Instructions for requesting a statement

The request for a statement must be submitted to the secretary of the Ethics Committee no later than three weeks before their meeting. The request must be submitted electronically as a single PDF file using the electronic form (please click 'in English' to change the language of the form).

The committee processes all requests and the related documents in strict confidence. Its decisions are not published. The applicants will be informed personally.

More information is available from the secretary of the committee, Research Manager This email address is being protected from spambots. You need JavaScript enabled to view it. or the members of the committee.

When preparing a request for a statement, special attention should be paid to clear and comprehensible expression.  The reviewers do not necessarily represent the same field of science as the applicant. If the application concerns a project that was reviewed earlier and returned with a request to provide more information, the applicant must clearly indicate which parts of the documents have been amended. The amended sections must be listed in a separate cover letter in which the applicant explains how they have responded to the requests for amendments presented by the committee and/or indicate the amended sections on the documents using a highlighter pen, for example.

The request for a statement must be included in a single PDF file and contain the following, numbered documents:

Documents to be included in the request for statement:

 
1. A cover letter providing the following information:

  • The purpose of requesting a statement. Does the request for a statement concern a new study, changes made to the research project or the provision of additional information for an application that was processed earlier?

  • The reason for requesting a statement. According to the guidelines provided by the Finnish Advisory Board on Research Integrity (TENK), an ethical review is always required in certain cases. The reason for requesting a statement can be one of the requirements determined by TENK: www.tenk.fi/en/ethical-review-human-sciences/ethical-review

    The applicant may also provide a reason other than those provided by TENK. These include cases where an external party, such as a provider of funding or a scientific publisher, requires an ethical review of the research project.

  • Name of the research project/plan, date and any version numbers.

  • Name of the contact person for the request for a statement and their contact information. The contact person will be sent a notification specifying whether the application was complete or additional information is needed. The contact person will also be informed about the processing of the request for a statement and about the decision of the Committee on Research Ethics. The person in charge of the research project may also serve as the contact person.

  • Information about the person in charge of the research project: name, contact information, educational background and position/organisation. The person in charge of the research project is the head of the project or the head researcher. They are responsible for ensuring compliance with laws and good scientific practices and for ensuring the safe and competent performance of the research group. They are also responsible for ensuring that competent personnel are available for the research project, along with sufficient equipment and instruments, that the quality of the research is high and that the research project can be carried out safely. In addition, they must ensure compliance with the Personal Data Act (523/1999) and other data privacy regulations and international obligations concerning the status of research subjects, as well as other regulations and guidelines concerning research. An assessment of the ethical aspects related to the research project must be included in the request for a statement. This assessment must be prepared by the person in charge of the research project (see Appendix 2).

  • Operators involved in the project (research centres and higher education institutions and their units/departments and researchers, other units and researchers participating in the project). If the research project is international, the participating countries must be specified on the form as well. A separate appendix can be used for this purpose, if necessary.

  • Estimated start and end date of the research project

  • Establishment and maintenance of a research register. If a research register is established for the project, the application must specify in which unit, department or organisation the register will be kept and maintained. The registrar, the person responsible for preparing the description of the file and the person or organisation responsible for data privacy must also be specified.

  • Research subjects and material and the number of research subjects. If the study concerns a specific group of people, this must be specified. If the study concerns underage people or people residing in an institution (e.g. prison, nursing home), this must always be specifically mentioned. If the study involves people who are not able to independently provide written consent, the consent practices must be described and justified on the application.

    Separate information bulletins, consent documents and other materials must be prepared for underage children and young people and their guardians. The information bulletins and consent documents must be prepared separately for each group of research subjects in popularised form and in line with the developmental stage of the children. In addition to people, the study may concern personal data registers, animals other than test animals, the environment or documents, for example.

  • Information about research finances, the party that ordered the study, the provider of funding, and fees and compensation paid to research subjects. The party that ordered the study must be specified. The provider of funding must be specified as well, if different from the party that ordered the study. The party that ordered the study (sponsor) may be a private individual, a company or an organisation that is responsible for starting, managing and funding the study. In investigator-driven studies, the researcher is usually regarded as the party that ordered the study. The provider of funding must be mentioned even in these cases (e.g. a grant or funding agreement issued by the Academy of Finland, a foundation or a company). In order to assess the ethical standards of the project, the Ethics Committee needs a summary of the budget for the research project. Estimates of the fees to be paid to researchers and research centres must be presented as itemised calculations under this item or as a separate appendix. In addition, any costs incurred by the research subjects and the related compensation must be specified.  13)

  • Insurance. Any insurance policies and insurance coverage for the research subjects must be specified.

