Ethical review of research on animals

Statements on the ethics of research on animals can be requested from the Research Ethics Committee on Animal Research in the following cases:

• Research on animals (excluding humans). Projects that fall outside the purview of the Act on the Protection of Animals Used for Scientific or Educational Purposes, since they are likely to cause a level of harm lower than that caused by the introduction of a needle to the animals studied.
  • In accordance with the Act on the Protection of Animals Used for Scientific or Educational Purposes, projects that cause harm equivalent to, or higher than, that caused by the introduction of a needle are supervised by the Project Authorisation Board (previously the Animal Experiment Board).
  • However, studies that cause discomfort equal to or larger than a needle prick as part of regular treatment procedures can be reviewed by the Research Ethics Committee on Animal Research.
• Scientifically peer-reviewed research.
  • Statements can also be requested for master’s and doctoral theses. In such cases, applications are to be submitted by the supervisor together with the student or doctoral researcher.
• Projects that are part of research activities carried out by University of Helsinki researchers or students under the auspices of the University.

Surveys

Does the review of my survey fall within the purview of the Research Ethics Committee on Animal Research or the Ethics Review Board in the Humanities and Social and Behavioural Sciences? 

At times, information on animal subjects is collected through surveys targeted at animal owners.  In these cases, the nature of the research is based on both human and animal sciences. For these studies, a single statement from one of the two ethics committees will suffice.

If a survey is used to gather information only on animal subjects and/or if the study includes the examination of animal subjects with other methods (e.g., sample collection, dietary changes, etc.), statements on ethics are to be requested from the Research Ethics Committee on Animal Research.

When the sole purpose of surveys is to gather information pertaining to animal owners (for example, surveys focused on the method of animal treatment, the significance of animals to their owners, etc.), statements are to be requested from the Research Ethics Committee in the Humanities and Social and Behavioural Sciences.

When necessary, the committees will support each other in reviewing the ethics of studies that fall in between these two categories.

When necessary, the committees will provide support in reviewing the ethics of studies that fall in between these two categories. If uncertain of the committee to which your application is to be submitted, please ask for advice from the committee secretary via email. In reviewing study elements related to human subjects, the committees observe the ethics principles of the Finnish National Board on Research Integrity TENK.

Applications for research ethics review statements must be submitted before study implementation.

For special and well-grounded reasons studies can be reviewed retroactively. If a retroactive review is required, please contact the committee secretary in good time for further instructions. 

Requests for statements to be discussed at committee meetings should be submitted to the committee secretary using an electronic form. The request for a statement in its entirety, attachments included, is to be submitted as a single PDF document no later than two weeks before the desired meeting. 

The committee will review the application in the meeting and make a decision to either issue a statement on research ethics or to ask the principal investigator for supplementary information. Ethics review statements or requests for supplementary information will be sent to investigators by email within two weeks of the meeting.

Requests for supplementary information should be answered as soon as possible. Minor supplements to requests for a statement will be reviewed by the chair and secretary of the committee without delay before the next meeting. More substantial supplements demonstrating a change in the experimental setting significant to research ethics will be examined at the next committee meeting.

Language of application

Applications may be written in Finnish, Swedish or English.

Material to be given to animal owners must be drafted in a language that they understand.

Application sections

The following must be submitted as part of the request:

1. Cover letter for the Committee
2. A concise research proposal, including references
3. Principal investigator’s personal assessment of the ethics of the study
4. Information sheet and consent form for the owner of the subject animal
5. Other written material to be given to the animal owner
6. Data protection stetement for scientific research  

Below are more detailed instructions for drafting these sections.

Cover letter for the Committee

The cover letter must contain at least the following details:

• Title of the study
• Study site
• Start and end dates of the study
• Statement applicants and their ties to the University of Helsinki 
• Grounds for the application, such as
  • The funding bodies or cooperation partner requires an ethics review.
  • Research results are to be published in journals that require an ethics review.
  • The researchers wish to obtain a statement from the ethics committee to support their deliberations.

Concise research proposal

The proposal, no longer than three pages, is a concise and clear description of the study.

Abbreviations and field-specific jargon should be avoided in the proposal. The research proposal is scientifically grounded by referring to the most important prior studies supporting the proposal.

A concise research proposal includes at least the following information:

• Background, purpose, objectives and significance of the study.
  • In a drug trial, basic information on the pharmacological properties of the active ingredient (e.g., drug category).
• Research design and methods.
  • Additionally, information on the permits required for the study (parties granting the permits, permit codes and validity).
• Study progress and description of procedures, such as
  • Number of animals and inclusion criteria for sampling (e.g., species/breed, age, health, etc.)
  • Concrete procedures that animals will be subjected to and how they differ from the regular handling and/or treatment practices
  • Number of research or evaluation visits for individual animals
  • Duration of procedures/evaluation/interviews for each individual participant.

Principal investigator's personal assessment of the ethics of the study

In their personal assessment, the principal investigator must consider, among other things, the research data collection method, the study implementation method, the manner in which subject animal owners are provided with information, and the plan for processing and protecting data related to animal owners from the perspective of avoiding risks and damages.

The assessment must weigh up potential negative effects and harm caused by study participation to animals or animal owners in relation to the desired knowledge value of the study and potential benefits for participating animals.

