Ethical review of research on humans

The University of Helsinki has two committees reviewing the ethics of non-medical research on humans: the Research Ethics Committee in the Humanities and Social and Behavioural Sciences and the Research Ethics Committee of the Faculty of Medicine. This website provides basic information on the committee duties and operations as well as instructions for requesting a committee statement.

Both committees review research falling outside the scope of the Medical Research Act (488/1999).

The committees review research on humans. This includes not only studies in the humanities and social sciences, but also, for example, natural scientific and engineering research focused on humans, research conducted using the methodology of the humanities or social or behavioural sciences, and non-invasive medical and health research on humans. The committees comply with the ethical principles of research with human participants and ethical review in the human sciences in Finland, as outlined by the Finnish National Board on Research Integrity.

In medical research, the researcher must request a statutory statement from the ethics committee of the hospital district in which the person responsible for the research is working or in whose area the research will primarily be conducted, or from the National Committee on Medical Research Ethics. One ethics committee operates in the HUS Specific Catchment Area.  

By law, medical research requires a favourable opinion from a research ethics committee. In the humanities and behavioural and social sciences, researchers must request a statement from an ethics committee if their research design requires ethical review, as defined by the Finnish National Board on Research Integrity.

Which committee will consider my statement request?

The committee reviewing a research project is determined on the basis of the research design and questions, and the field of the researcher and their project. If the project clearly falls within the scope of the humanities or social or behavioural sciences, it is reviewed by the Research Ethics Committee in the Humanities and Social and Behavioural Sciences, regardless of the faculty involved. If the project addresses health behaviour, diagnostic disorders or diseases, or clinical teaching or practices, it is reviewed by the Research Ethics Committee of the Faculty of Medicine. 

In multidisciplinary projects applying methods relevant to the purview of both committees, the committee is selected based on the project’s primary discipline or method. In such projects, the person requesting a statement must contact the committee secretary at least two weeks before submitting their request. 

If you have any questions, contact the committee secretaries by email. Please contact the secretaries only via the service email eettinen-toimikunta@helsinki.fi.

Does an ethics statement constitute a research permit?

The University of Helsinki’s research ethics committees issue statements on research ethics. This type of statement is not a research permit, nor does it transfer the researcher’s responsibility for the ethics of their research to the committee.

The actual permit is usually provided by the subject organisation, that is, the unit in which the research data are collected or the research is otherwise carried out in practice. In contrast, consent to participate in research is given by individual research subjects. 

Instructions for statement requests

The University committees reviewing research ethics must be contacted to obtain a statement on the ethics of a planned research project, regardless of its field, if the project fulfils the conditions for research design set out by the Finnish National Board on Research Integrity

  • 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. 
  • The research exposes participants to exceptionally strong stimuli. 
  • The 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 others closest to them. 
  • Conducting the research could involve a threat to the safety of participants or their family members or others closest to them. 

In addition, researchers can request a statement from an ethics committee if  

  • It is required by the research topic, funder or collaboration partner 
  • The plan is to publish the research results in a scholarly journal requiring an ethical review 

 

Ethics committees do not review the protection of privacy in research publications. Such review is the responsibility of the researchers themselves and the relevant editorial boards. 

The committees base their statements on the following required documents: 

  1. Cover letter 
    The cover letter presents the grounds for requesting a statement and includes both the contact details of the person responsible for the research and their signature. When the applicant is a doctoral researcher, their supervisor serves as the principal investigator. The cover letter must also include a list of all researchers participating in the project so that the committee members can comment on their potential disqualification before proceedings begin. 
  2. Grounds for requesting an ethical review statement 
    Click here to download the form Grounds for requesting an ethical review statement. 
  3. Research plan (max. 6 pages) 
    For English-language research, submit the abstract in Finnish or Swedish. 
  4. Assessment of the ethics of the study by the person responsible for it 

The ethics assessment outlines the risks and ethical issues involving the study and explains how these are taken into account. Doctoral researchers write the ethics assessment together with their supervisor. They and students pursuing advanced studies must also submit their supervisor’s supporting statement for the request. 

