Key Benefits:
Law of the treatment biobobos (the processing biobobobit). |
| Date | LAW-200-02-21-12 |
| Ministry of | Health and custody ministry |
| Last modified | LAW-2015 -06-19-65 from 01.10.2015 |
| Published | In 2003 booklet 3 |
| Istrontrecation | 01.07.2003 |
| Changing | |
| Announcement | |
| Card title | Processing biobobit law-biobl. |
Lovens title modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). -See law 20 June 2008 No. 1 44 kep 6.
Law's purpose is to ensure that collecting, retention, treatment and destruction of material that is part of a biobank is being conducted in an ethical defensible manner, and that biobanchor is exploited to indiviets and society's best. This is supposed to happen in accordance with basic privacy concerns, principles of respect for human rights, human rights and personal integrity, and without discrimination by humans as the biological material stems from.
The law shall be added that the material in the biotank can be used for health purposes, herunder diagnostics, treatment and teaching in an ethical defensible manner.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
With diagnostic biobank and processing biobank is understood in this law a collection of humane biological material that has been given for medical examination, diagnostics and treatment.
With humane biological material understood in this law of organs, parts of organs, cells and tissue and possess parts of such material from living and dead people.
With the giver understood in this law a person who embers biologically material to a diagnostic biobank or treatment biobank.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
The law applies to collection, retention, treatment and destruction of humane biological material and information that is part of a biobank, as well as the organizers of this business.
Unless otherwise follows by this law, health and personal information derived from humane biological material is processed after the Privacy Act, health care law, health labor law and any other legislation that particularly reguates protection of personal information.
Biological material that is being issued in connection with examination, diagnostics and treatment, and which are destroyed after short time, is not retaken by the law.
The law does not apply to humane biological material and health and personal information derived by humane biological material that uses or should be used in research. For collection, retention, processing and destruction of humane biological material and information in the research context applies to the health research law.
The law applies to Svalbard and Jan Mayen in the extent that the King decides. The king can determine further rules under consideration of the place of affairs, herunder rules as the absence of regulations in this law.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
Biobanchor being created in connection with diagnostics and treatment shall be reported to the ministry. The message must be submitted the ministry within 2 months after the biotank was created. The message should include details of
| 1. | the purpose of the creation, |
| 2. | what kind of material it should contain and how the material is obtained, |
| 3. | which and how many people the material is obtained or to be obtained from, |
| 4. | how consent is to be obtained and what information is provided at the forefront, |
| 5. | The biobanken duration and what is to happen with the material by the termination of the biotank, |
| 6. | what security measures are related to the biobankbusiness, |
| 7. | who is responsible for the Section 7 and Data Processing Manager or the Processing Manager of Health and Privacy Law and the Privacy Act and |
| 8. | Funding of the biotank and whether the material in the biotank can give ancesti to economic recovery. |
If material from a biobank created for diagnostics and treatment shall be used for research, the provisions of the Health Research Act apply.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
The Ministry of Justice is in charge of bringing a register of the signed biobanchor. The registry shall be publicly available.
Each biobank shall have a responsible person with medical or biological education of higher degree. If the biotank contains information that can be associated with individuals, it will also have a treatment responsible for the health care law or the Privacy Act. The treatment manager shall designate the liability of the officer. The Ministry of Justice can decide that some biobanchor in addition to the responsible person shall have a board of directors.
The Responsibility and Board shall ensure that the biotank is created and managed in accordance with this and other law.
The Ministry of Justice can at regulation determine closer rules for which biobanchor is supposed to have a rule, the board's tasks and compound mv.
Whoever wants to downturn a biobank or who wants to self-destruct the material in a biobank hero or partly, should send message to the ministry about this, or follow in advance determined and filed procedures for such closure or destruction.
Of the message, it shall progress how the closure of the bank or the destruction of the material shall occur.
If the ministry within 45 days after such message has been received no objection or requested for further information, the biotank can completely or partially be destroyed or be destroyed in accordance with the message. If the ministry finds that the biotank due to its content should not be downplaced or destroyed, the ministry may decide that the biotank is still to be retained, or that it should be transferred to another biobank. The Ministry must then assume the financial responsibility and ensure that the biotank is being looked after and the stewards of the thread with this law.
Part Article SECTION 9. Retention of retentionThe material in biobanchor shall be retained and in accordance with regulations granted in law or in co-preservation of law ; the preservation shall happen with respect to the giver of the material.
The Ministry of Justice can at regulation give closer rules about how humane biological material and information in a biobank should be retained.
A biobank or parts of a biobank can only be sent out of the country after approval from the ministry, and in accordance with the consent of the giver of the material. The Ministry may ask terms that the material is destroyed or sent back after use.
