Ethical review in human sciences research

Ethical review in research serves two purposes: it protects the research subjects and endures the researcher’s legal protection. It is an important part in maintaining the public’s trust in scientific research and researchers.

Ethical review in human sciences

Ethical principles of research with human participants serve as a starting point for ethical review in human sciences. These principles are described in the guidelines for The ethical principles of research with human participants and ethical review in the human sciences in Finland  by Finnish National Board on Research Integrity (TENK).

The guidelines are intended for research designs where ethical review is not regulated separately in the Medical Research Act (488/1999). These research designs include humanities and social sciences, research with human participants in natural sciences and technology, in artistic research, and in some cases also in non-invasive health or medical research. For information on ethical review in medical research, please refer to page Ethical review in medical research. These research designs include humanities and social sciences, research with human participants in natural sciences and technology, in artistic research, and in some cases also in non-invasive health or medical research. For information on ethical review in medical research, please refer to page Ethical review in medical research.

Research designs requiring ethical review

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.

What is assessed in ethical review?

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

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, it is recommended that the student requests it jointly with the supervisor.

Register-based research

Research based solely on register data does not need to undergo ethical review.

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

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.

> Finnish Information Centre for Register Research
> The Office of the Data Protection Ombudsman

Contents of an ethical review statement

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.

Appealing against the statement

If the person who has requested an ethical review statement does not accept the decision or the changes proposed in the statement of the ethics committee, they may request a statement on the matter from Finnish National Board on Research Integrity (TENK). The request must be submitted within two months of the committee’s decision. The opportunity to appeal is also stated in the Ethics Committee’s review statement.

Requesting for an ethical review statement

Request for an ethical review statement must be submitted by e-mail to the secretary of the committee two weeks before the meeting in which you wish to have your research plan reviewed. The request form and the required documents must be merged into a single PDF document.

Secretary of the Ethics Committee for Human Sciences
Development Specialist Kirsi Klemelä
kirsi.klemela@utu.fi

The upcoming meetings of the committee divisions are listed below. Please contact the secretary of the committee, if you need support in determining the committee division in which your research plan is to be reviewed.

Health Care Division, upcoming meetings

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

2019
21 Oct
14 Nov
16 Dec

2020
27 Jan
24 Feb
23 Mar
20 Apr
18 May
15 Jun

Humanities and Social Sciences Division, upcoming meetings

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

2019
22 Oct
13 Nov
17 Dec

2020
28 Jan
25 Feb
24 Mar
21 Apr
19 May

Ethical review request form

The request form is currently being updated.

Please note that the request form contains outdated information according to which the request for an ethical review must include a description of the personal data file if data containing identifiers is collected from the participants. Instead, in compliance with the GDPR the request must contain a data protection statement which can also be used to inform the participants about processing of their personal data in the research. Instructions for preparing a data protection statement can be found in the university intranet.

In addition to the documents mentioned in the request form, a Data Management Plan must be appended to the request. Instructions for preparing a data management plan can be found in the Research Data Guide of the University of Turku.

> Ethical review request form
> Instructions for Ethical review request form

Appendices to the request for an ethical review statement

* mandatory

  • research plan*
  • assessment of the ethicality of the research by the person responsible for the research*
  • information intended to be given to research participants and the possible consent form, as well as other data to be given to participants (e.g. questionnaire, interview outline)*
  • clarification on the proceedings for obtaining the consent
  • justifications for the research, when research subjects are persons unable to give their informed consent
  • clarification on the detailed proceedings in choosing the research subjects
  • other material given to research subjects (e.g. questionnaire, journal)
  • data management plan*
  • data protection statement for scientific research (if data containing identifiers is gathered from participants)*
  • clarification on the funding of the research and on the possible compensations and rewards to be paid to research subjects*
  • other possible attachments

 

Who makes the request for an ethical review?

An ethical review statements 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, it is recommended that the student requests an ethical review statement jointly with the supervisor.

Ethics Committee for Human Sciences at the University of Turku

The Ethics Committee for Human Sciences at the University of Turku issues ethical review statements on the ethics of non-medical research conducted on human subjects. In addition, the committee initiates and upholds discussion on research ethics in the university, and acts as on expert body in problematical situations concerning research ethics, apart from alleged violations of responsible conduct of research.

The committee is divided into two divisions:

  • 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
Health Care Division

Term of office: 1 Oct 2019 - 30 Sep 2022

Chair:
Professor Sanna Salanterä, Faculty of Medicine

Members:
Professor Elina Haavisto, Faculty of Medicine
University Research Fellow Mari Kangasniemi, Faculty of Medicine
Senior Advisor Hanna Lagström, Faculty of Medicine
Assistant Professor Leo Lahti, Faculty of Science and Engineering
Lecturer Jarmo Niemi, Faculty of Science and Engineering
Professor Riitta Suhonen, Faculty of Medicine
University Teacher Susanne Uusitalo, Faculty of Social Sciences

Alternating expert members:
Lawyer Timo Juhola
Lawyer Johanna Linna

Secretary:
Development Specialist Kirsi Klemelä
kirsi.klemela@utu.fi
Tel. +358 50 303 0346

Humanities and Social Sciences Division

Term of office: 1 Oct 2019 - 30 Sep 2022

Chair:
Professor Janne Salminen, Faculty of Law

Members:
Professor Heini Kainulainen, Faculty of Law
University Lecturer Mika Koivisto, Faculty of Social Sciences
Professor Veikko Launis, Faculty of Medicine
Associate Professor Eriikka Paavilainen-Mäntymäki, Turku School of Economics
University Lecturer Helena Siipi, Faculty of Social Sciences
University Lecturer Riikka Turtiainen, Faculty of Humanities
Associate Professor Marjaana Veermans, Faculty of Education

Alternating Expert members:
Lawyer Timo Juhola
Lawyer Johanna Linna

Secretary:
Development Specialist Kirsi Klemelä
kirsi.klemela@utu.fi
Tel. +358 50 303 0346