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Administrative data >> Ethical approval >> Requirements to acquire approval from an ethics committee
According to the Act on Research Ethics Review of Health Research Projects, any health research project must be notified to the system of research ethics committees (cf. Section 14 2-5).
Administrative data >> Informed consent >> Conditions for consent
In the Danish Act on Processing of Personal Data there are a number of different conditions legitimatizing the processing of personal data, treated as open alternatives. Thus, the data controller is not required to obtain consent of the data subject if one of the other conditions applies, even though getting consent would be practical and not inappropriate. The conditions regarding the processing of sensitive data and strictly private data are more severe than those applying to other data.
Administrative data >> Legal approval >> Requirements to acquire approval from data protection authorities
Obligation to notify   According to the Norwegian Personal Data Act, a data controller is obligated to notify the Data Protection Authority in Norway before processing personal data by automatic means or establishing a manual personal data filing system which contains sensitive personal data (cf. Article 31). [1]  The notification duty applies whether or not the data subjects have given their consent to the processing.
Administrative data >> Ethical approval >> Requirements to acquire approval from an ethics committee
The Regional Committee for Medical and Health Research Ethics (REC) Research on humans, human biological material and personal health information, which aims to generate new knowledge about health and disease, is required to obtain a prior approval from the Regional Committee for Medical and Health Research Ethics (REC) under the Health Research Act (cf. Article 9).
Administrative data >> Informed consent >> Conditions for consent
Consent as main condition In the Norwegian Personal Data Act, consent remains the main condition for processing personal data. Other criteria for the processing of data are seen as exceptions, and consent is usually given priority unless there are strong arguments to do otherwise (Kvalheim 2004).  
Administrative data >> Access an reuse >> Conditions for access and reuse
Consent or exemption from duty of confidentiality There are two main conditions for access and reuse of administrative data. Either the processing should be based on the informed consent of the data subject, or it should be exempted from the duty of confidentiality. See Conditions for consent.
Administrative data >> Legal approval >> Requirements to acquire approval from data protection authorities
According to the Swedish Personal Data Act, personal data is defined as all kinds of information that directly or indirectly may be referable to a natural person who is alive (cf. Section 3). The processing of non-sensitive personal data that is completely or partially automated is subject to a notification duty (cf. Section 36). Such notification is however not required if the controller has appointed a data representative and given notice of this to the Data Inspection Board (cf. Section 37).
Administrative data >> Ethical approval >> Requirements to acquire approval from an ethics committee
Administrative data >> Informed consent >> Conditions for consent
In order to be allowed to process personal data, the Swedish Personal Data Act requires either that the data subject has given his or her consent, or that the processing is necessary e.g. for research purposes (necessary in the manner stated in Section 10 of the Personal Data Act, implementing Article 7 of the EU Directive 95/46/EC).
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire approval from data protection authorities
According to the Estonian Personal Data Protection Act, personal data are defined as any data concerning an identified natural person or a natural person to be identified, regardless of the form or format in which such data exists (Article 4-1). Sensitive personal data are defined as (cf. Article 4-2): 1)  data revealing political opinions or religious or philosophical beliefs, except data relating to being a member of a legal person in private law registered pursuant to the procedure provided by law; 2)  data revealing ethnic or racial origin;
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Ethical approval >> Requirements to acquire approval from an ethics committee
There are two ethics committees on biomedical research involving human subjects. The committees  review all kind of human studies (including psychological and behavioural studies), biomedical research and clinical trials: Tallinn Medical Research Ethics Committee and Ethics Review Committee on Human Research of the University of Tartu. The committees are independent bodies coordinated by the Council of Ethics located at the Ministry of Social Affairs. Projects are reviewed by only one REC so that if a project is rejected by a REC, it should be resubmitted to the same committee.
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Informed consent >> Conditions for consent
Conditions for consent As a general principle in the Estonian Personal Data Protection Act, the processing of personal data is allowed only based on the respective consent of the data subject, unless otherwise provided by law (cf. Article 10-1). In order to protect the interests of a data subject, a valid consent shall at least include the following issues (cf. Article 12, 1-8): ·         which data are to be collected and processed ·         the purpose of the processing of the data
Administrative data, Audio-visual (AV) data, Survey data >> Preservation >> Conditions for preservation
Preservation for purpose of scientific research or official statistics According to the Personal Data Protection Act, collected personal data may be processed for the purposes of scientific research regardless of the purpose for which the personal data was initially collected. Personal data collected for scientific research or official statistics may be stored in a coded form for the purposes of using it later for scientific research or official statistics (cf. Article 16-4).
