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: 1) the researcher’s contact information, 2) the research topic, 3) the data collection method and the estimated time required, 4) the purpose for which data will be collected, used in secondary research and archived, and 5) 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 1) how data containing identifiers will be protected or have identifiers removed, 2) whether signing a pledge of confidentiality will be required of persons using or processing the personal data, and 3) 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:
1) 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;
2) Data collection does not involve risks to participants;
3) If possible, research subjects will be informed afterwards of the nature and purpose of the research;
4) 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:
1) 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;
2) 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.);
3) 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.