Overview of Mandatory Reporting

The obligation to report includes:

  • Experiments on live-born human individuals, human gametes intended to be used for fertilization, human fertilized eggs, embryos and fetuses, tissues, cells and genetic material from humans, fetuses and the like or deceased persons (Section 2(1) of the Committees Act).

  • Clinical trials of medicinal products in humans, i.e. trials in humans intended to determine the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products or to identify adverse reactions to one or more investigational medicinal products or to study the absorption, distribution, metabolism or excretion of one or more investigational medicinal products in order to assess the safety or efficacy of the medicinal product (section 2(2)(2) of the Danish Committees Act) (see the Danish Medicines Agency's definition of clinical trials).

  • Clinical investigation of CE-marked and non-CE-marked medical devices, i.e. human trials aimed at identifying or verifying the safety or performance of medical devices (section 2(3) of the Danish Committees Act) (link to section 1(3) of the executive order on medical devices. Medical devices are devices for examining, monitoring, treating or alleviating disease in humans, e.g. syringes, surgical equipment, hospital beds, pacemakers, hip implants, crutches or condoms.

  • Clinical testing of CE-marked and non-CE-marked in-vitro diagnostic devices.

  • Health data science research projects, i.e. projects involving the use of sensitive bioinformatic data where there may be a risk of significant secondary health findings. The term includes research on genomic data or imaging data generated in previous research projects or in connection with clinical diagnostics of patients.

Read more - primarily aimed at applicants to RVK and NVK

Health science encompasses both treatment, examination, and prevention as well as rehabilitation, and will therefore be able to capture that within all types of health science research, experiments are conducted, which may contain relevant ethical aspects of science.

Health science research primarily deals with medical science, pharmaceutical science, nursing science, dentistry, etc. Biological, clinical, epidemiological, social medicine, and psychological research methods are used, for example.

The Committee on Revision of the Scientific Ethics Committee System, Ministry of Health, 2010, proposes in Report No. 1515, that 'research requiring reporting is defined as health science intervention research.' This makes it clear that the research requiring reporting must involve a subject (or material from such a person) who is subjected to an intervention, which in most cases will involve treatment, examination, or preventive intervention.

Thus, the purpose of health science research is to create new knowledge or test existing knowledge about, for example:

  • the emergence or treatment of diseases, diagnostics, prevention, rehabilitation of humans
  • the biological, physiological, or psychological processes and genetic makeup of humans.

In order for it to be a notifiable health science research project, the project must both have a health science purpose and intervention."

 

Health data science research projects cover the same research areas and purposes as health science research projects, except that the subject of the research is solely the dry bioinformatic data, i.e., there is an absence of intervention.

A health data science research project therefore involves:

  • A planned and well-organized project that uses sensitive bioinformatic data and aims to systematically acquire knowledge about the emergence or treatment of diseases, diagnostics, prevention, rehabilitation of people, as well as human biological, physiological, or psychological processes and genetic predispositions.

A health data science research project must have a precisely defined purpose and be designed to achieve the described goals. Relevant methods must be used that make this possible and are assumed to be replicable and reach the same conclusion. The project and its conclusions should also be assumed to provide generalizable knowledge that extends beyond the specific conditions being studied and finally be of significant, relevant importance to the area that is the subject of the project.

Health data science research projects involving imaging data have their explicit and primary focus on imaging data as the specific subject matter of the research project. In addition to the image medium being the primary focus of the research project, data from patient records in general or data from health registries may secondarily be included. If research in biological material is also included, the project is considered a health science research project.

Health data science research, like health science research projects, must be distinguished from patient treatment and quality control.

The health data science research projects concern the same research areas and the same purposes as the health science research projects, but the object of the research is solely the dry bioinformatic data, i.e., there is an absence of intervention.

A health data science research project therefore involves:

  • A planned and well-organized project, which uses sensitive bioinformatic data and aims to systematically acquire knowledge about the occurrence or treatment of diseases, diagnostics, prevention, rehabilitation of people, and human biological, physiological, or psychological processes and genetic traits.

A health data science research project must have a precisely defined purpose and be designed to achieve the described purposes. Relevant methods are used, which can make this possible, and which can be assumed to be repeatable and reach the same conclusion. The project and its conclusions must also be assumed to provide generalizable knowledge, which extends beyond the specific conditions being investigated and finally be of significant, relevant importance for the area that is the subject of the project.

