sou · H2B345 · 2014-06-25 00:00:00 — Utredningen föreslår mot den bakgrunden att Svenskt biobanks- register görs om till ett nationellt system för registrering av biobanks- prover, . Det föreslås att blir personuppgiftsansvarig för registret. Uppgifterna i registret ska få behandlas för att underlätta spår- barhet vid vård och behandling av den registrerade, vid forskning, kvalitetssäkring och framställning av statistik och vid förstörande eller avidentifiering av vävnadsprover när den registrerade har åter- kallat sitt samtycke. De uppgifter som får registreras avser i första hand provgivarens identitet, provgivarens ställningstagande till hanteringen av proverna (samtycke), vävnadsprovernas karaktär, i vilken biobank de finns och uppgifter om diagnos och analysresultat. Absolut sekretess ska gälla för de uppgifter som finns i registret, men med sekretessbrytande regler för till exempel forskning. Upp- gifter ska också kunna lämnas ut när det handlar om den enskildes vård och behandling. Registreringen bygger på samtycke, det vill säga att den enskilde när det biologiska provet sparas i en bank tar ställning till hur upp- gifterna om provet får behandlas. Uppgifter om de prover som redan finns i biobanker får dock registreras utan särskilt samtycke. Det ska understrykas att de berörda har samtyckt till att proverna sparas i biobanken och hur de får användas. Avsaknaden av samtycke gäller endast själva registreringen i det nationella registret. Möjligheten att återkalla samtycke finns alltid och underlättas med den ökade spårbarhet som följer med det centrala registret. The 2012 Research and Innovation (Government 2012/13:30) notes that Swedish registers are unique in many respects. Combining data from them yields great opportunities for research. There are a number of important questions that can be answered by means of various registers and bodies of data. Against this background, the Government has commissioned the to institute a function with the task of improving access to register data and facilitating their use for re- search purposes. Statements made in the bill also constitute the background to this . 's terms of reference give pro- minence to the potential existence of legal impediments to register- based research. My task has been to analyse these impediments and to submit legislative and other proposals in order to increase the extent to which agencies responsible for registers may disclose data for research purposes with regard paid to the pro- tection of the individual's privacy, facilitate joint processing of register data for research purposes and make possible the privacy-assured collection of personal data for registers maintained for specific and explicitly stated research pur- poses and for longitudinal studies confined to the scope of such purposes. With regard to the last point, this task is further specified in the terms of reference. The terms speak of the need for being able to create new database infrastructures for definite, but relatively general, research purposes. I have been asked to make proposals for the of these infrastructures that can be used by researchers in various research projects and that can be updated and augmented with new data when performing, e.g. longitudinal studies. I have also had the task of investigating whether the existing secrecy protection regarding data handled within research is ade- quate to protect the individual's privacy in research. In the work on this inquiry, I have been assisted by Associate Judge , in the capacity of secretary, and by an expert group with representatives from ministries, government agencies and the research community. During the work, I have had numerous contacts with researchers possessing extensive experience of register-based research and with many of the agencies concerned. What is meant by a register? In the present context, registers principally refer to structured collec- tions of personal data that have been created at government agencies primarily for purposes other than research. Examples may be given of registers at central government agencies that have been created for administrative or statistical purposes and registers at regions and county councils that have been created for evaluation and quality in health care. Also of great interest in this context are biobanks, which are collections of biological specimens from individuals taken mainly in connection with care and treatment. However, in the committee's terms of reference, registers also denote certain collections of data that have been primarily created for research purposes. The data in these can be collected from indi- viduals directly or from theagency registers in question. Research registers of this kind are usually created for a specific research pro- ject, but there are also instances of registers being constructed to provide a basis for a number of future research projects that have not initially been defined. In this inquiry, these research registers are called research databases. They are an example of the infra- structure mentioned in the terms of reference. Why is register data good for research? It is a great advantage in many contexts for research to have access to extensive bodies of data. Agency registers, which generally contain data on all Swedish residents, or at least all those relevant in some respect, are invaluable when seeking to describe the state of the popu- lation. The inclusion of all residents means that minorities and un- usual phenomena can also be captured. An example of the latter might be rare diseases. As a rule, the alternative to using data from registers is the collec- tion of data directly from a sample of individuals. Such sample surveys are sometimes necessary because registers do not contain all the data in which researchers are interested. However, sample surveys may entail certain problems. Often, the research subjects selected are not especially representative. Even when the samples