Does your research need to be reviewed by Ethics Committee ?

• When is ethical review mandatory and when is it not?
• Alternatives when review is not necessary according to TENK but a funder, publisher, research partner or research subject demands an ethical review.
• How to deal with additions and changes made to a previously reviewed research.
• Studies under the Research Act.

When ethical review is mandatory: the TENK criteria

The researcher (PI or thesis principal supervisor) must request an ethical review statemen from the Ethics Committee if their research involves any of the research designs listed in the TENK guidelines (TENK criteria, see below).

An ethical review statement may also be requested when a funding body, collaborative partner, research object or publisher so requests. In such cases, the first step is to find out from the body in question whether the TENK's description of the ethical review practice in Finland or Ethics Committee's statement on the need for an ethical review is sufficient.

Deviation from the principle of informed consent for participation in research occurs where the participation is not voluntary or the participants are not given sufficient or correct information about the research (if, for example, the nature of the research demands this kind of research design).

When the research deviates from the principle of informed consent, it must be ensured that:

research participants are appropriately informed of the processing of their personal data where the research design so permits
the research is justified and could not be carried out if participants were asked to consent to participating in the research
data collection does not cause damage or harm to participants
the real content and purpose of the study are explained to participants as soon as this is possible in view of the research.

Note: The review of the Ethics Committee is not required for the research of public and published data, registry and documentary data and archive data.

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.

Note: 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.

If a participant under the age of 15 participates without the separate consent of a parent or carer and without a parent or carer being informed, must meet at least one of the following criteria:

The research focuses on issues of which sufficient research information cannot be obtained if the participation of children requires the consent of the parent or carer (e.g. domestic violence, social problems and similar).
The research focuses on issues that minor participants do not themselves want their parents or carers to know about (e.g. drug or alcohol use, sexual orientation and similar).

Note: It must be ensured that the research does not cause harm to the participant and that the minors asked to participate in the research are capable of understanding the topic of the research and what the research requires of them in concrete terms.

Exceptionally strong stimuli for participants may be, for example, data containing violence or pornography which the participants will be shown as part of the research design.

Exceptionally strong stimuli may also be involved in research designs in which the participants are deliberately presented with ideas and data that are completely incompatible with their values.

A risk of causing mental harm that exceeds the limits of normal daily life to the research participants or their family members or others closest to them may arise, for example, if the research is associated with traumatic experiences of research participants or their family members or others closest to them.

Research situations can and may, however, include mental strain and emotional experiences similar to situations of everyday life.

Harm beyond the limits of normal daily life must be assessed on a case-by-case basis, as the limits of normal daily life vary greatly between people.

A threat to the safety of research participants or researchers or their family members or others closest to them may arise, for example, in research into domestic violence or in research conducted in crisis situations or areas.

Data security risks can also form a safety threat, e.g. if the research participants’ personal data is collected and combined from several different sources.

In principle, your study does not need to be reviewed if none of these criteria apply

See the options for ethical review under "Options for ethical review when TENK criteria are not met".
Even if ethical review would not be necessary, research must always follow , For more information on requirements such as informed consent, see these Ethics Committee guidelines: Information sheet for participants, Consent.

If the research contains any of the factors above and the research has not undergone ethical review, this may constitute a violation of research integrity (RI) and, when necessary, it may be resolved through the process of handling allegations of research misconduct.
An ethical review statement cannot be issued retrospectively, i.e. once recruitment of participants is under way.

When no ethical review is needed

When the study does not meet any of the criteria listed above in the TENK guidelines. Even if an ethical review is not required, you must always comply with ethical principles, data protection legislation and request an informed consent from the subjects. See these Ethics Committee guidelines: Information sheet for participants, Consent.
When the study is based on public and published information, register and document data and archived materials. It should be noted that data security risks can also form a safety threat, e.g. if the research participants’ personal data is collected and combined from several different sources. In that case, TENK criterion 6. is met.
When the research complies with the principles of subjects’ autonomy and does not include a risk of mental strain beyond the risks encountered in normal life.
The study of children does not in itself require an ethical review, unless the principle of asking for parental consent or informing the guardian of the study is deviated from, or another TENK criterion is met.
The data collection method (e.g. questionnaire, interview, observation, video observation) or research setting (e.g. intervention research) as such does not determine the need for an ethical review, unless any of the six criteria of TENK is met.

Special cases:

Medical research under the Research Act (Act on Medical Research 984/2021) is assessed by (HYVAKS) (in Finnish).

TENK: If the Human Sciences Ethics Committee considers that the plan under review falls within the scope of the Medical Research Act, it returns the plan to the researcher and communicates its reasons for this. The committee instructs the researcher to contact the secretary of the local medical ethics committee in accordance with the Medical Research Act.

The Medical Research Act and its application

The Committees have jointly agreed on the interpretation of the Medical Research Act from the point of view of which Committee the research falls under.

Medical research means research

1) Involving intervention in the physical or psychological integrity of a person,

AND

2) Aims to increase knowledge about health, causes, symptoms, diagnosis, treatment, prevention or the nature of diseases in general.

Both criteria must be met at the same time in order to constitute medical research as defined by law.