Administrative data, Audio-visual (AV) data, Survey data >> Access an reuse >> Conditions for access and reuse
Exemption from consent
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire approval from data protection authorities
What is personal data? According to the Finnish Personal Data Act (PDA), personal data is any information on a private individual and any information on his/her personal characteristics or personal circumstances, where these are identifiable as concerning him/her or the members of his/her family or household (cf. Article 3.1).  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Ethical approval >> Requirements to acquire approval from an ethics committee
Requirements to acquire ethical approval The organisation of ethics committees is based on a regional system, with at least one ethics committee in every healthcare district. Each of the hospital districts operating a university hospital must have at least one ethics committee. The Hospital District of Helsinki and Uusimaa, the largest of the Finnish hospital districts, has currently four ethics committees. In addition, there is the National Committee on Medical Research Ethics (TUKIJA), which is located in the Ministry of Social Affairs and Health (TUKIJA website).  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Informed consent >> Conditions for consent
Informed consent
Administrative data, Audio-visual (AV) data, Survey data >> Preservation >> Conditions for preservation
Preservation for research purposes
Administrative data, Audio-visual (AV) data, Survey data >> Access an reuse >> Conditions for access and reuse
Reuse of personal data for a new purpose The exclusivity of purpose is the main rule of the PDA. Personal data must not be used or otherwise processed in a manner incompatible with the stated purposes. However, later processing for purposes of historical, scientific or statistical research is not deemed incompatible with the original purposes (cf. Section 7). So, if sensitive data is of scientific value or is historically unique, a request for permission to archive data can be submitted to the National Archives (The National Advisory Board on research ethics’ proposals).
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire approval from data protection authorities
Data protection supervision in the Federal Republic of Germany is regulated by the Federal Data Protection Act (FDPA), as well as each of the 16 states’ own data protection acts. The FDPA mainly deals with the use of data by public bodies that are either part of or influenced by the Federation and any use of data by private persons or enterprises. By contrast, the scope of application of the state Acts is limited to public bodies being part of, or being influenced by, the respective state.
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Ethical approval >> Requirements to acquire approval from an ethics committee
Description of the REC system
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Informed consent >> Conditions for consent
General requirements for consent
Administrative data, Audio-visual (AV) data, Survey data >> Preservation >> Conditions for preservation
Preservation for research purposes Personal data must be deleted as soon as they are no longer needed to achieve the purpose or if further storage would conflict with legitimate interests of the data subject. Further storage of (sensitive) personal data is, however, allowed e.g. if: ·         the data subject has given his or her consent ·         the data has already been made public by the data subject ·         these following cumulative conditions are met:
Administrative data, Audio-visual (AV) data, Survey data >> Access an reuse >> Conditions for access and reuse
Reuse of personal data for research purposes The reuse of special categories of personal data for new purposes is allowed by the same provisions as further storage, e.g. if: ·         the data subject has given his or her consent ·         the data has already been made public by the data subject ·         these following cumulative conditions are met: o   it must be necessary for the purposes of scientific research, whereas
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire approval from data protection authorities
The Icelandic Data Protection Authority (Skrifstofa Persónuverndar) deals with specific cases on the basis of inquiries from public authorities or private individuals.   On 1 January 2001 a new Act on the Protection and Processing of Personal Data, No. 77/2000 (DPA), entered into force. The act implements the Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 
Administrative data >> Ethical approval >> Requirements to acquire approval from an ethics committee
The National Bioethics Committee (Vísindasiðanefnd (NBC)) represents the ethics committee in Iceland. Task of the NBC is to consider scientific research protocols in the biomedical field. The members of the committee should have an expertise in biomedical sciences, ethics of research, human rights and social science.
Administrative data >> Informed consent >> Conditions for consent
Conditions for consent A main condition for the processing of personal data is that the data subject has unambiguously agreed to the processing or given his consent (cf. Article 8.1 in the DPA).
