You are here: AU  Staff Faculties  Health Research support Standards for the responsible conduct of research at the Faculty of Health 1. From project initiation to project conclusion – ensuring responsible conduct of research

1. From project initiation to project conclusion – ensuring responsible conduct of research

This section presents a range of fundamental guidelines designed to provide support for planning, executing and concluding research projects in a transparent, credible manner. Each section is accompanied by a note highlighting requirements that must be complied with. Each section also states where further information can be found if needed.

1.1. Preparing the research project

In the case of projects involving a number of parties, it is important to harmonise expectations regarding the overall project management and to describe this in the project description before the research project begins.

A project description, which must also be approved by the Health Research Ethics Committee, must comply with the requirements of the Danish health research ethics committees act (videnskabsetiske komitélov) as summarised in a list detailing requirements in regard to content that is available on the Danish National Committee on Health Research Ethics Committee (NVK) website.

  • The project description or protocol must include the following information:
  • Who is participating in the project and which functions and responsibilities have been assigned to the various participating persons/parties
  • Who is assuming primary responsibility for the project as a whole
  • Who is managing the project and the project manager’s function
  • Which functions and responsibilities are being delegated to external project participants
  • The data flow 1 and responsibility for the data processes described
  •  Drafting of publications and crediting of authorship in accordance with international guidelines as described in AU’s policy for research integrity, freedom of research and responsible conduct of research. (See also section 3)
  • How and by whom any disputes are to be resolved
  • Who is responsible for funding the project, and who is responsible for applying for funding.

    When partners from outside AU participate in a research project, a collaboration agreement must always be drafted for the parties involved in the project. The collaboration agreement must state that all parties agree to comply with Aarhus University’s guidelines for responsible conduct of research and freedom of research. The collaboration agreement must include a description of how the project is to be managed that includes the information stipulated above. The legal aspects of all collaboration agreements must be approved by the Technology Transfer Office (TTO) at Aarhus University, and by the head(s) of the department(s) with which the project is affiliated.

    • TTO reviews the legal aspects of the following:
    • Publication clauses
    • Data flow
    • Clauses regarding rights, including who has the right to dispose of data and any patent rights
    • Confidentiality clauses
    • Substitution and insurance clauses
    • Disputes, including where and how any differences are to be resolved
    • Exclusivity clauses.
    • Publicity (e.g. publication of sub-reports or statements in general).

Footnotes

1 The concept ‘data flow’ is used here to refer to the processing of research data during and after the project’s ‘lifetime’, including collection, registration, storage, sharing/transfer, etc. of data during and after the project.

1.2 General guidelines regarding health science research projects

  • The project description and other necessary documents, including contracts and permits must be completed before a project begins. This also applies to pilot experiments on human subjects.
  • The project description must be drafted in a manner that makes it possible to repeat the experiments, even several years later. This means that complete traceability is required with regard to the origin and generation of data.
  • In connection with some projects, it will be necessary to add descriptions of any departures from the original project plan in the relevant passages. In connection with clinical trials, it will thus be necessary to describe any amendments to the trial in a new version of the protocol, which in most cases will require separate approval by the authorities. 
  • In connection with clinical trials, errors and discrepancies must be documented in the data management system or on the Case Report Form (CFR). Any amendments to the project description must be clear, dated and accounted for, and the identity of the person responsible for the amendment must be stated.
  • If any of the collected data is omitted from the final publication, this must be stated clearly and accounted for in connection with the final report and in the event of publication.
  • The majority of research projects at the Faculty of Health involve animal experimentation, human subjects research or research on human biological material, which are governed by special legal requirements. See the descriptions below. 
  • Projects which may potentially lead to the development of biological weapons are subject to the approval of the Centre for Biosecurity and Biopreparedness.

1.3 Animal experimentation

  • Anyone conducting experiments on animals must comply with the provisions of the Danish animal experiments act (lov om dyreforsøg, in Danish only), and no such experimentation may be initiated without prior authorisation from the Danish Animal Experiments Inspectorate. In accordance with the Danish clinical trials of medical products act (lov om kliniske forsøg med lægemidler, in Danish only), no clinical trials of medical products may carried out on animals without prior authorisation from the Danish Medicines Agency. In addition, a report must be submitted to the Danish Medicines Agency in the event that adverse effects occur during such experiments.
  • If alternative methods of achieving the knowledge that the animal experimentation is intended to produce exist, as a general rule, applications for authorisation to perform an animal experiment will be denied.
  • Another requirement is that the smallest possible number of animals be used, and the necessary steps must be taken to ensure that the animals are subjected to as little suffering as possible.
  • Finally, the law stipulates that animal experimentation must be of significant benefit, and that the benefit of the research must outweigh the suffering inflicted on the animal.
  • Anyone involved with animal experimentation must have completed a mandatory animal experimentation training course.

