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This is not a mandatory annex:

• If you wish to attach a summary to your request, the maximum length is one page.

Contents:

• Clear and easy-to-read description of the research in Finnish or English, depending on the language of the research plan
• Avoid abbreviations and special terminology
• Refer to most important prior studies that support the research plan
• The summary includes the list of contents of the research plan

If you already have a research plan summary made for some other purpose, you can attach it to your statement request as such.

General guidelines:

• The research plan is drawn up in such a way that it includes the elements and clarifications necessary for an ethical review.
• Make use of the table of contents below and the instructions provided by the links.
• Exception: you can use the research plan you have already prepared for other purposes (e.g. for a funding application), but make sure that all the issues required in the request for a statement are covered. The structure and subheadings do not need to be as described below.
• There is no need to repeat everything in different documents: you can refer to other annexes where the issue is described. Make sure that there are no contradictory descriptions of the same issue in different documents.
• Please note the risk of harm assessment for theses: the thesis author makes the assessment in the research design (section 2.5), but the supervisor prepares Annex 3 in its entirety.

The research plan shall include the following subpoints:

Make subheadings for the research plan according to these subheadings.

2.1 Background, objective and significance of research

Describe here the background, purpose and significance of the study in the same way as in the funding proposals, for example.

Describe in this chapter the composition, affiliations and roles of the research team.

2.2  Research design and methods used

Describe here the research design, protocol and methods used in the same way as in the funding proposals, for example.

2.3 Recruitment of participants and informed consent procedure

Describe here:

• Persons or groups of persons invited to be investigated for research: quantity, age range, entry and exclusion criteria.
• How are the subjects identified?
• How and who assesses the take-in and exclusion criteria?
• What procedures will be used to contact the participants? For example, where the study is notified, how to contact the participants (the first contact).
• Describe as concretely as possible how you get in contact with the participants, how they express their interest (etc.)
• Mention the source of the contact information of the potential participants.
• At what stage will the participants be informed of the study and consents (precise procedure) will be sought?

2.4 Conduct of the study and  description of methods

• Describe how the data will be collected and justify the choice of methods in terms of answering the research question. 
• From an ethical point of view, unnecessary procedures or unnecessarily extensive data collection from subjects should be avoided. 
• Where a study involves interference with the physical integrity of the subjects, the design of the study must follow the guidelines issued under the Medical Research Act, where applicable.

The research process described in this chapter will be used in the content of the information sheet / research notification: the content must be consistent, but the information sheet will describe the research process in language that is easy to understand.  Avoid contradictions between annexes.

How the Ethics Committee will assess the description of the conduct of the study and the methods

• Is the conduct of the study designed to avoid unnecessary risks or harm to subjects.

• The committee will assess the questions to be asked in the questionnaires from the point of view of whether they are likely to cause discomfort or more serious distress to the participants, i.e. whether the principle of avoiding harm is respected.

2.5 Assessment of potential risks and harms 

The Ethics Committee will pay particular attention to this issue.

The issues described here overlap with Annex 3 (PI's Ethical Assessment), so the PI is advised to provide a comprehensive description in one section of the request and refer to it in other annexes to avoid conflicts between annexes. 

Note, however, that for thesis, the assessment of risks and harms is carried out in such a way that the PI makes the assessment in the research design (section 2.5), but the supervisor completes Appendix 3 in its entirety.

This section of the research plan describes the potential risks and harm to participants, their families or the researcher themselves as well as the damage resulting from participation in the research in relation to their likelihood in relation to the plans drawn up to avoid them.

The description of potential risks and plans to avoid them can be used to prepare the information of the research subjects, i.e. to the information sheet.

How are the above-mentioned risks assessed in the ethical review

According to TENK (2019, p. 19), the Ethics Committee assesses whether the study has the following
risks:

1. Participation in the research deviates from the principle of informed consent.
2. The research involves intervening in the physical integrity of research participants.
3. 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.
4. Research exposes participants to exceptionally strong stimuli.
5. 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.
6. Conducting the research could involve a threat to the safety of participants or researchers or their family members or others closest to them.

• The assessment compares the information value sought with the potential harms and the
  ways to mitigate (physical and psychological harms) or prevent (data protection) any harm to
  subjects during or after the study
• The committee will assess the risks, harms and likelihood of harm to subjects, their relatives
  and possibly the researcher themselves in relation to the plans made to avoid them.
• An assessment of whether the risks are morally acceptable at all. The threshold of morally
  acceptable risk can be raised if the scientific value of the research is very high and the
  research will not harm the subjects, or if the people taking part in the research are able to
  assess the potential harm also themselves on the basis of the information given to them

The same research situations or topics may bring up different reactions in different people. Research situations can and may, however, include similar mental strain and emotional experiences as situations of everyday life. Researchers assess whether the risks or harms of a particular research design are beyond the scope of normal everyday life.

