WMO or non-WMO

  • WMO
  • Non-WMO

WMO

Research subject to the Medical Research Involving Human Subjects Act (WMO) must be reviewed and approved beforehand by an independent accredited Medical Research Ethics Committee (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). The purpose of the review is, among others, to safeguard the rights, safety and welfare of participants. It also weighs scientific importance against any potential burden and risks to participants.

Research is subject to the WMO if the following criteria are met:

  1. It concerns medical-scientific research; and
  2. Participants are subjected to procedures or are required to follow rules of behaviour.

In addition to the WMO, several other laws and regulations exist for medical-scientific research involving human subjects, such as the Embryo Act, the European Clinical Trial Regulation (CTR), the European Medical Devices Regulation (MDR) and the European In Vitro Diagnostics Regulation (IVDR). A number of supplementary laws, decrees and ministerial regulations, CCMO directives and codes of conduct may also be relevant.

Non-WMO

If your research does not meet the WMO criteria, it does not require approval from an accredited MREC or the CCMO. However, a statement from a review committee confirming that your research is not subject to the WMO may be necessary - for example, when publishing the results in a scientific journal.
At Amsterdam UMC, the Non-WMO Review Committee provides such statements. Additionally, they offer advice on other applicable laws and regulations, including: Dutch Medical Treatment Contracts Act (WGBO), General Data Protection Regulation (GDPR), Code of Conduct for Health Research, Population Screening Act (WBO) and the Amsterdam UMC Research Code.

If you are uncertain whether your research is subject to the WMO, more details and guidance is available on the CCMO website. You can also direct your questions to the METC Office via metc@amsterdamumc.nl. For more information, visit the MREC Amsterdam UMC website.

Biobank

Biobank research involves the use of human biological material collected during standard care, specificially collected from patients or healthy volunteers for scientific purposes, or made available by external parties.

"A biobank is a collection of human tissue that is brought together for scientific purposes or treatment, together with medical, genetic, genealogical and/or other data from the donors."

Common types of data found in biobank collections include:

  • Clinical data (e.g. patient records);
  • Genetic and metabolic data (e.g. blood, tissue, urine);
  • Genealogical data (e.g. family trees);
  • Lifestyle and environmental data collected through questionnaires.

    When conducting biobank research, researchers must comply with the Code of Conduct for Health Research, which outlines ethical and legal standards for handling human biological material. At Amsterdam UMC, the Regulations of the Biobank Review Committee (CTB) of Amsterdam UMC also apply.

    Types of biobanks

    There are different types of biobanks:

    1. Further use biobank (in Dutch: Nader gebruik biobank)
      Stores residual human biological material collected during diagnostics or treatment as part of standard care, or unexpectedly leftover material from a study subject to the WMO. The material is stored for potential future use - either in ongoing standard care or for research purposes. However, at the time of collection/storage no specific research question was known.
    2. De Novo biobank
      Stores human biological material collected specifically for research purposes. Written informed consent is required from the donors.

      Clinical biobank:
      A De Novo biobank which focuses on collecting and studying human biological materials from patients to improve understanding of specific diseases. These materials are particularly valuable when compared to materials from individuals without the disease, typically found in Population or Further use biobanks.
    3. Population biobank
      Stores human biological material collected from a large group of individuals over a long period of time (e.g. 10 years or more), facilitating long-term research into the health of a population.

      For more information, visit Biomedisch onderzoek in Nederland | Biobanken Nederland

      Biobanks at Amsterdam UMC

      Amsterdam UMC encourages that biobanks for medical-scientific research are set up either department-wide or disease-specific. These biobanks are governed by a specific biobank protocol, and the responsibility for the stored material and associated data lies with the head of the initiating department. Researchers are therefore asked to first consider whether the material they wish to store can be accomodated within an existing biobank.

      Researchers who wish to set up a new biobank ('biobank opzetten') or conduct research with material from an existing biobank ('biobank uitgifte') must submit a request to the Amsterdam UMC Biobank Review Committee (Commissie Toetsing Biobanken, CTB). Detailed instructions on the submission procedure are available on the MREC website.

      To request materials or data from biobanks of specific departments - such as Clinical Chemistry, Pathology, or Human Genetics - researchers may need to complete an application form specific to that department. Click on the links for more information.