Before the research is begun, all permits, reviews and reports must be in order. The specific requirements vary by the type of the research.
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Preliminary ethical review
A preliminary ethical review is a statutory prerequisite for medical research. A review is also recommended for other types of anthropological research, even if there is no legal requirement. Very often a party like a sponsor, international partner, publication forum or the party managing the health and welfare data may require a preliminary ethical review for the research.
Below is a categorisation by data type of whether the research usually requires a preliminary ethical review. The need for a review must always be investigated before starting any research.
|Data source for research||Is a preliminary ethical review needed?|
Patient documents and social welfare customer documents
Data collected in population studies
|No statutory requirement; may be required by a sponsor, the party managing the health and welfare data or the party publishing the research. The need must be assessed before research is begun.|
|Biobanks||The use of biobank data always requires a statement on the ethicality of the research. You can prepare the statement yourself. It does not have to come from an ethical review committee.|
|Data compiled from several sources||The need for review depends on if the research is of medical or similar nature, and the requirements of the research’s sponsor, the party managing the health and welfare data and the party publishing the research. The need must be assessed before research is begun.|
Ethical review committees give statements on the ethical nature of research
The committee to be used is determined by the researcher’s discipline and organisation. The preliminary ethical review of medical research is the responsibility of the Finnish National Committee on Medical Research Ethics (TUKIJA), as well as the six regional ethical review committees of the hospital districts. In the humanities and social and behavioural sciences the ethical review committees of the researcher’s organisation, i.e. their university or research institute. perform the review.
The Finnish Advisory Board on Research Integrity (TENK) maintains a list of organisations who have committed to holding preliminary ethical reviews according to the principles advocated by TENK. TENK does not carry out preliminary ethical reviews for individual research projects.
Permits and reporting to the authorities
The use permit may require consent from the research subjects for the use of the data. Consent is required from subjects for medical research and research that will combine data collected straight from study subjects, e.g. in surveys, with data collected from registers or other sources.
|Data source for research||Need for consent|
Patient documents and social welfare customer documents
|In general, consent from the subjects is not needed|
|Data collected in population studies||Data collected in population studies may only be used for the purposes that the studie’s subjects have consented to.|
|Data is collected in biobanks and data lakes with the explicit consent of the subject, and their use for research does not usually require separate consent.|
|Data compiled from several sources||If the data collected from the research subjects is combined with data from registers or other sources, consent must be obtained from the subjects for combining the data.|
Use permits for health and welfare data are granted by the authorities
The permit for the research use of health and welfare data is typically granted by the authority acting as the data controller. If use permits are required from several authorities under the same ministry, the permit will be granted by the ministry in charge. The National Institute for Health and Welfare (THL) grants use permits for patient documents and social welfare customer documents if the research uses documents from a private service provider, independent practitioner or one or more municipalities or joint municipal authorities.
The use permit may be applied for in the permit service (currently in development). The permit service allows users to submit one application for permission and permits to use data located in several data sources. This will mean that each authority will not have to be contacted separately when data is needed for research from data sources governed by different authorities.
Before drawing up the use permit application, you should study the legislation concerning your research and the health and welfare data to be used, as it will determine the terms for research use. As a rule, a research plan and file description should be appended to the use permit application, often also a statement from an ethical review committee regarding the research, as well as consent for research participation, if the research will use data collected from the subjects in addition to said health and welfare data.
Reporting on your research to the authorities
According to the Personal Data Act, you must notify the Data Protection Ombudsman if you use sensitive personal data in your research without the subjects’ consent. Once the decree on personal data enters into force, the general duty of notification will be rescinded. The future data protection authority will only be consulted in cases where the processing of personal data carries a high risk, according to the preliminary impact analysis.
The data protection authority must be notified of any data security breaches without undue delay. The data subjects must also be notified of the breaches if they pose a high risk to the subjects’ rights and liberties.
The Medical Research Act lists special requirements for the notices sent to ethical review committees and the Finnish Medicines Agency (Fimea) regarding clinical pharmaceutical research. These notices concern the starting, progress, ending and premature discontinuation of research.