Act Relating To Medical And Health Research (The Health Research Act)

Original Language Title: Lov om medisinsk og helsefaglig forskning (helseforskningsloven)

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Read the untranslated law here: https://lovdata.no/dokument/NL/lov/2008-06-20-44

Act relating to medical and health research (the Health Research Act)


Date LOV-2008-06-20-44


Ministry of Health and Care Services

Edited

LOV-2015-05-07-26 from 01.01.2016, LOV-2015-06-19-65 from 10/01/2015


Published in 2008 Booklet 6


Commencement 01/07/2009

Changes


Promulgated
20.06.2008 kl. 14.40

Short Title
Health Research Act - hforsknl.

Chapter Overview:

Chapter 1. Purpose and scope (§§ 1-4)
Chapter 2. Requirements for the organization and provision of medical and health research (§§ 5-8)
Chapter 3. Application and notification to the regional committee for medical and health research (§§ 9-12)
Chapter 4. Consent (§§ 13-21)
5. Research involving human beings (§§ 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. Audit (§§ 46-49)
Chapter 10. Compensation, orders, punishment mm (§§ 50-54)
Chapter 11. Final provisions (§§ 55-56) || |
See also Law 30 June 2006 No.. 56. Sml. Law February 21, 2003 No.. 12.

Chapter 1. Purpose and scope

§ 1. Purpose The purpose is to promote good and ethically sound medical and health research.

§ 2. Substantive scope This Act applies to medical and health research on humans, human biological material or health information. Such research also includes pilot studies and experimental treatments.
Act does not apply for the establishment of health records.
To the extent not otherwise provided by this Act, the Personal Data Act and regulations as supplementary provisions. Clinical testing of drugs on humans comes Medicines Act § 3 with regulations. Clinical testing of medical devices legislation on medical devices regulations. This Act applies complementary mutandis.
Ministry may issue bestemmeler1 on the application of specific areas within medical and helsefagelig2 research.

§ 3. The territorial scope This Act applies research on Norwegian territory or if the research is being managed by a research manager who is established in Norway.
The law does not apply to the use of health information as the entity responsible for research is established in another state within the European Economic Area. The law does not apply to the use of health information as the entity responsible for research is established in a country outside the European Economic Area and the institution does not use aids in Norway for more than mere transmission of health information.
King may by regulations determine to what extent the Act applies to Svalbard and Jan Mayen.

§ 4. Definitions For the purposes of this Act with:

A)
medical and health research: activities undertaken with scientific methodology to acquire new knowledge about health and disease,

B)
human biological material, organs, parts of organs, cells and tissues and parts of such material from living and dead people,

C)
biobank: a collection of human biological material used in a research or be used for research,

D)
health information: confidential information pursuant to the Health § 21 and other information and reviews about health conditions or which are of significance for health conditions that can be linked to an individual,

E)
research responsible: institution or another legal or natural person who has the overall responsibility for the research and who have the necessary prerequisites to fulfill the research administrator's duties under this Act,

F)
project: an individual responsible for the daily operations of the research project, and who have the necessary research qualifications and experience to fulfill the project manager's duties under this Act.

Chapter 2. Requirements for the organization and provision of medical and health research

§ 5. proper medical and health research should be organized and exercised prudent.
The research will be based on respect for research participants human rights and human dignity. The participants' welfare and integrity must prevail science and society.
Medical and health research should safeguard ethical, medical, health care, scientific and policy aspects.

§ 6. Main Requirements to the organization of research, medical and health research should be organized with a research manager and a project manager and is described in a research protocol. Funding sources must be stated in the protocol.

There shall be internal tailored to size, characteristics, activities and risks.
Ministry may issue regulations with further demands on the organization of medical and health research, requirements for the research protocol and the internal as well as provide provisions for the project manager and research administrator's duties.

§ 7. Confidentiality Anyone can access health records and other personal data are processed in a research project should prevent others from gaining access to or knowledge of the information.
Confidentiality obligation shall not prevent the information from being made known to those they directly apply or disclosed when the recipient has a legal basis to get the information disclosed, cf. § 13.

