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Table 1 Required documents in tissue research by the official Research Ethics Committee of Hospital District of Northern Savo

From: Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

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