2.6 Publishing the research

• It is not generally appropriate to publish the data of people who have participated in the research in a way that allows them to be identified. 
• Thus, the general principle is the protection of the privacy of people who have participated in the research and are mentioned in the publications. Decisions are to be made on a case-by-case basis taking freedom of expression into account.
• It is not generally appropriate to publish the data of people who have participated in the research in a way that allows them to be identified. 
• On the other hand, research participants and people who have provided information for the research must not be promised complete anonymity if this cannot be guaranteed. For example, providing anonymity for the participants in research publications does not necessarily prevent their identification by those who are familiar with the activities of the community or organisation that has been the subject of the research.
• Please note that consent may not be used to reveal an identity unless there is justification based on scientific arguments. The justification must be described.

Examples of exceptions:

• A research publications based on personal interviews or memory data may include participants' names and other background information: for example, research on artists.
• Public figures who exercise or have exercised significant power and whose privacy is narrower than that of other individuals: for example, politicians.  On the other hand, even public figures have a private life, which must always be respected.
• Well-known athletes whose identity would be difficult to conceal or it is essential for the study to know who the subject is.

However, even public figures have a private life, which must always be respected.

How is the publication of research assessed in an ethical review

In its assessment, the Committee pays attention to whether the privacy of the subjects has been adequately addressed in the publication plan. Identification in results or publications must be justified on the basis of scientific arguments. 

This annex sets out the main issues to be assessed in the ethical evaluation. 

• The PI of the study assesses the processes related to informed consent and other issues requiring ethical review. 
  • To avoid duplication of work, these points can be written either in chapter 2.5 of the research plan or in Annex 3 and cross-referenced to another document. 
• Thesis principal supervisor draws up Annex 3. 
  • The author of the thesis will undertake Annex 2, section 2.5. for an assessment of the risks of harm and other ethical issues.  
  • In this case, cross-referencing cannot be added.  

NOTE that the same issues are not described again in different appendices: appendix 3 does NOT describe data management, data protection, etc. You can use cross-references where appropriate. 

Use these headings as subheadings in the appendix. 

1. Ethical guidelines, ethical principles and legislation related to your study

Basic guidelines to be followed in all research involving human participants

• In Finland, all scientific research follows the TENK guidelines on good scientific practice.
• The ethical principles of human research are described in TENK's Guideline on
• When making an assessment of the ethicality of your study or the study you are supervising, use these principles to give you some guidance. 

Specific guidance related to the discipline or research topic

• For example Declaration of Helsinki, Ethical guidelines in the field of psychology, JYU Child Protection Policy

Legislation applicable to the study

• What legislation should be followed in this study?
• For example, data protection or copyright legislation. 

2. Ethical aspects of research methods and dissemination of research results

• Ethical issues related to the methods used.
• In the case of vulnerable groups of participants, justification.
• Are there risks involved in disseminating research results? For example, is there an intention or risk that the participants could be identified from publications? 

3. Description of the recruitment of participants and the informed consent process

The process of recruiting participants

• Who/what kind of groups will be recruited?
• How will people be reached and how will they be approached in concrete terms?
• Inclusion and exclusion criteria.
• If the study will reward participants, assess its potential attractiveness. 
  • TENK guidelines: Research participants are not usually paid a separate fee. If, however, the researcher wishes to thank participants for their time and trouble in a tangible way, the gift should be reasonable (such as a movie ticket, a product pack or equivalent). Research participants may also be compensated for reasonable travel and food costs, for example. Please take note of the tax authorities' guidance on the tax treatment of fees and reimbursements of expenses.
• Assessment of the implementation of ethical principles: in the context of recruitment, in particular the principle of voluntary participation in the recruitment of participants. 
  • TENK guidelines: It is particularly important to ensure that participation is voluntary if the research participant is in a customer, employee, service or student relationship or in another dependent relationship with the research organisation, or if a person other than the participant decides on their behalf on their participation in the research. The research participant must not feel that participation is compulsory or feel afraid of negative consequences if they refuse to participate in the research.  

Implementing the informed consent process

• How and exactly at which stage of the recruitment process will the participants be informed?
• Who is responsible for giving information?
• How is it ensured that participants have sufficient time to consider their participation?
• How will the information of minors and their guardians be taken into account?
• How and at what stage will subjects' consent be sought?
• Find JYU Ethics Committee guidance here.

4. Potential risks or harms to participants and measures to minimise them

• Consider the risks in a comprehensive and wide-ranging way. 
  • Consider the following types of risks, for example: physical, psychological, social, economic and environmental, as appropriate. Consider risks from the perspective of both researchers and participants.
  • Describe any other relevant risks to subjects and how you are preparing for them, for example, preparing for a corona or other similar general risk.
• Estimate the probability of the risks materialising.
• Describe the means of managing and mitigating risks and assess their adequacy. What will the research project do if a risk materialises?
• Another key question for the overall assessment is the extent to which the harm to subjects (at least in terms of time) is proportionate to the benefits of the research.
  • Where there may be significant risks for participants or where e.g. participation in a study may be time-consuming, it is also necessary to be able to assess the benefits for the participants. 
     