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

Chapter 3. Application and notification to the regional committee for medical and health research ethics

§ 9. Requirements for prior research project must be approved by the regional committee for medical and health research, cf. Act 30 June 2006 no. 56 on ethics and integrity in research § 4.

§ 10. Application for approval Application for approval of a research project together with the research protocol submitted to the regional committee for medical and health research.
The regional committee for medical and health research should make a general research ethics review of the project and 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 may impose conditions for approval.
Decisions regarding pre-approval may be appealed to the National Research Ethics Committee for Medical and Health Sciences, ref. Law 30 June 2006 No.. 56 on ethics and integrity in research § 4.
Ministry may issue regulations on application requirements , procedural time limits for the regional committee for medical and health research, and whether the conditions for approval.

§ 11. Application to make substantial changes of the research project If the project manager wants to make substantial changes to the research project purpose, methodology, timeframe or organization, application shall be submitted to the regional committee for medical and health research that has given prior approval. The application must describe the desired changes made and the reasons for these.
The Regional Committee for Medical Research Ethics determines whether the application should be granted. If the changes of the project is so large that it must be considered as a new project, the Regional Committee for Medical Research Ethics decide that it must be applied for prior authorization in accordance with § 9, ref. § 10, again.
Ministry may issue regulations on procedural requirements and procedural deadlines.

§ 12. Final report and reports project manager must submit a final report to the regional committee for medical and health research when the research ends. In its final report, results are presented in an objective and accountable manner, which ensures that both positive and negative findings stated.
The regional committee for medical and health research ethics may impose requirements for the contents of the final report.
The Regional Committee for Medical Research Ethics can impose project to submit annual or extraordinary reports if the committee deems this necessary.

Chapter 4. Consent

§ 13. General rule on consent requires the consent of participants in medical and health research, unless otherwise provided by law.
The consent must be informed, voluntary, explicit and verifiable. The consent must be based on specific information about a specific research project unless it is to cast a wide consent, cf. § 14
If the research participant may be considered in such a dependent relationship with the person requesting consent, the research participant will could feel pressured to give consent, the informed consent is obtained by another research participant does not have such a relationship.
Ministry may issue regulations on requirements for consent.

§ 14. Wide acceptance Research participants may consent under § 13 of human biological material and health data used for specific, broadly defined research purposes.
The regional committee for medical and health research ethics may attach conditions to the use of broad consent and may impose project 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 human biological material or personal health data event of significant changes in the research project must be renewed consent pursuant to § 13 if the changes are believed to be important for the participant's consent.
If it is difficult to obtain new consent, the regional committee for medical and health research approve new or changed use of previously collected human biological material or personal health information without new consent obtained. This can only happen if such research is of significant interest to the community and the participants' welfare and integrity is safeguarded. The Regional Committee for Medical and Health Research to impose conditions on its use.

§ 16. Withdrawal of consent Consent to participate in a research project may at any time be withdrawn.
By withdrawal of consent must research on their biological material or personal health data cease. Whoever has withdrawn his consent, may require that the biological material is destroyed and that health information is deleted or delivered within 30 days.
Right to demand destruction, deletion or disclosure by the second paragraph does not apply if the material or information is anonymous, if the material after processing forms part of another biological product, or if the information is already entered in the analyzes performed.
If particularly strong social or research interest, can the regional committee for medical and health research ethics allow continued research on the material and deferred destruction, deletion or disclosure to the research project is completed.

§ 17. Who has to consent Right to consent to participation in medical and health research has:

A)
persons over 18 years, unless otherwise required by the sixth paragraph, and

B)
people between 16 and 18 years, unless otherwise determined by special laws or nature of the measure.

Consent Competence after the first paragraph may be waived in situations referred to in patient and user Rights Act § 4-3, second paragraph.
Parents or others with parental responsibility must consent to research by minors between 16 and 18 involving bodily or drug testing.
For consent for research including participants under 16 years, the consent provisions of the patient and user Rights Act § 4-4 accordingly. If children between 12 and 16 years for reasons that should be respected, not want their parents, others with parental responsibility or child welfare service made aware of information about the child, this should be safeguarded.
For people without consent by patients and clients Rights Act § 4-3 second paragraph shall be next of kin for patient and user Rights Act § 1-3 letter b consent.
For persons deprived of legal capacity on the personal site, the patient and user Rights Act § 4-7 accordingly.
Ministry may in regulations provide that for specific types of research, children between 12 and 16 even consent to research on health information. The Ministry may issue further regulations on the requirements for such consent.

