sou · H6B34 · 2018-01-29 00:00:00 — Terms and definitions in the Biobanks Act Some changes should be made in the definitions of the terms used in the Biobanks Act. Scope of the Biobanks Act The biobanks act should be applicable to identifiable human bio- logical material (i.e. samples) used for –care and treatment or other purposes –clinical trials, or –education, quality , product manufacturing or develop- ment work in health care or research. Exemption for samples not saved for a long time The Inquiry proposes a limitation of the scope of the Biobanks Act: The Act is not applicable to samples analysed within nine months from when the samples were collected and destroyed immediately after the analysis. Samples altered through processing The Biobanks Act should not be applicable to samples that have been materially modified within the framework of research or manufacture of products provided that information to this effect has been given and consent to this use has been obtained thereafter under the pro- visions of Chapter 4 of the Act. Relationship between the Biobanks Act and other legislation The new Biobanks Act should not be generally subordinate to other legislation. However, the provision in other acts of law on the con- ditions for being allowed to collect and store samples in biobanks should take precedence over the rules in the Biobanks Act on in- formation and consent. The provisions on processing of personal data in the Biobanks Act should take precedence over the provisions of other acts on the processing of personal data. The provision for collecting and preserving samples from children without the consent of the guardian shall take precedence over pro- visions of other law. and head of biobank The head of the biobank is a healthcare provider, university or other legal person holding a biobank. When the biobank is established, the head of the biobank has to consider what purpose or purposes the biobank will be used for and who will be responsible for the biobank. The head of the biobank has to ensure that conditions are in place to make it possible to meet the requirements of the Act in its activities. He or she is also responsible for the processing of per- sonal data performed by the biobank. The person responsible for the biobank has to lead its activities in accordance with the require- ments of the Act. The head of a biobank is responsible for the decision to establish the biobank to be notified to the Health and Social Care Inspectorate within one month of the decision to set up the biobank. The notification shall contain information on the purpose of the biobank, who is responsible for the biobank and the extent to which the biobank is intended. If any change is subject to a previously notified notification, this shall be notified to the Health and Social Care Inspectorate within one month of the date of the change. Samples belonging to a biobank have to be stored in such a way that they do not risk being destroyed and that unauthorised persons do not gain access to them. The Government or the agency designa- ted by the Government should be authorised to issue further regu- lations on management system and coding of samples. Rules about preservation periods or the agency designated by the Government should be authorised to issue regulations about preservation periods regarding samples to be preserved in clinical pathology and cytology. If a sample may no longer be stored in a bio- bank because of provisions in an act of law, the person responsible for the biobank should be responsible for destroying or de-identifying the sample concerned as soon as possible. The Government or the agency designated by the Government should be authorised to issue further regulations on preservation periods and the weeding of bio- bank samples. The Inquiry proposes the of a national biobanks register to which all care providers have to submit information about samples taken for health care and that are covered by the Biobanks Act. This obligation should not apply when care providers collect samples for research or clinical trials or when samples are taken out- side health care. The national biobank register should contain in- formation that is sufficient to make it possible to find every sample that belongs to or has belonged to the biobanks covered. The national biobanks register shall only contain information about 1.the identity of the donor, 2.who has taken a stand for the collection, conservation or use of the sample if it is not the sample donor, 3.consents and withdrawals and limitations of consent, 4.date when the sample was taken, 5.date when the sample was collected to the biobank, 6.identity, character and handling of the samples, 7.to whom samples are released. The Government or the agency authorised by the Government should decide whether additional information should be transferred to the national register. The government or agency authorized by the government may issue enforcement regulations regarding how information is to be submitted to the National Biobanks Register. shall be appointed the central controller responsible for personal data of the National Biobanks Register. Patients or donors should have the right to oppose information about samples taken for health care being registered in the national biobank register. If a patient or examiner opposes the treatment, the data should be immediately blocked by the controller responsible for the personal data in the register. The healthcare provider collecting samples to a biobank and trans- mitting data to the National Biobanks Register is obliged to inform the sample donor, or the person who can take the position for the sample donor, in connection with the collection of samples, 1.what information is registered, 2.the purpose of the registration, and 3.his or her right to oppose registration. In addition, information must be provided in accordance with the general data protection