Documents required by the research ethics committee | Required main contents | Justification for the need | Relevant legislation |
---|---|---|---|
Application form | General detailed information of the study (e.g. scientists, place of study) | 2004-2005 included the ethics statement by principal investigator | Not based on law, administrative order |
Study Plan | All scientific details of the study | Scientifically essential | Medical Research Act 488/1999 |
Information form | All information about the study for the potential participants | To check that it is understandable by lay people | Medical Research Act 488/1999, Act of Medical Use of Human Organs and Tissues 101/2001 |
Consent form | Clarification for what the participants are actually consenting | Signed permission of the participant to be involved in the study | Medical Research Act 488/1999 |
Separate statement about research ethics by the principal investigator | Ethical justification of the study; how ethical principles will be taken into on account in practice | To ensure legally and ethically defensible practices | Not based on law; practice of the research ethics committee |
Document explaining the registry of personal data files | Included personal data, access of data, storage and disposal, responsible person | To ensure personal data protection | Personal Data Act 523/1999 |
Other documents e.g. questionnaire, letters, advertisements | Type and contents depend on the particular study | To check understandability, legality and discretion | Medical Research Act 488/1999 |