Checklist for applications for clinical investigations of medical devices

  1. Document requirements

List of documents to be submitted when notifying clinical investigations of medical devices.

The documents must be submitted as separate files. Help documents are available for several of the sub-sections, follow the link:

01.01 Cover letter

01.02 Application form

  1. The relevant forms can be found here.   

02.01 Investigator’s Brochure

02.02 Instructions for use

02.03 Checklist for fulfilment of general safety performance requirements

03.01 Clinical investigation plan

  1. An international investigation plan must be supplemented by Danish requirements in an appendix in case the international investigation plan does not fulfil Danish legislation. The appendix must refer to the original project title listing date and version number.

04.01 Participant information

04.02 Consent forms

05.01 Copy of the conformity assessment if the device is not CE marked

06.01 Sponsors statement on how to comply with GDPR

07.01 Danish synopsis

08.01 Questionnaires (submitted either in a single file or as several documents numbered accordingly, e.g. 08.01, 08.02 and so on)

09.01 Recruitment material
For example ads, postings, recruitment letters, text on www.sundhed.dk or social media

10.01 Proof of insurance cover in case the Patient Compensation Association does not provide cover

Please also see the guidelines on insurance.

11.01 Danish version of relevant parts of a sponsor contract
On publication matters and fees payable to researcher/research participants and researcher's access to data

12.01 Proof of CE marking 

13.01 Documentation of the investigators’ experience, training and identity (for all investigators at all Danish sites (if submitting several documents numbered accordingly, e.g. 13.01, 13.02 and so on) – Note! Only one investigator per site

  1. CV
  2. Registration ID (copy of physical card, not a transcript from the register of licensed health practitioners)
  3. Registration certificate or examination certificate if there is no registration certificate
  4. Copy of health insurance card, driving licence or passport, if preferred striking out the final four digits of the civil registration number

14.01 Documentation of the sponsor’s identity (if submitting several documents, numbered accordingly, e.g. 14.01, 14.02 and so on)

  1. The company’s address and VAT no.
  2. Contact person:
  3. If the sponsor is placed outside the EU (with the exception of Norway, Iceland, Lichtenstein and Turkey), provide information on the EU-appointed representative’s address and CVR no.

15.01 Billing information

  1. Link to form
  2. The billing form must be signed and attached to the application when the application is submitted
  3. Requirements applicable to the clinical investigation plan

Your clinical investigation plan must provide the following information:

  1. The original title of the investigation
  2. Description and classification of the device
  3. Information about the manufacturer or the authorised representative and importer in the EU
  4. Purpose
    1. Rationale and purpose of the investigation, including if the investigation takes place within the scope of the device’s CE marking. For non CE marked devices, you must indicate if the purpose of the investigation is to obtain CE marking.
    2. Short literature review and list of references
    3. For repetitions of previously conducted trials, state the reasons why
  5. Method
    1. Including design, methodology and use of control group and randomisation
    2. The practical implementation, investigations and scope
    3. Monitoring plan
    4. Indicate if algorithms are used in the device
    5. Start and duration of the investigation
  6. Statistical considerations
    1. Strength analysis or other statistical aspects that support the number of research participants
  7. Research participants
    1. Inclusion criteria
    2. Exclusion criteria
  8. Risks, side effects and inconveniences in the short and long term
    1. Including safety precautions to minimise pain, discomforts, anxiety and other risks
  9. Sampling of biological material or collection of material from an already existing biobank

    See also Exemption from the consent requirement.

    Describe:
    1. What material is sampled and how much
    2. The purpose thereof
    3. Whether the material will be destroyed after analysis

      If the material is stored in a research biobank (i.e. beyond 5-7 days from sampling)

      See section 5.2 of the Biobank guidelines:
    4. Stored for how long and for what purpose?