§ 18. Terms for research that includes people without consent Research including minors and people without consent by patients and clients Rights Act § 4-3 take place only if

A.
Any risk or inconvenience to the person is insignificant,

B.
Person himself does not oppose it, and

C.
There is reason to assume that the results of the research can be of benefit to that person or to other persons of the same age-specific disorder, disease, injury or condition.

For minors requires that similar research can not be done on people who are not minors.
For people without consent is required that there is no reason to believe that he would have resisted participation in research if they had to consent, and that similar research can not be done on people with consent.

§ 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 the consent of their next of kin, the research only happen if

A)
any risk or inconvenience to the person is insignificant,

B)
person himself does not oppose it, and there is no reason for scientists or other personnel to believe that he would have opposed the plan if he had had to consent,

C)
it is only possible to carry out research in clinical emergencies, and

D)

Research undoubtedly justified by the view to the results with great preventive, diagnostic or therapeutic value.

Competent or his next of kin shall as soon as possible given information about the research. Consent pursuant to § 13 of the Act. § 17, is a prerequisite for further research and should be obtained as soon as possible.

§ 20. Anonymised human biological material and health data Consent is not required when using anonymous human biological material and anonymous information. For obtaining the material and information that will later be made anonymous, consent is required by this chapter.

§ 21. Research on human biological material from dead for research on biological material taken from the deceased comes autopsy Act § 7 subsections for information and nearest relatives' right to refuse donation etc.

5. Research involving people

§ 22. General provisions regarding research on humans Research on humans can take place only if there are no alternative methods that are almost equally effective.
Prior research on humans conducted shall be made a thorough assessment of risk and burden for participants. These must be proportionate to the anticipated benefits for the research participants themselves or for other people.
Research should be halted if it turns out that the risk is greater than the potential benefits or if there is sufficient evidence of positive and beneficial results.
Research can only be combined with treatment if the research is believed to have health value for the research participant. The benefits, risks, burdens and effectiveness of a new method should be tested against the best methods of prevention, diagnosis and treatment at any given time is available, unless particularly weighty considerations.

§ 23. Obligation to adverse events manager shall promptly give written notice to the supervisory authorities of serious and adverse and unexpected events that are believed to be connected with the research.
Project manager, other researchers and other personnel acting on its own initiative provide supervisory information on factors that may endanger the research participants safety. Upon unnatural deaths, the police notified immediately.

§ 24. Duty to participant by injuries and similar project leader shall promptly inform research participants if they have suffered damage, or has experienced complications resulting from the research project.
The Project Manager shall also do research participant familiar with the right to seek compensation from the Norwegian Patient and other insurance schemes.

Chapter 6. Research Biobanks and research involving human biological material

§ 25. Establishment of research biobanks A research biobank can be created only after being approved by the regional committee for medical and health research.
Research Biobanks established in connection with the collection, storage and use of human biological materials as part of a research project, to be described in the project's research protocol.
Research Biobanks established in connection with the collection and storage of human biological material unrelated to a specific research project must be approved by the regional committee for medical and health research. The same applies to research biobanks to be used for storage and reuse of human biological material, when the original purpose of a research project are met.
Ministry may issue regulations about what applications for the establishment of research biobanks should contain.
Ministry may issue regulations establishing and other treatment of human biological material in biobanks associated health records for Filing Systems Act §§ 8 to 11.

§ 26. Responsible Every biobank shall have a responsible person with medical or biological higher degrees. The research responsible shall nominate the person responsible.
Ministry may issue regulations providing that certain research biobanks as well as the responsible person shall have a board and modalities.
The agent, responsible for research and the Board shall ensure that the biobank created and managed in accordance with this and other law.

§ 27. Requirements for storage and processing material research biobanks must be stored and handled properly. Storage and processing must be done with respect for the donor of the material.
Human biological material from research biobanks can not be extradited for insurance purposes, to employers, to prosecutors or to court, even if the material originates from its consent.

