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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@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.

Technical instructions about compiling the documents

Appendices

You need to compile a list of the appendices, where you name the documents submitted to processing (see appendices of the application form). The list should adhere to the numbering system of the appendices presented in the statement application form.

The appendix list should include the version number and date of the documents in the format desired in the final statement of the ethics committee. If an appendix or a report is omitted, please leave a short justification for it in the appendix list.

Remember to mark the appendix header, the name or identifier of the research in all appendices.

The appendix list should be submitted in Word document format (.doc or equivalent) by e-mail to the address eettinen.toimikunta@tyks.fi by the deadline day.

Changes

Changes should be marked so that the changed text is also visible in black & white printouts, for example as bold or italic text. The version number changes according to the changes made in the document (i.e. version 1, version 2 and so on).

Other issues to be considered:

Do not staple the documents together.

Submit the documents as one-sided black & white printouts.

Print copies of the documents for yourself as well.

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: 29/11/2017 09:56
Luotu: 07/11/2014 21:14