Regulation on the implementation of surveys and more for contagious disease of biological materials for non-diagnostic purposes.
Date-1998-12-22-1432 Ministry health and Human Services Department published in 1998 2258 entry into force 01.01.1999 Recently changed-2013-01-17-61 Change applies to Norway Pursuant LAW-1994-08-05-55-section 3-7 Announced short title regulations on research for infectious disease Chapter overview: Kap. 1. purpose, scope, definitions (§ § 1-1-1-3) Chapter. 2. Implementation etc. (§ § 2-1-2-4) Chapter. 3. other provisions (§ § 3-1-3-2): of the State's legal authority set forth health 22. December 1998 under the legal authority of the law of 5. August 1994 no. 55 on protection against infectious diseases section 3-7 fifth paragraph.
Changes: modified by regulations 19 des 2001 No. 1541, 17 jan 2013 No. 61. Chapter. 1. purpose, scope, definitions section 1-1. Purpose the regulation has as its purpose the execution of surveys available and more of biological material for the purposes of a contagious disease shall be made responsible so that professional and personvernmessige considerations are taken care of.
The regulations also have to purpose that results of monitoring surveys and method to be used for testing utility for infectious diseases work.
§ 1-2. Scope this Regulation applies to all laboratories or institutions that perform research in view of a contagious disease in the trial material from people.
§ 1-3. Definitions Of biological material is meant here samples of blood, serum, tissue samples, secretions, urine, feces, shine and more from the ill or healthy people. Microbiological isolates are not included.
With the available means that the material, which are the responsibility/in a specific purpose collected, is kept and can be set at the disposal of other purpose.
With non-diagnostic purposes meant that the biological material used to analysis that is performed in other purpose than diagnostic mode, the choice of treatment or control by the given material.
With monitoring survey a systematic examination of the understood a number of samples of a particular species with a view to a specific infectious disease by detection of infection the drug directly, or by characteristic markers or antibodies. Seroepidemiologiske research that is used as a term when the trial material is serum, covered here by the term monitoring surveys.
With the method testing be understood a systematic use of available biological material to determine whether an analysis method is suitable for a given purpose.
With avidentifisert be understood that the information is not personal identifiable without through a code key.
Kap. 2. Implementation, etc.
section 2-1. Academic requirements Monitoring investigations and trials to be carried out method according to the usual good professional practice. This implies that there should be a justification, that execution has good quality and that the results be considered correct. It should among other things be considered which individual results that can foranledige further initiatives in infection protection purposes, see section 2-4.
section 2-2. Privacy Sample material utilised to a survey that covered by this regulation, shall be avidentifisert. Only the laboratory Director to have access to the information/code key that connects information from the sample material with the person the material originates.
§ 2-3. Reporting The laboratory or the institution that is responsible for the implementation of a monitoring survey to report to the Directorate for health when the survey is completed with the recommendation of any measures.
The reporting obligation can be fulfilled by publishing the results of the study in the peer reviewed journal. Results of the method should be made known to the trials relevant laboratories.
§ 2-4. The return is done so by investigations or trials covered by this regulation a analysis findings showing that the person try the material stems from having a contagious disease that can be treated or requires measures to counter the disease transmission, the who is responsible for the survey/trials bring the person's identity on the clean and inform the attending physician or the doctor if the municipality found.
The doctor who will be notified, shall inform the person it applies if found and give offers for further diagnosis and treatment as well as carry out measures that may discourage the transmission of infection. Is the attending physician and the municipality of doctor not same person should follow up in consultation with the municipality happen doctor. There is the risk of disease transmission, to local Government take the necessary doctor smitteforebyggende measures.
Kap. 3. additional provisions § 3-1. Economic conditions a laboratory or an institution that has received the order of the Health Directorate to carry out a survey in which the possible biological material used due to get their expenses reimbursed by Health Affairs. The survey should not be put in the works before an expense budget is set up and secured coverage of the expenses is given.
section 3-2. Entry into force this Regulation shall enter into force 1. January 1999.
