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The most relevant laws are also available in English as unofficial translations as listed below (find the law by using the search and the number of the law):
http://www.finlex.fi/en/laki/kaannokset/
(Attached to the Ethics Committe application but need not be sent to the Data Ombuds Man)
Act on the Status and Rights of Patients (785/1992)
Act of the Medical Use of Human Organs and Tissues (101/2001) and Decree (594/2001)
The Finnish Patient Insurance Centre
Other Guidance:
National Agency for Medicine Guidance
Sub-Comittee on Medical Research Ethics (TUKIJA):
Instructions for Researchers and Ethics Committees
Instructions on Patient Information Concerning DNA Tests
Report on Children in Medical Research
A template for Clinical Trial Agreements has been drafted by PIF in coorperation with the Association of Finnish Local and Regional Authorities and with the Hospital Districts. The template takes into consideration things that need to be considered when drafting an Agreement in the public setting. The use is recommended as it speeds up the negotiations, but it is not mandatory. At negotiations it is useful to highlight possible differences in your Agreement to the template in order to speed up the negotations. The template is available in Finnish and in English.
» Clinical Trial Agreement (english)
» Clinical Trial Agreement (finnish)
Informed Consent Form
In addition to the detailed information related directly to the specific trial, all participants should be informed of their rights, the purpose and nature of the trial, procedures and possible risks and harm. This information shall be given so that research subjects are in a position to give their informed consent as regards issues connected with the trial that have a bearing on their decisionmaking.
Research subjects shall be entitled to withdraw their consent at any point prior to the completion of the trial. They shall be informed of this right before giving their informed consent. In order to ensure that all relevant information is provided and that the consent is received for all aspect a template has been drafted by Pharma Industry Finland, the Data Protection Ombudsman and the Sub-Comittee on Medical Research Ethics.
» Consent to Participate in the Clinical Trial for Adults (english)
» Consent to Participate in the Clinical Trial for Adults (finnish)
Trial Information and Informed Consent Document Templates for Clinical Trials for Children (english)
Trial Information and Informed Consent Document Templates for Clinical Trials for Children (swedish and finnish)