Health data science research projects with image data have their explicit and primary focus on image data, as the specific field of study of the research project. In addition to the image medium being the primary focal point of the research project, data from the patient record or health registries may secondarily be included. If research on biological material is also included, the project is considered a health science research project.

Health data science research must, in the same way as health science research projects, be delimited against patient treatment and quality control.

Prevention, diagnosis, and treatment, etc., in relation to a specific individual do not need to be reported. Treatment trials, where the doctor takes responsibility with heightened informed consent for an experimental treatment of a specific, critically ill patient as a "last resort", are also not subject to mandatory reporting.

From the Danish Health Authority's Guidance no. 11052 of July 2, 1999, regarding the introduction of new treatments in the healthcare system, it is stated: "Where there is an – implicit or explicit – hypothesis-testing and knowledge-generating element in relation to the choice of treatment method, the patient in relation to the treatment becomes not just a 'target', but also a 'means', namely a means to achieve new knowledge. Thus, there is not – especially not from the patient's perspective – a clear and unambiguous coincidence between the patient's concrete interest in a good treatment outcome and the doctor's interest in the use of the treatment. It is this that necessitates a scientific-ethical assessment of the procedure, and thus that the procedure is formalized and reported.”

If there is doubt as to whether new treatment methods should be reported as a research project or not, the decisive factor is the purpose. If the purpose is to generate new knowledge beyond treating the patient, then the project must be reported.

It is not necessary to report a project to a scientific-ethical committee or to prepare a protocol if there is extensive clinical experience that convincingly illuminates the effect, side effects, and risks of the treatment. The responsible doctor must therefore consider whether there is sufficient evidence to introduce the treatment. If there is doubt, the trial should be reported to the scientific-ethical committee system. This also applies if there is doubt about the professional results underlying the introduction of a new treatment.

 

 

Quality control and quality development do not need to be reported to the scientific-ethical committee.

Guidance no. 11052 of July 2, 1999, on the introduction of new treatments in the healthcare system, states regarding quality control: "Quality control does not aim to obtain new knowledge about the value of the treatment but tests the function of the clinical unit."

Quality development is the development of new methods or new indicators within already established areas. It provides new knowledge locally in the organization, but it is not generalizable outside of this.

Quality control or quality development are typically activities that are part of the operation of the healthcare system concerning, for example, a hospital department's achieved treatment results for a given patient group. It may involve comparing a current treatment with the adopted treatment instruction, evaluating the effect and costs of different treatment principles. Often, these are retrospective or observational prospective studies, where there is no intervention in the treatment, etc.

Research in alternative treatment can be subject to mandatory reporting if the above-mentioned purposes are fulfilled. For example, trials with mindfulness have been known to be reportable in the committee system. Even if the intervention itself can be characterized as alternative, the requirements for well-defined inclusion and exclusion criteria and effectiveness goals are unchanged, and the interventions must be reproducible.

The projects can be carried out under public management, including in a region, municipality, or university, or under private management. Projects on prevention in the municipalities, where evaluation occurs, can be health science or health data science research – for example, if one wants to know more about which interventions are effective in relation to the causes of disease, and the health-promoting effort is expanded with a scientific method/measurement to obtain generalizable knowledge about the health effect.

Only research activities in Denmark, conducted by a trial responsible or research responsible with a workplace in Denmark, must be reported to a scientific-ethical committee.

A project can cross borders, either by trial subjects traveling out of or into the country, or by biological material being imported/exported. If, for example, trial subjects are sent abroad for further examination or diagnosis in a trial, notification must also be made to the relevant scientific-ethical committee abroad, as the Danish committee does not have the authority to set conditions for activities abroad. However, the Danish committee may choose not to approve the research activity in Denmark if there is no information on satisfactory protection of the trial subjects' safety, rights, and welfare in connection with the further course abroad. The same applies to entry into a foreign trial. A research project with, for example, imported personally identifiable biological material must also be reported. The crucial factor is that the research activity takes place in Denmark.

If a trial responsible wants to research in Denmark using biological material from abroad (e.g., from a clinical biobank abroad) with the purpose of creating new knowledge about, for example, a disease area, etc., it must be reported to the regional scientific-ethical committee in Denmark.

However, if it is a matter of a Danish researcher or a laboratory department performing analysis of biological material from abroad on behalf of a researcher or a company based abroad, this does not need to be reported. In such a situation, the research is not conducted in Denmark when it is merely a laboratory service or similar, where the results are returned to the researcher or company abroad.

Below are examples of practice in the committee system regarding the obligation to report.