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire approval from data protection authorities
What is personal data? According to the Dutch Data Protection Act (DPA), personal data is defined as any information relating to an identified or identifiable person (cf. Article 1(a)). As the Act itself leaves it open as to who can identify the data subject, the Guidelines to the DPA states that:  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Ethical approval >> Requirements to acquire approval from an ethics committee
Research involving human subjects According to the Medical Research Involving Human Subjects Act (WMO), all medical research on human subjects must be assessed by an ethics committee in advance, either by the Central Committee on Research Involving Human Subjects (CCMO) or an accredited medical ethical reviewing committee (MREC). [1]   Both observational and interventional medical research is covered by this ethical review obligation, as long as it involves medical research on humans.  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Informed consent >> Conditions for consent
Informed consent According to Article 8 (a) of the DPA, personal data may only be processed if the data subject has unambiguously given his or her consent for the processing. The consent must be freely given and aimed at a specific processing or processings of data. The consent does not need to be in writing, but there must be no doubts about the data subject’s consent (Ministry of Justice, Guidelines for Personal Data Processors 2001:50). An unambiguous consent can however be given implicitly (Wright and Terstegge 2004:287).  
Administrative data, Audio-visual (AV) data, Survey data >> Preservation >> Conditions for preservation
Preservation for research purposes According to Article 10.1 of the DPA, personal data shall not be kept in a form which allows the data subject to be identified for any longer than is necessary for achieving the purposes for which they were collected or processed.   However, personal data may be kept longer for historical, statistical or scientific purposes, and where the data controller has made the necessary arrangements to ensure that the data concerned are used solely for these specific purposes (cf. Article 10.2).  
Administrative data, Audio-visual (AV) data, Survey data >> Access an reuse >> Conditions for access and reuse
Reuse of personal data for a new purpose The basic rule of the DPA is that personal data may not be processed further in a manner incompatible with the purposes for which it has been obtained (cf. Article 9.1). Article 9.3 provides, however, that the further processing of personal data for historical, statistical or scientific purposes shall not be regarded as incompatible as long as the data controller has made the necessary arrangements to ensure that the further processing is carried out solely for these specific purposes.  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire legal approval
  What is personal data? The 95/46/EC Directive was formally implemented in Spain in November 1999 through the Organic Law 15/1999 (Ley Orgánica 15/1999 de Protección de Datos de Carácter Personal) (LOPD). According to the LOPD, personal data is defined as “any information concerning identified or identifiable natural persons” (cf. article 3.a). What is sensitive personal data? According to article 7 of the LOPD, personal data that requires special protection entails information revealing: -          political orientation
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Ethical approval >> Requirements to acquire ethical approval
Requirements for obtaining ethical approval According to chapter III of the Royal Decree 223/2004, each institution planning to carry out clinical trials must have approval from an Ethics Committee (EC). The ECs of each institution are accredited by the health authority of each of Spain’s 17 autonomous regions, and have to be notified to the Spanish Agency of Medicine and the Coordination Centre of Ethics Committees (Privireal 2005).
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Informed consent >> Conditions for consent
Informed consent The unambiguous consent of the data subject is the main requirement for the processing of personal data (cf. Article 6 of the LOPD).   According to the LOPD, consent of the data subject is defined as “(…) any free, unequivocal, specific and informed indication of his wishes by which the data subject consents to the processing of personal data relating to him (cf. Article 3.h).  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Preservation >> Conditions for preservation
Preservation for research purposes Personal data must be stored in a form that permits the data subject to exercise its right to access the data (cf. Article 4.6 of the LOPD). Furthermore, the data controller shall provide the technical and organisational measures necessary to ensure the security of the personal data, and prevent their alteration, loss, unauthorised processing or access (cf. Article 9 of the LOPD).
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Access an reuse >> Conditions for access and reuse
Reuse of personal data for new purposes In Article 4.2 in the LOPD, it is specified that personal data may not be processed for purposes that are incompatible with the purpose for which it was originally collected. However, the article also states that the “further processing of the data for historical, statistical or scientific purposes shall not be considered incompatible”.  
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Legal approval >> Requirements to acquire approval from data protection authorities
What is personal data? According to the UK Data protection Act (DPA) personal data is defined as: “(…) data which relate to a living individual who can be identified - a) from those data or, b) from those data and other information which is in the possession of, or is likely to come into the possession of, the data controller, and includes any expressions of opinion about the individual and any indication of the intentions of the data controller or any other person in respect of the individual” (Section 1 (1) of the DPA). 
