Ethical review in human sciences research

Responsible conduct of research provides that research designs containing given elements must undergo ethical review prior to the commencement of the research. The ethical review must be carried out before data is collected. An ethical review statement cannot be issued afterwards.

• The research design must undergo ethical review, if it contains any of the following elements:
• Participation in the research deviates from the principle of informed consent
• The research involves intervening in the physical integrity of research participants
• The focus of the research is on minors under the age of 15, without separate consent from a parent or carer or without informing a parent or carer in a way that would enable them to prevent the child’s participation in the research
• Research exposes participants to exceptionally strong stimuli
• Research involves a risk of causing mental harm that exceeds the limits of normal daily life to the research participants or their family members or other closest to them
• Conducting the research could involve a threat to the safety of participants or researchers or their family members or others closest to them

If the research design contains any of the elements mentioned above and it has not undergone ethical review, this may constitute a violation of responsible conduct of research.

An ethical review statement may also be requested if a funding body, collaborative partner, research object or publisher requires it. If some of the aforementioned parties require an ethical review statement for a commenced study, the ethics committee may provide a description of the ethical review practice in Finland instead of a review statement.

Ethical review assesses the following elements in the research design:

• Potential risks and harm that may be caused to research participants, their families and the researchers themselves due to the research or its results
• Sufficiency of the information given to the participants about the content of research, their participation in the research and processing of their personal data
• Data management plan containing a description of the processing of personal data throughout the lifespan of the research
• Research participant’s written or electronic consent to participate
• The way in which the consent of participants is requested and documented if written or electronic consent is not used
• The significance of the new information that the research aims to obtain in relation to potential harms and risks

Theses supervisors are responsible for ensuring that their supervees are familiar with ethical principles. However, the writer of the thesis is responsible for the ethicality of the work. If ethical review is necessary, the student / doctoral candidate requests it jointly with the supervisor.

At the bachelor's and master's degree level, however, it is recommended to use research designs which do not require ethical review.

Ethical review is not required for the research of public and published data, registry and documentary data and archive data. It must be noted, however, that also data security risks can form a safety threat, e.g, if the research participants' personal data is collected and combined from several different sources, in which case research of registry data and documentary data must be evaluated.

The use of national registers for research purposes is regulated by:

• EU General Data Protection Regulation
• Data Protection Act
• Act on the Openness of Government Activities

Register-based research that involves delicate information can be conducted if the researcher has been given permission to use the register by the authority controlling it (e.g. National Institute for Health and Welfare, Population Register Centre, Legal Register Centre, Stakes or Ministry of Social Affairs and Health).

Participants’ informed consent or informing the participants about the use of register data are usually not required in research based solely on register data. However, if some of the research data is collected from the participants themselves, the participants must be informed about the use of register data. If the research involves combining data containing delicate information, participants’ informed consent is required.

> The Office of the Data Protection Ombudsman

An ethical review statement may be positive, conditionally positive (requiring changes) or negative (requiring changes).

If the Ethics Committee gives a negative review statement, the research plan must be changed according to the quidance in the statement. The revised research plan must be presented to the committee by filling in a new request for comment form. The researcher must append a cover letter in which the changes to the research plan are explained and described. Additionally, all changes are to be marked clearly in the documents (e.g. different font color, strikethrough).

If the guidance in the statement is not complied with, this may constitute a violation of responsible conduct of research.

If the person who has requested an ethical review statement does not accept the decision by the Ethics Committee, the changes proposed in the statement, the changes proposed before a statement is issued, or the procedure followed in the ethical review process, they may request a statement on the matter from Finnish National Board on Research Integrity (TENK). The right to appeal is also stated in the Ethics Committee’s ethical review statement.

If the researcher wants to request for statement on an ongoing ethical review process from TENK, they must inform the Ethics Committee that they do not accept the changes proposed by the Ethics Committee and do not continue the ethical review process in the Committee. TENK does not issue a statement if the ethical review process of the Ethics Committee is unfinished. The same request cannot be processed in the Ethics Committee and TENK simultaneously.