regulations and the proposal for updated patient data law. No data on samples may be registered in records of the sample donor or the person who can take the position of the sample donor after receiving information according to the first paragraph, opposing the registration of the data. The Government or the agency authorized by the Government shall be instructed by the Government to design and implement an information effort to ensure, as far as possible, that the sample donor who already have samples stored in biobanks get to know this trans- fer of information, the purposes of the transfer and the right to oppose registration. If data on samples in research collections is to be registered in the National Biobanks Register, consent to this registration must be obtained in connection with the collection of these samples. Personal data in the national biobanks register are proposed to be processed for purposes of research, quality or production of statistics. The data shall be covered by the statistics section 24 chap. Section 8 of the Public and Privacy Act (2009: 400), OSL. The data included in the registry should be able to be used as search terms. Identifiable data in the national biobanks register are suggested to be handed out to another authority or researcher if the task can be disclosed without the individual or any related person suffering from it. For public service purposes, secrecy shall be valid for a maximum of seventy years. The confidentiality imposed by the con- fidentiality will thus restrict the constitutional right to disclose and publish information. Direct access to data in the registry should not be allowed. shall limit the electronic access of their employees and contractors to what each person needs to fulfil his duties. Data disclosure in the registry must be in accordance with the Protection Regulation. For data on biobank samples submitted for research purposes from a national register to another authority for the purpose of linking samples and data with associated test information, it shall transmit absolute statistical confidentiality in accordance with Chapter 24, Sec- tion 8 of the Public and Privacy Act (2009:400) applies in respect of other primary confidentiality provisions of the receiving authority. Head of biobanks who retain sample collections without re- gistering them in the National Biobank Register of samples, are responsible for 1.that there is a register at the biobank with sufficient data to trace every registered sample is registered, and 2.that data that is sufficient for each sample collection to be iden- tified is to be registered in a publicly available database. Several research principals may have a joint public database of research collections. The conclusion of the inquiry’s analysis is that there is no need of a special regulation in the Biobanks Act concerning consent for saving samples in a biobank for health and treatment purposes or for pre- serving samples for research. What applies to information and con- sent in health care is regulated in both the Patient (2014: 821) and the Dental Care Act (1985: 125), and what applies to information and consent in research is regulated in the Act (2003: 460). According to the Patients Act, a patient's consent to health care and treatment also includes consent to save samples in a biobank for care and treatment provided that the individual investigator receives and has sufficient information. The term ”health care and treatment” also includes the objectives of quality and development work in the field of healthcare and for healthcare education. Such samples should may also be used in research with approval after ethical vetting according to the consent rules for samples collected for or to be used in research in the Act. The Patient clarify that the patient is entitled to infor- mation if samples for health care and treatment are to be collected and preserved in a biobank. The patient should receive information about 1.the purpose of collecting and preserving the sample, 2.the purpose of collecting the sample and for what purpose which the sample may be used, 3.what purposes are permitted under the Biobanks Act, and 4.the right to revoke or limit consent for the collection, preser- vation or use of a sample in a biobank. The inquiry proposes that should formulate regulations on information dissemination and to formulate information material relating to samples stored for health care and treatment purposes. The inquiry proposes that samples retained in a biobank should not be used for any purpose other than previously provided infor- mation to and consent from the sample donor, or the person who on the sample donor’s behalf, has been informed and consented to the new purpose. If the new purpose is research or clinical trial, the requirement for information and consent is in accordance with Section 15 of the Act. Sample donor should be able to give consent to storage of samples for future non-specified research in accordance with recital 33 of the Data Protection Ordinance. The inquiry proposes that the Government investigate the issue of a national consent service. A sample donor may at any time report that a preserved sample may not be used for one or more of the permitted purposes. If the revocation concerns the preservation of the sample or all use of the sample, the person responsible for the biobank is responsible for the immediate destruction of the sample. If it is not possible to de- stroy the sample without the destruction of other samples, the person responsible for the biobank will be responsible for immediately anonymising the sample. Samples may not be identified for use for purposes other than those agreed with the sample donor. Information regarding the preservation of samples and the sample donors position regarding consent shall be documented in the journal manual for samples stored for healthcare. Information about the retention of samples and