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Act on Medical and Health Research (Health Research Act)
Date LOV-2008-06-20-44
Department of Health and Care Services
Last amended LOV-2020-12-04-133 from 01.06.2021
Published in 2008 issue 6
Entry into force 01.07.2009
Announced 20.06.2008 at 14.40
Short title Helseforskningsloven - hforsknl

Chapter overview:
Chapter 1. Purpose and scope of the Act (§§ 1 - 4)
Chapter 2. Requirements for the organization and practice of medical and health research (§§ 5 - 8)
Chapter 3. Application and reporting obligation to the regional committee for medical and health research ethics (§§ 9 - 12)
Chapter 4. Consent (§§ 13 - 21)
Chapter 5. Research involving humans (§§ 22 - 24)
Chapter 6. Research biobanks and research involving human biological material (§§ 25 - 31)
Chapter 7. Research on health information (§§ 32 - 38)
Chapter 8. Openness and transparency in research (§§ 39 - 45)
Chapter 9. Supervision (§§ 46 - 49)
Chapter 10. Compensation, orders, penalties, etc. (§§ 50 - 54)
Chapter 11. Final provisions (§§ 55 - 56)

See also Law 28 Apr 2017 No. 23. Sml. Law 21 Feb 2003 No. 12.

Chapter 1. Purpose and scope of the Act
§ 1. Purpose
The purpose of the Act is to promote good and ethically sound medical and health research.

§ 2. The objective scope of the Act
The law applies to medical and health research on humans, human biological material or health information. Such
research also includes pilot studies and experimental treatment.
For the processing of health information, the Privacy Ordinance and the Personal Data Act with regulations in it apply
to the extent not otherwise provided by this Act. For information that is confidential afterthe Health Personnel Act § 21 , and for
information about deceased persons, the provisions of this Act on the processing of health information apply as far as they are appropriate. The law
does not apply to the establishment of health registers.
Section 3 of the Medicines Act applies to clinical trials of medicinal products in humans . For clinical trials of
medical equipment applies to the Medical Equipment Act with regulations. The law here applies in addition as far as it is appropriate.
The Ministry may issue regulations on the application of the Act for special areas within medical and health research.
0 Modified byLaws of 22 June 2018 No. 76, 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 3. The geographical scope of the Act
The law applies to research on Norwegian territory or when the research takes place under the auspices of a research manager established in Norway.
The King may in regulations determine the extent to which the Act applies to Svalbard and Jan Mayen.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 4. Definitions
For the purposes of this Act:
a) medical and health research: activities carried out with scientific methodology to obtain new knowledge about
health and disease,
b) human biological material: organs, parts of organs, cells and tissues and constituents of such material from living and dead
human beings,
(c) "research biobank" means a collection of human biological material used in or to be used in a research project
research,
d) health information: personal information about a natural person's physical or mental health, including the performance of
health services, which provide information about the person's state of health, cf. the Privacy Ordinance Article 4 no. 15
e) research manager: an institution or other legal or natural person who has the overall responsibility for
the research project, and which has the necessary prerequisites to be able to fulfill the research supervisor's obligations under
this law,
f) project manager: a natural person responsible for the day-to-day running of the research project, and who has the necessary
the research qualifications and experience to be able to fulfill the project manager's obligations under this Act.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

Chapter 2. Requirements for the organization and practice of medical and health research
§ 5. Properness
Medical and health research must be organized and carried out properly.
The research must be based on respect for the research participants' human rights and human dignity. Consideration for
the welfare and integrity of the participants shall take precedence over the interests of science and society.
Medical and health research shall take care of ethical, medical, health, scientific and privacy matters.

§ 6. Main requirements for organizing research
Medical and health research shall be organized with a research manager and a project manager and described in one
research protocol. Sources of funding must be stated in the minutes.
Internal control must be carried out adapted to the company's size, uniqueness, activities and risk conditions.
The Ministry may issue regulations with further requirements for the organization of medical and health research, requirements for
the research protocol and for internal control, as well as provide provisions on the duties of the project manager and research manager.

§ 7. Duty of confidentiality
Anyone who has access to health information and other personal information that is processed in a research project must prevent
that others gain access to or knowledge of the information.
The duty of confidentiality does not prevent information from being made known to the person to whom it directly applies or disclosed when the recipient has
legal basis for having the information disclosed, cf. § 13.

