The UMCG Board of Directors is ultimately responsible for all scientific research performed by UMCG staff, at the UMCG or elsewhere, as well as for quality assurance and quality control at all stages of the research process and for the promotion of academic integrity.
UMCG researchers and research staff should be knowledgeable, well-trained, and aware of the legislation and regulations that apply to the research in question and should comply with this legislation and regulations.
There are dedicated Research Support Teams that help researchers meet procedural quality requirements (Research Support Service Portal or reachable via [email protected]). Individual departments also have a Research Coordinator who can sometimes provide support.
The following general principles apply to all scientific research.
When doing research on human subjects, participants should be treated with respect. Their participation in the research is entirely voluntary, and their health, safety, and rights must be protected. This is the responsibility of the UMCG and the researchers.
Research participants are protected by legislation and regulations. For an overview, see the website of the CCMO, the Code of Conduct for Health Research 2022, and the Netherlands Code of Conduct for Research Integrity 2018, p.28 (UNL).
There are two types of research with human subjects:
The CCMO provides tools to determine whether research is governed by the WMO.
The WMO is currently the most important law for research involving human subjects in the Netherlands.
Research with medical devices (including many apps), in vitro diagnostics, and medicines is regulated by European regulations. For these types of studies, the WMO refers to the MDR, IVDR and CTR. It is mandatory that all clinical trials follow the guidelines for good clinical practice (for research with medical devices, see ISO 14155:2020; for drug research, see ICH-GCP E6(R2)). The GCP Directive is also a good guideline for many other types of research.
The WMO is based on the Nuremberg Code, the Helsinki Declaration, and the ICH-GCP. The WMO concerns medical-scientific research in which people are subject to actions or have rules of conduct imposed on them. The main objective of the WMO is to protect the subjects in such research and to guarantee the integrity of the research data. For research that falls under the MDR, IVDR, or CTR, those European regulations are referred to. For other research governed by the WMO, the following protective measures must be taken:
The WMO sets additional requirements for research with subjects under the age of 16, pregnant or breastfeeding women, and people who are temporarily or otherwise unable to give informed consent (for example, people with dementia or those in acute care situations).
The UMCG follows the NFU Guideline Quality assurance of research involving human subjects 2023. This guideline describes the minimum requirements that must be met in research on human subjects in UMCs. In accordance with this guideline, the UMCG has implemented its policy and procedures for research governed by WMO in the Research Management System.
The METc UMCG is recognised by the CCMO.
Monitoring is the responsibility of the sponsor. This means that in a researcher-initiated WMO-governed study, the researcher is obliged to arrange monitoring for the participating centres. Monitoring depends on the risk classification:
For drug trials, sponsors are legally required to publish the results in the European Union Clinical Trials Database (EudraCT, for studies under the CTD) or in the CTIS (for studies under the CTR) within one year of the completion of the study.
nWMO-governed research must be submitted to the CTc UMCG if it meets at least one of the following criteria.
the submitted files against relevant legislation and regulations, including the WGBO, the GDPR, and the Code of Conduct for Health Research 2022. Researchers who want to use healthcare data for research can use the NFU Guideline: Reuse of healthcare data for scientific research. In the case of research with biomaterials, the WZL will apply once it comes into effect.
The protection of laboratory animals is a key focus of the Wod. This law prohibits the use of animals in research if the research question can also be answered without their involvement. The three ‘Rs’ should be followed here:
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1. Replacement Use of laboratory animals is prohibited if the research question can be answered without their use |
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2. Reduction The number of animals used should neither exceed nor fall short of what is necessary to answer the research question. |
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3. Refinement The discomfort for the animals should be minimised and limited as much as possible before, during, and after the experiment. |
The Wod includes provisions regarding:
Other regulations include:
The UG has a licence to conduct animal experiments, which also covers the UMCG. The UMCG and the UG have an IvD at their animal facilities that is responsible for supervising compliance with the Wod within their respective facilities. Annually, the UG submits data to the NVWA on all animal experiments conducted (number of animals, species, degree of discomfort, etc.).
All UMCG staff members involved in animal experiments are required to conduct them with integrity following applicable standards and safety regulations. The fundamental principle of the Wod is that an animal has intrinsic value. This recognition places obligations on researchers, for example they must take the intrinsic value of the animals and the species-specific behaviour into account when designing an experiment.
Experiments on animals can only be conducted after obtaining a permit from the national CCD for a specific project.
More information about UMCG animal research.
Research with a product based on or produced by genetically modified organisms will be subject to authorisation under the Decision on genetically modified organisms environmental management. For laboratories, a Contained Use Permit must be applied for through the Biological Safety Officer. Occupational health and safety rules also apply for work with biological agents. For more information, see the Biological Safety Manual and Genetically Modified Organisms in Research. For clinical research, the researcher must apply for a ‘release into the environment’ permit through the Environmental Safety Officer. The clinical study and the associated permit application are assessed by the CCMO and the Government Gene Therapy Office.
Scientific research with embryos, residual embryos, and gametes used to create embryos falls under the Embryo Act. This research should be reviewed by the CCMO. The CCMO offers tools for researchers who want to conduct this type of research.
Before the genetic material is obtained, the country of origin must give permission for this use. The provider and receiver together determine how the benefits are distributed. This contributes to the preservation of biological diversity and sustainable use of its components.
Research and actions involving the use of ionising radiation or radioactive substances are prohibited under the Nuclear Energy Act unless there is a specific nuclear energy law licence for this. The UMCG has a global Nuclear Energy Act Complex licence. This type of research and these actions must demonstrably be brought under the complex licence via a written IntP Nuclear Energy.
In addition, the UMCG Nuclear Energy Act Complex licence states that research on human subjects must comply with ICRP 62. A dose calculation and ICRP classification of each study should be demonstrably part of the IntP.
For more information about the existing IntPs or to request an IntP, please contact the responsible Radiation Protection Expert ([email protected]/T:61360 or 06 25651416) or the formally appointed coordinating Radiation Protection Expert of a department that works with ionising radiation emitting devices or radioactive substances.