  1. Information sheet for research subjects 
    If the study deviates from the principle of informed consent, the grounds for conducting such a study must be presented in the assessment of the ethics of the study. 
  2. Consent form to be signed by research subjects 
    A consent form is required to supplement the information sheet for research subjects if the analysed research data includes identifying or sensitive information. Read more about personal data, identifiers and other research data protection on Flamma. 
  3. Other material submitted to the research subjects 
    For example, an interview framework, journals and questionnaires 
  4. Data management plan 
    A data processing, storing and archiving plan 
  5. Data protection notice for scientific research 
    This notice is required if the research involves collecting any personal data or if identification is possible, for example, by combining data. Read more about personal data, identifiers and other research data protection on Flamma. 

Statement requests must contain all the above documents submitted as a single PDF file. Separately submitted documents will not be considered. 

Please note before drawing up a request for a statement

Each study to be reviewed must be part of the University of Helsinki’s research activities. The principal investigator or another researcher responsible for the study or the relevant study component must be employed by the University of Helsinki. Sufficient affiliations also include project funding, a grant or a visiting principal investigator’s contract at the University of Helsinki for the duration of the project. 

The committees do not review studies that have already commenced. 

If your study falls outside the remit of the research designs requiring an ethical review according to the guidelines of the Finnish National Board on Research Integrity, first find out whether a description of the Finnish system suffices for the publisher. Such a description is available upon request from the committee secretary. 

Doctoral researchers must discuss the necessity of an ethical review with their supervisor. If the review is necessary, it must be requested together with the supervisor. 

As a rule, the committee does not consider master’s theses. According to the 2019 proposal for ethical reviews by the National Advisory Board on Research Ethics (now the Finnish National Board on Research Integrity), the guidelines for ethical reviews are intended to cover postgraduate research. At the undergraduate stage, thesis supervisors are responsible for ensuring that thesis work complies with ethical principles. It is recommended that theses not use research designs requiring an ethical review. 

Publishing part of the results of research as a master’s thesis does not preclude requesting an ethical review, but the request should primarily be submitted by the supervisor.  

If considering a review request for a master’s thesis, the supervisor must contact the committee secretary in advance. 

If you have any questions, contact the committee secretaries.

The researcher must describe potential harm and risks so that the ethics committee can evaluate whether the study is ethical, weighing possible risks to the research subjects against the intended scholarly value of the study. 

Studies must be conducted so as to minimise any harm and risks to participants. 

The intended scholarly value will be weighed against any potential harm and the measures taken to reduce harm to the participants during or after the study (physical and mental harm) or to prevent them altogether. The review must take into account the free will and autonomy of the participants. To a certain degree, the participants can always independently assess the risks associated with participating in a study. 

When reviewing experimental studies, the ethical guidelines in the particular field can be applied in a supplementary manner. A researcher can also request an ethical review if the research topic, funding agency or cooperation partner so wishes or if the results are to be published in a scholarly journal which requires ethical review. 

Ethics committees do not review the protection of privacy in research publications. The ethical review of publications is the responsibility of the researchers themselves and the publication editorial boards.  

In their studies, researchers must consider data protection and information security. A preliminary data protection assessment and an impact assessment, if relevant, must be completed before submitting the statement request, and the assessment results must be described in it. University of Helsinki researchers can log in to Flamma to read instructions for data protection and information security

When designing consent forms and questionnaires, a number of aspects should be taken into consideration prior to requesting an ethical review, as they may affect the research subjects’ understanding of and attitude to the study. 

When designing forms for research subjects, note the following. 

Clarity and intelligibility

The information sheet and consent form must be written so that the target group can understand them. 

When studying children, it is important to plan how the research can be described to them intelligibly and appropriately for their developmental level. 

Information sheets and consent forms aimed at laypersons should avoid complex discipline-specific terminology and jargon. 

Language

Information sheets and consent forms must be written in the respondents’ first language or a language they understand well. 

Within the resources of the study, the translation of questionnaires should be considered to enable the participation of linguistic minorities. 

For example, it is recommended that in national surveys based on random samples the questionnaire be translated into Swedish. In addition, the language used in forms should be clear and grammatically correct. 

Gender- and status-neutral language

Depending on the research topic and target group, it may be necessary to consider whether a group of respondents is unintentionally excluded because of the language used in forms.  

For example, if studying families or family diversity, it is necessary to include other alternatives for the background variables of ‘men’ and ‘woman’ or ‘father’ and ‘mother’, such as ‘other’ or ‘other parent or adult carer’. 