are representative, they often have to be limited, if nothing else, for economic reasons, and a certain loss also has to be accommodated, i.e. that some of those approached do not wish to participate for various reasons. Representativeness, sample size and loss all increase the uncertainty of research results. There are numerous examples of conclusions that have been drawn on the basis of smaller sample studies and proven to be incorrect when tested on the entire population in question. Researchers are also dependent on extensive bodies of data in contexts other than the study of unusual phenomena. When they want to study how a particular intervention affects different indi- viduals, a sample study might be adequate, but if they want to identify the various causes of a complex social phenomenon, a more exten- sive body of data is required. In longitudinal studies, which follow individuals or study one and the same phenomenon over time, re- gisters are a particular asset. If these involve repeated contact with the individuals, there is a great risk that the sample will dwindle fairly quickly, e.g. because they get tired of participating. It is often advantageous to be able to combine data that researchers themselves have collected during sample studies with data from registers. If certain data can be retrieved from registers, researchers will be able to limit the number of questions that they need to ask their interviewees. To obtain historical data on an individual parti- cipating in a sample, registers can frequently contain more reliable information than the individual is able to provide from memory. To follow up on the progress of individuals who have participated in a sample study, register data can be used to avoid inconvenien- cing these individuals with repeated questions. Data on all the different individuals involved in various sample surveys can only be found in comprehensive registers. Data on individuals, also sensitive data, is often necessary for research. This is especially true of research, whose aim is to understand the origin and development of diseases and to find cures. At the same time, all processing of personal data entails certain risks to the personal privacy of individuals. The greatest risk is of someone being exposed to the contempt of others if his or her per- sonal circumstances become known. This is the background to the extensive legislation that is designed to protect the personal privacy of individuals and to manage the weighing of various interests that may be required. Legal prerequisites for register-based research Several international organisations, the United Nations (UN), , () and Union (EU), have pro- duced guidelines on how personal data must be handled. Of parti- cular importance to is Convention on Human Rights, incorporated in Swedish law since 1995, and the Protection Directive, which in has been implemented through the Act (PUL). The EU is currently discussing a new Data Protection Regulation, which, if adopted, will become directly applicable in all Member States and thus replace PUL in . It is unclear when this might be adopted, and this inquiry therefore proceeds on the basis of existing law. states that everyone shall be protected against significant invasions of their personal privacy, if these occur without their consent and involve the surveillance or systematic monitoring of the individuals personal circumstances. This provision may be restricted by law, but only to satisfy a pur- pose that is acceptable in a democratic society. PUL governs the processing of personal data. Such data may be collected only if this is legal and only for specific, explicitly stated and justified purposes. It may not be processed for any purpose that is incompatible with that for which the information is collected. Government agencies usually have legal support for the processing of personal data in special register statutes, which, i.a. specify the purpose and the data that may be processed. Under PUL, the pro- cessing of data for historical, statistical or scientific purposes shall not be regarded as incompatible with the purposes for which the information was collected. The aforementioned means that it is possible, e.g. in research, to make secondary use of data that has been collected for other purposes. The processing of data for purposes other than the original requires either the consent of the persons concerned to this pro- cessing or its necessity for, e.g. being able to perform a task of public interest. Research might be an example of such a task. PUL classifies certain personal data as sensitive and prohibited to process. This applies to data disclosing race or ethnic origin, political opinions, religious or philosophical beliefs, membership of a trade union or pertaining to health and sex life. However, following ethics approval, such data, as well as data pertaining to certain kinds of legal offence and biological specimens, may be processed in re- search. Ethics approval is granted pursuant to the Act concerning the Involving Humans (Act) by an ethical review board consisting of government-appointed representatives of the research community and the general public. The ethical review board shall also assess whether consent should be obtained or whether the data can be processed without consent. Where utilisation of an agency register is extensive, the praxis is not to require consent, as this would presuppose a disproportionate investment of resources. The collection and other processing of personal data by govern- ment agencies is often justified by their need of that data in being able to fulfil their administrative tasks. This may relate to track of the country's residents, to producing electoral registers for general elections, to assessing how much tax citizens should pay and the grants they are entitled to, and so on. In many cases, the data is used for decisions concerning individuals. In cases where agencies have been instructed