The King may issue regulations providing that disclosure of human biological material to prosecutors or the court in very exceptional cases can happen if very weighty private or public interests do so lawfully.
Ministry may issue further regulations on how human biological material in a research biobank shall be stored and processed.

§ 28. Access to the use of biological material collected in the health and care services for research The regional committee for medical and health research ethics may decide that human biological material collected in health and care services as part of diagnosis and treatment, or be used for research purposes without obtaining the patient's consent. This can only happen if such research is of significant interest to the community and the participants' welfare and integrity is safeguarded. The regional committee for medical and health research ethics may impose conditions for use.
Patient should previously have been informed that human biological materials in certain instances be used for research and must have obtained permission to opt out research on human biological material.
There shall be established an electronic registry with an overview of the patients who have reserved against their biological material used for research.

§ 29. Transfer of human biological material to and from abroad Human biological material from a biobank may only be deported or taken into the country after the approval of the regional committee for medical and health research, and it can be demonstrated that the requirements to consent in Chapter 4 and the requirements for processing of health information in Chapter 7 are met.
Ministry may in regulations make exceptions from the requirement for approval of the transfer of biobank material which is part of general international cooperation.
Ministry may issue regulations stipulating conditions for submission and distribution of human biological material, and the use of material from abroad for research in Norway.

§ 30. Termination, shutdown or takeover of biobank research coordinator shall seek the regional committee for medical and health research for permission termination, closure or takeover of a research biobank. The regional committee for medical and health research must approve the procedure in the event destruction.
Ministry may issue regulations on human biological material in certain cases should be transferable to other research managers rather than destroyed.

§ 31. Andres access to the material in a research biobank The research administrator will give other researchers access to human biological material in the company's research biobanks, unless the research administrator has the need for material or other special circumstances apply. Before the delivery of the material can take place, the necessary approvals pursuant to Chapter 3 exist.
In assessing whether there are special reasons under subsection shall be given to research quality and relevance to the purpose of the biobank. Emphasis must be placed on statutory obligations concerning the storage and processing of the material interests of the donor and the research administrator's need for material.
If the person responsible for the biobank refuses a request for access, the decision may be appealed to the regional committee for medical and health research that has approved the creation of the biobank. The committee's decision is final.

Chapter 7. Research on health information

§ 32. General rules for processing of health information Treatment of health data in medical and health research should be explicitly stated purposes. Health information must be relevant and necessary to achieve the research objectives of the project. The degree of personal identification for health information shall not be greater than necessary to achieve the objectives.
Health data may not be used for purposes incompatible with the original purpose without the research participant agrees, unless otherwise provided by law.
Health data may not be extradited for insurance purposes, to employers, to prosecutors or to court, even though the information originates agrees to it.
The King may issue regulations providing that disclosure of health information to the prosecuting authority or court in very exceptional cases can happen if very weighty private or public interests do so lawfully.


§ 33. Requirements for treatment basis and prior research projects must have a basis for discussion. Prior approval of the regional committee for medical and health research for Chapter 3 is necessary and sufficient basis for discussion for health data in medical and health research.
Treatment of health data from health registries for Filing Systems Act §§ 8 to 11 do not require permits under subsection unless otherwise provided by the regulations of the registers.

§ 34. Treatment of health information Health information can be processed, assembled and delivered in line with the research objectives of the project, any consent, treatment basis under § 33 and in accordance with the study protocol.
The regional committee for medical and health research ethics may by approval pursuant to Chapter 3 refuse to assembly and delivery if this is found to be medically or ethically indefensible.
Assembly and disclosure of health information can happen to data controller or research administrators who have special treatment basis to receive and process information. Such treatment basis can be a license or pursuant to law or regulation.

§ 35. Access to the use of health data collected in the health and care services for research The regional committee for medical and health research ethics may determine that health data can or should be given by health professionals for use in research, and that it can happen without the duty of confidentiality. The same applies to data collected in health and care services. This can only happen if such research is of significant interest to the community and the participants' welfare and integrity is safeguarded. The regional committee for medical and health research ethics may impose conditions for use. Confidentiality rules under § 7 shall apply correspondingly to the receiving the information.
Ministry may issue further provisions on the use of confidential information in research.

