Biobanks

Please note! This guidance is under revision due to the changed rules on data protection. Sections with references to the Personal Data Act no longer apply, and instead, reference is made to The Danish Data Protection Agency for information on the rules in the General Data Protection Regulation (GDPR) and the Data Protection Act. (08-08-2019)

Also note that health science research projects no longer need to be reported to The Danish Data Protection Agency. However, the data controller and data processor must maintain internal records of their processing of personal data. See The Danish Data Protection Agency's guidance on record-keeping. In the regions and at the universities, there may be requirements to report to internal records.

The purpose of this guidance is to provide an overview of the requirements for research involving biological material as per the committee law. The guidance describes when research involving biological material must be reported and how biological material should be handled if it is extracted, stored, and/or used in a reportable project.

Health science research projects can involve human tissue and other biological material (committee law § 6). This guidance only covers biological material that is extracted or given from living persons. If the biological material is extracted from deceased persons, see instead Guidelines for Research on Deceased Persons

Research on fertilized human eggs or sex cells intended for fertilization (embryonic stem cells) is specifically described in the guidance.

The guidance will also – where necessary – refer to other relevant legislation that also regulates the handling of biological material. The Personal Data Act contains processing rules that apply in connection with the collection, storage, use, transfer, disclosure, and destruction, etc., of biological material in biobanks. The Personal Data Act applies even if a processing activity is not reportable to The Danish Data Protection Agency.

2.1 Biological Material

Biological material is not specifically defined in the committee law, but in practice, it includes human tissue, blood, cells, genetic components, skin, nails, hair, eyes, and other human organs, feces including meconium (newborn feces), and human bacteria, as well as body fluids from humans, including saliva, semen, and urine samples, etc.

2.2 Tissue Donor

The trial participant, patient, or similar, who has provided the biological material.

2.3 Biobank

A biobank is a structured collection of human biological material that is available under specific criteria, and where the information tied to the biological material can be traced back to individuals.

A biobank is considered a manual register, according to The Danish Data Protection Agency's guidance as it contains personal data, i.e., personally identifiable information.

The material is personally identifiable if it is possible to directly or indirectly identify the tissue donors or donors, e.g., either by name or code. If just one person has the "key" to the code, the material is personally identifiable and not anonymous. For more guidance on when information can identify a person or is anonymous, refer to The Danish Data Protection Agency's guidance on anonymization. See also https://www.datatilsynet.dk/english. Additionally, refer to section 2.9 below and section 3.1.1 about anonymous material.

The purpose of the biobank determines the type of biobank in question (e.g., biobank for a specific research project (research biobank), biobank for clinical purposes (clinical biobank), etc.

2.4 Research Biobank

A research biobank is defined as "A structured collection of human biological material, stored for a specific health science research project, and which is available under specific criteria, and where information tied to the biological material can be traced back to individuals" (committee law § 2, no. 13).

A research biobank is created when the material is stored beyond the time it takes to collect and analyze the samples, typically around 5-7 days. Samples that are immediately destroyed after extraction and analysis are not considered part of the biobank concept.

A research biobank is an integral part of a research project.

The establishment of a research biobank in a project applies whether the biological material is extracted in the project or collected from an already existing biobank (committee law § 2, no. 13).

Read more in section 5.2. (establishment and consent) and 6.3 (exemption from consent).

2.5 Clinical Biobank

A structured collection of personally identifiable human biological material, extracted and stored primarily for clinical purposes, i.e., to prevent disease, diagnosis, nursing, or patient treatment, or management of medical or health services. It may be anticipated that there may be a need for further investigation of the sample in connection with the continued treatment of the patient, or because it can be used for quality assurance procedures, method development, or in connection with the teaching of doctors or other health personnel at the treatment site.

Read more in section 6.2 (exemption from consent).

2.6 Biobank for Future Research

A structured collection of human biological material, stored for future unspecified research, and which is available under specific criteria, and where information tied to the biological material can be traced back to individuals.

Read more in section 5.3 about extra material intended to be stored for future research. See section 5.2.2 about surplus material intended to be stored for future research. For possibilities of exemption, see section 6.1.

2.7 Surplus Biological Material

Biological material extracted for a specific health science research project but not destroyed after the project's completion, as it is in surplus.

