Research code UMCG

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.

General principles for scientific research

The following general principles apply to all scientific research.

  • The head of the department is responsible for all scientific research conducted at or from the department. A study can be started only after their consent.
  • A principal investigator is available and responsible for all aspects of a study.
  • All research takes place within the context of a research programme or group.
  • The basic principle is that the public and/or patients are involved before the start of a study. (e-learning module, participation compass, patient participation UMCG, CCMO).
  • The study’s research goals and methods are laid down in a high-quality and complete research protocol with a DMP. The use of eLabJournal is mandatory for laboratory research.
  • All studies in human subjects are recorded in the UMCG Research Register (see UMCG Research Register) via Superusers of the department.

    • ProjectID and title
    • Names of the UMCG staff involved in the design or conduct of the project
    • Study type and characteristics
    • Funding, parties involved, and contracts
    • Study population, privacy measures, and data management
  • Any experimental research with human subjects is preregistered in a public register such as the European Clinical Trial Register or Pre-registration is also strongly encouraged for other types of research. This can be done, for example, via the platforms of the Open Science Foundation or Prospero (systematic reviews).
  • Some types of research require that specific guidelines or procedures be followed. It is the researcher’s responsibility to determine which legislation and regulations apply to the research and to comply with them.

Respect for research participants

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:

  • WMO-governed research
    This is scientific research that falls under the Medical Research Involving Human Subjects Act (WMO). This applies to medical-scientific research in which participants are subject to actions or have rules of behaviour imposed on them.
  • Non-WMO-governed research (nWMO)
    This is scientific research with human subjects that does not meet the above definition of WMO-governed research.

The CCMO provides tools to determine whether research is governed by the WMO.

WMO-governed research

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 study should be as safe as possible for the subjects and should put as little burden on them as possible. Proportionality is key here: the benefits of the study must outweigh the disadvantages/risks for the research participant.
    • The research must be evaluated against medical, scientific, and ethical standards and approved before the start of the study.
    • The subject must be provided with written information about the study (CCMO Model Subject Information) and given sufficient time to reflect on their participation.
    • An independent expert must be available to inform the subject.
    • Subjects must give written informed consent before participating in the study.
    • The sponsor must take out liability insurance and WMO Subject Insurance to cover any damage to the subjects. Under certain conditions, exemption from the WMO Subject Insurance obligation is possible.
    • Those conducting the research must ensure that the privacy of the subjects is adequately protected.

    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.

Inclusion of subjects for a WMO-governed study may only start after approval of a recognised METc or the CCMO. The CCMO describes which research areas it reviews and provides tools to determine by which committee a WMO-governed study must be assessed.

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:

    • The principal investigator may request a monitor from the UMCG Monitor pool for projects with negligible risk. The principal investigator can also hire a monitor.
    • The principal investigator should hire an expert monitor for medium or high-risk projects. To this end, the principal investigator should request a cost quote from the SD CRO.

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.

All clinical researchers involved in WMO-governed research (see Objective in Training and examination regulations OER eBROK 2020) are required to complete the Basic Course on Regulations and Organisation of Clinical Trials (eBROK®) of the NFU. UMCG researchers can find information about the eBROK® course here. For others involved in WMO-governed research (research nurses, students, etc.), WMO-GCP training is mandatory. See overview.

nWMO-governed research

nWMO-governed research must be submitted to the CTc UMCG if it meets at least one of the following criteria.

  • The UMCG is ultimately responsible.
  • Research participants are included in or from the UMCG (either through informed consent or the ‘no objection’ system).
  • It concerns the start of a biobank or databank for future scientific research or the release of stored materials or data to researchers.

A national coordination effort is currently underway to harmonise this assessment between institutes and, in the near future, to triage study files. The CTc assesses
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.

Handling laboratory animals

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:

1. Replacement
Use of laboratory animals is prohibited if the research question can be answered without their use

2. Reduction
The number of animals used should neither exceed nor fall short of what is necessary to answer the research question.

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:

    • The competences of individuals involved in designing and conducting animal experiments.
    • The educational qualifications required for these individuals (referred to as ‘Article 9 officer’).
    • The further training of personnel responsible for animal care and conducting experiments.

    Other regulations include:

    • Every institution performing animal experiments must have an IvD that oversees the experiments on animals and the welfare of laboratory animals on behalf of this institution (licence holder), in accordance with the Wod. To minimise animal discomfort, binding agreements are made within the research protocol between the researchers and the IvD.
    • Any institution holding a licence for animal experiments must employ a veterinarian with expertise in laboratory animal veterinary medicine or another suitably qualified ‘Article 14 officer’.

    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.

    • The proposal for the animal experiments is submitted to the IvD by an ‘Article 9 officer’ of the research department. At minimum, the proposal should include:
      • The scientific background of the project and a rationale for the chosen animal models.
      • The experimental procedures.
      • The impact of the procedures on the animals and measures to minimise this.
      • The number of animals required, along with justification based on the three R’s.
    • After review by the IvD, the proposal will be submitted to the CCD.
    • The CCD requests an ethical assessment by an DEC. The DEC evaluates the burden of the research on the animals (the costs), weighs it against the scientific and societal importance of the research (the benefits), and advises the CCD.
    • The CCD makes the decision to grant or deny the permit.
    • After the permit has been granted, the researcher submits a proposal (IvD protocol) to the IvD describing the experiments in detail. The experiments must align with the granted permit.

    More information about UMCG animal research.

Genetically modified organisms (and biological agents)

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.

Gametes and embryos

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.

Genetic material from abroad

The Nagoya-protocol is an international agreement on access to genetic material from abroad for research purposes and the fair sharing of the benefits. The UMCG complies with this protocol, and the NVWA monitors this.
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.

Ionising radiation (nuclear energy law)

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 order for a proposed study to fall under an existing IntP, it is necessary, amongst other things:
      • to know which IntP number applies,
      • for it to have been assessed that the operations, the device, the nuclide, or the radiopharmaceutical fall under the operations described in the IntP and within the risk contours of the radiological risk analysis present,
      • that all locations where ionising radiation or radioactive substances are used for the study are covered in the existing IntP (including non-exempt blood and urine samples, for example),
      • that it is known who, as a radiation expert, supervises radiation safety in the conduct of the study.
    • If there is no covering IntP, an existing IntP must be expanded or a new IntP must be requested.

    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.

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Elizabeth Koier Policy Advisor Research Office