Medical research covered by the Research Act IS NOT:

Register research based on documents only.
Survey and interview research.
Service development and observational studies, quality and process development projects in health care, when they do not interfere with human integrity.
Sport science studies, if the subjects are healthy persons or athletes and the aim is to increase knowledge about performance rather than health.
Taking a blood test, using nutritional supplements or taking a routine muscle biopsy does not in itself make a sport science study medical.
Research that focuses on psychological phenomena (e.g. motivation or interaction) but not on psychological problems or illnesses, unless non-standard research methods are used.
Studies whose impact on the subject's own mental well-being can be assessed by the subject.

Medical research covered by the Research Act IS:

Research on human samples such as blood and tissue samples, including microbiological and chemical research (excluding sports research studying performance development).
Medical research on human germ cells.
Sport science research when the purpose is other than performance or performance enhancement (e.g. health-related research) or when the target population is people who are not fundamentally healthy.
Psychological research where subjects are diagnosed or potentially ill (depression, anxiety).
Psychological research using non-standard research or treatment methods (e.g. new therapies), the effects of which cannot be assessed by the subject when considering taking part in the research.
The JYU Ethics Committee CANNOT give a statement on research subject to the Research Act.

Research that may be covered by the Research Act is:

For example, neuropsychological research on autism or attention deficit disorder may be considered medical research under the Research Act, depending on the situation or research design.
Research in which a diagnosis is made and an intervention is implemented. Research where the subjects are not diagnosed and the subject is able to assess the effect of the intervention is not covered by the Research Act.
The Research Ethics Committee of the Wellbeing Services County issues statements on research projects that are not subject to the Research Act, but where the target group of the research are patients of the hospital district.
The PI’s of projects located in the border area of the Research Act must take particular care when assessing the nature of the research. If necessary, additional experts, previous research project classification practice or research findings on the impact of a similar study on subjects should be used.
If you are not sure whether your study is medical research, please contact the secretary of the Hyvaks Committee: eettinentoimikunta@hyvaks.fi.

Further information:

(984/2021), (in Finnish).
(in Finnish)

What to do if you have received a positive prior review and something is added or changed in your study: experimental design, group of subjects or new researchers, questionnaire or interview.

Send a message to the Committee by e-mail, including

Original statement of the Committee attached
Description of any previous amendment proceedings and their dates
Description of planned amendments
- If the changes are small, describe them in a free-form way
- If the changes are major and affect several points in the research plan: attach the original or the most recent (if previous changes have been discussed) research plan in which you have clearly marked (e.g. in colour) the proposed changes.
An assessment of any risks to participants arising from the amendments and a plan to minimise the risks.
If relevant, e.g. an updated information sheet, privacy notice and consent form.

Send to ethics-committee@jyu.fi

Processing the amendment

The chair and secretary assess the amendments and the risks they may pose to the subjects. Options:
- The amendments do not require further discussion and the study may proceed as planned, subject to the decision of the Chair and Secretary.
- On the basis of the evaluation, it is concluded that the matter requires discussion at the meeting.
The matter will be discussed as an amendment at the committee meeting.
- The Committee may request further clarification or a completely new request for a statement if it considers that the matter is not just an amendment but an independent (sub)study.

Instructions for cases in which the study does not include any of the research settings mentioned in TENK’s guidance (six criteria), but a funder, publisher, research partner or research subject demands an ethical review.

Find out whether the description of the TENK or the Committee's statement on the need for ethical review is sufficient.
Follow the instructions below.
If necessary, contact the Secretary of the Ethics Committee for advice.

Options:

Ask from the Ethics Committee a description of the ethical review practice in Finland recommended by TENK: “If a funding body or publisher requires ethical review for a research which does not require ethical review in Finland and which has not undergone ethical review prior to the commencement of the research, the ethics committee may provide a description of the ethical review practice in Finland instead of issuing a statement.”

Such a description can be given once the study has already started, but it does not take a position on the individual study.

Request a description by e-mail, ethics-committee@jyu.fi
If the aforementioned TENK description is not sufficient for the publisher, you can ask the Ethics Committee for a statement on the need for an ethical review. The statement takes a position on the individual study and is given a register number.

The Committee only evaluates whether any of the six TENK criteria are met. However, this process does not review documents related to informed consent or data protection: please follow the guidance provided by the JYU and seek expert advice if necessary.

Such a statement can be given even if the study has already started.

Please do the following:

- Provide The committee with, for example, a research design or other description showing in sufficient detail the methods used and how informed consent will be implemented. Based on this description, the Committee will assess whether the study design meets any of the criteria for ethical review as defined by the TENK.

- Please indicate the exact title of the study or article and in whose name the statement is to be written.

- Request a statement on the need for an ethical review by e-mail, ethics-committee@jyu.fi
Submit a full statement request, which will be discussed in an Ethics Committee meeting. Please indicate on the request form which publisher or other party is concerned.

The request for a statement must be made before the study starts. The request for a statement is submitted through the Vasara system.

Funders:

The most important funding bodies (the Academy of Finland, EU, foundations) do not require an ethical review of the research plan before submitting a funding application. Once the funding decision has been made, the funders require an ethical review when it is necessary according to the or the Medical Research Act.

TENK description JYU 2023.pdf

JYU Statement on the need for an ethical review 2023.pdf

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