See more about authority approvals in section 5.2.2 and the possibility of subsequent research with exemption from consent in section 6.3 and the checklist in section 6.5.

2.8 Extra Biological Material

Extra biological material extracted from patients in connection with treatment but for a future unspecified research purpose.

It can also be extra biological material extracted for future unspecified research purposes from trial participants in connection with a specific health science research project. See section 5.3

See sections 6.2 and 6.3 about the possibility of subsequent research with exemption from consent.

2.9 Anonymous Biological Material

Human biological material where the tissue donor or donor cannot be identified, including via code or similar to data, and which is thus not personally identifiable, and where the material cannot be directly or indirectly traced back to a person.

Pseudonymized material, where the biological material can be traced back to the tissue donor or donor via, for example, name or numerical code, is not considered anonymous in the sense of the committee law. If there is just one person who has the "key," then the material is not anonymous, but personally identifiable.

Without a personally identifiable name or code, the information tied to the biological material could potentially be traced back to individuals if it concerns a very small group of people with a rare diagnosis, such as carried by 5-10 people. Here, it would be difficult to describe the material as completely anonymous.

It should also not be possible to indirectly link personal information to the material. If the biological material is extracted by the researcher themselves in connection with or for use in the project, the material cannot normally be considered anonymous, as the researcher knows who the procedure was performed on and can identify the tissue donor or donor.

In determining whether a person is identifiable, all means that could reasonably be used to identify the individual either by the data controller or by any other person should be taken into account. For more guidance on when information can identify a person or is anonymous, refer to The Danish Data Protection Agency's guidance on anonymization.

A health science research project involving personally identifiable human biological material must be reported to a scientific ethics committee (committee law § 14, para. 1 and § 2 no. 1). See below about anonymous biological material.

For a definition of human biological material, see section 2.

Read more about the rules for research on already extracted biological material in section 6.

3.1. Exceptions to the Reporting Obligation

Below is a description of when research involving biological material does not need to be reported.

3.1.1 Anonymous or Fully Anonymized Material

Research projects that only include completely anonymous or anonymized human biological material, collected in accordance with the legislation at the collection site, do not, as a rule, need to be reported to the committee system (cf. committee law § 14, para. 3). See above in section 2.9.

The material must have been collected in accordance with the legislation at the collection site. If the material is collected in Denmark, it is assumed that the rules of the health law are met.

If the material is collected abroad, those responsible for the trial must ensure that the material is collected in an ethically defensible manner, for example, by the company or institution from which the trial responsible purchases the material, providing a declaration that the material is collected in accordance with the legislation at the collection site.

The trial responsible must therefore ensure that research involving biological material, whether it needs to be reported or not, is conducted ethically responsibly, and is collected in a legal and defensible manner.

Health science research projects concerning fertilized human eggs and sex cells (§ 25 of the reproduction law) must always be reported to the committee system, regardless of whether it involves research on anonymous material. See section 3.2.

3.1.2 Research in Cell Lines

Trials on cell lines (laboratory cultures) or similar (e.g., cell cultures) do not need to be reported to the committee system if the material originates from trials with the collection of cells or tissue that have already received the necessary approval, cf. committee law § 14, para. 4. See, however, below about research on fertilized eggs, stem cells, and stem cell lines, which must always be reported to the committee system (section 3.2).

Cell lines arise when a subculture is made from a primary cell culture taken directly from the organism. The law has assumed that collected tissue can give rise to a large number of research projects in the same cell line. The expression "cell lines or similar" should be interpreted broadly until a more precise delimitation may be provided by the Ministry of Health.

Note that it is also a condition that the original consent was given with the information that the trial participant's biological material may be used as cell lines, which under the tissue donor's name or in an anonymized form can be used for trials in several countries.

With the necessary approval, imported cell lines or laboratory cultures acquired from other countries that have obtained the required approval for use in trials at the collection site are also considered. This could be EU countries, other European countries, as well as countries like the USA and Canada and others that have a scientific ethics committee system or similar legal guarantees. The trial responsible bears the burden of proof that the required approval exists. At a minimum, the trial responsible must be able to present written documentation from the seller upon request, confirming that the biological material has been collected, transferred, and sold for research purposes in accordance with national law at the collection site. If this documentation does not exist, the project must be reported to the committee system according to the general rules on research in biological material. See section 6 on research in biological material and section 7.2 on research in material from abroad.

