The preliminary ethical review is the evaluation of a research plan by a separate ethical review committee in accordance with the ethical practices of each branch of science. The ethical review is particularly concerned with the potential harm or damage caused by participation or the results to the subjects compared to the value of the data being sought by the research.

An approved committee review is a mandatory requirement for all medical research. There is no statutory preliminary ethicalreview in Finland for humanities, sociological or behavioural science research.

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Preliminary ethical review for medical research

The Medical Research Act (488/1999) stipulates that before medical research is begun, the research plan must be approved by an ethical review committee.

Ethical review committees give statements on the ethical nature of research

Clinical pharmaceutical research requires a decision from TUKIJA on whether they will assess the research plan themselves or transfer the task to a regional ethical review committee. The preliminary ethical review of other medical research, including the final statement, are the responsibility of the regional ethical review committee in whose area the person in charge of the research is operating in, or in whose area the main body of the research is to be carried out. The regional ethical review committees work in conjunction with the hospital districts.

The statement of TUKIJA or an ethical review committee is final and cannot be appealed. A new statement may be requested if alterations and corrections are made to the research plan based on a statement of rejection. If a regional ethical review committee rejects a research plan and the applicant resubmits it without changing the content, the ethical review committee must request a statement from TUKIJA.

According to section 3 of the Medical Research Act, the ethical review committee must be informed of changes to the research plan, the research declaration or the product being researched if the changes may affect the safety of the research subjects, the alteration has a bearing on the interpretation of the scientific documents used in support of the research, or where the alteration is otherwise considerable. Notice and grounds must also be given to the ethical review committee if the research is not begun or if it is discontinued.

In clinical pharmaceutical research, the Finnish Medicines Agency Fimea must also be notified of changes to the research plan, in addition to the ethical review committee. The guidelines of the European Commission on clinical pharmaceutical research must be taken into account when evaluating the significance of changes in clinical pharmaceutical research.

The ethical review committees assist in questions of research ethics

TENK promotes good scientific practice and the observing of ethical research principles. Ethical instructions for research and related statements are also issued by the Finnish National Advisory Board on Social Welfare and Health Care Ethics (ETENE), who focus on the ethical questions related to the health and welfare sector and the position of patients and customers.

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Preliminary ethical review for other human sciences

The statutory requirement for a preliminary ethical review only applies to medical research. A review is recommended, however, when individual-level health and welfare data is used in the research. Very often a party like a sponsor, international partner, publication forum or the party managing the health and welfare data may also require a preliminary ethical review for the research.

The ethical review committee of the researcher’s organisation assesses the ethical acceptability of the research

The preliminary ethical reviews in human sciences are the responsibility of the ethical review committees of the researcher’s organisation, i.e. their university or research institute. It is recommended for researchers to undertake a preliminary ethical review if their research includes one of the following arrangements:

1
The research interferes with the bodily integrity of the subjects.
2
The research deviates from the principle of informed consent (the review is not required for studying public and published data, registers, documents, and archive data).
3
The research targets persons below the age of 15 without separate consent from or notice to their guardian, which would allow the guardian to prohibit the child from participating in the research, and the research is not part of the normal operations of an early childhood education organisation or school.
4
The research exposes the subjects to exceptionally strong stimuli that require expert opinion to assess their potential harm (e.g. research involving violence or pornography).
5
The research poses a risk of long-term mental detriment to the subjects that exceeds the limits of normal everyday life (trauma, depression, insomnia).
6
The research may pose a threat to the subjects’ safety and security (e.g. research on domestic violence).

A preliminary ethical review can also be requested from an ethical review committee when a research sponsor or partner requires one, or the results are to be published in a scientific publication that requires the review. For example, the instructions of the Academy of Finland state that it is sufficient to deliver the statement after a positive funding decision has been made.

The risk and harm to the subjects are to be minimised

The preliminary ethical review is based on the guidelines of TENK. Ethical instructions for research and related statements are also issued by ETENE, who focus on the ethical questions related to the health and welfare sector and the position of patients and customers.

Nearly all the universities, research institutes and archives operating in Finland in the humanities, sociology and behavioural science are committed to the TENK guidelines of ethical research for those fields. This is a voluntary commitment and includes an obligation to arrange preliminary ethical reviews according to the principles advocated by TENK.

The preliminary ethical review assesses the data collection plan, the execution methods of the research, the way subjects are informed, and the plan for data handling and storage. The review is particularly concerned with the potential harm or damage caused by participation to the subjects compared to the value of the data being sought by the research. The aim is to ensure that the research is free of unnecessary risks and damage potential that can be avoided without reducing the scientific value of the research.

The premise for preparing the statement request and the assessment of the research’s potential harm and risks are the ethical principles of human sciences on avoiding harm, respecting self-determination, and ensuring privacy and data protection. More detailed ethical guidelines of the field of research will be applied as necessary. For example, psychology and commercial sciences have their own ethical standards. Furthermore, the research institutes maintaining statutory registers have ethical guidelines for the use of the registers’ data.

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