TENK issues statements on the decisions by the ethics committees, the ethical review statements issued by them, and the procedure followed by them in the ethical review process. TENK may also issue its own statement on the ethicality of the research.

The request must be submitted to TENK within two months of the Ethics Committee’s decision.

Health Care Division issues ethical review statements on non-medical research related to health care.

Humanities and Social Sciences Division issues ethical review statements on research that uses methods in the fields of humanities, social sciences and behavioural sciences.

> Ethical review request form

> Instructions for request for ethical review

All appendices are mandatory. Please include a title in each appendix.

> Instructions for request for ethical review

1. Signature of the thesis supervisor

• Signature of the thesis supervisor

2. Summary of the research plan

3. Research plan

4. Assessment of the ethical nature of the research by the person responsible for the study

5. Documents delivered to the research participants

• Information sheet - template
• Informed consent - template
• Besides the information sheet and informed consent, the Committee requires the following separate appendices:
  • Clarification of the research participant recruitment, meaning how research participants are recruited for the study (e.g. advertisements in newspapers and on noticeboards, random sample from a certain register). At procedure for carrying out the telephone calls/visits/interviews with persons who are in contact through on an advertisement.
  • Clarification of the methods for obtaining the informed consent.
• Other data to be given to research participants
  • Questionnaires, interview outlines etc.

6. Data management plan

7. Data protection statement for scientific research, or justification for why it is not needed

• Data protection statement - template

8. Data protection impact assessment (DPIA), or justification for why it is not needed

• Prior to carrying out an impact assessment, please contact the Data Protection Officer (dpo@utu.fi) to determine whether your study needs an impact assessment
• Data protection impact assessment (DPIA) - template

9. Other possible attachments

An ethical review statement is requested by the person who is in charge of the research and selected by the research team. The person in charge of the research is usually the main researcher of the study or the leader of the research project.
 
Regarding theses, the student / doctoral candidate requests an ethical review statement jointly with the supervisor.

The Ethics Committee for Human Sciences at the University of Turku issues ethical review statements to researchers and research organisations outside of the University of Turku and the wellbeing services county of Southwest Finland (Varha) for a fee.

Fee rates for ethical review:

• Ethical review of a research plan 2,850.00 € (incl. VAT)
• Changes to a research plan 900.00 € (incl. VAT)

For more information, please contact the secretary of the Ethics Committee for Human Sciences.

Term of office: 1 Oct 2022 - 30 Sep 2025

Chair

Professor Sanna Salanterä, Faculty of Medicine

Members

Professor Mari Kangasniemi, Faculty of Medicine
Senior Advisor Hanna Lagström, Faculty of Medicine
Lecturer Jarmo Niemi, Faculty of Science and Engineering
Agricultural Entrepreneur Ilkka Pilpola
Associate Professor Noora Scheinin, Faculty of Medicine
Professor Riitta Suhonen, Faculty of Medicine
Senior Researcher Susanne Uusitalo, Faculty of Humanities, University of Oulu

Expert member 

Lawyer Perttu Tuuppa
petatu@utu.fi
puh. 040 094 4282

Secretaries

Development Specialist Kirsi Klemelä
eettinen@utu.fi 
Tel. +358 50 303 0346

Development Specialist Elina Mäntylä
eettinen@utu.fi 
Tel. +358 50 478 0425

Term of office: 1 Oct 2022 - 30 Sep 2025

Chair

Professor Janne Salminen, Faculty of Law

Members

University Lecturer Mika Koivisto, Faculty of Social Sciences
Professor Leo Lahti, Faculty of Science and Engineering
Professor Eriikka Paavilainen-Mäntymäki, Turku School of Economics
Postdoctoral Researcher Elsa Saarikkomäki, Faculty of Law
University Lecturer Helena Siipi, Faculty of Social Sciences
University Lecturer Riikka Turtiainen, Faculty of Humanities
Professor Marjaana Veermans, Faculty of Education