3.2. Specifics on Research Involving Fertilized Eggs and Stem Cells

Health science research projects may involve trials on human sex cells intended for fertilization, as well as human fertilized eggs and cells, etc. (committee law § 2). These trials must be reported to a scientific ethics committee.

Trials on embryonic stem cell lines originating from trials with the collection of cells or tissue that have received the necessary approval must be reported to a scientific ethics committee (committee law § 14, para. 4).

According to § 25 of the law no. 93 of January 19, 2015, on assisted reproduction in connection with treatment, diagnostics, and research, etc. (reproduction law), research on fertilized eggs and on sex cells intended for fertilization may only occur if the purpose is:

1. To improve in vitro fertilization or similar techniques for inducing pregnancy or
2. To improve techniques for genetic examination of a fertilized egg to determine serious hereditary disease or significant chromosomal abnormality (preimplantation diagnostics)
3. The research with fertilized eggs and stem cells aims to obtain new knowledge to improve the possibilities for treating diseases in humans.

Eggs must not be extracted and fertilized for other trials than the above (reproduction law § 25, para. 2).

Reproduction law § 28 contains a prohibition against conducting research aimed at enabling the production or development of:

1. Genetically identical human individuals
2. Human individuals by merging genetically different embryonic anlagen or parts of embryonic anlagen before they attach to the uterus
3. Living human individuals that are hybrids, with a genetic makeup that includes components from other species
4. A human individual in a foreign-species uterus.

3.2.1 Requirements for Reporting – Fertilized Eggs and Stem Cells

Research protocols should generally contain the usual information in the researcher's guide about describing purpose, method, literature, financial conditions about sponsors, publication of results, etc. See more in Information for Researchers.

The couple must give consent to the research following the general rules in the notification and information regulation, including both consent to the storage of the fertilized egg and to the research project.

The couple must also be informed that all research projects concerning stem cells and stem cell lines from embryos must be reported to a scientific ethics committee – also in cases where the researcher seeks exemption from obtaining consent in a possible new project or fully anonymizes the material.

Public health science research projects that process personal data must be reported to The Danish Data Protection Agency. In practice, the reporting should be done to the region's or university's contact person, as the projects are included in the authority's joint report, which covers research and statistics at the authority.

Private health science research projects, which are subject to the law on the scientific ethical treatment of health science research projects and involve the processing of personal data, do not need to be reported to The Danish Data Protection Agency. However, the Personal Data Act must still be complied with in such projects, and private projects must still be reported to the scientific ethics committee.

The storage of biological material in a biobank for future research not associated with a health science research project must always be reported to The Danish Data Protection Agency.

If biological material is transferred and/or shared abroad in a research project, special requirements apply, see section 5.4.

There are also special requirements for obtaining permission under § 10, para. 3 of the Personal Data Act when sharing sensitive personal data (including biological material) with a new data controller for research purposes, see section 5.5.

See the graphical overview on reporting the processing of sensitive personal data in connection with a research project on The Danish Data Protection Agency's website.

The Danish Data Protection Agency's website also describes the general and specific requirements of the Personal Data Act for processing personal data in a health science research project.

5.1. Basic Principle: Biological Material Should Be Destroyed After Use

If, in a specific health science research project, personally identifiable biological material is extracted or stored for a certain period before or after analysis of the material, it constitutes the establishment of a research biobank.

Conversely, if blood samples are taken for immediate analysis and then destroyed afterward, there is typically not considered to be actual storage, and thus it does not constitute the establishment of a research biobank.

Whether a research biobank is established is a concrete assessment. If storage extends beyond a few days (5-7 days) for later analysis, it will usually be considered a research biobank according to practice.

A research biobank is linked to the specific project and ends at the latest upon the completion of the project (i.e., as soon as all analyses related to the specific research project are completed).

Biological material solely extracted for future research outside the research project does not constitute a research biobank in the sense of the committee law. See section 5.3 on the extraction of extra material for future research.

5.1.1 Consent Requirements for Storage in the Project

If biological material is extracted from the test subject in a research project for storage in a research biobank, the researcher – in addition to consent to participate in the research project – must request the test subject's consent for the biological material to be extracted for storage in a research biobank (committee law § 6).