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Ethical approval >> Requirements to acquire ethical approval
Institutional requirements for ethical approval Most research and educational institutions have their own specific requirements for ethical conduct of research activity in the social sciences and humanities. Research staff should generally confer with the head of department and the research office at the institution, and students should confer with their supervisors and/or tutors for the programme of study. Institutional requirements for ethical approval may vary, but often there are requirements for:
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Preservation >> Conditions for preservation
Preservation for research purposes According to the fifth data protection principle (cf. Schedule 1, part 1 (5)), personal data shall not be kept for longer than is necessary for the original purpose or purposes. However, this principle does not apply to personal data processed only for research purposes (Bristol 2014a). Research activity is exempt from this requirement provided that it has met all the conditions for exemption for research, history and statistics purposes (cf. Section 33 of the DPA). See: Conditions for exemption for research purposes
Administrative data, Audio-visual (AV) data, Survey data, Web data >> Access an reuse >> Conditions for access and reuse
Reuse of personal data for a new purpose
Web data >> Ethical approval >> Requirements to acquire approval from an ethics committee
According to the Act on Research Ethics Review of Health Research Projects, any health research project must be notified to the system of research ethics committees (cf. Section 14 2-5).
Web data >> Informed consent >> Conditions for consent
In the Danish Act on Processing of Personal Data there are a number of different conditions legitimatizing the processing of personal data, treated as open alternatives. Thus, the data controller is not required to obtain consent of the data subject if one of the other conditions applies, even though getting consent would be practical and not inappropriate. The conditions regarding the processing of sensitive data and strictly private data are more severe than those applying to other data.
Survey data >> Ethical approval >> Requirements to acquire approval from an ethics committee
According to the Act on Research Ethics Review of Health Research Projects, any health research project must be notified to the system of research ethics committees (cf. Section 14 2-5).
Survey data >> Informed consent >> Conditions for consent
In the Danish Act on Processing of Personal Data there are a number of different conditions legitimatizing the processing of personal data, treated as open alternatives. Thus, the data controller is not required to obtain consent of the data subject if one of the other conditions applies, even though getting consent would be practical and not inappropriate. The conditions regarding the processing of sensitive data and strictly private data are more severe than those applying to other data.
Audio-visual (AV) data >> Ethical approval >> Requirements to acquire approval from an ethics committee
According to the Act on Research Ethics Review of Health Research Projects, any health research project must be notified to the system of research ethics committees (cf. Section 14 2-5).
Audio-visual (AV) data >> Informed consent >> Conditions for consent
In the Danish Act on Processing of Personal Data there are a number of different conditions legitimatizing the processing of personal data, treated as open alternatives. Thus, the data controller is not required to obtain consent of the data subject if one of the other conditions applies, even though getting consent would be practical and not inappropriate. The conditions regarding the processing of sensitive data and strictly private data are more severe than those applying to other data.
Audio-visual (AV) data >> Legal approval >> Requirements to acquire approval from data protection authorities
Obligation to notify According to the Norwegian Personal Data Act, a data controller is obligated to notify the Data Protection Authority in Norway before processing personal data by automatic means or establishing a manual personal data filing system which contains sensitive personal data (cf. Article 31). [1]  The notification duty applies whether or not the data subjects have given their consent to the processing.  
Audio-visual (AV) data >> Ethical approval >> Requirements to acquire approval from an ethics committee
The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH) The National Committee for Research Ethics in the Social Sciences and the Humanities (Den nasjonale forskningsetiske komité for samfunnsvitenskap og humaniora (NESH)) works at a policy level by setting guidelines and general statements for research in social sciences, law, humanities and theology, and is also available to safeguard ethical considerations in specific projects.
Audio-visual (AV) data >> Informed consent >> Conditions for consent
Consent as main condition In the Norwegian Personal Data Act, consent remains the main condition for processing personal data. According to the Personal Data Act there is, however, a legal possibility to exempt the processing of personal data from consent if the processing is necessary to perform a task in the public interest (cf. Article 8 d), and the processing of sensitive personal data is necessary for historical, statistical or scientific purposes and the public interest clearly exceeds the possible disadvantages for the data subjects (cf. Article 9 h).

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