Expert member

Lawyer Johanna Rauma
johanna.rauma@utu.fi
tel. +358 46 921 5818

Secretaries

Development Specialist Kirsi Klemelä
eettinen@utu.fi 
Tel. +358 50 303 0346

Development Specialist Elina Mäntylä
eettinen@utu.fi 
Tel. +358 50 478 0425

In the Finnish ethical review practice the requirement for an ethical review is not tied to a specific research theme. In order to determine the need for an ethical review, you must assess whether or not your research contains any of the elements specified in TENK’s (2019) guidelines. The decision to request for an ethical review is on the researcher’s own responsibility.

When considering requesting for an ethical review, also take into account that some publishers require an ethics committee’s statement. This may be the case even if the Finnish ethical review practice does not require the research to ethically reviewed. You may request for an ethical review statement also when you assume that your publisher, funding body or partner requires one. However, an ethical review statement cannot be requested once the research has commenced.

There are many factors affecting the duration of the ethical review process, and one simple answer cannot be given. The single most important factor affecting the duration is the quality of the application and the related documents. For the ethical review statement to be issued, the application must receive an approval from the Committee. If the Committee requests you to supplement the application, the approval requires taking into account the Committee’s comments and revising all documents affected. Furthermore, the data protection documents must receive an approval from the lawyers of the Committee before a statement can be issued.

The Ethics Committee for human sciences at the University of Turku monitors its average processing times. The median duration of the process is around 6 to 7 weeks from the time of submitting the application (2 weeks prior to the meeting date). In applications which receive the Committee’s approval without amendment requests at first instance, the median processing time is around 3 to 4 weeks from the time of submitting the application.

The possible amendment requests from the Committee are sent to the applicant by email after the minutes of the Committee’s meeting have been signed. The applicant submits the revised documents using the upload link included in the email. The amendments requested by the committee must be made to all documents affected. The changes made to the documents must be indicated clearly by using e.g. colored fonts and strikethroughs. Furthermore, a separate document listing all changes made must be included in the response.

The ethics committee may present the applicant two kinds of amendment requests. If the needed amendments as minor, the application does not need to be processed in the committee’s meeting again. Instead, the chair of the committee may approve the amendments. In this case, the processing of the made amendments is not tied to the meeting schedule of the committee, and the applicant usually receives the statement soon after the revised documents are submitted. If the needed amendments are significant, the revised application must be processed in the committee’s meeting. In this case, the applicant must submit the revised documents 2 weeks before the next committee’s meeting.

In addition to amendment requests by the ethics committee, the lawyers of the Committee may request the applicant to revise the data protection documents. Typically, the amendment requests concerning data protection are sent to the applicant after the ethics committee has favored the ethical review request. 

When research, which has been given a favorable opinion, changes, it must be considered whether the change requires a reassessment of the ethics of the research. The nature of the change determines whether an evaluation of the ethics of the change is needed. If, in the opinion of the responsible researcher, the change does not affect the ethics of the research, there is no need to apply for a new statement and the committee should not be informed of the change.

A new statement must be applied for if the aspects affecting the ethics of the previously evaluated research change significantly. A new statement must be applied for e.g. if the research plan is changed in such a way that the change may weaken the rights of the research participants or increase the risks, damages or harm caused by the research to communities or other research subjects.

A new statement must also be applied for if a research design, sub-study or data is added to the research plan, which was not mentioned in the original plan and which has an impact on the ethics of the research. On the other hand, changes in the members of the research team or a change in the research schedule are typically not factors that affect the ethics of the research, for which a new statement should be sought.

The new request is made the same way as the original request. In the application, all changes made to original documents must be indicated clearly by using e.g. colored fonts and strikethroughs.

If the 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 you a description of the ethical review practice in Finland instead of issuing a statement.