      For exported project material:
    5. To which country and for what purpose?
    6. That the Data Protection Regulation and the Danish Act on Processing of Personal Data are complied with. In case of transfer to a third country, add that Chapter V of the Data Protection Regulation is complied with
    7. The applicable law protecting personal data in countries outside Denmark in case it is not the Data Protection Regulation and the Danish Act on Processing of Personal Data

      In case of leftover biological material after completion of the project:

      See section 5.2.2 of the Biobank guidelines:
    8. Whether the material will be destroyed or full anonymity ensured, or
    9. Whether the material will be kept for future research purposes and that compliance with the data protection rules is still ensured

      If additional material is also sampled for future unspecified research purposes:
    10. This area falls outside the regulatory scope of the committee and is regulated by the Data Protection Regulation and the Danish Data Protection Act. However, you can indicate in the investigation plan that the research participants will be asked specifically about this to be able to document at a later stage that the material held in the biobank was sampled in connection with this specific research project.

      For imported project material:
    11. Submit documentation/a statement from the company/institution verifying that the material was sampled/collected in an ethically correct manner in compliance with the legislation at the point of collection and legally exported.
  10. Information from patient records
    If information from patient records is to be used in the project, the following must be described:
    1. Indicate which information is needed and for what purposes. You must distinguish between information needed before the participants give their consent to participate in the project, e.g. for identification/recruitment purposes, and information needed for the project after the participants have given their consent to participate in the project.
    2. Indicate that the information needed for the project before the participants give their consent to participate in the project will be disclosed to the researcher.
    3. Indicate that the consent gives investigators, the sponsor and the sponsor’s representatives and possibly also a regulatory authority direct access to obtaining information in the patient’s records, etc., including the electronic record, the purpose being to see information about the research participant’s health matters needed for them to conduct the research project and comply with their statutory control duties including self-inspection, quality control and monitoring.
  11. Processing of personal data in the project
    1. You must indicate that compliance with the Data Protection Regulation and the Danish Data Protection Act is observed. Please note that it is the responsibility of the sponsor or the investigator to ensure that the data protection rules are observed when processing personal data in the project. The administrative region or the university may require that the project be registered in an internal record.

      For cross-border transfer of personal data:
    2. To which country and for what purpose?
    3. That the Data Protection Regulation and the Danish Act on Processing of Personal Data will be complied with, and for transfer to third countries, adding that you will comply with Part V of the Danish Act on Processing of Personal Data
    4. The applicable law protecting personal data in countries outside Denmark in case it is not the Data Protection Regulation and the Danish Act on Processing of Personal Data
  12. Finances
    1. Describe who initiated the investigation.

      Specify for funders, if applicable:
    2. Name of funders, including the sum provided by each funder (fixed sum and/or per research participant)
    3. How the funding is included in the investigation, e.g. remuneration of staff, funding of laboratory tests, etc. (enclose a budget, if any)
    4. Whether the funding will be paid directly to a researcher, the researcher's department/institute, research fund or other (for researchers in regional research ethics committees in Southern Denmark stating the account no. where the sum is deposited).
    5. Whether the investigator has financial ties to the companies or foundations with interests in the study.
  13. Remuneration and/or other benefits offered to research participants

    Please also see Appendix 1: Guidelines to pay various forms of compensation to voluntary research participants
    1. The size of the fee, including any transport refund, loss of earnings compensation and/or disadvantage compensation
    2. How much will the research participants be paid, proportionately, if they leave the investigation prematurely?
    3. Any other benefits – financial value
    4. In the case of trial patients, explain how the conditions listed in Appendix 1 are fulfilled.
  14. Recruitment of research participants and informed consent

    Please also see the standard Guidelines for oral communication to research participants (in Danish).

    Describe the recruitment and the procedure for oral communication and receiving the consent:
    1. How will research participants be recruited (postings, ads, recruitment letters, internet, social media or magazines)?
    2. What will be the first contact to the research participant?
    3. The procedure used to obtain informed consent
      1. Where and when is the oral and written information given and by whom?
      2. What is done to ensure the interview takes place undisturbed?
      3. How the right to have an observer present is ensured
      4. The amount of time given to think things over in between the oral and written information and obtaining consent
      5. When the consent will be taken
  1. Publication of results
    1. The place of publication of the report on the investigation of the device’s performance and a summary thereof written in terms that the intended user can understand.
  2. Ethical aspects
    Describe:

    1. Why the risks neither individually nor in relation to the benefits of the investigation are irresponsible, and
    2. Why the therapeutic benefit for the research participants or future patients justifies the investigation.
  3. Information about insurance cover
    1. Whether the investigation is covered by the Patient Compensation Association or whether insurance has been taken out separately.
    2. Synopsis requirements

You are required to submit a Danish summary of the investigation plan, i.e. a synopsis, which must be a true and fair and comprehensive description that persons with no health-professional training can understand. It must be written in simple Danish terms, either explaining or rewriting clinical terms.