1.4 Research with human subjects

This refers to projects involving experiments on live-born human individuals, human gametes intended for fertilisation, fertilised human eggs, embryos and fetuses, tissues, cells and genetic material from humans or deceased persons.

All research projects involving human subjects or human biological material are required to comply with the Helsinki Declaration. To the extent that the project falls under the scope of the Danish health research ethics committees act, it must be applied for and granted by the Health Research Ethics Committee in the region in which the principal investigator is employed. Empirical projects, including observational studies and surveys which require ethical approval but which fall outside the scope of the health research ethics system, may be submitted to the Research Ethics Committee at Aarhus University. 

In addition, informed consent, consent by proxy or regulatory authorisation must be obtained in connection with all research projects involving human subjects or human biological material.

All studies under section 1.4 must also be reported to either Aarhus University’s internal research project register or to Central Denmark Region’s internal research project register (guide under development).


1.4.1. Health science research projects that must be approved by the Health Research Ethics Committee

All studies under 1.4.1 must be authorised by the Health Research Ethics Committee on the background of an application. An application for authorisation of the research project (a notification) must be submitted to the Health Research Ethics Committee in the region in which the principal investigator is employed. The committee will then assess whether the proposed project is in compliance with the Danish health research ethics committees act. The legal obligation to apply for authorisation from the research ethics committee system applies to all clinical investigations, regardless of whether or not the equipment used bears the CE mark. 

A new act on clinical trials of medicinal products has been adopted in Denmark under which new medicinal product research ethics committees will be established. The act is expected to come into force simultaneously with the EU regulation on clinical trials that will revise the rules for clinical trials throughout the European Union.

1.4.1.1 Interventional studies

All health sciences research projects under section 1.4.1.1 must also be reported to an approved register.

With regard to registration, WHO defines an interventional study (clinical trial) as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. All interventional studies must be registered concurrently with or before the first human participant is assigned to the trial on the WHO International Clinical Trials Registry Platform (ICTRP), or with ClinicalTrials.gov. When applications for the authorisation of clinical trials of medicinal products or medical devices in phase II-IV are submitted to the Danish Medicines Agency, these trials are automatically registered in the EU Clinical Trials Register. Phase I trials and other trials (for example, involving alternative medicine, hypnosis, exercise and so on) can be registered at ClinicalTrials.gov, for example. The Trial Nation unit (formerly Én Indgang) can provide assistance with registering trials in ClinicalTrials.gov.

Interventional studies involving medicinal products or medical devices under sections 1.4.1.1. a and 1.4.1.1 b must also be approved by the Danish Medicines Agency on the background of an application.

The legal obligation to apply for authorisation from the Danish Medicines Agency applies to all clinical investigations of medical devices with and without CE marking if the objective of the investigation is to use the medical device for a new purpose. The Danish Medicines Agency is the supervisory authority in regard to the technical/scientific assessment of the clinical investigation of the device. On the Danish Medicines Agency website on medical devices, an introduction to clinical investigation of medical devices is available, along with instructions on how to submit an application for authorisation to conduct clinical investigations of medical devices.

Both the Danish National Committee on Health Research Ethics and the Danish Medicines Agency have guidelines for drafting project descriptions for clinical studies. A single overall project description covering all of these points in detail may be prepared.

1.4.1.1. Interventional studies of medicinal products

Clinical trials of medicinal products are defined as any investigation intended to determine or test the clinical, pharmacological and/or other pharmacodynamic effects of medicinal products on human subjects, including the identification of any adverse reactions, or to investigate their pharmacokinetics in order to gain knowledge about their safety or efficacy for humans.

As a general rule, clinical trials of medicinal products initiated and conducted at the Aarhus University Hospital or another hospital in Central Denmark Region must be reported to the Central Denmark Region research project registry, and in case of PhD projects under AU, must also be further reported to AU (guide under development).

Clinical trials of medicinal products must comply with the Danish GCP (Good Clinical Practice) ministerial order, in Danish only. Researchers can contact the GCP unit at Aalborg University Hospital and Aarhus University Hospital for assistance and monitoring of trials.

If the trial includes laboratory analyses performed in a research laboratory, the laboratory should as far as possible comply with the OECD’s guidelines on Good Laboratory Practice (GLP). If the laboratory analyses are performed at a hospital laboratory, the same requirements apply at a minimum, but as such analyses performed will often be accredited, as such they will implicitly be in compliance with the GLP.