§ 8. Commercial exploitation
Commercial exploitation of research participants, human biological material and health information as such is prohibited.

Chapter 3. Application and notification obligation to the regional committee for medical and health sciences
research ethics
§ 9. Requirement for prior approval
The research project must be pre-approved by the regional committee for medical and health research ethics, cf.
Research Ethics Act § 10 first paragraph.
0 Modified bylov 28 apr 2017 nr. 23 (ikr. 1 mai 2017 acc.res. 28 Apr 2017 No. 505).

§ 10. Application for prior approval
An application for prior approval of a research project must be sent together with the research protocol to the regional
the Committee for Medical and Health Research Ethics.
The regional committee for medical and health research ethics shall make a general research ethics assessment of
the project, and assess whether the project meets the requirements set out in this Act or pursuant to this Act. The Regional Committee for
Medical and health research ethics can set conditions for approval, including measures to protect the data subjects
fundamental rights and interests.
Decisions regarding prior approval can be appealed to the National Research Ethics Committee for Medicine and Health Sciences, cf.
Research Ethics Act § 10 third paragraph.
The Ministry may issue regulations on requirements for the application, on case processing deadlines for the regional committee for medical and
health research ethics, and on the detailed conditions for prior approval.
0 Modified bylover 28 Apr 2017 No. 23 (ikr. 1 May 2017 acc.res. 28 Apr 2017 no. 505 ), 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no.
1195).

§ 11. Application to make significant changes to the research project
If the project manager wishes to make significant changes in the research project's purpose, method, time course or organization,
The application is sent to the regional committee for medical and health research ethics, which has given prior approval. The application
shall describe what changes are desired to be made and the reasons for these.
The regional committee for medical and health research ethics decides whether the application should be approved. If the changes of
the project is so large that it must be considered a completely new project, the regional committee for medical and health professional
research ethics determine that prior approval must be applied for pursuant to section 9 , cf. section 10 , again.
The Ministry may issue regulations on requirements for case processing and on case processing deadlines.

§ 12. Final report and reports
The project manager must send a final report to the regional committee for medical and health research ethics when
the research project ends. In the final report, the results must be presented in an objective and accountable manner, which ensures that both
positive and negative findings emerge.
The regional committee for medical and health research ethics may set requirements for the content of the final report.
The regional committee for medical and health research ethics may order the project manager to submit annual or extraordinary
reports if the committee deems it necessary.

Chapter 4. Consent
§ 13. Main rule of consent
The consent of participants in medical and health research is required, unless otherwise provided by law.
By consent is meant any voluntary, specific, informed and unambiguous expression of will from the participant where the person in question by a
statement or clear confirmation gives its consent to the processing of health information or human biological material. The consent
shall be based on specific information about a specific research project unless it is permissible to give a broad consent, cf. § 14 .
If the research participant can be considered to be in such a dependent relationship with the person requesting consent, that
the research participant may feel pressured to give consent, the informed consent must be obtained from another
the research participant does not have such a relationship with.
The Ministry may issue regulations on requirements for consent.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 14. Broad consent
Research participants can consent to § 13 for human biological material and health information to be used for further purposes
specific, broadly defined research purposes.
The Regional Committee for Medical and Health Research Ethics may set conditions for the use of broad consent and may impose
project manager to obtain new consent if the committee deems it necessary.
Participants who have given broad consent are entitled to regular information about the project.

§ 15. New or changed use of collected human biological material or health information
In the event of significant changes in the research project, new consent must be obtained accordingly § 13 if the changes are assumed to have
significance for the participant's consent.
If it is difficult to obtain new consent, the regional committee for medical and health research ethics may
approve new or changed use of previously collected human biological material or health information without new consent
obtained. This can only happen if such research is of significant interest to society and consideration for the participants' welfare and
integrity is safeguarded. The regional committee for medical and health research ethics may set conditions for its use.

