How the ethical review is carried out and what the statement means.

• When to ask and who can ask for an ethical review.
• Ethical review for theses.
• The binding nature of the statement.
• The process and timetable for processing requests for statements.
• Research permit at the Ģ��ֱ��.

The Ethics Committee assesses the ethical acceptability of the research from the point of view of ethical principles, in accordance with . These principles are the principles of non-harm, self-determination and privacy.

The ethical review assesses the ethicality of the proposed research, in particular with regard to

Ethical review in human sciences means evaluating the research being planned from the perspective of avoiding risk and harm to any of the parties.
The review weighs up the potential harm to participants, their families or the researcher themselves as well as the damage resulting from participation in the research in relation to the intended scientific value of the research.
Responsibility and ethics in the recruitment of research participants, and sufficiently clear information to participants about the content of the research, their participation and the processing of their personal data.
The appropriateness of participants' consent and the way in which the consent of the participants is sought.
Processing personal data and ensuring data security throughout the research lifecycle, as described in the Data Management Plan and Privacy Notice.

According to the TENK guidelines, an ethical review is carried out before data collection, and a statement cannot be issued once the research has already started.

The Ethics Committee follows the in its work.

The request for a statement must be submitted when the decision to carry out the study is taken, but before the participants are recruited.

The request for a statement is submitted before the recruitment of subjects, as the evaluation of the recruitment methods, including the method of first contact, is one of the most important tasks of the committee. In this same context, the processes for informed consent will also be reviewed from both an ethical and data protection point of view.
Responsible recruitment procedures are an important means of ensuring that the principle of voluntary participation, and thus the right to self-determination, is respected.

If participants are contacted before the actual recruitment process, it is particularly important to emphasise the voluntary nature of the participation to the participants during the recruitment process. In some research contexts, the process of applying for a research permit (institutional authorisation) is also easily intertwined with elements of the process of recruiting participants. However, as far as possible, the two processes should be kept separate.
If a researcher chooses to submit a request for a statement only after recruitment has started, they must be able to justify this decision as necessary for the research design or to obtain funding.

Non-standard procedures in the preparation of a study with prospective participants and in recruitment procedures may be justified, for example, in the case of an action research study, where participants are to be involved at the design stage of the study.

If a researcher is considering submitting a request for a statement after recruitment has started, they should contact the Secretary of the Committee in good time to check the robustness of their arguments: ethics-committee@jyu.fi

The request for a statement must be submitted when the decision to carry out the study is taken, but before the participants are recruited.

An ethical review can be requested by:

Ģ��ֱ��'s own researchers: the principal investigator (PI) or the thesis principal supervisor is JYU staff.
Researchers/researcher groups with close cooperation with the Ģ��ֱ��, if the study is carried out in accordance with the JYU guidelines.

As a rule, it is required that the applicant has an employment contract or other contractual relationship (e.g. grant holder) with the Ģ��ֱ��. Any other close cooperation must be described in the research plan.

The request for a statement is submitted via the Vasara system by the principal investigator (PI) or the thesis principal supervisor.

The PI can delegate the technical submission of the request for a statement to their assistant via the Vasara system, but the supervisor cannot delegate the submission to their supervisee.

Conditions:

The research to be reviewed must be part of the research activities of the Ģ��ֱ��.
The researcher requesting for a statement (PI) must have an employment contract or other contractual relationship (e.g. grant researcher) with the Ģ��ֱ��.
Participation in a coordinated research group from JYU, project funding granted to the Ģ��ֱ�� for the research in question, a grant or a visiting agreement for principal investigator (PI) for the duration of the implementation of the project is also considered a sufficient affiliation.
Other close collaboration should be described in the research plan.
An adjunct professor's (docent's) position alone is not a sufficient affiliation here.
The study will be carried out in accordance with JYU guidelines. The JYU must be the controller or a party to a joint controller contract.

In Jyväskylä, JAMK has its own ethics committee that provides ethical reviews for the JAMK
staff.

Who submits the request for a statement

The request for an opinion is submitted via the Vasara system by the principal investigator (PI) or the thesis principal supervisor.

See also: Ethical review for thesis and dissertations

The supervisor's duties and responsibilities regarding an ethical review

According to the TENK guidelines, the researcher is always responsible for the ethical and moral solutions in the research, and submitting the research for ethical review never transfers this responsibility to the ethics committee.
According to JYU instructions, it is the supervisor’s duty to introduce the student and doctoral student with the research integrity and good research practices and JYU Code of Conduct, Ethical principles of publishing and Research Data Policyof JYU.
The supervision document prepared with a doctoral student also states if the topic requires an ethical review

Supervision and submission of a request for a statement

For theses where an ethical review is required, it is the practice that. the student applies for it together with their supervisor.
As part of their studies, students will also practise preparing the appendices to the request for a statement, but it is the supervisor's responsibility to advise the thesis writer on how to prepare the statement as part of the thesis guidance process.
At JYU, the principal supervisor of the thesis (bachelor, master thesis and doctoral dissertation) fills in a request form in their own name (there is a field on the form for the supervisee's details).
The supervisor directs the request for a statement the preparation of the annexes as part of the thesis supervision process and when the request for a statement is submitted checks that the documents have been properly prepared.
The student does not have access to the Vasara system, so the case is handled in the name of the main supervisor for the duration of the process.

