Legal guidelines for collection of patient data Sept 2015
VIA University College Legal guidelines for collection of patient data for use in assignments and projects 1. Introduction The purpose of the Bachelor of Science in Nursing Programme is to qualify students to independently perform professional nursing as well as quality and development work. As a part of this qualification, students make assignments and projects including empirical data material. Empirical data can comprise data from patients/clients and their records, data on patients from relatives and healthcare staff and data collected at observation studies in relation to nursing. Data are being used as a basis of reflection and analyses. In compliance with Ministerial Order no. 1519 of 16/12/2013 on tests and examinations in professionally oriented higher education programmes section 52, part 3, the student together with the educational institution and the clinical practice setting in which data collection takes place and in compliance with applying rules on copyright, agrees on the extent to which parties are entitled to have data at their disposal and use the data resulting from the data collection. In the following the term ”patient” is understood broadly and covers patient, user and client. 2. Informed consent Prior to involving a patient as an informant in data collection, the patient must give written informed consent. If information about a specific patient is collected by interview with relatives, written informed consent from the patient must be obtained. Informed consent requires the patient to be cognitively able and able to understand the consequences of participation. Patients with temporary or permanent cognitive impairment (e.g. due to unconsciousness or insanity) cannot be included in data collection in connection with assignments and projects. If under-aged patients below the age of 15 years are included, parents must give their consent. Under-aged at 15 years can independently give consent to the passing on of health information. The persons with custody of the minor must be informed that the minor has been requested to give consent (Ministerial Order no. 913 of 13/07/2010, The Danish Health Act). Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 1 af 11 NOTAT Udarbejdet af: Troels Frost Christensen AC-fuldmægtig E: [email protected] T: +4587552183 Dato: 22. september 2015 Journalnr.: U0272-7-01-1-13 1/11 Find vejen frem VIA University College Contact to the under-aged patients and parents must take place at the same time to give those with custody of the minor the possibility to influence the decision. When obtaining informed consent, the student must be particularly careful if the participant has a dependency relationship with the student. The head of the specific clinical department or the responsible healthcare employee must ensure that informed consent has been obtained from the patient. 3. Procedure for obtaining informed consent from patients in connection with data collection for use in assignments and projects In connection with assignments and projects, the student and the counsellor are obliged to discuss how to comply with the legal guidelines prior to collection of data. If it is relevant and well founded to collect data by questionnaire, interview or observation, informed consent must be obtained in accordance with the following procedure: 1. The student makes a written request to the head of department or responsible healthcare employee to perform data collection for use in assignments and projects. The request must be included in the information material handed out to the patient. 2. The student is responsible for the drafting of information material to the patient, which must include the following: Description of the purpose and preliminary problem statement of the assignment/project Clear statement that participation is voluntary and that it has no consequences to decline participation Clear statement that the participant can withdraw the consent to participate at any time without any consequences for treatment and care A description of how to maintain confidentiality and anonymity in the handling of the collected data, including deleting and shredding of confidential information A description of the possible risks and discomfort which may be associated with participation A description of who to contact in case of questions and problems related to participation. 3. The head of department or the responsible healthcare employee obtains oral consent from the patient to allow the student to subsequently contact the patient. 4. When the patient has given oral consent, the student informs the patient of the data collection and goes through the information material. 5. Subsequently, the patient must sign a consent form. 6. The consent form will be kept in the department and must be shredded when the assignment has been evaluated. Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 2 af 11 / Okt. 2014 Find vejen frem VIA University College 3.1 Data collection for assignments and projects when informants are healthcare staff When data are collected among healthcare staff and other staff, the student will obtain approval to conduct the data collection from the head of department or the healthcare employee responsible. When approval is given, the student will inform participants about project purpose, the problem statement, method and data collection procedure. If healthcare staff is going to inform about a specific patient, written consent must be obtained from the patient cf. item 3. 4. Anonymity and confidentiality Health information and other personal information in relation to patients and relatives of patients are confidential and must be handled accordingly. The student is responsible for managing data during data collection and for storage of data to ensure confidentiality and anonymity. As e-mails are considered as open letters, they must not include personal data or information about patient pathways, relatives, the department or healthcare staff. During the drafting of the project and in the final project report, the student is responsible that information about health and treatment and other personal information are anonymised. Anonymisation means that name, civil registration number, job position, address, hospital, municipality etc. have been removed. Other information of a specific nature must also be removed or camouflaged to avoid identification of the patient. This means that it must be impossible for others to identify the patient. The student is subject to the Danish Public Administration Act concerning rules on confidentiality (The Public Administration Act section 27, Ministerial Order no. 433 of 22/04/2014). The anonymised ”patient information” is considered as anonymous health and treatment data. In this way the information can be used without violating confidentiality. The student is responsible for shredding the data material (e.g. interview transcripts, medical record information etc.) three weeks after finishing/passing the assignment or test. Thus, interview transcripts must not be used in the appendix of assignments, tests etc. The clinical practice setting where data was collected has a copy of the data material. Assignments and projects comprised by the legal guidelines are based on anonymised information and they may thus be published or made public (Kristensen K. Sundhedsjura, Gads Forlag 2014). 5. Danish Act on Processing of Personal Data and the Danish Data Protection Agency All personal data (e.g. on patients, relatives and staff) and all kinds of data collection methods are comprised by the Danish Act on Processing of Personal Data. Students’ collection and registration of personal information in connection with writing projects and theses etc. is exempt from the demand for notification of and approval from the Danish Data Protection Agency given certain prerequisites. Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 3 af 11 / Okt. 2014 Find vejen frem VIA University College To be exempt from duty of notification it is a demand that the student is enrolled in a professional bachelor degree programme. Secondly, collection and registration of personal data require explicit consent from the persons about whom information is concerned. If students are part of other students’ projects, the students must be listed as either data collector or data manager; an appendix to the existing application must be made with the students’ names, which can be sent electronically through the website www.datatilsynet.dk. Notification to the Danish Data Protection Agency is omitted: If the student does not write down information which can identify the patient If the head of department or responsible healthcare employee stores the written consent in the department during the work with the assignment If the head of department or the responsible healthcare employee shreds the written consent forms when the assignment has been assessed. Notification to the Danish Data Protection Agency can also be omitted if data collection comprises information that is not sensitive personal information (e.g. interview with staff). If the above conditions cannot be met, the Danish Data Protection Agency must be notified to obtain permission to collect and manage sensitive personal information. In case of any doubts, the Danish Data Protection Agency will help the student clarify if the data material in question requires approval. Further information and application form at: www.datatilsynet.dk. 6. Forms for use when informing patients and obtaining consent The following forms have been made to provide information and obtain consent: Application to the clinical placement institution concerning data collection for assignments and projects (Appendix 1). Information in connection with participation in assignments/projects (Appendix 2). Declaration of consent – assignments and projects (Appendix 3). 7. References Bekendtgørelse om uddannelsen til professionsbachelor i sygepleje, BEK nr. 29 af 24/01/2008) Lovbekendtgørelse nr. 913 af 13/07/2010. Lovbekendtgørelse nr. 433 af 22/04/2014. Forvaltningsloven. Lov nr. 578 af 01/06/2014 om behandling af personoplysninger, som ændret ved lov nr. 280 af 25. april 2001. Bekendtgørelse nr. 665 af 14.9.1998 om information og samtykke og om videregivelse af helbredsoplysninger m.v. Bekendtgørelse nr. 1519 af 16/12/2013 om prøver i erhvervsrettede videregående uddannelser (eksamensbekendtgørelsen) Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 4 af 11 / Okt. 2014 Find vejen frem VIA University College Vejledning nr. 161 af 16.9.1998 om information og samtykke og om videregivelse af helbredsoplysninger m.v. Kristensen, Kent. (2014) Sundhedsjura. Gads Forlag. 5. udgave. Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 5 af 11 / Okt. 2014 Find vejen frem VIA University College Appendix 1 Application to clinical placement institution concerning data collection for use in assignments and projects: In the period:_______________________________________ Assignment/project: __________________________________ Purpose:__________________________________________ Research question:_______________________________ Data collection method: (mark with x) Interview of individual persons: Group interview: Questionnaire: Observation: Other: Participants: Describe type and number Which group? How many? Professionals Patients at a specific ward or with a specific diagnosis Other Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 6 af 11 / Okt. 2014 Find vejen frem VIA University College Information to participants When? Who informs? When was infor- Who gives the in- mation given? formation? Oral information is given Written information is given Yours sincerely Name and student number: Educational institution: E-mail address and phone: The above is approved by Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 7 af 11 / Okt. 2014 Find vejen frem VIA University College Counsellor (lecturer): ___________________________________ Educational institution:______________________________________ E-mail address and phone:________________________________ Counsellor’s signature: ____________________________________ Responsible clinical staff: The undersigned hereby accommodates the above application: Date:_______ Name:___________________________ The undersigned can unfortunately not accommodate the above application: Date: _______ Name:___________________________ VIA University College, Faculty of Health Sciences, School of Nursing Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 8 af 11 / Okt. 2014 Find vejen frem VIA University College Appendix 2 Information in connection with participation in assignments and projects at the Bachelor of Science in Nursing Programme Date:___________ I am a student at the School of Nursing in Aarhus. In connection with my studies I am doing an assignment/a project concerning: (brief description of purpose of assignment/project and research question). For this purpose I need to contact (number of patients): (brief description of the study method) I would like to ask if you are willing participate in the assignment/project on the following conditions: Your participation is voluntary and you can withdraw from the study at any time. If you withdraw, none of the information you have contributed with will be used. Your information will be kept confidential and anonymous. Information that is part of the assignment/project will be stored safely until the assignment/project is finished. Afterwards all information is deleted/shredded. There are no risks involved in participation in this assignment/project. If you have any questions and/or problems related to your participation, please contact:________ (state who is the contact person) Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 9 af 11 / Okt. 2014 Find vejen frem VIA University College If you accept to participate, please sign a declaration of consent. This form will be filed with your medical record at the department. Yours sincerely _____________________________________________ (student/students) Counsellor: ______________________________ Name:____________________________________ Signature: _______________________________ Phone – at work: ______________________ E-mail – at work: ____________________________ Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 10 af 11 / Okt. 2014 Find vejen frem VIA University College Appendix 3 Declaration of consent in connection with assignments/projects at the Bachelor of Science in Nursing Programme Assignment/project: __________________________________ Made by: __________________________________________ Purpose of assignment/project: ________________________ Research question of assignment/project: ________________ I hereby give my consent to participate in the above assignment/project. In this connection my information etc. can be used by the student/students who make the assignment/project. I have been informed that: 1. Participation is voluntary and that it has no consequences to decline participation. 2. I can withdraw from the study at any time. 3. No information is passed on in a form where my identity can be revealed. 4. Confidential information is deleted/shredded after the assignment/project is finished. 5. There are no risks involved in participation in the project. Name: Signature: Date: Legal guidelines for collection of patient data for use assignments and projects Sygeplejerskeuddannelsen, VIA Sundhed Side 11 af 11 / Okt. 2014
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