§ 16. Withdrawal of consent
A consent to participate in a research project can be withdrawn at any time.
Upon withdrawal of consent, research on the person's biological material or health information must cease. It
who has withdrawn their consent may demand that the biological material be destroyed and that the health information be deleted or
delivered within 30 days.
The right to demand destruction, deletion or extradition pursuant to the second paragraph does not apply if the material or information is
anonymised, if the material after processing is included in another biological product, or if the information is already included in
performed analyzes.
If particularly strong societal or research considerations so require, the Regional Committee for Medical and Health Sciences may
research ethics allow continued research on the material and postponed destruction, deletion or disclosure to the research project is
completed.

§ 17. Who has consent competence
The right to consent to participation in medical and health research has:
a) persons over 18 years of age, unless otherwise provided in the sixth paragraph, and
b) persons between 16 and 18 years of age, unless otherwise provided by special legal provisions or by the nature of the measure.
Consent competence pursuant to the first paragraph may lapse in situations as referred to in patient and User Rights Act § 4-3 second
joint.
Parents or others with parental responsibility must consent to research with minors between the ages of 16 and 18 which involves
physical intervention or drug testing.
For consent to research that includes participants under the age of 16, the consent provisions in patient and
the Users' Rights Act § 4-4 corresponding. If children between the ages of 12 and 16, for reasons that should be respected, do not want their parents,
others with parental responsibility or the child welfare service are made aware of information about the child, this shall be taken care of.
For persons without consent competence pursuant to the Patient and User Rights Act § 4-3 second paragraph, the next of kin pursuant to
the Patient and User Rights Act § 1-3 letter b consent.
For persons who have been deprived of legal capacity in the personal area, patient and the Users' Rights Act § 4-7
equivalent.
The Ministry may stipulate in regulations that for special types of research projects, children between the ages of 12 and 16 may consent to them
research on health information. The Ministry may in regulations issue further rules on the requirements for such consent.
0 Modified bylover 14 Nov 2008 No. 80 ,24 June 2011 no. 30 (ikr. 1 Jan 2012 acc.res. 16 December 2011 No. 1252 ),March 26, 2010 No. 9 (ikr. July 1, 2013 according to Res. 5
Apr 2013 No. 338 ) as amended by Act 5 Apr 2013 No. 12 .

§ 18. Conditions for research that includes persons without consent competence
Research that includes minors and persons without consent competence according to patient and the User Rights Act § 4-3 can
only take place if
a. any risk or inconvenience to the person is negligible,
b. the person himself does not oppose it, and
c. there is reason to believe that the results of the research may be of benefit to the person concerned or to other persons with
same age-specific disorder, disease, injury, or condition.
For minors, it is required that similar research cannot be carried out on persons who are not minors.
For persons without consent competence, it is required that there is no reason to believe that the person in question would oppose participation in
the research project if the person in question had had consent competence, and that similar research cannot be carried out on
persons with consent competence.
0 Modified byAct of 24 June 2011 No. 30 (ikr. 1 Jan 2012 according to Res. 16 Dec 2011 No. 1252).

§ 19. Consent to research in clinical emergencies
In clinical emergencies where the patient is unable to give consent, and where it is impossible to obtain consent from
the person's next of kin, research can only take place if
a) any risk or inconvenience to the person is negligible,
b) the person himself does not oppose it, and there is no reason for researchers or other personnel to believe that the person in question would have
opposed this if the person in question had had consent competence,
c) it is only possible to carry out the research in clinical emergencies, and
d) the research is undoubtedly justified due to the prospect of results with great preventive, diagnostic or therapeutic
value.
The person or his next of kin shall be given information about the research as soon as possible. Consent after§ 13 ,
cf. § 17 , is a prerequisite for further research and must be obtained as soon as possible.

§ 20. Anonymised human biological material and health information
Consent is not required for the use of anonymous human biological material and anonymous information. For obtaining
material and information that will later be anonymised, consent is required according to the chapter here.

§ 21. Research on human biological material from the dead
For research on biological material taken from the deceased, applies Autopsy Act § 7 first to third paragraphs on information and
the next of kin's right to refuse an autopsy, etc.
0 Modified bylover 7 May 2015 no. 26 (ikr. 1 Jan 2016 acc.res. 13 Nov 2015 No. 1289), 16 June 2017 no. 54 (ikr. 1 July 2017 according to res. 16 June 2017 no. 761).