If in doubt whether a project should be reported to a scientific-ethical committee, one should submit the case to the committee.

An experiment aimed to find a method for differentiating flavorings in food ingredients by recording the brain's electrical activity (EEG) in healthy subjects, where the right and left sides of the tongue were alternately stimulated with ingredients including sucrose.

The committee found the experiment reportable because:

  • The experiment involved living human individuals, and
  • There was an intervention to examine the biological processes in the brain in connection with the intake of sweeteners with the aim of creating new, general knowledge about these processes.

Also taken into account were:

  • Legislation contains limits on which foods these ingredients may be added to and in what quantities, to ensure their intake does not pose a health risk.
  • In the course of EEG measurement of the brain, incidental findings relevant to the participants could arise.
  • Investigations into whether the brain can differentiate between the taste characteristics of food ingredients, which can have health-promoting purposes, for example, obesity prevention or diabetes.

An experiment aimed to investigate whether the cognitive mechanisms of action in mindfulness training have an effect on working memory, attention, decision training, and stress. It involved physical tests and behavioral tests on healthy subjects (young athletes).

The decisive factors for the obligation to report were:

  1. The experiment involved living human individuals.
  2. It was a therapeutic intervention with effectiveness goals, reflecting an expectation of clinical effects of the intervention on various psychological and somatic parameters.

Also taken into account were:

  • Mindfulness is used in some clinical departments as a treatment method.
  • The taking of pulse measurements and blood samples.

In an experiment, researchers believed, based on SNP chip analyses, that they had established that the Central Asian population largely showed European, Caucasian, South Siberian, and East Asian origins. They planned to perform complete genome sequencing to conduct a thorough demographic study. Additionally, they aimed to identify regions of the genome under natural selection and possibly determine regions of the genomes that have given the Central Asian population adaptive advantages to their environments. Saliva samples had been collected from living persons of Central Asian origin. Furthermore, the plan was to "produce genome-wide data from 140 prehistoric individuals."

The NVK assessed that the project was not subject to mandatory reporting for the following reasons:

  • The main purpose of the project was to conduct demographic studies and investigate which genomes have given the Central Asian population group adaptive advantages to their environments.
  • The project intended to use health science research to support other research that was not related to medical research.
  • Even though knowledge about the biological development process of the Central Asian population could potentially be obtained in the study, this was not the main purpose of the project.
  • The main purpose was not to generate new knowledge about the occurrence of diseases or about the prevention, diagnosis, or treatment of diseases.
  • The mere mapping of the human genome (with the possibility of creating knowledge about biological processes) did not in itself mean that it was a reportable health science research project.
  • The genome was also mapped from archaeological samples, where the protection interest (in relation to the individual and relatives) is not the same.

The following are not mandatory to report:

  • Health science questionnaire surveys and interview studies that do not involve human biological material (section 14(2) of the Danish Act on Committees).
  • Register research projects that do not include human biological material but are based on pure data, i.e. letters, numbers, characters, etc. (section 14(2) of the Danish Act on Committees), unless it is a health data science research project. See also the Danish Medicines Agency's page on clinical trials of medical devices.
  • Research projects involving only anonymous human biological material that has been collected in accordance with the legislation at the place of collection, i.e. material that cannot be irreversibly attributed directly or indirectly to specific individuals (see the biobank guidelines) (however, research projects mentioned in section 25 of the Danish Act on Assisted Reproduction in Connection with Treatment, Diagnostics and Research, etc.)
  • Trials on cell lines etc. originating from an approved trial with collection of cells or tissue and which has obtained the necessary approval (however, an exception applies if the trial concerns the use of fertilized eggs, stem cells and stem cell lines from these, as mentioned in section 25 and section 27(2) of the Danish Act on Assisted Reproduction in connection with Treatment, Diagnostics and Research etc. which must be notified).
  • Non-interventional studies with medicinal products as defined in section 2, no. 5 of the Executive Order on Good Clinical Practice in Clinical Trials of Medicinal Products in Humans.
  • Patient treatment or treatment trials.
  • Quality assurance or quality control.

Report to RVK

As a general rule, you must report health science research projects involving humans, as well as trials with tissues, cells, etc. to the regional committee for the area in which you work as a principal investigator. However, NOT trials with pharmaceuticals, medical devices or in-vitro diagnostic devices as these fall under the VMK.

As a principal investigator, you should therefore first and foremost contact the relevant regional research ethics committee. Here you can get answers to questions related to the specific research project.