More information and guidance

Timetable for submitting a request for a statement

Requests for statements must be submitted to the Vasara system at least two weeks before the meeting at which the study is to be reviewed.
The Committee's meeting schedule and deadlines for submission of requests for statements can be found

Processing of the request for a statement, duration of the process and timetable

The decision of the committee is delivered immediately after the meeting, as a rule no later than the working day following the meeting. The statement will be delivered once it has been signed.
The timetable depends on whether the decision is positive or whether the committee requires corrections to the request (conditionally positive decision).
If the decision is positive without any corrections requiring revision, the statement is delivered within a few days of the meeting.
If the decision is conditionally positive, the committee will require corrections to be made to the documents.
- The corrections are not discussed at the meeting, but checked by the Chair, the Secretary, the Lawyer, the Data Management Specialist and the member representing the discipline.
- The time taken to process a conditionally positive decision depends on when the corrections required by the Committee are submitted to the Committee for checking.
- From check to delivery of the statement takes from a couple of days to a maximum of a week.
More information on decision types below.

Where can I get help in drafting a request for a statement?

on the advice offered by the Committee (at the bottom of the page).
Secretary of the Ethics Committee: ethics-committee@jyu.fi

Decision types

Positive statement

When the Committee's decision is “positive statement”, it does not require any revisions to be made, and the statement can be written immediately after the meeting and is received within 1-3 working days of the meeting.
However, the committee may require the researcher to make some corrections, in particular to the material to be provided to the participants before the study can be started. These are no longer checked by the committee.

Conditionally positive statement

If the Committee decides on “a conditional positive statement”, it will require corrections to documents in order to issue a final statement. Requests for corrections shall be submitted to the researcher in an extract from the minutes, which is at the same time the decision of the Committee.
Corrections will be sent by e-mail to the committee's e-mail address.
Corrections should be clearly marked, preferably in colour, on both the minutes and the appendices of the request.
The corrections are not discussed at the meeting, but checked by the chairman, the experts and the member representing the discipline.
Once the corrections made have been approved, the statement can be written.
It should be noted that the study must be carried out as indicated in the corrected documents.

No statement

In a decision "no statement", the reasons why the statement could not be issued and advice on how a new request for a statement may be issued.
- Such a decision may be reached if the request for a statement is not accompanied by all the mandatory annexes or is otherwise significantly deficient.
- A completely new request for a statement must be submitted for another meeting.
The committee will not issue a statement if the research is not subject to the JYU Ethics Committee.

Negative statement

It is very rare, but possible, for a research design to have very high risks that could not be acceptably minimised or completely avoided.
In such a case, the Ethics Committee could issue a negative statement stating that the research in question is not acceptable from an ethical point of view.
Such a situation may arise, for example, when one or more parties to a study are likely to face significant security threats that cannot be prevented.

A study is covered by the Research Act

If the Human sciences ethics committee considers that the study under review falls within the scope of the Medical Research Act (488/1999), it returns the request for a statement to the researcher and communicates its reasons for this. The Committee instructs the researcher to contact the Secretary of the local medical ethics committee in accordance with the Medical Research Act.
(previously Central Finland Health Care District). (in Finnish)

What is a research permit?

The Ethics Committee’s task is not to grant research permits but to give statements on the ethical considerations and acceptability related to the research.

Often, in addition to an ethical review, you will need to apply for (go to the Responsible Science website) before you can start collecting data.

If the research or thesis relates to the activities of an organisation, public body (e.g. a municipality/city) or company, and material is to be collected from its employees, permission will be sought directly from the research target (company, municipality/city), which will grant permission in accordance with its own procedures.

Research permission practices vary, so the practices of each organisation should be checked directly with the organisation concerned.

See .

NOTE: The research must be conducted in a manner described to the Ethics Committee, or there may be a violation of research integrity (RI)

The Committee will issue a statement on the ethical acceptability of the proposed research, provided that the research is conducted in accordance with the final research plan and related documents that have been approved by the Committee.
Any changes to the already reviewed study must be approved by the Committee in accordance with the guidelines.

TENK: If the conduct of the investigation differs from that described to the Committee, this may constitute a violation of research integrity (RI), which will be investigated in accordance with the process established by the TENK. This process will be led by the Rector of the University.
The Ethics Committee is not responsible for whether or not the research is carried out in accordance with ethical principles.

Ģ��ֱ��