  1. The original title of the clinical investigation plan
  2. Name of investigator/sponsor and investigation site
  3. The purpose of the investigation
  4. The method, design and investigation procedures, including information about a research biobank, if any
  5. Research participants, including inclusion and exclusion criteria
  6. Side effects, risks and inconveniences
  7. Finances
  8. Recruitment of research participants
    Same requirements as the investigation plan requirements, item 12
  9. Publication of the results of the investigation
  10. Research-ethical account
  11. Requirements applicable to the participant information

The document must be marked with a date and version number to be updated each time changes are made.

The written participant information must comprise the following: 

  1. The original title of the investigation
  2. The invitation to participate in a clinical investigation
  3. The objective, significance and scope of the investigation
  4. The method and practical organisation of the investigation
  5. The risks of the investigation
    1. The expected risks, side effects, complications, inconveniences and burdens in the short and long term – including radiation risks
    2. Safety precautions, if applicable
    3. State that the investigation might involve unexpected risks and burdens.
  6. What is the standard treatment and are there are other forms of treatment?
  7. Information from patient records
    If information from patient records is to be used in the project, the following must be indicated:
    1. The information that is going to be used and for what purpose
    2. That the consent of the research participant gives the investigator, the sponsor and the sponsor’s representative direct access to relevant health information in their patient record needed for them to carry out, monitor and control the investigation
  8. Processing of personal data
    1. Describe that personal data will be processed in the investigation. Indicate that the Danish Data Protection Act and the Data Protection Regulation will be complied with (be aware of the information that you must provide (the rights of data subjects) under the Data Protection Regulation, see the Danish Data Protection Agency’s guidelines thereon)
  9. Sampling of biological material from research participants
    Please also see the Guidelines on the use of biological material in health research projects (in Danish).
    Describe:
    1. The type and amount of material sampled
    2. What the purpose is of taking the sample
    3. Whether the material will be destroyed after analysis
      Or if the material will be stored in a research biobank (i.e. beyond 5-7 days from sampling):
    4. For how long the material will be stored
    5. What the purpose is of storing it
      For exported material:
    6. To which country and for what purpose?
    7. Indicate how the Data Protection Regulation and the Danish Act on Processing of Personal Data are complied with. If the material is to be transferred to third countries, state also the country and recipient and that Chapter V of the Data Protection Regulation and the Danish Data Protection Act are complied with.
    8. Describe the applicable law protecting personal data in countries outside Denmark in case it is not the Data Protection Regulation or the Danish Data Protection Act.
      In case of leftover biological material after completion of the project:
    9. Whether the material will be destroyed or full anonymity ensured, or
    10. Whether the material will be kept for future research purposes, and, if so, that compliance with the data protection rules is still ensured. It must be stated that any new research on the biological material is subject to approval by a research ethics committee and that generally a new consent must be obtained but that the committee may grant an exemption (see section 5.2.2 of the biobank guidelines)
  10. Benefits of investigation
    1. What are the benefits to the research participants, others and research in general?
  11. If the investigation must be discontinued
    1. The circumstances that may result in the research participant being withdrawn from the investigation or the entire investigation being discontinued.
  12. Any fees and/or other benefits offered to research participants
    Describe:
    1. The size of the fee, including any transport refund, loss of earnings compensation and/or disadvantage compensation
    2. How much will the research participants be paid, proportionately, if they leave the investigation prematurely?
    3. Any other benefits – financial value
    4. Taxation
  13. Finances
    Describe:
    1. Who initiated the investigation?
    2. The names of funders
    3. Who funds the investigation? The sum provided for each funder and how the investigation uses the funding.
    4. Whether the investigator has any financial ties to the companies or foundations with interests in the study.
  14. Contact person:
    1. How the research participant can receive further information
    2. The name, address, email address and telephone number of the investigation’s contact person.
  15. General rights of research participants
    1. You must include the information appearing from the page ‘The rights of research participants in investigations of medical devices” (in Danish only)

Tips

Writing proper participant information

Below are a few sources offering additional guidelines on how to produce proper written participant information:

Template for proper participant information (in Danish)

How to write proper participant information (in Danish)

Information to 15 to 17-year-olds (in Danish)

  1. Requirements applicable to the Investigator’s Brochure

The Investigator’s Brochure (IB) must contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application.