The requirement of the ministry's approval does not apply if the transfer abroad occurs in connection with the performance of health assistance to individuals.
The Ministry of Health may in regulation make exceptions from claims of approval from the ministry for the transfer of samples and information clause in general international cooperation.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
Samfat to health care for patient and Human Rights Act Section 4-1 and 4-2 also includes acquisition, retention and treatment of humane biological material, herding the material for prevention, quality control and method development.
For people without consent of consent after patient and Human Rights Act Section 4-3, the patient and Human Rights Act Section 4-4 to 4-8 1 about consent on behalf of other equivalent.
| 0 | Modified by law 24 June 2011 # 30 (ikr. 1 jan 2012 ifg. res. 16 des 2011 # 1252). |
| 1 | Patient and Human Rights Act Section 4-8 is repeaited. |
By modified, extended or new use of previously collected material in a biobank created for diagnostics and treatment shall be new voluntarily, explicitly and informed consent obtained unless otherwise follows by law on medical and health care professional research.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
The person who has been given consent after Section 11 and 13 may at any time recall such consent.
If the consent of the recalled, the person who has given consent may require the biological material to be destroyed.
The Addiction to recall the consent or claim of destruction, deletion, or extradition after first or other clause, does not apply if the material or information is anonymised, if the material by beworked part in a different biological product, or if the information has already entered into scientific works. The Admission to the destruction also does not apply if it is by law determined that the material or information should be retained.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
If the consent of the materials from the material of the material in the thread with Section 11 and 13, others may be given access to the biological material in the biotank or closer specific parts of the material. Access can happen by that the appropriate material is set at the disposal of the person responsible, by the material lender or by the material or parts of it issued. The requesting access shall account for the purposes of which the material is thought to be exploited, how and how long the material will be processed, and whether the material will be destroyed, deleted, or reeleved when the planned use has finished.
At the assessment of whether to be granted access to material after the first clause, it shall be placed emphasis on whether access will unenable or significantly the difficulties of the legislating of the statutory duties regarding retention and treatment of the material, The management of the interests of the materials of the materials and the protection of the materials and optionally the treatment of the material. If the material donor has already reserved against such access, this is to be respected.
Access to personidentifiable material can only be given if the recipient is permitted to process it according to the health of the health care law or the Privacy Act.
It can be required for the costs associated with giving other access to material in a biobank after this paragrafen.
If the responsible for the biotank declines the request for access, the decision can be scratched to the ministry. The Ministry of the Ministry cannot be incurred.
The king can in regulation determine that the issue of humane biological material to the prosecution or court completely exclusion can happen if very heavy-weighing private or public interests do this rightfully.
| 0 | Modified by law 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865). |
Health personnel above regulations regarding the disclosure of the equivalent of anyone who create, store, use or in other ways manage or work at a biobank.
State health care shall in accordance with the Health Regulations Act of the Act shall be supervising that the regulations of the law be overheld.
The Data Authority shall be supervising that treatment of the health and personal information derived from the material in a biobank occurs in thread with the personal information of the personal information and health care regulations.
| 0 | Modified by law 24 June 2011 # 30 (ikr. 1 jan 2012 ifg. res. 16 des 2011 # 1252). |
The Ministry may give the injunction or halt further operation of the biobanchor that is driven in violation of this law or where the drive will go out over what has been reported to the ministry after Section 5. The Ministry of the Ministry can take over the further operation or demand the biotank closed down.
With fines or imprisonment until one year or both, it is punishable by which intentional or coarse negligent collector, store, processes, or destroy material that is part of a biobank in violation of this law.
| 0 | Modified by laws 20 June 2008 No. 44 (ikr. 1 July 2009 ifg res. 26 June 2009 No. 865), 19 June 2015 # 65 (ikr. 1 oct 2015). |
The treatment managers and liability of the Section 7 shall replace damage that has been occurred as a result of the business being driven in violation of this law, unless it can be well-made that the damage is not due to failure or neglect on the disses side. The replacement shall respond to the financial loss that the injured as a result of violation of the provisions of this law ; the treatment responsible and responsible can also be imposed to pay such compensation for non-economic species (vindicated) seems fair.
For private biobankking, it shall at insurance face security of the financial liability that may occur after the first clause.
The Ministry of Justice can in regulation give closer regulations on the duty of insurance.
The law applies from the time the King decides. 1 The king can put in effect the individual regulations at different times.
| 1 | From 1 July 2003 ifg. res. 23 May 2003 # 625. |
For business as being retaken by this law, and which is already in progress when the law takes effect, it shall be sent to the ministry of information mentioned in Section 4 first clause 1-8 within two years after the law of law enforcement.
Part Article SECTION 22. Changes in other laws----
Part Article
