Medical Research Ethics Committee of the Central Finland Health Care District
26 August 2013
Medical Research Ethics Committee of the Central Finland Health Care District
University of Jyväskylä Ethical Committee
Medical Research Act and its application
Medical Research Act
To comply with the Medical Research Act (488/1999 and its amendments), prior evaluation of research projects and delivering opinions on them is the responsibility of the statutory ethics committee of the region where the person in charge of the research is based or of the region where the research is to be principally conducted. In Central Finland, the research ethics committee of the Central Finland Health Care District performs the prior evaluation of research ethics and delivers the opinion.
In the Medical Research Act, medical research means research that
1) involves intervention in the physical and/or mental integrity of a person, human embryo or human foetus
AND
2) has the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general.
The definition was amended in 2010 (794/2010), when the word ”health” was added and the scope of the act was extended to include the increasing of health-related knowledge as a purpose of medical research. Medical research means research that pertains to nursing science or health science and that involves intervention in the integrity of a person, including research pertaining to sports science and nutrition science.
Both of the requirements above must be met at the same time to fulfil the requirements of medical research covered by the Medical Research Act.
Intervention in the physical integrity includes taking blood samples, research that includes physical strain and research that aims at affecting health or the risks or symptoms of illnesses through food. In case of intervention in mental integrity, the research could endanger the test person’s mental wellbeing. The act is to be applied if the research may expose the test person to harm that exceeds the strain of everyday life and that the test person is not able to estimate when deciding on participation.
The person who submits the request for statement must justify if the research is medical or not. However, the justification may be excluded when there is no room for interpretations.
Research NOT COVERED by the Medical Research Act:
- Register research based solely on documents
- Questionnaires and interview surveys, service development and field observations in the health care unit, and quality and process development projects, as long as they do not intervene in the integrity of a person
- Sport science research targeted to basically healthy test persons or healthy athletes when the purpose is to increase knowledge of performance, not health. Research pertaining to sports science does not necessarily become medical research only because of a blood sample, a muscle biopsy or use of additional nutrients
- Research of psychological phenomena (for example, motivation or interaction) outside mental problems or illnesses, unless involving unusual research methods
- Research from which the test person is able to assess how it will affect his/her mental wellbeing
Research COVERED by the Medial Research Act:
- Research of human blood and tissue samples, including microbiological and chemical research (excluding sports research related to the enhancing of performance).
- Medical research of human gametes
- Research pertaining to sports science when not targeted to performance or performance enhancement (e.g. research related to health), or when the target group comprises persons who are not basically healthy
- Psychological research that uses diagnosed patients or potentially ill test persons (depression, anxiety)
- Psychological research that uses unusual research or treatment methods (e.g. new forms of therapy) and whose effect the test person is not able to assess when deciding on participation
Research possibly covered by the Medical Research Act:
- Neuropsychological research of, for example, autism or attention deficit disorders may, depending on the situation or research frame, be considered as medical research covered by the Medical Research Act. Research that involves a diagnosis and an intervention is covered by the Medical Research Act. Research is not covered by the Medical Research Act if no diagnosis has been made and the test person is able to assess the effect of the intervention.
When a project is on the borderline of the scope of the Medical Research Act, the researchers responsible for the project must be especially careful when assessing the nature of research. It may be necessary to use the help of other experts, categorisations practices of earlier research projects or research information on the effects of similar studies to test persons.
The University of Jyväskylä Ethical Committee cannot give statements on research covered by the Medical Research Act. The Research Ethics Committee of the Central Finland Health Care District also gives statements on research projects that are not covered by the Medical Research Act and belong to the scope of the University of Jyväskylä Ethical Committee, when the projects are targeted to patients of the Central Finland Health Care District.