5. The capacity of the researchers to address any ethical challenges that may arise in the course of the study

• When research involves human subjects, PI and researchers should be familiar with human science methods and the ethical principles of human research. 
• Research ethics competence must be ensured for all researchers involved in the project. 
  • For example, is there a need to provide training in research ethics for more junior researchers, or to have regular meetings to discuss and collectively solve ethical problems that have arisen?

How the Committee assesses the ethicality of research

The ethical review assesses:

• The significance of the new knowledge sought by the research in relation to the potential harms and risks.
• How the research complies with ethical principles.
• How the risks involved in the research are identified and how they are addressed.

The Ä¢¹½Ö±²¥'s research data policy requires researchers to prepare a Data Management Plan (DMP).

The DMP needs to be prepared in accordance with the JYU guidelines and using the JYU template.

Read the JYU guidelines and get help

When you start planning the management of your research data, the first thing to do is to familiarise yourself with the JYU Open Science Centre guidelines:

• Research data management at the Ä¢¹½Ö±²¥

Counselling: 

• DMP, Open Science Centre: researchsupport-osc@jyu.fi
• Data privacy: tietosuoja@jyu.fi
• Data security: tietoturva@jyu.fi

How the Committee assesses the DMP

Checking whether the DMP has been carried out in accordance with the JYU guidelines.

Risks related to the processing of research data

• Has due consideration been given to the risks to subjects and others associated with the handling of the research data? 
• The risks are usually related to data protection and safeguarding privacy.
• They can also involve the loss of valuable research data and undermine the results.
   

Evaluating the design of information management and technical information security solutions

• The ethics committee will check the study's data management plan and ensure that the study has taken into account the requirements of data protection legislation and designed appropriate technical security measures.
• The DMP should specifically address the information security practices used in the research.

A privacy notice is a legal document that is mandatory under data protection legislation whenever personal data, which are any data relating to a person from which the subject (or another third person) can be identified, directly or indirectly, are processed in the course of research.

The privacy notice will be given to the subject as an annex to the information sheet (see guidelines).  It provides the data subject with information about the processing of his or her personal data, in accordance with the legislation ("informing the data subject").

When JYU is the data controller, the privacy notice is sent to the registry office, but 

only after the final version of the privacy notice has been approved by the ethics committee.

Data privacy:  see JYU guidelines 

• . Includes instructions and templates for students.
• Use the latest JYU template (updated 1/2024). Find templates here. 
• Counselling and further information: tietosuoja@jyu.fi

How the Committee assesses the Privacy Notice

• Whether the privacy notice has been drafted in accordance with the JYU guidelines using the latest JYU template.The use of a template other than the JYU template must be justified.
• Assess whether the privacy notice complies with the legal requirements and whether the notice is consistent with the research plan and the data management plan.
• The Committee includes a lawyer who assesses the privacy notice. 

The information sheet to participants is the most important annex to the request for a statement, both for the participants and for the Ethics Committee. Please take the time to draft it. The most important section of the  information sheet is "The course of the study", as it describes what the study will entail for the participants. The content must follow what is described in the research design, but it must be popularised in such a way that anyone can easily understand it. Clarify with lists, tables, photos, etc. The aim is to "sell" the study, so it is essential to think about the text from the point of view of the recipient. You should try to keep the text short and to the point. If the text is very long and looks like a big chunk, the person may not bother to read it. 

Click here for detailed guidelines on how to inform the subject, how to recruit subjects responsibly and how to write an information sheet/research notification.

Click here for guidance on how to conduct the consent process and the content of the consent form.

All material used in the collection of data from participants or provided to participants must be attached here.

The Committee must be able to assess whether this material poses any risks to subjects and whether these risks have been adequately addressed in the research design.

Other material means, for example:

• Questionnaire or content of the questionnaire(s) if the exact questions are not yet known.
• Interview questions or draft interview questions if the exact questions are not yet known.
• Assessment or evaluation forms, tests etc.
• Guidelines for research visits.
• NOTE: This does not refer to Annexes 5, 6 and 7. 

At the moment, the request for a statement can only be submitted in Finnish. The process will be translated into English as soon as possible. 

Advice on drafting the annexes to the request for a statement

• If you cannot find the information you need on the Commitee's website, you can ask the Secretary of the Committee for advice.
• For advice on the request for a statement, please contact the Secretary via e-mail or telephone (contact information below).
• In the first instance, the Secretary will provide advice by answering individual, clearly worded questions and only exceptionally on the wording of an individual annex.
• In the context of the consultation, please note the deadlines for submitting a request.
• The advice given by the Secretary shall not have any binding effect on the Committee's review or on the content of its decision.
   

Theses:

• It is the responsibility of the supervisor to provide guidance on the attachments to the request for a statement.
• Therefore, advice is given through the advisor, especially for undergraduate students.
• For doctoral students, the supervisor must also be involved in the correspondence.
   

Contact information:

• Advice on the drafting of the annexes and on ethical principles in the human sciences: Secretary of the JYU Ethics Committee: ethics-committee@jyu.fi  +358400248067
• Questions relating to data privacy, in particular in relation to Privacy Notice, should be addressed to the Data Protection Officer: tietosuoja@jyu.fi
• Questions relating to data management: researchsupport-osc@jyu.fi