Such consent cannot include consent for any later use of the biological material in another research project (consent for future research). Such broad consent is not legally valid under the Committee Law, as the consent is not related to and based on information about a specific research project. See more in section 5.3.

5.1.2 Surplus Material Desired for Future Research

The committee can approve the storage and use of biological material in connection with a specific research project.

If a researcher wishes to save any surplus biological material from the experiment for future research after the project's completion, it must be stated in the participant information for the research project that the donated biological material is stored after the project's completion for possible future research. The committee should also be informed about this in the protocol.

In addition, permission from The Danish Data Protection Agency is required to establish a biobank (Personal Data Act § 50, para. 1) or permission under § 10, para. 3, if it involves transferring to a new data controller.

The following can be stated in the participant information:

"According to the Personal Data Act, surplus biological material from the project should be destroyed at the end of the project. However, we will seek permission from The Danish Data Protection Agency to establish a new biobank with the surplus material for future research. Any new research project will be reported to the scientific ethics committee. With permission for new research, a new consent from you/the test subject for the research should generally be obtained. However, the committee can allow new research without obtaining consent if there is no risk or burden to the test subject in the new research."

5.2. Research Biobank – If Personally Identifiable Material is Stored in the Project

If, in a specific health science research project, personally identifiable biological material is extracted or stored for a certain period before or after analysis of the material, it constitutes the establishment of a research biobank.

Conversely, if blood samples are taken for immediate analysis and then destroyed afterward, there is typically not considered to be actual storage, and thus it does not constitute the establishment of a research biobank.

Whether a research biobank is established is a concrete assessment. If storage extends beyond a few days (5-7 days) for later analysis, it will usually be considered a research biobank according to practice.

A research biobank is linked to the specific project and ends at the latest upon the completion of the project (i.e., as soon as all analyses related to the specific research project are completed).

Biological material solely extracted for future research outside the research project does not constitute a research biobank in the sense of the committee law. See section 5.3 on the extraction of extra material for future research.

5.2.1 Consent Requirements for Storage in the Project

If biological material is extracted from the test subject in a research project for storage in a research biobank, the researcher – in addition to consent to participate in the research project – must request the test subject's consent for the biological material to be extracted for storage in a research biobank (committee law § 6).

Such consent cannot include consent for any later use of the biological material in another research project (consent for future research). Such broad consent is not legally valid under the Committee Law, as the consent is not related to and based on information about a specific research project. See more in section 5.3.

5.2.2 Surplus Material Desired for Future Research

The committee can approve the storage and use of biological material in connection with a specific research project.

If a researcher wishes to save any surplus biological material from the experiment for future research after the project's completion, it must be stated in the participant information for the research project that the donated biological material is stored after the project's completion for possible future research. The committee should also be informed about this in the protocol.

In addition, permission from The Danish Data Protection Agency is required to establish a biobank (Personal Data Act § 50, para. 1) or permission under § 10, para. 3, if it involves transferring to a new data controller.

The following can be stated in the participant information:

"According to the Personal Data Act, surplus biological material from the project should be destroyed at the end of the project. However, we will seek permission from The Danish Data Protection Agency to establish a new biobank with the surplus material for future research. Any new research project will be reported to the scientific ethics committee. With permission for new research, a new consent from you/the test subject for the research should generally be obtained. However, the committee can allow new research without obtaining consent if there is no risk or burden to the test subject in the new research."

5.3. Extraction of Extra Material for Future Research

In some cases, a researcher may wish to extract extra biological material in connection with the specific research project, not to be used in the specific experiment, but only to be stored for future research.

Extraction and storage of biological material for use in future research are not considered within the committee system's competence, and consent declarations and information about the extraction and storage cannot be assessed or approved by the committee system according to current practice.

This is based on the fact that the committee system, under current legal status, only has the competence to approve concrete research projects.

The Personal Data Act, however, applies to the treatment of the extra material. Biobanks with a future research purpose must be reported to The Danish Data Protection Agency, and there are, among other things, requirements for sharing from a research biobank to other research projects, see The Danish Data Protection Agency's website. See also section 4.