Sensitive questions

The cover letter should be carefully formulated to ensure that the recipient is prepared for any sensitive questions from the researcher. 

Attention should also be paid to the content of the background variables and questions on the form, the options provided for potential responses and the accuracy of measurements. 

For example, is the collection of details on a specific sensitive matter really necessary? 

Collection of unnecessary data

Questionnaires and consent forms should not contain irrelevant questions posed ‘just in case’. 

Data protection

Forms must be designed so that the respondents need not worry about the misuse of the information they submit. 

For example, identification markers printed on the form may raise suspicion. When asking for background data, it is advisable to mention that such data are collected for statistical purposes. 

Respect for others

When drafting information sheets and forms, use polite, respectful language. Depending on the target group, the manner of addressing the recipients may well serve as a sign of respect for them. 

Further information in Finnish about designing forms

Harinen, Päivi. 2009. Tarkastelussa taustamuuttujat. Yhteiskuntapolitiikka 74:3, 338–340. 

Finnish Social Science Data Archive: Kyselylomakkeen laatiminen (‘Designing a questionnaire’) 

The checklist below was created to support researchers in business collaboration. The purpose is to help researchers give due consideration to the perspective of research ethics. 

Researchers are responsible for ensuring that research ethics principles are taken into account in collaborative work, as partner companies may not have the necessary competence in research ethics. 

Researchers should prepare to describe the thinking and principles behind research ethics to companies. 

The guidelines below have been drafted collaboratively by the University’s research ethics advisors and legal counsels for research affairs. 

Questions of ethics

Ethical review

Does the conduct of research require ethical review? 

Researchers are responsible for ensuring that, if necessary, a statement is requested from a research ethics committee. 

Ethics guidelines and principles

Has the research group and the company scrutinised the following guidelines and principles and agreed to comply with them? 

  • Responsible conduct of research and procedures for handling allegations of misconduct in Finland (Finnish National Board on Research Integrity: RCR guidelines 2012, PDF) 
  • Ethical principles of research with human participants and ethical review in the human sciences in Finland (Finnish National Board on Research Integrity 2019)  
  • Ethical principles of business collaboration at the University of Helsinki 

In addition, find out how the University of Helsinki’s name and logo can be used. 

We recommend that you also read the following documents containing guidelines in support of business collaboration: 

  • European Code of Conduct for Research Integrity 
  • Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations 
Conflicts of interest between researchers and companies

Have potential conflicts of interest between the researcher and company been examined? If any have been identified, has the University been notified? 

Conflicts of interest relevant to research must be notified to the legal counsels for research affairs in accordance with the instructions on Flamma. 

Content and nature of collaboration

Does the collaboration relate to product development, scholarly research, or both? 

The scholarly contribution to the collaboration must be demonstrable, unless it has been agreed with the company that the collaboration involves no research. 

Owning, using and publishing research results
  • Have the research results and how the parties can use them been defined, and has the owner of the results been determined? 

In accordance with the University of Helsinki ethical principles for business collaboration, collaborative research conducted even partially with public funds must take into account that the University cannot use budget funding from the government or other public funds to support companies. Consequently, companies cannot obtain exclusive rights to the results of such research, but rather the results must be published and utilised according to the funding terms and the University's principles. 

As noted in the Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations: “Agreements that unduly or unnecessarily restrict dissemination of data, findings or other research products should be avoided.” 

  • Have the collaboration partners agreed how the results will be published? 

As a rule, the University (the research group) should retain the power of decision over scholarly publishing. It is a good idea to agree at the outset of the writing process on the contributors to scholarly publications and their input (Montreal Statement). 

In addition, ALLEA’s European Code of Conduct for Research Integrity notes: 

“Authors and publishers consider negative results to be as valid as positive findings for publication and dissemination.” 

Data management
  • Has an appropriate data management plan been devised for the project? 

If data are to be transferred to a company, the partners must agree how the transfer and management of data can be implemented without compromising the research subjects’ data and privacy protection. 

Unless separately agreed, non-anonymised data should not be transferred outside the University or research group. It must also be ensured that no personal data are transferred to a company without the relevant individual’s consent. 

Moreover, the partners should agree what will be done if a research subject wishes to withdraw from the study. At what stage is it possible to remove the collected data without undue effort, and after what stage is this no longer possible?  

