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Notices and Statement Applications

Healthcare science research

Application form

Statement application form for healthcare science research or for a significant change in a research (In Finnish)

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: turkucrc(a)tyks.fi

The Ethics Committee of the University of Turku can give statements about other research than healthcare science research, if necessary.

Changes, see statement application form and filling instructions

Note the following information in the accompanying letter or in the form:

  • what are you changing?
  • why is the change necessary?

Deliver the altered documents and mark the changes clearly. Also deliver the research's responsible person's ethical assessment of the changes.

Clinical trials

Clinical trials are assessed by the National Committee of Medical Research Ethics (TUKIJA) or the regional ethics committee assigned by TUKIJA. Instructions about the advance notice procedure and applying the statement and the requested forms can be found at the TUKIJA web site.

Statement applications about clinical trials and significant changes in them and notices of the end of a clinical trial must, in all cases, be made by a form certified by the Ministry of Social Affairs and Health.

Transferring samples to the biobank and using samples in biobank research

Application forms and filling instructions

Statement application about the transference of samples to the biobank and using in biobank research (In Finnish)

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.

Statement application for a biobank research

Statement application for a biobank research (In Finnish)

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.

Read this before sending a statement application

  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 eettinen.toimikunta(a)tyks.fi 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.
  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.

Support material

A Template for Clinical trial information leaflet and consent in English and in Finnish (Asiakirjamalli kliinisiä lääketutkimuksia koskevasta tiedotteesta ja suostumuksesta). This template is for clinical trials with medicinal products, however the template can be used in other healthcare science researches as well.

Paediatric consent and information documenttemplates (FINPEPMED).

Päivitetty: 30/03/2021 14:20
Luotu: 07/11/2014 21:14