It can be stated in the protocol that biological material is collected in connection with the experiment for a biobank for future unspecified research, but any separate information and consent material cannot be approved by the committee system. However, storage of biological material in a biobank for future research must always be reported to The Danish Data Protection Agency. See also section 6.3.1 on the subsequent possibility of researching this material (with exemption from the consent requirement).

5.4. Requirements When Sending Biological Material Abroad

5.4.1 General Requirements

In projects that involve the export of biological material and personal data, it is a condition that the project is conducted in accordance with the Personal Data Act (cf. committee law § 20, para. 1, no. 4 and no. 6).

Danish Personal Data Act applies if the data controller is established in Denmark. In some cases, data controllers established in third countries must appoint a representative established in Denmark – in these cases, the Personal Data Act also applies (Personal Data Act § 4, para. 4). See The Danish Data Protection Agency's guide on the geographical scope of the Personal Data Act

The committees will normally assume that it is the Danish trial responsible (in regional research – the region) or sponsor, who is the data controller (the one who decides the purpose and the means of processing the data), and that the data controller is established in Denmark. In these cases, the Personal Data Act will apply.

It is the trial responsible (in regional research – the region as data controllers) and/or sponsor who is responsible for ensuring that the information in the project material about the legal position regarding the protection of personal data is correct. If there is doubt about whether the Personal Data Act should be followed in the experiment, The Danish Data Protection Agency should be contacted. Reference is also made to The Danish Data Protection Agency's guide on the geographical scope of the Personal Data Act.

It must be stated in the protocol and in the participant information if biological material is transferred abroad, and that the rules of the Personal Data Act are followed, or if the Personal Data Act does not apply (e.g., if the data controller is established in another EU country), which country's legislation applies for the protection of personal data in the biological material. See the researcher's guide.

5.4.2 Sending to EU Countries

The Personal Data legislation in Denmark implements the European Parliament and Council Directive 95/46/EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

If the material is sent to another EU country, it should be stated in the protocol and in the participant information, and it should be informed if the other country's legislation on the protection of personal data applies.

5.4.3 Sending to Third Countries (Outside the EU)

A third country is a state that is not part of the European Community or the EEA cooperation. That is, countries outside the EU, which are not EEA countries, for example, the USA, but also the Faroe Islands and Greenland.

The transfer of personal data and biological material to a third country requires a specific legal basis under the Personal Data Act (§ 27). See more in The Danish Data Protection Agency's guide on transfers to third countries.

It is a condition for the approval of a research project that projects, in which biological material and information are performed to third countries, are carried out in accordance with the Personal Data Act. This follows from the committee law § 20, para. 1, no. 6).

It must therefore be stated in the protocol and participant information if biological material is sent to these countries, as well as it is assumed that the dispatch is carried out in accordance with the Personal Data Act, including § 27 of the Personal Data Act (cf. committee law § 20, para. 1, no. 6). See Information for Researchers.

It is the data controller who is responsible for ensuring that the transfer of biological material or information is carried out in accordance with the Personal Data Act.

5.4.4 What Applies if Sending Only Occurs for Analysis/Data Processing?

If the biological material is sent abroad solely for the purpose of having the material analyzed (service agreement), the Danish Personal Data Act will still apply.

In this situation, there is not a "disclosure" of information under the Personal Data Act, but a transfer of information to a data processor for carrying out the task on behalf of the data controller.

According to the Personal Data Act, a (data processor) agreement must be established, stating that the data processor only acts according to instructions from the data controller. If a public authority transfers information to a data processor, the security ordinance must be fulfilled.

Analyses abroad of the biological material should be described in the protocol and participant information, and it should be clearly stated what happens with any surplus material after the analysis abroad, including whether it is destroyed or returned to the trial responsible.

If there is also a dispatch to a third country, the above section 5.4.3 also applies.

5.5. When the Biological Material is to be Transferred to a New Data Controller

Special rules apply to the processing and transfer of personal data (including biological material) for research use.

Information processed for scientific or statistical purposes, according to the Personal Data Act § 10, para. 1 and 2, may, after para. 3, only be transferred to a third party – meaning a new data controller – after prior permission from The Danish Data Protection Agency and only for the purpose of conducting other statistical or scientific studies. The Danish Data Protection Agency may set specific conditions for the transfer. The Danish Data Protection Agency may also, in connection with a report of processing of personal data in a research project, take a general stance on future transfer.