Read more about good data management practices and services. 

Read also the data protection guide for researchers (Flamma link, requires log in). 

Research participation from the research subject’s perspective

Has the amount of compensation paid to research subjects been defined, and does it ensure that their participation is voluntary or does it add to the pressure to participate? 

The costs of research subjects can always be reimbursed, and they can be compensated for their time and effort either monetarily or with an equivalent product or service. When deciding on the amount and method of compensation, follow the instructions of the University’s Financial Services on compensating research subjects. See Flamma for the instructions.   

Research designs and the contribution required of research subjects vary widely according to study. If the compensation paid is high, subjects typically feel pressured to participate. 

It is the researcher’s duty to ensure that this does not happen. For example, when determining the compensation provided to groups, the researcher must consider whether it leads to peer pressure to participate in the research. 

Sponsoring a group and compensating it for its research participation should be clearly differentiated so that no one feels pressured to participate. 

Is the selection of participant groups recruited for the study ethically justified? Who benefits from the research? 

The selection of participant groups and their size can affect the research results. When studying, for example, new products or services, the conduct of research may be guided by the goal of achieving as positive results as possible. This may lead to bias in the selection of the participant groups. 

At the same time, it is important to consider how the benefits of the study are distributed. They should be distributed as fairly as possible. The researcher should consider whether it is more justified to conduct the research with groups that are privileged to begin with, or whether it is possible to recruit respondents or respondent groups whose participation could increase equality. 

Have the risks been assessed from the perspective of the research subject? Can the research harm or damage research subjects? Have the risks been minimised? 

While the researcher is responsible for assessing the research impact from the subjects’ perspective, the company has information on the product or service. The assessment of any risks and damage must be done collaboratively. 

Discuss openly

The Montreal Statement underlines the importance of discussion: 

“Diversity of perspectives, expertise and methods, and differences in customary practices, standards and assumptions that could compromise the integrity of the research should be addressed openly.” 

Legal and other contractual and administrative matters 

The researcher’s relationship with the University
  • Is the researcher responsible for the research employed by the University of Helsinki? 
Drafting a research agreement
  • Has a research agreement been signed with the company? 

All business collaboration agreements are concluded in writing. The University’s legal counsels have drafted templates for this purpose. 

As the templates are always general in nature and provide only a preliminary overview of the University’s policies, they must be edited to fit each individual case. 

To assess the suitability of and need to amend or supplement the templates, always contact a legal counsel responsible for research matters. The research plan must be completed before agreement negotiations begin. 

Dividing and defining responsibilities

Have the University’s and the company’s respective responsibilities (e.g., tasks, risks, damage, funding) been clearly agreed with the company? 

The University’s responsibilities must be limited in the agreement, as approved by the University’s legal counsel. 

Tasks refer to the actual research, usually agreed on in the research plan for which the researcher is responsible. 

Pay close attention to the language and expressions used. Problems may arise if research plans associated with agreements are written, for example, in the passive voice (e.g., it will be implemented, it will be investigated) rather than clearly dividing the parties’ duties. 

Legal counsels for research should review any risks and damage from a legal perspective (e.g., limiting responsibilities and setting a liability cap within the law). 

Research-related risks and damage must be reviewed by the researchers. 

Depending on the project type, either a project accountant or a controller helps researchers in budgeting. The legal counsels for research affairs address only clearly problematic issues (e.g., if the University is responsible for 80% of the costs in a €100,000 project, but the results are divided on a 50/50 basis). 

Scheduling research

Does the agreement indicate the date of commencement of the study or commission? Has its date of completion been defined clearly (e.g., a specific date or specific results)? 

Matters of scheduling are often highlighted in the research plan and are the researcher’s responsibility. 

Payments

If financial transactions are made between the company and the University, have the payment schedule and the amounts to be paid to the University been clearly defined? 

Legal counsels for research affairs address only clearly problematic issues (e.g., if the commissioning party pays for everything only after the commissioned research). The counsels have drafted a template agreement for commissioned research, including a proposed payment schedule. 

Contact information

Have the official contact details of the collaboration partners been verified from the Business Information System

Communication within the University

Has the principal investigator contacted the necessary persons within the University (a controller or project accountant, a legal counsel, a department director or dean)? 

