The Ethics Committee

• Research Coordinator Sunna Rannikko, tel. 050 4383 708
• Secretary Sanna Karppinen, tel. 050 536 3594

Email: eet­ti­nen.toi­mi­kun­[email protected] or firstname.lastname(a)varha.fi 

Mailing address (statement applications and other documents should be sent via email whenever possible):

The Wellbeing Services County of Southwest Finland
Ethics Committee / Research Services

P.O. Box 52
FI-20521 Turku

Visiting address (visits to be agreed beforehand with Sanna Karppinen tel. 050 536 3594)
Kiinamyllynkatu 4-8, Turku
Building 9B, 2nd floor

Chairman: 

1. The studies are assigned a diary number (ETMK current number / year) and are processed by diary number for each study.
2. Prepare and submit appendices for each study (separate printouts for each different study).
3. If an appendix or a report is omitted, please leave a short justification for it in the appendix list.
4. Remember to mark the appendix header, the name or identifier of the research and the version number and date of the document in all appendices.
5. E-mails: enter the name of the study or other appropriate identifier in the subject field. Note! E-mail appendices should be pdf of docx format. The maximum size of the e-mail is about 2–2,2 Mt. If necessary, the appendices may be provided in different messages.
6. Send your application also in hard copy. Printouts should be one-sided and paper should not be stapled together.
7. You need to compile a list of the appendices, with the version numbers and dates of the documents recorded. (Use the same numbering as in the statement application form).
8. The appendix list should be submitted in pdf or docx format by e-mail to the address [email protected] by the deadline day. You can also enter an appendix list in the message section of an e-mail.
9. Also save the files to yourself and make copies of the signed appendices to your archive.

Changes

1. Changes to research plans should be marked so that the changed text is also visible in black-and-white printouts. Note. Colour markings, such as Word's highlighting tool or highlighters on paper documents, should not be used because these markings do not appear on black-and-white printouts or black-and-white scanned documents.
2. The changes can be made for example as bold or italic text or as track change.
3. The version number changes according to the changes made in the document (i.e. version 1, version 2 and so on).
4. Make a personalized list of changes for the committee.

Supplements and additional clarifications

Also applies to corrections and additions to be submitted to the secretary for filing and approval by the chairman.

The corrections should be marked so that the changed text is also visible in black-and-white printouts, for example as bold or italics or as a track change, so that the deleted text can be identified. The version number changes according to the changes made in the document (i.e. version 1, version 2 and so on). The extract from the record of the committee (all pages) must be attached to the documents.

Statements and decisions of the ethics committee, e-mails

After the meeting, the Ethics Committee can send the decisions by e-mail only at the request of the opinion seeker. The request should be expressed in the statement request or in the relevant section of the form. The decision / extract from the record can be sent in an encrypted message, which requires the message reader to register before reading the message. You can register when you have received an encrypted email from the ethics committee. Encrypted email does not work with Internet Explorer. If you want to send encrypted e-mail and attachments to the ethics committee, send the request to the secretary of the ethics committee or to the address [email protected].

Note. You can only start the application by e-mail, but in addition, the documents must be submitted as hard copies for meeting processing. Paper prints must be single-sided and unstapled. The committee also requires signatures for some reports. Deadlines are indicated further down the page under Meetings and deadlines.

Submit to the committee the statement application form with its attachments, a list of attachments and, if necessary, a form for invoicing the statement (see below).

Health care researches from the University of Turku or the Tyks expert responsibility area can request personal and free assistance in filling out the statement application and its appendices from the Turku Clinical Research Centre. E-mail: [email protected]

According to the instructions, the invoice form for the statement fee will be sent as a filled-in Word file by e-mail to [email protected]. The form can be sent at the same time as the list of attachments to the statement application.

An application for an opinion on a significant change in a clinical trial and notification of the end of the clinical trial shall in all cases be made on a form approved by the STM. The necessary forms and instructions can be found on the Tukija website.

According to the instructions, the invoice form for the statement fee will be sent as a filled-in Word file by e-mail to [email protected]. The form can be sent at the same time as the list of attachments to the statement application.

The statement application and appendices are sent to the ethical committee of the region where the samples are stored.

The contact person will be notified of the possible lack of information in the application, information regarding the processing of the statement application and he/she will be sent the statement of the committee and a possible statement fee. If the space in the statement application form is not sufficient, you can use a separate appendix.

The form is used in applying a statement about biobank research, namely in applying for the permission to use the samples of the biobank and their respective information in research.

The contact person will be notified of the possible lack of information in the application, information regarding the processing of the statement application and he/she will be sent the statement of the committee and a possible statement fee. If the space in the statement application form is not sufficient, you can use a separate appendix.

• Applications and instructions (Tukija.fi, in Finnish)
• Paediatric consent and information document templates (FINPEDMED)