Population screening is medical research with humans who do not suffer from health complaints. The research is focused on discovering diseases, hereditary predisposition to disease, or risk factors which increase the chance of disease. The most well-known type of population screening is for breast cancer (in women between 50 and 75 years), cervical cancer (in women between 30 and 60 years) and the Guthrie test (heel jab in babies).

Definition

The definition of population screening, as laid down in the Population Screening Act (Wet op het bevolkingsonderzoek, Wbo, in Dutch), is: ‘medical research in persons carried out on an entire population or a category thereof aimed at the detection of certain types of disease or certain risk indicators for the benefit of the participating subjects’ (non-official translation). This definition contains a number of elements:

  • It must concern a medical research within the population screening;
  • The research must be carried out in the entire population, or a category thereof, that is it concerns screening. The investigator must be presented to the population or the population group through, for example, individual consultations, advertisements or other general communication, such as in the waiting room of the practice of the investigator.
  • The screening should partly take place for the benefit of the participants, so that the individual results of the research can be offered to every participant as a health care benefit. With ‘partly’ is meant that the research can possibly also be a ‘trial population research’ and may have a medical/scientific character.
  • The term ‘disease’ is defined in the wider sense to include disorders, pain, injuries, deficiencies, or other physical or psychological conditions.
  • Risk indicators are seen to be ‘information on an individual containing details concerning the level of risk to that individual defined within a set time period and clinical manifestation. These increase the chance of contracting certain diseases’ (non-official translation).

License obligation

There are three categories of population research for which a license is required:

  1. population screening whereby ionising radiation is used;
  2. population cancer screening;
  3. population screening of serious diseases or defects for which there is no treatment and prevention is not possible.

A license must be obtained from the Ministry of Health, Welfare and Sport for population research. Questions on this can be put to the Ministry of Health, Welfare and Sport (website in in Dutch). More information on population research can be found on the website of the Health Council (Gezondheidsraad, website in Dutch) and the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu, wesbite in Dutch).

Population Screening Act (Wbo) or WMO: either/or

Research can be both population research (as covered by the Population Screening Act (Wbo)) and medical/scientific research (within the sense of the Medical Research Involving Human Subjects Act, WMO): the definitions of both legislations overlap. However, only one of the laws apply: in the case of research for which a license is needed the Population Screening Act (Wbo) Applies, and otherwise the WMO.

Population screening which does not require a license does not fall under the scope of the Population Screening Act (Wbo). However, if the screening concerns scientific research within the sense of the Medical Research Involving Human Subjects Act (WMO), then it must be reviewed on the basis of the WMO.

Research which is determined to be population screening on the grounds of the Population Screening Act (Wbo) and for which a license is required does not have to be reviewed on the basis of the WMO, whether or not it meets the two criteria of the WMO.

Protection of research subjects

Research subjects who participate in population screening for which a license is required are also protected. The Population Screening Act (Wbo) has its own protection regime. In the case of screening for which a license is required, the Health Council is asked to give advice prior to the Minister reviewing the screening and issuing a license. The standards for execution of screenings are laid down in the Population Screening Act (Wbo) and the Population Screening Decree (Besluit bevolkingsonderzoek, in Dutch).