The purpose of the IB is to give the investigator and other persons involved in the investigation guidance and a clear understanding of the possible risks and side effects of the investigation including the specific tests, observations and safety precautions required during the completion of the investigation.

The IB must be clearly identifiable and contain in particular the following information:

  1. Cover page with the following information:
    1. Name of the sponsor
    2. The investigational device
    3. Version number
    4. The release date of the IB
    5. A reference to the version replaced by the current IB
  2. Non-disclosure agreement
    1. In the event that the sponsor wants the investigator to treat the IB as a confidential document for use by the investigator team and the authorities only.
  3. Table of contents
  4. Summary
  5. Introduction
    1. A brief introduction of the device being used in the investigation, the rationale for the investigation of the medical device and its expected subsequent use.
  6. A description of the investigational medical device
    1. Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII of the Medical Device Regulation (MDR), design and manufacturing of the device and reference to previous and similar generations of the device.
    2. Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed on the label, and instructions for use to be provided with the device when placed on the market. In addition, information relating to any relevant training required to handle the device.
    3. In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal substance or on the tissues, cells or their derivatives, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues, cells or their derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the clinical benefit and/or safety of the device.
    4. A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I of the MDR, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking.
  7. Non-clinical studies
    1. Pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in particular regarding in-design calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, reliability tests, sterilisation validation, software verification and validation, performance tests, evaluation of biocompatibility and biological safety, as applicable.
  8. Clinical studies
    1. Existing clinical data from:
      1. relevant scientific literature available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices 
      2. other relevant clinical data available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of equivalent or similar devices of the same manufacturer, including length of time on the market and a review of performance, clinical benefit and safety-related issues and any corrective actions taken
    2. Summary of data and guidance for investigator
      1. Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, contraindications and warnings.
      2. A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.

I. Special requirements: Special investigation populations

  1. Research with children
    The investigation plan must be supplemented by the following:
    1. Provide a scientific justification showing why it is necessary to conduct the investigation with children.
    2. State the reasons why the investigation has the potential to produce a direct benefit for the participant outweighing the risks and burdens involved.
    3. Describe the age of the children, specifically justifying the choice of age group; older children should be included rather than younger children.
    4. Describe any precautions to be taken to minimise pain, anxiety or inconveniences in relation to the child’s development.
    5. The procedures for information and consent must be supplemented by the following:
      1. State that the project will seek consent from both parents in case of joint custody. Please also see the consent forms (in Danish only).
      2. State the qualifications of the health professional responsible for giving information, i.e. their knowledge in the field and pedagogic skills to inform the age group.
      3. The information given to children must be adapted to their ability to understand the investigation and their age and maturity (except for children under four years of age).
      4. That consent will be obtained separately from adolescents who come of age if the research enrols participants who come of age during the course of the investigation.
    6. In research specifically involving investigations with minor invention where authorisation has been sought to obtain consent from the adolescent independently, you must:
      1. indicate that it is a 15 to 17-year-old who will not be exposed to an intervention or any other form of burden, e.g. swab investigations, and
      2. indicate that the holder of custody will receive the same information as the adolescent and will be involved in decisions about the investigation.
  1. Research with adults lacking capacity
    Please also see the Guidelines on informed and proxy consent in health research projects, section 1.1
    The investigation plan must be supplemented by the following:
    1. Describe why the research participants lack capacity (are incapable of handling their own affairs).
    2. Provide a scientific justification showing why it is necessary to conduct the investigation with participants who lack capacity.
    3. State the reasons why the investigation has the potential to produce a direct benefit for the participant outweighing the risks and burdens involved.
    4. The procedures for information and consent must be supplemented by the following:
      1. That consent by proxy will be obtained from the next of kin and the trial guardian. Please also see the consent forms (in Danish only).
      2. The qualifications of the health professional enabling them to include the research participant.
      3. That the information to research participants has been adapted to their ability to understand the investigation.
      4. That written participant information has been prepared for the proxy.
      5. How the trial guardian is selected. This person must use his/her expert knowledge to assess if the research participant in question can participate in an investigation of this nature. See section 3.4 in the Guidelines on informed and proxy consent.
      6. That consent will be obtained separately from the research participant if capacity is regained during the investigation. This applies only to investigations of such a nature that capacity is likely to be regained.
  1. Research with pregnant or breast-feeding subjects
    The investigation plan must be supplemented by the following:
    1. Provide a scientific justification showing why it is necessary to conduct the investigation with pregnant or breast-feeding subjects.
    2. State specifically that the investigation has the potential to produce a direct benefit for either the participant, embryo, foetus or child outweighing the risks and burdens involved.
    3. If the investigation involves breastfeeding subjects, state that particular care for the welfare of the child is taken.
  2. Research in emergency situations
    The investigation plan must be supplemented by the following:
    1. Provide a scientific justification showing why it is necessary to conduct the investigation in emergency situations.
    2. State specifically that the investigation has the potential to produce a direct benefit for the participant resulting in a measurable health-related improvement.
    3. State that the investigation entails minimal risks and burdens compared with the standard treatment.
    4. The procedures for information and consent must be supplied by the following:
      1. State that the research participant due to sudden illness or a life-threatening condition is unable to receive prior information and to give prior informed consent.
      2. State that without undue delay consent from the research participant (if possible) or their legally designated representative will be obtained.
      3. State that without undue delay the informed consent will be sought from the research participant as soon as possible.
      4. State that it is not possible to give prior information and seek prior proxy consent from the research participant’s legally designated representative.
      5. State that the investigator does not know of any research participants having previously refused to participate.
      6. Describe how the trial guardian is selected. This person must use his/her expert knowledge to assess if the research participant in question can participate in a clinical investigation of this nature. See section 3.4 in the Guidelines on informed and proxy consent.