consent shall be documented in a register with the biobank for samples stored for research. A sample from a child that has not attained such an age and degree of maturity as to be able to make their own decision may be collected and preserved without the consent of their custodian if there would otherwise be a substantial risk of harm to the health of the child. In these cases, the sample may only be used for the care and treatment of the child. Decisions to collect or preserve samples against the will of the custodian have to be taken by the head of the biobank. It should be possible to appeal the decision of the head of the biobank to the Health and Social Care Inspectorate. It should be possible to appeal the decision of the Inspectorate to a general administrative court. When the donor reaches 18 years or attains such an age and degree of maturity as to be able to make their own decision, they have to be informed that a sample has been preserved against the will of their custodian and that they have the right to decide about the future handling of the sample. The head of the biobank should be responsible for this information being given. The Act should also be re-worded to state that it is the donors them- selves who decide on the handling of the samples collected previously if they have attained sufficient age and maturity after collection to be able to make their own decision on the matter. The exemption rule that will allow for collecting and preserving samples from children without the consent of the custodian in certain situations shall take precedence over provisions of other law. Access to samples and information for health care and research The Inquiry proposes that data about samples taken for care and treatment and stored in laboratory information system should be made available to care providers and reached by direct access in systems for integrated records under Chapter 6 of the Act (208:355), for the purposes stated in Chap- ter 2, Section 4, first paragraph, points 1–3 of that Act. Further- more, it is suggested that the data be made available to patients in accordance with Chapter 5. Section 5 Act. The authority the government decides shall designate a controller of personal data responsible for overall issues of technical and orga- nizational security measures in the context of coherent record of test data, according to Chapter 6. Section 6 Act. For research, ethics vetting according to the Act (2003:460) is required. Samples may only be collected and retained in a biobank for purposes relating to research on collection and pre- servation of samples and sensitive personal data have been tested and approved by an Board in accordance with the Act. The same rules apply to samples already collected if the purpose is changed. Access of samples and data Samples in a biobank may be made available to other principals of biobanks after a decision by the person responsible for the biobank by release or by sending them for a specific measure. Samples in a biobank can also be made available to other principals by transfer- ring the biobank or part of the biobank. The inquiry proposes that: –the general prohibition on storing samples abroad is removed. –the general requirement that samples must be returned or de- stroyed when no longer needed for the purpose for which they were issued or sent should be removed and replaced by specific conditions that will apply when a sample is sent for a specific measure. –samples from a biobank may only be made available to legal entities. –the availability of samples or to the samples related personal data (such as the code) may not be in breach of the provisions of the data protection regulation –samples from a biobank that are sent for a measure constituting research or clinical trials shall be pseudonymised, unless this pre- vents the purpose of availability being met. Samples from a bio- bank sent for a measure other than research or clinical trials shall be coded, unless this prevents the purpose of the disclosure being met. –If an individual’s personal data is made available at the same time as a coded or pseudonymized sample from this, they shall be dis- closed in such a way that the personal data cannot be linked to the sample. –If the patient, or the person taking a stand on behalf of the patient, agrees, an individual health care record relating to a particular patient shall be made available to the recipient who has access to a coded or pseudonymised sample from the patient. –Samples from a biobank may not be made available for profit. Samples that are released cease to be part of the biobank they are released from. The samples form a new biobank or become part of an existing biobank at the recipient. Samples can only be released to a principal who has a biobank in . Samples sent for specific measures Samples sent to another legal entity for a certain measure to be performed will not cease to be included in the biobank or biobank register from which they were sent. When a sample is sent for a measurement, the biobank sending the sample or the information shall: 1.establish an agreement with the recipient on what will happen to the sample after the measurement has been taken, and 2.set as conditions for availability –that a sample retained at the recipient should be returned if the biobank requests it, and immediately destroyed or, if it is not possible to destroy it without losing significant values, be anonymising if the biobank so requests; and –that the recipient does not use the sample or information for anything other than the purpose of which the samples were sent. –When the person responsible for a biobank decides that samples will not be made available in accordance with an application for withdrawal or release, the applicant may request that the decision should be re-examined by the head of the biobank. –In case of rejection, shall the person responsible for the biobank inform the applicant of