1.4.1.1 b Interventional studies of medical devices

A clinical investigation of medical devices on humans is defined as any investigation involving humans that aims to determine or test the safety or performance of medical devices. The device tested may be a new medical device or a familiar device already being marketed in Denmark.

Clinical investigations involving medical devices must comply with the standard DS/EN ISO 14 155 (the equivalent to ICH-GCP for medical devices).  The GCP Unit at the university hospitals in Aalborg and Aarhus may be contacted in connection with investigations of medical devices that must be authorised by the Danish Medicines Agency on the background of an application.

The Development of health apps and software is classified as a medical device, and must comply with the European Commission’s Guidance and Danish ministerial order 1263 of 15 December 2008 on medical devices (bekendtgørelse 1263 af 15/12/2008 om medicinsk udstyr). Read more in the Danish Medicines Agency’s guide.

1.4.1.1 c Other interventional studies

Examples include dietary intervention trials (for example, cod liver oil), the effect of hypnosis, the effect of exercise on pain, etc.

1.4.1.2. Biological material

The collection of human biological material for a biobank in association with a specific health research project (including a clinical trial) must be approved by the Health Research Ethics Committee.

The collection of human biological material for biobanks requires the informed consent of the trial subject.

The use of previously collected human biological material in connection with a new project requires the authorisation of the Health Research Ethics Committee as well as the informed consent of the trial subject to the new project, unless a waiver with regard to consent is granted by the Health Research Ethics Committee.

Only licensed medical doctors, nurses or certified laboratory technicians trained in the extraction of human biological materials for scientific or medical purposes may extract biological material in accordance with the conditions set out in the authorisation. This rule does not apply to non-invasive collection of biological fluids, such as semen, saliva, milk and so on. The principal investigator is responsible for ensuring the confidential, safe and appropriate storage and ethical use of the biological materials, respect for donor confidentiality and appropriate disposal of the material.

Transfer of biological materials to a third party must be approved by the Danish Data Protection Agency.


1.4.2. Health science research projects that do not require approval by the Health Research Ethics Committee

Health science research projects under sections 1.4.2 that do not require approval by the health research ethics committee must be reported to Aarhus University’s internal research project register or to Central Denmark Region’s internal research project registery. Applications for approval of empirical projects, including observational studies and surveys that involve collecting data from individuals, may be submitted to the Aarhus University Research Ethics Committee.

1.4.2.1. Data from patient records

In trials involving the collection of information from patient records, the disclosure of such information must be approved by the Danish Patient Safety Authority.

1.4.2.2. Interview/questionnaire

The objective of interviews and/or questionnaires is to collect knowledge from or about the respondents within the field of the research project.

1.4.2.3. Data from registers

Register-based research is defined as non-interventional research based on analysing health data (electronic data and biological materials) from existing databases and registers/biobanks.

1.4.2.4 Electronic health data

Register-based research projects involving electronic health data must be reported to the Central Denmark Region internal research project register if the research project is based in Central Denmark Region, or to Aarhus University’s internal register of research projects if the research project is based at Aarhus University (guide under development).

Collecting sensitive personal data from an existing legal database[2] must be approved by the database administrator and with the associated conditions for disclosure as laid down in applicable data protection legislation.

1.4.2.5 Human biological materials

Human biological materials include human tissues, blood, cells, genetic material, skin, nails, hair, eyes and other human organs, faeces, including meconium (the feces of newborn infants) and human bacteria, as well as human bodily fluids, including saliva, semen, urine and the like.

Research involving individually identifiable biological material that has already been collected (biobank (register) research) must be reported to the Health Research Ethics Committee in the region in which the principal investigator is employed, with the exception of research trials involving cell lines (laboratory cultures or the like). However, research involving fertilised eggs, stem cells and stem cell lines must always be reported.

Material or information from a clinical biobank or a research biobank may only be used in a research project with an authorisation from the Danish Data Protection Agency. Applications to the Danish Data Protection Agency can either be made via Aarhus University’s internal research project register or Central Denmark Region’s internal research project register. In addition, as a general rule, the consent of the research subject from whom the biological material was extracted must be obtained, unless the Health Research Ethics Committee has granted an exemption from the consent requirement. Finally, Vævsanvendelsesregistret (the tissue utilisation register) must be consulted to ensure that the human subject has not registered a decision that their biological material may not be used for research.

A waiver from the consent requirement may be granted by the Health Research Ethics Committee on the background of a concrete assessment, on condition that the project does not represent a health risk or have the potential under the given circumstances in general to burden the test subject in other ways, or if it would be impossible or disproportionately difficult to obtain informed or proxy consent.

Footnotes

2 Examples include national registers or local databases approved for future research.


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