II. Special requirements: Genomics research

For extensive mapping of the human genome, you must also provide the details below. For other genome projects where there is also a risk of making important health findings, the committee may apply the same principles in its assessment, for example in the case of targeted examination of a very high number of genes. The checklist for research on biological material applies in addition to the following information.

Describe: 

  1. Investigational methods
    1. The investigation involves extensive mapping of the human genome
    2. The region of the genome (e.g. gene panels, exomes, the whole genome, the epigenome, RNA) and type of sequences that will be studied (rare and/or common variants, structural variants, etc.)
      See list of methods here:
    3. The sequencing platform or high-density array used and sequencing depth.
    4. The bioinformatic tools used.
  2. Storing of data
    1. How data are stored including where and for how long.
  3. Reporting of incidental findings
    1. In the case of testing entailing the risk of mutation in highly penetrant genes: That the research participant will receive genetic counselling prior to the investigation.
    2. How you otherwise estimate the probability of incidental findings and the reasoning behind this. The handling of the research participant’s feedback preferences for both the genes being examined and incidental findings being made. The Guidelines on genomics research must be complied with if incidental findings are discovered.
    3. That a group of independent experts will be formed for assessing incidental findings and giving advice on how to handle them.
    4. Whether you are moreover using the method to minimise the probability of incidental findings that exclusively targets specific regions of the genome and disregards other regions involving clinically relevant genes, e.g. the genes on the ACMG list. If so, it must appear that these genes will be filtered out such that neither data generation nor data registration will take place for this unwanted information. Please see the Guidelines on genomics research and use the wordings provided therein if useful.
  4. Research collaborations
    Please see the Guidelines on genomics research
    Describe
    1. The name of the collaboration partner
    2. What the collaboration is about:
      1. For laboratory analyses, including bioinformatic analyses: Describe that a data processor agreement will be entered into (see the Danish Data Protection Agency).
      2. If there is an actual (e.g. supplementary) research collaboration:  Describe that the external party is only allowed to do research within the scope of the investigation plan and is aware of the five feedback criteria in the Guidelines on genomics research.
    3. The data to which access is authorised (and whether it is in coded form)
    4. Whether genomics data are transferred to another country
    5. That personal data from the sequencing process are treated in compliance with the rules of the Data Protection Regulation and the Danish Data Protection Act and in compliance with the principles of the Danish Health Act for relatives.
  5. Participant information in genomics research
    You may find it useful to use the optional preprinted standard on proper information in genomics research as well as the standard consent form and the form to opt out of receiving findings.
    If you will not be using the standard, the information must include the following:
    1. Explain that the investigation involves extensive mapping of the research participant’s genetic material and the purpose thereof.
      Describe:
    2. The method shortly (whole genome research or exome sequencing, etc.)
    3. The knowledge you expect to acquire.
    4. Whether the research participant will benefit and, if so, how
    5. If the investigation entails the risk of mutations in highly penetrant genes: Indicate that the research participants will receive genetic counselling prior to the investigation
    6. If genomics data will be stored after the investigation: That storing of it will take place in compliance with the Data Protection Regulation and the Danish Data Protection Act.
    7. If you have formed a research collaboration with national or international collaboration partners, state:
      1. The name of the collaboration partner