Multicenter trials must be notified to the regional committee for the area where the coordinating investigator works, unless the multicenter trial concerns the particularly complex case areas.

Find contact information for the regional research ethics committees.

Report to VMK

Research projects involving the testing of medical devices, in vitro diagnostic devices and pharmaceuticals:

  • Health science research projects in humans with medicinal products (including advanced therapy medicinal products)
  • Testing of medical devices for the purpose of obtaining the CE marking or extending the CE marking
  • Post-market testing of CE marked medical devices - clinical follow-up studies
  • Investigations of medical devices for other purposes
  • Health science research projects related to in-vitro diagnostic devices (IVD)
  • Cluster Trials

Medical device and in vitro diagnostic device trials must be submitted via email to VMK.

Trials with medicinal products must be submitted via CTIS (Clinical Trials Information System): https://euclinicaltrials.eu/home

 

Report to NVK

Research projects in particularly complex areas:

  • Comprehensive mapping of the individual's genome, in which an exemption is applied for in accordance with section 10 of the Committee Act
  • Health data science research projects without biological material with pre-existing genome data or pre-existing imaging data

In addition, trials concerning:

  • Psychosurgery
  • Research on a deceased person as part of the removal of their organs

Your application to the NVK must still be submitted via "Anmeldelsesdatabase": www.drvk.dk

Reviews for RVK and NVK are submitted via the "Anmeldelsesdatabase" (www.drvk.dk).

Notifications of clinical trials with medicines must be submitted to VMK via CTIS (Clinical Trials Information System)

Applications for testing of medical devices and in vitro diagnostic devices must be submitted by email to VMK. Read more and find the application forms here:

 

Who Should Submit the Application?

For trials that must be submitted to RVK, NVK or VMK under the directive, it is the investigator or principal investigator and sponsor who must notify the research project. Read more below.

Health science projects

The obligation to notify a health science research project lies jointly with the investigator and the sponsor(s), and both must sign the notification, unless the investigator and sponsor are the same.

Health data science projects

The obligation to notify a health data science research project rests jointly with the principal investigator and the sponsor, and both must sign the notification, unless the principal investigator and the sponsor are the same.

Multicenter trials

In the case of a multi-center trial, this must be notified by the coordinating investigator and the sponsor.

Trials funded or initiated by a company

Research that a company has initiated or financed, e.g. For research initiated or financed by a company, e.g. clinical trials with medicines, the company or others can take care of the practicalities of preparing the notification, but it is the coordinating investigator or principal investigator and sponsor jointly who must submit the notification - under the responsibility of both.

For applications under CTR, MDR or IVDR

For applications under MDR and IVDR, it is the principal investigator together with the sponsor who must notify the trial.

Under CTR, it is the sponsor who notifies the trial.

If the sponsor and the principal investigator are the same, they are the sponsor-investigator and can submit to both MDR, IVDR and CTR.

The principal investigator will often be the same as the investigator, but if there are multiple sites, the principal investigator will be the Principal Investigator (PI)

Definitions

The responsible investigator is a person who exercises a profession recognized for the conduct of research and is responsible for the practical conduct of the trial at a specific trial site. A profession recognized for the conduct of research may be employment as a researcher or PhD student, or it may be employment in specific research work.

The PI is a person who exercises a profession recognized for the performance of research, e.g. through employment as a researcher or PhD student or otherwise through employment in specific research work, and who is responsible for the implementation of a health data science research project.

A sponsor is a natural or legal person who assumes responsibility for the initiation, management or funding of a health science or health data science research project.

A multi-center trial is a trial conducted according to the same protocol but at different sites with one investigator as coordinator or with different investigators

If you are unsure whether or not your project is notifiable to VMK or NVK, try our Interactive Application Guide.

If you are still in doubt, you can also contact us by email. In the subject line of the email, write: Inquiry about the obligation to notify. In the email, attach either a synopsis or protocol (preferably a PDF) describing the following:

  • Title of the project,
  • Background of the project,
  • The purpose of the project,
  • Methodology of the project; is it a medical device or in-vitro device trial, we want to know if it is CE marked or not
  • Participants,
  • What is being measured (endpoints). 

The email should be sent to kontakt@dvmk.dk or kontakt@nvk.dk We will then assess whether or not you need to submit and get back to you as soon as possible.

If you are unsure whether your project should be notified to RVK, please contact the committee in your region. See The Regional Research Ethics Committees

Last updated 01-02-2024

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