ethics Committee will make a decision on its ethical acceptability. The researcher is always responsible for his/her study and the decisions he/she makes; the ethical review does not transfer responsibility to the Ethics Committee.
If you are unsure of whether your study needs to be submitted for ethical review, please contact the Ethics Committee's secretary: email@example.com, +358 40 190 1389
When is an ethical review not issued
The committee does not grant research permission for the study, but it should be separately obtained form the organisation in question. The ethics committee gives a statement on the ethical aspects relating to the statement request/research plan.
Ethical reviews are intended for postgraduate research. At graduate level, supervisors must ensure that thesis research complies with ethical guidelines.
The Ethics Committee does not process research plans if the person conducting the research is only in the process of becoming a postgraduate student and has not yet been admitted.
The committee does not issue statements on research that has alreaby been completed. Statements are not issued retroactively. The committee does not issue statements on research either if the research is not yet totally completed, but the participants have already been interviewed and surveyed.
The committee does not issue an ethical review if the researcher is in the process of applying a funding for the research/project. The ethical review can only be issued after the granting has been granted.