Chapter 5. Research involving humans
§ 22. General provisions on research on humans
Research on humans can only take place if there are no alternative methods that are nearly as effective.
Before conducting research on humans, a thorough assessment of risk and strain for the participants must be made. These must
be in proportion to the foreseeable benefits for the research participant himself or for other people.
Research should be stopped if it turns out that the risk is greater than possible benefits, or if there are sufficient
evidence for positive and beneficial results.
Research can only be combined with treatment if the research is assumed to have health-promoting value for the research participant.
The benefits, risks, strains and efficacy of a new method should be weighed against the best methods of prevention,
diagnostics and treatment that are available at all times, unless particularly weighty considerations so require.

§ 23. Duty to report unwanted medical incidents
The project manager must immediately notify the supervisory authorities in writing of serious as well as unwanted and unexpected medical
events that are believed to be related to the research.
The project manager, other researchers and other personnel shall, on their own initiative, provide the supervisory authorities with information on matters that may arise
endanger the safety of research participants. In the event of an unnatural death, the police must be notified immediately.

§ 24. Duty to provide information to participants in the event of injuries and the like
The project manager must immediately inform the research participants if they have been harmed or have occurred
complications as a result of the research project.
The project manager must also inform the research participant of the right to apply for compensation from Norsk
Patient injury compensation and other insurance schemes.

Chapter 6. Research biobanks and research involving human biological material
§ 25. Establishment of research biobanks
A research biobank can only be set up after being approved by the Regional Committee for Medical and Health Sciences
research ethics.
Research biobanks established in connection with the collection, storage and use of human biological material as a
part of a research project, shall be described in the project's research protocol.
Research biobanks established in connection with the collection and storage of human biological material without
connection to a specific research project, must be approved by the regional committee for medical and health research ethics.
The same applies to research biobanks to be used for storage and new use of human biological material, when the original
the purpose of a research project is fulfilled.
The Ministry may in regulations issue provisions on what applications for the establishment of research biobanks shall contain.
The Ministry may in regulations issue regulations on the establishment and other processing of human biological material in biobanks
which are connected to health registers according to the Health Register Act §§ 8 to 11.
0 Modified byAct of 20 June 2014 No. 43 (ikr. 1 Jan 2015 according to Res. 19 Dec 2014 No. 1732).

§ 26. Responsible
Each research biobank must have a responsible person with a higher degree of medical or biological education. It
research leaders must appoint those responsible.
The Ministry may in regulations decide that certain research biobanks in addition to the responsible person shall have a board and
detailed rules.
The person in charge, the person responsible for research and the board shall ensure that the research biobank is established and managed in accordance with
this and other laws.

§ 27. Requirements for storage and processing
Material in research biobanks must be stored and treated properly. Storage and treatment must be done with respect for
the donor of the material.
Human biological material from research biobanks cannot be handed over for insurance purposes, to the employer, to the prosecuting authority
or to court, even if the material originates from consent to it.
The King may in regulations decide that the disclosure of human biological material to the prosecuting authority or court in exceptional cases
can happen if very overriding private or public interests do so rightfully.
The Ministry may in regulations issue further rules on how human biological material in a research biobank shall be stored
and treated.

§ 28. Access to the use of biological material collected in the health and care service for research
The Regional Committee for Medical and Health Research Ethics may decide that human biological material collected in
the health and care service as part of diagnosis and treatment, can or shall be used for research purposes without obtaining
patient consent. This can only happen if such research is of significant interest to society and the interests of the participants
welfare and integrity are safeguarded. The regional committee for medical and health research ethics may set conditions for its use.
The patient must have been informed in advance that human biological material can in certain cases be used for research and must have
have been given the opportunity to reserve themselves for research on human biological material.
An electronic register shall be established with an overview of the patients who have reserved themselves against their biological
material is used for research.
0 Modified byAct of 24 June 2011 No. 30 (ikr. 1 Jan 2012 according to Res. 16 Dec 2011 No. 1252).

§ 29. Transfer of human biological material to and from abroad
Human biological material from a research biobank can only be sent out of the country or taken into the country after approval from the
the Regional Committee for Medical and Health Research Ethics, and it can be demonstrated that the requirements for consent in Chapter 4 and the requirements
for the processing of health information in Chapter 7 is met.
The Ministry may, in regulations, make exceptions from the requirement for approval for the transfer of biobank material that is part of general
international cooperation.
The Ministry may in regulations set conditions for the submission and distribution of human biological material, and on the use of material
from abroad to research in Norway.