Study ethics can be reviewed also from wider perspectives, for example from the perspective of society or environmental protection.

The assessment must consider and justify at least the following factors:

How will the study observe the 3R principle (Replacement, Reduction, Refinement)? Why will the study be conducted on animals and the species/breed in question? How is the required number of animals justified? How are risks and discomforts caused by the study minimised? Why is the research design in its entirety the best option for obtaining the desired results?

What are the primary inclusion and exclusion criteria for individual animals? Are there special groups, such as newborn, old or sick animals, or rare species, among the study participants?

Should any procedures be conducted on animals, their foreseeable risks, benefits, adverse effects and discomforts must be assessed, for example in comparison with regular treatment visits.

Should any participating animals be put down, relevant criteria must be assessed and justification must be given. Are there alternatives to putting animals down and if there are, why are these not utilised? This item requires special attention when putting down animals is a routine procedure in the research proposal, not only a last resort in emergencies.

If a drug is under study, the safety and efficacy of the drug must be assessed based on information collected so far (describe briefly the results of prior, relevant studies and adverse effects). Also to be verified is whether an advance notification of a clinical trial on a veterinary medicinal product must be submitted to the Finnish Medicines Agency Fimea.

If the investigative product is not medicinal (e.g., food additives), its safety must be assessed on the basis of scientifically peer-reviewed research data collected so far.

If a placebo or control compound is used in the study, its use must be assessed and justified. What risks and adverse effects can lack of treatment cause and how will potential adverse events be handled? This should be considered also in the event animals are used to test a procedure on whose safety and efficacy there is no consensus due to lack of extensive and applicable scientific research.

If personal data will be collected in the study, a description of their processing and protection in the study must be provided. You should familiarise yourself with the University of Helsinki’s data protection guide for researchers and the data protection statement for scientific research (link to the Flamma intranet, requires login with University credentials). The possibility of individuals being seen and heard in video and audio recordings must also be taken into consideration.

Have animal owners been provided with appropriate information before giving their consent? If animals or their owners are hurt in connection with the study for one reason or another, who will pay compensation? Have insurance policies been taken?

Information sheet and consent form for the owner of the subject animal

The information sheet should include all relevant information about the study that the subject animal owner needs to give informed consent for participation.

The following study details will be described in a concrete manner and in layman's terms:

• Names of the person in charge of the study, the background organisation and the funding body
• Funding bodies and cooperation partners, including their role in the study
• Name and telephone number of the contact person (when necessary, also outside office hours) for further information, adverse events and emergencies
• Topic, purpose and objective of the study, as well as its significance in the specific field
• Study site, study dates, duration and type (one-time or follow-up study)
• Approximate total number of subject animals, and primary inclusion and exclusion criteria
• Research data to be collected (e.g., observations, samples, measurements, photographs, tests, surveys)
• Effects of study participation on the everyday life of the animal and its owner (observation, special diets, physical activity and other effects) and what is expected of the participants
• Potential benefits or discomforts caused to the animal’s health by study participation and their likelihood (for example, compared with regular equivalent treatment procedures)
• The manner in which study risks have been minimised and preparations made in case risks are realised
• Procedures to be followed if adverse effects occur
• Purpose for using the research data (including scholarly publishing and popular communication)
• Method of ensuring the confidentiality of personal data (for example, by anonymisation)
• Handling of data collected up to the point of discontinuing study participation, should that occur
• Will the data and/or leftover samples be archived for the purposes of further research or teaching, and where?
• Any compensation for participation or cost reimbursements/price reductions offered to participants

As a rule, the consent form is no more than one page in length, but it should contain a summary of all relevant elements for which written consent is required: 

• Title of the study, those involved in the study, name of the researcher and the principal investigator, name of the animal’s owner, name of the animal and any other necessary identifying general description (e.g., species, breed, age, gender), name of the person who provides information orally to the animal's owner, place, date and signatures
• Expression of consent for study participation
• Notification that the owner was provided with a description of the study in accordance with the information sheet both orally and in writing, as well as with an opportunity to ask questions and receive answers to them
• Notification that the owner has familiarised themselves with the data protection statement (if personal data are processed in the study)
• The voluntary nature of study participation, the participant’s right to ask further information about the study and the right to discontinue participation without stating the cause and without any repercussions at any stage of the study. The consent form should indicate that any samples and data collected in the period between giving and withdrawing consent will remain available to researchers.

Other material given to the animal owner

• Survey forms
• Interview structure/themes
• Instructions and descriptions on, for example, diets or devices to be used during the study.

Data protection statement for scientific research  

Even in research on animals, personal data are processed in almost all studies. Such data include any data that can be linked, either directly or indirectly, to a certain identifiable individual. Personal data include the name and contact details of the animal’s owner or, for example, video and audio recordings where people appear in addition to animals.

The purpose of data protection statements is to describe the processing of personal data of individuals who can be identified from the study data or related documents. Such individuals can include the owners of study animals, suppliers of tissue specimens collected from wildlife by invasive means or individuals who appear in recordings related to the study.

When personal data are processed in the study, familiarise yourself with the data protection guide for researchers of the University of Helsinki and the data protection statement for scientific research (link to the Flamma intranet, requires login with University credentials), complete the data protection statement, and attach it to the end of the request for a statement.