Therefore, if a research biobank or material from it is desired to be transferred to a new data controller, permission from The Danish Data Protection Agency is required (Personal Data Act § 10, para. 3).

6.1. Exemption from the Consent Requirement

An exemption can be granted if:

• The project does not involve health risks or otherwise be a burden for the test subject under the circumstances, or
• It would be impossible or disproportionately difficult to obtain informed or proxy consent.

The committee must always make a specific assessment of the particular research project, thus protecting the individual's rights. See sections 6.2.1 and 6.3.1 about the practice of granting exemptions.

It follows from the legislative materials that this includes a scientific-ethical evaluation of whether it is justifiable to let the tissue donor's samples be included without new consent from them. In this evaluation, it should be considered whether it is in any way a burden for the person for these samples to be used for another purpose, including the possibility of new, clinically relevant information about the individual emerging.

The information in the previous participant information (about future research) cannot in itself form the basis for new research without renewed consent or exemption. However, the information in the previous participant information is part of the committee's assessment of whether an exemption can be granted.

The committee must also be aware of whether, for individual reasons (e.g., personal political or religious reasons), it would be scientifically unethical to let the previously collected material be included in a new research project without renewed consent.

In relation to assessing when it is impossible or disproportionately difficult to obtain informed consent, consideration is given to very large research projects or where a large number of tissue donors have passed away.

The rules on exemption from the consent requirement only apply to research projects that include biological material previously extracted from patients for treatment purposes (clinical biobank) or from test subjects in connection with a previously approved scientific research project (research biobank). It is also possible to grant an exemption if extra material has been extracted in connection with the above situations and informed about future research use.

6.2. Material from Clinical Biobanks

The rules on exemption from the consent requirement for research in material from clinical biobanks should be seen in conjunction with the rules in the Tissue Application Register in the Health Act, whereby patients can register a prohibition against further research in material extracted in connection with treatment (Health Act § 29, para. 1).

It is assumed that the patients have been informed about the rights regarding the extracted biological material at the time of extraction, including the possibility of being registered in the tissue application register (research prohibition). For example, the patient may have received the brochure "Your tissue, your choice" or similar on the ward.

If there is an extraction of extra biological material in connection with the treatment but for future research use (e.g., in a special biobank within a specific disease area), it is assumed that the patient has received information and has consented to this (possibly tacitly) in connection with the treatment situation. This information can be given as part of the general information on the ward or specifically in connection with the extraction of the extra material.

It is noted that the biobank responsible must always check whether a patient has registered a research prohibition in the tissue application register before handing out the patient's biological material for an approved scientific research project. Therefore, the protocol must state under what circumstances the biological material was collected and that the tissue application register will be checked. See Information for Researchers.

6.2.1 Exemption Practice – Clinical Biobanks

For research in biological material extracted from patients in connection with treatment (clinical biobank), the assessment of whether an exemption can be granted may include:

• Whether the material is extracted from patients for treatment purposes (and substantially within the same disease area as the research concerns),
• Whether the material is collected according to applicable rules, including Health Act chapters 5 and 7 about consent and the right to self-determination over biological material,
• The risk of new health-related findings (should be minimal or not burdensome),
• Whether a large part of the participants is assumed to have passed away.

6.3. Material Extracted in Previous Trials (Research Biobank)

If biological material has been extracted as part of a specific scientific research project, committees can exempt from the requirement for renewed consent for the use of this material.

This requires, according to practice, that participants in the previous project were informed and agreed that excess biological material from the experiment could be used for future research purposes.

In approving a request for exemption in the new scientific research project, the committee takes into account the rights of the test subjects.

The protocol in the new research project must state how the material was collected (journal number of the previous scientific research project where the material was collected), and the previously used participant information that forms the basis for the donation of the biological material must be attached along with approval from The Danish Data Protection Agency (see also the researcher guide).

It is noted that if the material comes from a previously approved research project, where it was informed to the test subjects that the material would be destroyed after use, then the material cannot be used for a new research project. This would be contrary to the agreement made with the test subject about the legal effects of participating in the experiment. See also section 5.1.