§ 30. Termination, closure or takeover of research biobank
The person responsible for research shall apply to the regional committee for medical and health research ethics for permission to discontinue,
closure or takeover of research biobank. The regional committee for medical and health research ethics must
approve the procedure in the event of destruction.
The Ministry may in regulations provide that human biological material in certain cases may be transferred to others
research managers instead of being destroyed.

§ 31. Other people's access to the material in a research biobank
The research manager shall give other researchers access to human biological material in the company's research biobanks, with
unless the person responsible for the research himself needs the material or other special reasons apply. Before the delivery of
material can take place, the necessary approvals must be followed Chapter 3 is available.
In assessing whether there are special reasons pursuant to the first paragraph, emphasis shall be placed on the quality and relevance of the research
in relation to the purpose of the research biobank. Emphasis must be placed on statutory obligations regarding the storage and processing of the material,
consideration for the material donor and the research leader's need for the material.
If the person responsible for the research biobank rejects the request for access, the decision can be appealed to the regional
the committee for medical and health research ethics that has approved the establishment of the research biobank. The committee's decision may
not appealed.

⎙

Chapter 7. Research on health information
§ 32. Main rule for processing health information
The processing of health information in medical and health research shall be in accordance with the principles in
Article 5 of the Privacy Regulation and have explicitly stated purposes. The health information must be relevant and necessary to reach
the purpose of the research project. The degree of personal identification for health information shall not be greater than necessary to achieve
the purposes.
Health information cannot be used for purposes that are incompatible with the original purpose without the research participant
agrees, unless otherwise provided by law.
Health information may not be disclosed for insurance purposes, to the employer, to the prosecuting authority or to a court, even if it
the information derives from consent to it.
The King may in regulations decide that the disclosure of health information to the prosecuting authority or court may take place in exceptional cases.
if very weighty private or public interests do so rightfully.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 33. Requirement for prior approval
Processing of health information in medical and health research requires prior approval from the regional committee
for medical and health research ethics according to Chapter 3 .
The Personal Data Act § 10 and § 11 second paragraph do not apply to medical and health research.
0 Modified bylover 20 June 2014 no. 43 (ikr. 1 Jan 2015 acc.res. 19 Dec 2014 No. 1732), 15 June 2018 no. 38 (i.e. 20 July 2018 according to announcement 17 July 2018
No. 1195), 4 Dec 2020 No. 133 (ikr. 1 June 2021 acc.res. 21 May 2021 No. 1578).

§ 34. Processing of health information
Health information can be compiled, made available and processed in other ways in line with the research project's purpose,
any consents, the prior approval after § 33 and in accordance with the research protocol.
The regional committee for medical and health research ethics may, in the approval pursuant to Chapter 3, refuse such
compilation, making available or other treatment if this is found to be medically or ethically unjustifiable.
0 Modified bylaws 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195),4 Dec 2020 No. 133 (ikr. 1 June 2021 according to res. 21 May 2021
No. 1578 ).

§ 35. (Repealed by Act 4 Dec 2020 no. 133. )
0 Modified bylover 24 June 2011 no. 30 (ikr. 1 Jan 2012 acc.res. 16 Dec 2011 No. 1252), 15 June 2018 no. 38 (i.e. 20 July 2018 according to announcement 17 July 2018
no. 1195), repealed by Act 4 Dec 2020 no. 133 (ikr. 1 June 2021 according to res. 21 May 2021 no. 1578 ).