to process personal data, the benefits from this processing have been assessed to outweigh the risks to personal privacy. Another aim involved in the processing of personal data by government agencies is the production of statistics or the evaluation and quality of activities. The production of statistics is often based on data from administrative registers, but in some cases, data is collected specifically for statistical purposes. Official documents held by Swedish agencies are in principle public, but the right of the general public to view such documents may be restricted if called for out of consideration to, e.g. the indi- vidual's personal and financial circumstances. In such cases, there are often varying degrees of secrecy. The strongest secrecy applies to data that has been collected for statistical purposes. Here, secrecy is absolute, which means that the data is in principle not to be dis- closed. However, also for this data, there exist certain provisions that override secrecy. For example, the data may be disclosed for research purposes if this can be achieved without risk of damage or harm to the person – or relatives of the person – whom the data concerns. If secret data is disclosed to another agency, such as a university or a university college, for research purposes, secrecy automatically attaches to that data. Where the disclosure is made to another party, it is usually with special reservations designed to provide equivalent protection. It is the duty of the agency holding the register to consider whether personal data may be disclosed. Where the disclosure is made for research, it is common for the data to be disclosed in anonymised form. This means that researchers do not know which individuals the data concerns. Anonymised data can be coded or de-identified. Coded data means that the researcher receives data with a designation, e.g. a serial number, that does not carry identity information, while the agency retains a code key that links serial numbers to personal identity numbers and that makes it possible to supplement the data later on. The existence of such a possibility is important, for example in the case of longitudinal studies. When data is de-identified, this possibility does not exist. Even if data is anonymised, there may be a risk of reverse identi- fication, i.e. identifying an individual by compiling a series of data about that person. This is prohibited and, as far as is known, has never occurred in research. It is nevertheless a potential risk that might even increase with advances in computer technology. For this reason, it is important to have a clear set of regulations and security arrangements regarding personal data in research environments as well. In some cases, particularly in research, there are instances of the disclosure of identifiable data. Often, the purpose is to allow researchers to contact the individuals in question or to check register data with data from patient records. Privacy and register-based research Responsibility for the processing of personal data in research lies with the responsible research bodies; as a rule, universities and uni- versity colleges. This responsibility ultimately belongs to their boards. There have been no instances of data leaking from research environ- ments. An important explanation for this is the rules for secrecy and secure management that are in force. But like researchers, uni- versities and university colleges also have other strong incentives for ensuring compliance; namely, to allow them to obtain data and conduct research. In addition, researchers are not primarily interested in individuals, but in population patterns. It was in 2011 that the current provision of the Instrument of Government was introduced regarding the individual's protection against significant invasions of personal privacy, where these occur without consent and involve the surveillance or systematic monitoring of the individuals personal circumstances. The question has been raised of whether the secondary use of personal data in agency re- gisters without consent could be in conflict with this constitutional provision. The effect of collecting data for research could, regard- less of intention, be considered to at least constitute the mapping of personal circumstances. The Government on a reformed Constitution noted that any assessment of significant invasions must attend, inter alia, to the purpose of processing data. The aim of research is not to map individual persons, but to identify patterns in a population. The processing of data from agency registers has its legal basis in the special register statutes that exist for agency registers and in PUL's provision stating that processing for scientific purposes is not in- compatible with the original purposes for the processing of that data. The legislator's intention is not likely to have been to prevent this processing of personal data in research. Also in the bill concer- ning the processing of personal data at Policy (IFAU), the Government noted that the IFAU database is not in conflict with the Con- stitution. However, it was the Government's assessment that con- sidering this case involves the retention of a lot of data for a long period, it is plausible that there is a legal basis for the database. My conclusion is that register-based research, research registers and research databases do not entail significant invasions of the personal privacy of individuals, but that it is important that there be clear legal support for this activity. According to the proportionality principle, central government should not impose restrictions or obligations beyond what is neces- sary to achieve the goal of a measure. The goal of register-based research is to gain knowledge about how society works and the measure being considered in this context; that is, the use of e.g., register data that has been collected for other purposes. There are great advantages to being