§ 36. Correction of health information, etc.. Project shall on its own initiative correct inaccurate information, update outdated information and complement the incomplete information.
Incorrect and outdated information be deleted or altered in a way that makes the change can be traced. Complete deletion of inaccurate and outdated information can only happen if it is claimed by some that the information may have a direct impact on, and deletion are not getting crucial impact on research results validity or representativeness.
Claim for deletion determined by the manager. If deletion is denied, the decision may be appealed to the regional committee for medical and health research.

§ 37. Transfer of data to and from countries outside the European Economic Area Person-identifiable health information which are treated as part of a research project can only be transferred between Norway and countries outside the European Economic Area if

A)
the foreign data controller in writing insures against the research supervisor that the treatment has taken place or will take place in accordance with Directive 95/46 / EC, and

B)
it is consented to by the data subject, or

C)
registered not reserved, and it has been given information that the information will be transferred to countries outside the EEA.

Health data is de-identified or pseudonymous, can be transferred to countries outside the EEA where coupling to personidentifikasjoner can not happen as long as the information is in the country concerned.
Ministry may issue regulations concerning the use of health information from abroad for research in Norway.

§ 38. Prohibition against storing unnecessary health data information shall be kept for longer than is necessary to complete the project. The regional committee for medical and health research ethics may decide that documents necessary for verifying the project shall be kept for five years after the final report is sent committee. If information is not then be stored in accordance with the Archives Act or other legislation, they should be made anonymous or erased.
The regional committee for medical and health research ethics may decide that the information must be kept for longer than is required by subsection. To such a decision can be made subject to conditions.
Ministry may issue regulations concerning the storage of information after the research is completed.

Chapter 8. Openness and transparency in research

§ 39. Openness The research administrators and the manager shall ensure transparency in the research.


§ 40. Right of access to research participants Research Participant has the right of access to personal identifiable and pseudonymous health information about themselves, as well as security measures at the processing of health data so far transparency not impair safety.
The information is provided pursuant to, to be presented in a way that is tailored to individual abilities and needs. Research Participant may require the manager elaborates the information mentioned in the first paragraph to the extent necessary for the research participant should be able to safeguard their own interests.

§ 41. The public right of access Any person shall upon application to the regional committee for medical and health research to learn which research projects under this Act as a research manager or project manager is or has been involved in, and the purpose of the project.

§ 42. Exemptions from access right of access pursuant to §§ 40 and 41 does not include information that

A)
if they became known, might endanger national security, national defense or relations with foreign states or international organizations,

B)
it is required to keep secret for the sake of prevention, investigation, detection and prosecution of criminal offenses,

C)
it is deemed inadvisable that the research participant learns, for the sake of their health or relations with persons who are concerned close,

D)
is subject to confidentiality,

E)
exclusively found in text that has been prepared for the internal preparation and which are not disclosed to others or

F)
it would conflict with obvious and fundamental private or public interests to inform, including the interests of research participants themselves.

Information that research participant is denied access pursuant to subsection c, a representative of the research participant right to access, unless the representative is deemed unfit for this. A doctor or lawyer may not be denied access, unless special reasons for this.
When access is denied pursuant to the first or second paragraph, this must be justified in writing with a precise reference to the governing exceptions.
Refusals of demands for transparency and information can be appealed the regional committee for medical and health research.

§ 43. Deadline for insight manager shall respond to requests for access in accordance with §§ 40 and 41 without undue delay and within 30 days from the day the request is received.
If special circumstances make it impossible to respond to the request within 30 days, may be postponed until it is possible to provide answers. Project shall then give a provisional reply stating the reason for the delay and likely when a reply can be given.

§ 44. Public record of research and research biobanks The regional committee for medical and health research should keep a systematic record of reported and research projects based on information in the application and final report, re. §§ 10, 11 and 12. The records shall be publicly available.
The regional committee for medical and health research ethics shall notify all research biobanks into Biobank Registry at the NIPH.