For the use of extra material extracted in connection with a specific research project, for future research purposes, it must likewise be assumed that the test subjects have been specifically informed and consented that the extra material will be used for future research purposes. Such information can be given as a separate written information (recommended) but is separate from the participant information in the approved research project. Such information may be part of the committee's assessment of whether an exemption from the informed consent requirement can be granted for the use of the extracted material.

6.3.1 Exemption Practice – Material from Previous Trials

For research in biological material collected by a (previous) approved project, the assessment of whether an exemption can be granted may include:

• The purpose and aim of the new project (must not deviate significantly from the original project from which the biological material was extracted),
• The risk of new health-related findings (should be minimal or not burdensome),
• Whether a large part of the participants is assumed to have passed away.

6.4. Other Types of Biobanks Established Outside of Treatment and Research Situations

There are several biobanks established outside of treatment and research situations, for example:

• Donor biobanks: e.g., blood biobanks, egg and sperm banks, organ banks for transplantation purposes,
• Biobanks for other health purposes (than treatment): e.g., stem cell biobanks,
• Biobanks established within the medicine and medical device industry, not used for treatment or research purposes,
• Biobanks for future research without connection to specific treatment or research situations (research registers).

It is not possible to apply for an exemption from the consent requirement for these types of biobanks, as the rule about exemption from the consent requirement (Committee Act § 10) only applies to research projects that include biological material previously extracted from patients for treatment purposes (clinical biobank), or from test subjects in connection with a previously approved scientific research project (research biobank).

There are special rules for donor arrangements with a clear treatment aim. Research in material from a donor biobank will therefore require specific consent from the donor.

The same applies to biobanks for other health purposes or biobanks for future research without connection to specific situations or treatment or research situations. Some of these biobanks may be covered by Health Act § 35, which states that a private enterprise collecting biological material for storage or drug production, etc., must ensure that there is a written agreement between the person providing the biological material and the enterprise unless otherwise provided by other legislation. It is stated in the legislative materials that the tissue donor must have freedom regarding consent when a specific research project is presented.

Read more about the framework for the committees' exemption practice in the letter of 2 July 2014 from the Ministry of Health and Prevention (appendix 1) and in Report No. 1414, on biobanks (May 2002).

6.5. Scheme with Overview of Exemption Possibilities and Information Requirements

The scheme below describes in an overview form the possibilities for exemption from the consent requirement when using biological material previously extracted and located in a biobank. At the same time, for each exception situation, it describes what consent and information requirements must be met in these cases.

The overview is based on a letter of 2 July 2014 from the Ministry of Health and Prevention on the legal framework for registry research with biological material (appendix 1).

Below are the requirements for research in imported biological material.

7.1. Reporting Requirement

A research project involving imported personally identifiable biological material must also be reported. The decisive factor is that the research activity takes place in Denmark.

If a researcher wishes to investigate biological material from abroad (e.g., from a clinical biobank) with the aim of creating new knowledge about a disease area, etc., it must be reported to the regional scientific ethics committee.

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

Regarding imported cell lines that have already obtained approval in connection with previously approved experiments, the requirements in section 3.1.2 apply. However, if there is no written documentation from the seller that the biological material has been collected and transferred for research purposes in accordance with the national law of the country of origin, the project must be reported to the committee system under the general rules on research in biological material (section 6 on research in previously extracted biological material and below).

7.2. Requirements for the Research Project

The starting point is that the Danish rules in the Committee Act will be applied analogously. This means that the frameworks or prohibitions that the Danish Committee Act or special law establishes for the research will also form the basis for the ethical assessment of research in the material imported from abroad.

The responsible parties for the experiment must ensure that it can be documented to the committee that the imported material has been extracted or collected in an ethically justifiable manner, for example, by the company or institution from which the responsible parties purchase or receive the material issuing a statement that the material has been collected in accordance with the legislation of the country of origin, and that it can be exported from the country according to its legislation.

If the material comes from abroad, the application must be accompanied by:

• Information about the country from which the material originates,
• A statement that the material has been legally extracted according to the rules of the country from which the material originates, and
• A statement that the material has been legally exported from the country from which the material originates.

Letter dated July 2, 2014, from the Ministry of Health and Prevention on legal frameworks for registry research with biological material.