§ 36. Correction of health information etc.
The data subject may demand correction or deletion in accordance with Articles 16 and 17 of the Privacy Ordinance. The exception in the Personal Data Act
§ 17 second and third paragraphs apply.
The project manager must, on his own initiative, correct incorrect information, update obsolete information and supplement incomplete information
information.
Incorrect and outdated information must be deleted or changed in a way that allows the change to be traced. Complete deletion of
inaccurate and outdated information can only occur if it is demanded by someone to whom the information may have a direct impact, and
the deletion does not have a decisive effect on the validity or representativeness of the research results.
Claims for deletion are decided by the project manager. If deletion is refused, the decision can be appealed to the regional committee
medical and health research ethics.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 37. (Repealed by Act of 15 June 2018 no. 38.)
0 Repealed by Act 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 38. Prohibition against storage of unnecessary health information
Information shall not be stored longer than is necessary to carry out the project. The Regional Committee for
medical and health research ethics may determine that documents necessary for follow-up of the project shall:
kept for five years after the final notification has been sent to the committee. If information is not then to be stored in accordance with the Archives Act
or other legislation, they shall be anonymised or deleted.
The Regional Committee for Medical and Health Research Ethics may decide that the information shall be kept for longer
time than that which follows from the first paragraph. Terms can be attached to such a decision.
The Ministry may issue regulations on the storage of information after the research project has been completed.

Chapter 8. Openness and transparency in research
§ 39. Transparency
The research manager and project manager must ensure transparency around the research.

§ 40. Right of access for research participants
The research participant has the right to access health information about himself or herself in accordance with Article 15 of the Privacy Ordinance.
also the right to access the security measures in the processing of health information as long as access does not impair security.
The information provided is to be presented in a manner that is adapted to the individual's abilities and needs.
The research participant may demand that the project manager elaborate on the information as mentioned in the first paragraph to the extent that this is necessary for
the research participant must be able to look after their own interests.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 41. The public's right of access
Everyone should contact the regional committee for medical and health research ethics to find out which ones
research projects under this Act that a research manager or project manager is or has been involved in, as well as the purpose of
the project.

§ 42. Exemption from access
The exceptions in § 16 and 17 of the Personal Data Act from the right to information and access and from the duty to notify breaches
personal data security, applies correspondingly to access pursuant to sections 40 and 41 of this Act.
Rejection of requests for access and information can be reviewed by the regional committee for medical and health professionals
research ethics.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 43. Deadline for inspection
The project manager must respond to inquiries about access §§ 40 and 41 without undue delay and no later than 30 days from
the day the inquiry came in.
If special circumstances make it impossible to respond to the inquiry within 30 days, the implementation may be postponed until it is
possible to provide answers. In that case, the project manager must provide a preliminary answer with information about the reason for the delay and the probable time
for when answers can be given.

§ 44. Public list of research projects and research biobanks
The regional committee for medical and health research ethics shall keep a systematic list of registered and
completed research projects based on information in the application and final report, cf. §§ 10 , 11 and 12. The registers shall be public
available.
The regional committee for medical and health research ethics shall register all research biobanks
The Biobank Register at the National Institute of Public Health.

§ 45. Deferred publication
The research manager and project leader can apply to the regional committee for medical and health research ethics
deferred disclosure where necessary to protect legitimate patent or competition interests, or by
with regard to ongoing research work. It must be stated from which time publication can take place.
The regional committee for medical and health research ethics may decide that sensitive information about a project
shall not be included in the register pursuant to section 44 or may not be required to be accessed pursuant to§§ 40 and 41 for a clearly delimited period of time, if
publicity can harm significant private or public interests. In that case, the committee shall, at the same time as the rejection of the request for access, grant
information on the time from which access can be granted. Only in special cases can the time period be extended.

Chapter 9. Supervision
§ 46. The authority of the Norwegian Board of Health Supervision
The Norwegian Board of Health Supervision supervises medical and health research and the management of research biobanks.

§ 47. The Data Inspectorate's authority
The Norwegian Data Protection Authority supervises the use of health information pursuant to this Act in accordance with the Privacy Ordinance and
the Personal Data Act.
When the Data Inspectorate has issued an order, the Norwegian Board of Health Supervision shall be informed of this.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 48. Duty to provide information to the supervisory authorities
The research manager, project manager and other personnel involved in a research project must provide
the supervisory authorities access to the company's premises, and without prejudice to the duty of confidentiality give and make available to
the supervisory authorities all information, documents, material and the like that are considered necessary for the exercise of supervision of medical
and health research.

§ 49. The supervisory authorities' duty of confidentiality
The supervisory authorities and others who perform services for the supervisory authorities have a duty of confidentiality pursuant to section 7 . The duty of confidentiality
also includes information on safety measures.