  • Date and signature. The request for a statement must be signed and dated by the person in charge of the research project.

2. A research plan (max. 5 pages) and its summaries in Finnish and English (max. 200 words)

The structure of the research plan should comply with the guidelines provided by the Academy of Finland, for example. The research plan must indicate whether the study is part of a more extensive research project or if it involves other sub-studies. Add the date to the document and preferably also the version number (e.g. version 1, version 2).

3. An assessment of the ethical standards of the research project, prepared by the person in charge of the project

The appropriateness of the goals and planning of the research project must be assessed, and its benefits and drawbacks must be compared from the perspectives of the various parties involved in the project. The assessment must also include a statement on any material or emotional harm that research subjects may be subjected to because of the study and on the principles that will be applied to dealing with and treating the research subjects or informants considering the nature of the field. If the study does not abide by the principle of informed consent, the justification for this must be presented in the ethical assessment provided by the person in charge of the research project. As part of the assessment provided by the person in charge of the research project, any special issues related to research ethics that arise from the fact that the study concerns children and young people must also be discussed.

4. An information bulletin for the research subjects (also in English, if needed)

Always include the date on the information bulletin and preferably also the version number (see Item 3). Depending on the research plan, several information bulletins may need to be prepared (e.g. separate ones for research subjects, reference subjects and family members). Separate information bulletins, consent documents and other materials must be prepared for underage children and young people and their guardians. The information bulletins must be prepared separately for each group of research subjects in popularised form and in line with the developmental stage of the children. The language used in the information bulletins must be comprehensible to the research subjects. Special attention must be paid to clarity and readability. 

According to the guidelines provided by TENK, the information provided to the research subjects must cover the following aspects:

  • The researcher in charge of the project and their contact information

  • The research organisation or organisations and the provider of funding

  • The purpose, goal and significance of the study

  • Data collection and research methods (what is required from the research subjects in practice, how much time they are expected to invest in participating in the study, etc.)

  • The rights of the research subjects: the voluntary nature of participation, the right to request additional information about the study and the right to discontinue participation in the study.

  • The purpose of use of the research material, the confidentiality of the material (anonymisation) and archiving for the needs of future studies.

  • If any information provided by the research subjects is combined with register information provided by the authorities, such registers must be specified for the research subjects.

  • The information intended for underage children and young people must be prepared in line with their developmental stage. If the study involves an intervention in the physical integrity of research subjects, the information must be provided in line with the guidelines for medical research as applicable. The guidelines are available at www.tukija.fi/c/document_library/get_file?folderId=18753&name=DLF...  

5. A consent form to be signed by the research subjects (also in English, if needed) and an explanation of providing consent

Always include the date on the consent document and preferably also the version number (see Item 3). Depending on the research plan, several consent documents may need to be prepared (e.g. separate ones for research subjects, reference subjects and family members). The consent documents must be prepared separately for each group of research subjects in popularised form and in line with the developmental stage of the children. The language used in the consent documents must be comprehensible to the research subjects.

An explanation of the selection of research subjects and the practices applied to providing consent:

A description of the selection process for research subjects (e.g. advertisements in newspapers and on bulletin boards, random sampling from a specific register). The procedure for managing calls and visits by and interviews of the people who respond to an advertisement. Include any newspaper and other advertisements in the application.

A description of the practices for securing informed consent from each research subject before implementing any measures included in the study. Informed consent is a process where a research subject confirms of their own volition that they are willing to participate in a specific study after having been provided, verbally and in writing, with sufficient information about all of the aspects of the study that are relevant with regard to their decision to participate. The research subject must have an opportunity to discuss their participation with their family members or close contacts.

6. Other materials to be presented to the research subjects during the study (assessment forms, tests, interview templates, journals, questionnaires, etc.)

7. Material management and information security plan (a plan for processing, storing, using and archiving material)

8. Description of the file form provided by the Data Protection Ombudsman if personally identifiable information is collected during the study. Instructions for filling in the form must also be available.

The form is available in Finnish at: 
www.tietosuoja.fi/fi/index/materiaalia/lomakkeet/rekisteri-jatietosuojaselosteet.html  

9. Any other appendices

Instructions for resubmitting applications
If an applicant amends their application and plan, the committee requests the applicant to clearly indicate the changes:

  • The applicant lists all of the changes in a separate letter of response or cover letter.

  • The applicant also highlights the changes on the application and the plan.

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