§ 45. Delayed publication The research responsible and project manager can search the regional committee for medical and health research on deferred publication where this is necessary to protect legitimate patent law or competitive interests or the interests of an ongoing research project. It must disclose the date from which publication can occur.
The regional committee for medical and health research ethics may decide that sensitive information about a project shall not be included in the register under § 44 or not be demanded transparency in accordance with §§ 40 and 41 for a clearly defined period of time, if public disclosure could harm essential private or public interests. The Committee shall then simultaneously with the rejection of the request for access, provide information regarding the date from which access may be granted. Only in special cases, the period is extended.

Chapter 9. Audit

§ 46. State of Health Authority Board of Health oversees medical and health research and management of research biobanks.

§ 47. Data Inspectorate authority Inspectorate supervises the use of health information under this Act.


§ 48. Obligation to provide information to the supervisory authorities The research administrator, manager and other personnel who are involved in a research project shall provide the supervisory authorities access to the premises, and notwithstanding the confidentiality provide and make available to regulatory authorities all information, documents, materials, etc. as deemed necessary for the exercise of supervision of medical and health research.

§ 49. The supervisory authorities confidentiality supervisory authorities and others performing services for the supervisory authorities, are bound to secrecy in accordance with § 7. The duty of confidentiality also covers information on safety measures.

Chapter 10. Compensation, orders, punishment mm

§ 50. Compensation for damage to people arising during clinical trials, the adverse Act accordingly.
The research shall compensate damage suffered as a result of human biological material or personal health data are processed in violation of the provisions in or pursuant to law, unless it is proved that the damage is not due to the fault or neglect of the research administrator's page.
The compensation shall correspond to the financial loss incurred by the injured party as a result of the unlawful treatment of the human biological material or personal health data. The data controller may also be ordered to pay such compensation for damage of non-pecuniary damage (reparation) which seems reasonable.
For private research administrator shall by insurance pledging of the financial liability that may arise after the second and third paragraphs.
Ministry may issue further provisions regarding the obligation of insurance.

§ 51. State of Health entitled to give orders to correct and discontinuance etc. If research projects or research biobanks operate in a manner that may have adverse consequences for research participants or others, or otherwise unsuitable or unsatisfactory, the Norwegian Board issue an order to rectify the situation. If Norwegian Board deems it necessary, it can be ordered discontinuance of the research project or closure of the biobank. Ministry may take over the further operation.
Rules on appeal and reversal of the Public Administration Chapter VI shall apply mutatis mutandis to an order under subsection. The appeal shall be granted suspensive effect, unless the Norwegian Board of Health determines that the decision should be implemented immediately.
When Norwegian Board of Health has issued an order, the other supervisors informed of this if the research project also falls under their supervision area.

§ 52. Data Inspectorate is entitled to give orders to correct and discontinuance etc. Inspectorate may order that the processing of health information in violation of the provisions in or pursuant to this Act shall cease, or set conditions to be met for the processing of health data shall be in accordance with the law.
Decisions Data Inspectorate pursuant to this section may be appealed to the Data Protection Tribunal.
When Inspectorate has issued an order, the Norwegian Board of Health informed.

§ 53. Coercive fines Norwegian Board and Inspectorate may fix a running penalty payment for each day, week or month from the expiry of the deadline set for compliance with the order pursuant to §§ 51 or 52 until the order is fulfilled. Coercive fines may also be imposed as lump-sum fine. Norwegian Board of Health and Inspectorate may waive fines.
Coercive fine shall not before the appeal deadline has expired. If the decision is appealed, runner no fines before appeals body decided it.
Unpaid contributions to cover the expenses are enforceable by execution.

§ 54. Penalties fines or imprisonment not exceeding one year or both to anyone who willfully or through gross negligence violates provisions of the Act or regulations issued pursuant to it.
In particularly aggravating circumstances, imprisonment for up to three years may be imposed. In deciding whether there are especially aggravating circumstances shall inter alia emphasized the danger of substantial harm or inconvenience to the research participant, the gain sought by the infringement, the infringement duration and scope, guilt, and if he has previously been convicted of violating equivalent decisions.

Chapter 11. Final Provisions

§ 55. Entry into force and transitional provisions This Act comes into force when the King bestemmer.1 King may determine that certain provisions of the Act shall come into force at different times.
King may issue transitional regulations.

§ 56. Amendments to other Acts - - -