Chapter 10. Compensation, orders, penalties etc.
§ 50. Compensation
For injuries to people that occur during medical trials, the rules of the Patient Injuries Act apply correspondingly.
The person responsible for the research shall compensate for damage that has occurred as a result of human biological material being treated in violation
with provisions given in or pursuant to the law, unless it is proven that the damage is not due to fault or negligence on the part
side of the research leader. The compensation shall correspond to the financial loss that the injured party has suffered as a result of the illegal
the treatment of the human biological material. The person responsible for research may also be ordered to pay such compensation for damages
non-economic nature (redress) that seems reasonable.
The data controller and the data processor shall compensate for damages that have arisen as a result of health information being processed in
in violation of the Privacy Ordinance, cf. Article 82 of the Ordinance. The responsibility applies correspondingly to the processing of health information in
violation of this law or regulations issued pursuant to the law.
For research managers and data controllers who are private, insurance must provide security for the financial responsibility
which may occur under the second and third paragraphs.
The Ministry may in regulations issue further provisions on the obligation to insure.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 51. The Norwegian Board of Health Supervision's right to issue orders for rectification and stoppage, etc.
If research projects or research biobanks are run in a way that can have harmful consequences for research participants
or others, or is otherwise unfortunate or unjustifiable, the Norwegian Board of Health Supervision may order that the situation be rectified. If
The Norwegian Board of Health Supervision finds it necessary, an order can be issued to stop the research project or close down
the research biobank. The Ministry can take over the further operation.
The rules on appeal and reversal in Chapter VI of the Public Administration Act shall apply correspondingly to orders pursuant to the first paragraph. The complaint must
is given suspensive effect, unless the Norwegian Board of Health Supervision decides that the decision shall be implemented immediately.
When the Norwegian Board of Health Supervision has issued an order, other supervisory authorities shall be informed of this if the research project also
falls within their area of ​supervision.

§ 52. The Data Inspectorate's right to make decisions on infringement fines
When processing health information in violation of the Act or regulations issued pursuant to the Act, the Data Inspectorate may impose
infringement fines under Article 83 of the Privacy Regulation and the Personal Data Act §§ 26 and27 .
When the Data Inspectorate has made a decision pursuant to the first paragraph, the Norwegian Board of Health Supervision shall be informed of this.
0 Modified byAct of 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no. 1195).

§ 53. Coercive fine
The Norwegian Board of Health Supervision may determine an ongoing coercive fine for each day, week or month that elapses after the expiry of the deadline that
is set for fulfillment of the order pursuant to § 51, until the order is fulfilled. A coercive fine can also be set as a one-off fine. Statens
health inspections may waive an accrued coercive fine. The coercive fine does not run until the appeal deadline has expired. If the decision is appealed, it does not run
the coercive fine before the appellate body has decided so.
The Norwegian Data Protection Authority may determine coercive fines pursuant to section 29 of the Personal Data Act .
Due contributions to cover the expenses are a compulsory basis for disbursement.
0 Modified byAct of 19 June 2009 No. 73 (ikr. 1 July 2009 according to Res. 26 June 2009 No. 866), 15 June 2018 no. 38 (ikr. 20 July 2018 according to announcement 17 July 2018 no.
1195).
Page 2

§ 54. Punishment
Fines or imprisonment for up to one year or both are punishable by anyone who intentionally or with gross negligence violates the provisions of
the law or regulations issued pursuant to it.
In particularly aggravating circumstances, imprisonment for up to three years can be imposed. In deciding whether it is particularly present
aggravating circumstances, emphasis shall be placed, among other things, on the danger of great harm or inconvenience to the research participant, the
the intended gain in the infringement, the duration and extent of the infringement, the guilt shown, and whether the person in question has previously been punished for
have violated similar provisions.
0 Modified byAct of 19 June 2015 no. 65 (ikr. 1 Oct 2015).

Chapter 11. Final provisions
§ 55. Entry into force and transitional rules
1 King may decide that the individual provisions of the Act shall enter into force
The law comes into force from the time the King decides. The

different time.
The King may issue transitional rules in regulations.
1 From 1 July 2009 according to res. June 26, 2009 No. 865.

§ 56. Amendments to other laws
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