Signing an undertaking on the transfer of rights

Have all the persons participating in the project on behalf of the University of Helsinki signed the University’s undertaking on the transfer of rights? 

This undertaking must be signed whenever at least one other party in addition to the University is involved in implementing the project, or when the University receives external funding to implement it. 

With this undertaking, the researcher transfers the rights to all the research results to the University of Helsinki. The undertaking is required to ensure the University can fulfil its obligations in the project to both collaboration partners and external research funders. 

University of Helsinki researchers can access further information and instructions on concluding agreements on the Flamma intranet (requires login). 

Request a statement

Submit your request for a statement as a single PDF document at least two weeks before the relevant meeting.  

To ensure the in-depth consideration of each statement request, the committees have limited the number of requests per meeting to 12. If more requests are submitted, the ones arriving last will be postponed to the next meeting. Remember to allow plenty of time for writing the request and having it processed. 

Submit your statement request on this form. 

Meeting schedules

If you wish for your statement request to be considered at a specific meeting, submit it as a single PDF document at least two weeks before the meeting. Submit your statement request on this form. 

Late requests will be processed in the following meeting. 

If the committee finds that the research complies with the ethics principles for research on humans, it will send the statement to the requester within two weeks of the meeting in which the request was considered. Usually, the committee first sends suggestions for revisions and amendments to the research plan. Once these have been made and accepted, the committee sends the statement to the requester.

The Ethics Committee in the Humanities and Social and Behavioural Sciences meetings scheduled for spring and autumn terms 2024 are as follows:

  • January 17, 2024
  • February 12, 2024
  • March 11, 2024
  • April 17, 2024
  • May 15, 2024
  • June 12, 2024
  • Summer break in July.
  • August 19, 2024
  • September 19, 2024
  • October 16, 2024
  • November 13, 2024
  • December 11, 2024

The Research Ethics Committee of the Faculty of Medicine meetings scheduled for spring are as follows:

  • January 30, 2024
  • February 27, 2024
  • March 19, 2024
  • April 30, 2024
  • May 28, 2024
  • June 18, 2024
  • Summer break in July.
  • The meeting schedule for autumn term will be published later on this page.

If you wish for your statement request to be considered at a specific meeting, submit it as a single PDF document at least two weeks before the meeting. Submit your statement request on this form.

Late requests will be processed in the following meeting.

If the committee finds that the research complies with the ethics principles for research on humans, it will send the statement to the requester within two weeks of the meeting in which the request was considered. Usually, the committee first sends suggestions for revisions and amendments to the research plan. Once these have been made and accepted, the committee sends the statement to the requester.

Committee members during the 2022–2025 term

Chair

University Lecturer Karoliina Snell

Secretary

Senior Advisor (Research Services) Heikki J. Koskinen, PhD. 
Senior Advisor (Research Services) Heidi Haggren

Contact by email! Please note that all enquiries must be sent to the Ethics Committee's service address.

Members (deputy member in parenthesis)

  • University Lecturer Heli Korkka-Knuts (Postdoctoral Researcher Jaakko Taipale)
  • Research Director Krister Lindén (University Lecturer Simo Kyllönen)
  • University Lecturer Viljami Salmela (University Lecturer Aino Saarinen)
  • Associate professor Mats Bergman (Associate professor Kris Clarke)
  • University Lecturer Laila Seppä (Professor Mikael Fogelholm)
  • University Lecturer Annukka Pursi (University Lecturer Saila Poulter)
  • Professor Auli Vähäkangas (University Lecturer Teemu Pauha)
  • Doctoral Candidate Jenna Sorjonen (Doctoral Candidate Esko Yli-Hemminki)

A data protection specialist participates in the board meetings.

Chair

Professor Antti Sajantila

Vice chair

University Instructor Aleksi Pajunen

Secretary

Senior Advisor (Research Services) Mila Hyytinen, PhD.

Members

  • University Lecturer Aura Heimonen
  • Clinical Instructor Mika Laitinen
  • Professor Samuli Ripatti
  • Professor Ossi Rahkonen
  • Clinical Instructor Petteri Arstila
  • University Researcher Paula Virtala
  • PhD Jukka Reivinen, lay member
  • Doctoral Researcher Anne-Marie Vartti (deputy member: Niklas Mäkelä)
See also