his right to have the application re- examined by the head of the biobank. Transfer means that one or more sample collections from a biobank are transferred to a biobank in . –The purpose of a sample collection is not changed when the sample collection is transferred. –Transfer of a biobank may only be made if there are special reasons and after permission from the Health and Social Care Inspectorate. –The government or the agency authorised by the government may issue further provisions about the transfer of biobanks and samples. Return of samples to the donor It should not be possible to return a sample from a biobank directly to the donor. Use of samples for the investigation of patient injury in health care The Inquiry proposes making it clear in the Biobanks Act that it is permitted to make biobank samples with the associated personal data available for use in investigation of patient injury according to the Patient (1996:799) The entity investigating patient injury is responsible for notifying the results of the examination of samples made available for the investigation of patient injury to the biobank who sent them. Identification of deceased persons If there are special reasons, tissue samples from biobanks and the associated personal data needed should be released on request to or the Swedish Authority for use in identifying deceased persons. If a biobank decides not to release a tissue sample in accordance with a request, it should be possible to appeal the decision to the Health and Social Care Inspectorate. It should be possible to appeal the decision of the Inspectorate to a general administrative court. Releases in order to identify deceased persons should be possible without consent. How- ever, the donor, or the person who can receive information instead of the donor, should be informed that samples from biobanks may be used for this purpose. It should also be possible to use samples that have already been preserved in biobanks to identify deceased persons. should be commis- sioned by the Government to design and carry out an information campaign in order to ensure that the donors who already have tissue samples preserved in biobanks are made aware of this new area of use. Conditions for closing a biobank The Inquiry proposes that the head of a biobank should be able to decide to close the biobank and that the requirement of a permit from the Health and Social Care Inspectorate to close a biobank should be abolished. When a biobank is closed, this should be noti- fied to the Health and Social Care Inspectorate. The notification shall contain information of what has happened to the samples in the biobank. Use of samples in the PKU biobank Samples collected from newborn babies in a genetic study under Chapter 3, Section 1, Act (2006: 351) on Genetic Integrity, etc. shall be preserved in a special biobank (PKU biobank). The healthcare provider the government decides shall be the head of the biobank. Samples may be collected and preserved in the PKU biobank only for the following purposes: 1.analyses and other investigations to detect and diagnose the diseases referred to in the genetic investigation, 2.retrospective diagnosis of other diseases of individual sample doners, 4.monitoring, evaluation and quality of operations, 5.clinical research and development, as well as 6.to identify persons who have died and to investigate patient in- juries under the Patient (1996: 799). A healthcare provider is obliged to release samples of newborns in a genetic investigation for analysis and storage in the PKU biobank, with due observance of the information and consent requirement. The healthcare provider who is the head of the PKU biobank, has a special register of samples in the PKU biobank (PKU registry). The healthcare provider is responsible for the personal data in the register. The PKU register may be used for the same purposes as for the samples in the PKU biobank and for the production of statistics. For each sample donor, only the following data may be registered in the PKU registry: 1.mother's name, personal identity number and place of 2.length of pregnancy, 3.the date of birth of the sample donor, birth weight and gender, and, in the order in the case of multiple birth, 4.the healthcare unit that has taken the sample, 5.analysis and survey results, 7.information on the treatment of diagnosed diseases, 8.information that may be relevant for the interpretation and follow- up of the results, and 9.information on and consent of the sample donors custodian. No data may be registered unless the sample donors custodian has been informed of the purpose of registration and what information is registered and then consented to the registration. A healthcare provider is obliged to provide, upon request, the information that may be registered to the PKU Registry, if the examiner's custodian has been informed and consented to the re- gistration. The Health and Social Care Inspectorate () shall keep a register of biobanks. The register may be used for supervision, in research and for the production of statistics. The register shall contain information on conditions for which there is a reporting obligation and may not contain information about individual persons from which samples have been taken. In addition, information must be registered about the head of the bio- bank, the head of the biobank and the biobank's contact information, the biobank's name and the number assigned to the biobank upon registration. The register shall also contain information on whether a biobank has been transferred or closed. The government or the agency designated by the government may issue regulations on which authority may have direct access to the data contained in the register. provide the Protection Officer with information of the existing biobanks they have registered. supervise the compliance with the Biobanks Act and the regulations issued in connection with this Act.