able to use register data in research. There is knowledge to be gained through such research that is difficult to gain with other methods. The risk of leaks and attendant harm to respondents is small. This is particularly true when data is disclosed in anonymised form, but even otherwise. When the benefits are weighed against the risks, register-based research appears to be a largely proportionate measure. Experience from the Nordic countries The prerequisites for register-based research are very similar in the other Nordic countries. They too have to proceed from applicable international regulations. Their counterparts to 's Act are, like that law, based on the Protection Directive and thus very similar. In some respects, they have chosen different solutions to in order to facilitate register-based research. Examples that may be given are that has created a well-developed system for remote access to health data and that has established an independent organisation for depositing and archiving research material. Such examples may serve as sources of inspiration when the systems are being developed in . Background, present situation and challenges There are four important sources of data for register-based research: agency registers, health care quality registers, biobanks and research registers of various kinds. Agency registers have been created primarily for purposes other than research. It is not possible for quality and documentation to always meet the needs of research. Data often needs to be processed before they can be used in research. There is potential for develop- ment in this respect. Quality registers in health care are constructed on the basis of interventions, disease episodes or chronic illnesses. They are of varying quality, but a major investment is now being undertaken by the Government and health care providers to increase quality and accessibility. At present, there are around 80 certified quality registers. Certification means that they meet certain quality standards. The current development programme covers the period 2013-16. When this expires, an assessment will have to be made about how to pro- ceed. Biobanks contain biological specimens. There are about 600 bio- banks in , of which half are with health care providers and around 50 at universities that conduct research. One challenge is to increase the traceability of biobank specimens to make them more available to research. There are many different kinds of research register. Most have been created for specific research projects. () is a national resource for the coordination of existing and new research registers in the social sciences, humanities and medicine. SND is currently a joint project between the and the . One of its aims is for data collected for specific research to be made available and to be reusable in new research projects. However, has determined that SND does not have the right to maintain registers containing personal data, by which is meant data that can in some way be identified (e.g. where a code key is still held). This represents a serious limitation of SND's activities. The use of sensitive personal data or biological specimens in research requires ethical permission. When data is to be provided in anonymised form, the ethical review boards assess the risks as minor and grant permission as a matter of routine. This assessment is well in line with that made in some appeal matters considered by a court or by the Government. For the disclosure of such data in and , these countries have chosen to work with general ethical permissions for certain authorised organisations. In , it should be possible to test a simplified process. Many of those concerned also perceive the forms that researchers have to fill in for ethics applications to be more detailed than necessary. There may be reason to review these forms, e.g. under the recently created by the . the past ten years, Statistics (SCB) has developed a system for remote access to data. It is called , Microdata Online Access. The system is used to make data available, not only from SCB but from most central government agencies responsible for official statistics. Researchers use a terminal in their work environment to connect to and can process data without this leaving SCB. Processed data, in the form of, e.g. tables, may then be sent to researchers by e-mail. An evaluation of the system has recently been initiated by the . As yet, there is no corresponding system for health data from , but the possibility of creating one will be examined during the evaluation of . There appear to be no legal impediments to providing data for research. The problems that may exist are instead found at the administrative level. For SCB, and also other agencies, research is not a priority task. In , the Statistics Inquiry pro- posed that SCB be instructed to make it a priority to supply data for research. The has announced that it intends to propose such an amendment, but no decision has yet been made. It is urgent that this be done as soon as possible. There may also be reason to make corresponding adjustments to the instructions of other agencies. A register service unit has now been created at . At present, SCB is conducting an internal investigation with a somewhat similar aim in view. It is urgent that SCB also should create a central research service unit. Much of today's research takes place in international collabora- tion. The disclosure of data across national borders is a challenge. These are complicated issues that have not been possible to analyse within the scope of this inquiry. However, discussions between the central agencies for statistics in the Nordic countries have recently been initiated by the and its research council, NordForsk, and are in progress. Joint processing of data from various registers is often necessary in research. Even when multiple agencies are involved, this joint processing appears to be functioning relatively well.