      2. What the collaboration is about
      3. The data to which access is authorised (and whether it is in coded form)
      4. Whether genomics data are transferred to another country
      5. That personal data from the sequencing process are treated in compliance with the rules of the Data Protection Regulation and the Danish Data Protection Act.
  1. Return of health findings
    Describe:
    1. That the investigation might provide knowledge that was not anticipated (incidental findings)
    2. That the research participant will be informed in the rare situation that the research discovers a gene change disposing to a serious disease that can be prevented or treated.
    3. That it might be necessary also to inform family members if the information can prevent death or serious deterioration in health.
    4. That the research participant can opt out of receiving incidental findings, but will need to contact the researcher separately (Declaration to opt out of receiving findings).
    5. How the research participant can receive information about the outcome of the investigation.
  2. Genomics research in biological material without consent
    1. Detailed reasons for not obtaining the consent of the research participants must be given. Describe the risk of incidental findings and how to handle these. Please see the Guidelines on genomics research
    2. You must provide the same information as for Research in biological material with an exemption from the consent requirement. See also the Guidelines on the use of biological material in health research projects (in Danish only)
  3. Genomics research with children
    1. State specifically how either I, II or III is complied with:
      1. That it concerns the child’s clinical condition, the patient population will benefit, and you are verifying data acquired from research with participants with capacity or other test methods. Genomics research with children is not advised.
      2. The investigation will be of immediate benefit to the child, and genomics research with adults does not offer the same benefit.
      3. Genomics research can only be done on this age group, which will benefit hugely and be exposed to minimal risk.
    2. Describe if the investigation is likely to discover incidental findings with onset not before adulthood.

III. Special requirements: Research with deceased persons

For research on deceased individuals, certain information from the standard investigation plan can be omitted as a matter of course, e.g. communication and consent procedures, etc. These guidelines are complemented by the legislation in force to clarify the interface to the Health Act.

  1. Describe whether the research involves material collected at autopsies (section 8(1) of the Committee Act):
    1. Coroner’s post-mortem examinations (section 184 of the Health Act).
      Describe if:
    2. The material was collected before 1 January 2012 (no consent required under the Health Act), or
    3. The material was collected after 1 January 2012 (with consent under section 187 of the Danish Health Act), see the Danish Ministry of Health’s Guidelines on consent to conduct research on tissue and other biological material collected at a coroner’s post-mortem examination (in Danish only).
    4. Clinical autopsies (with consent pursuant to section 187 of the Health Act), see, the Danish Ministry of Health’s Guidelines on consent to clinical autopsies, etc. (hospital autopsies) (in Danish only).
      Note: Declarations for information and consent need not be submitted.
  2. Describe that the project involves research on biological material from deceased individuals, but not from an autopsy, cf. section 8(2) of the Committee Act:
    1. The deceased individuals’ donation of their body to science pursuant to section 188 of the Health Act, or
    2. Other interventions pursuant to section 8(2) of the Committee Act
    3. e. smaller interventions such as sampling of blood, removal of patches of skin and similar interventions (but excluding the removal of retinas, which falls under an autopsy).
      Note: The submission of declarations for information and consent is required. Find the consent forms here
      You can find more information about research on deceased individuals in the committee system’s Guidelines on research on deceased individuals (in Danish only)