Course for Doctoral Students RESEARCH DATA MANAGEMENT AND OPEN DATA 23rd July 2015, Social Science Data Arhives, Faculty of Social Sciences, University of Ljubljana ECPR Summer School 2015 LEGAL AND ETHICAL ISSUES: CONSENT, ANONYMISATION, ACCESS REGULATION Veerle Van den Eynden, UK Data Service Options for sharing research data that may contain confidential information • Obtain informed consent, also for data sharing and preservation / curation • Protect identities e.g. anonymisation, not collecting personal data • Regulate access where needed (all or part of data) e.g. by group, use, time period Consent across the data life cycle • Engagement in the research process • Dissemination in presentations, publications, the web • decide who approves research outputs • Data sharing and archiving • consider future uses of data Always dependent on the research context – special cases for covert research, verbal consent, etc. A good information sheet & consent form • Meets requirements of data protection laws • purpose of the research • what is involved in participation • benefits and risks • mechanism of withdrawal • usage of research data – for primary research and sharing • strategies to ensure confidentiality of data (anonymisation, access etc.) where this is relevant • Need to balance • as simple as possible • complete for all purposes: use, publishing, sharing • avoid excessive warnings Timing of consent PROS CONS One-off • Simple • Least hassle to participants • Research outputs not known in advance • Participants will not know all info they will contribute Process • Ensures ‘active’ consent • May not get all consent needed before losing contact • Repetitive, can annoy participants Form of consent Written • More solid legal ground, e.g. participant has agreed to disclose confidential info • Often required by IRB • Offers more protection for researcher • Not possible for some cases: infirm, illegal activities Verbal • Can be difficult to make all issues clear verbally • Possibly greater risks for researcher • Best if recorded Aspects to consider • Different forms of consent for different materials, e.g. audio recordings vs transcripts • Right to withdraw – what to do with already collected data? • Informed consent for ‘unknown future data uses’ ? • Provide maximum information about reuse • who can access the data –authenticated researchers • purposes – research or teaching or both • confidentiality protections; agreement by future users • Enduring, broad, open consent •No time limits; no recontact required •Unspecified hypotheses and procedures • 99% consent rate (2500+ patients) – Wales Cancer Bank Medical research and biobanks Types of material and consent Different data sharing consent agreements may be applied to different types of research data, e.g. less sensitive (survey) vs. highly sensitive (medical) • Text and transcripts • can be anonymised • Images, audio/video recordings • data more likely to reveal identities • less usable after anonymizing (distortion or blurring) • anonymising costly Consent or access control may be better alternatives than anonymisation Special cases of consent Children • own consent (>16) or parent/guardian consent Employees • duty of confidentiality to employer, e.g. employment–related research Vulnerable people, disabilities of any kind • balance protection from harm with right to participate in research Internet research, blogs, social media – public vs. private information, can consent be asked? • ethical decision-making = deliberative process • nsmnss.blogspot.co.uk/2014/02/new-social-media-new-social- science-and.html • aoir.org/reports/ethics2.pdf Retrospective consent, covert research, observational experiments Do participants consent to share data with other researchers in future ? • Foot and mouth disease in N. Cumbria • sensitive community information • 40/54 interviews; 42/54 diaries; audio restricted • Finnish research on consent • re-contact participants: life stories, gender, etc. • 165/169 (98%) agreed to sharing • Timescapes • longitudinal data on personal relationships • > 95 % consent rate to share data In practice: wording in consent form / information sheet We expect to use your contributed information in various outputs, including a report and content for a website. Extracts of interviews and some photographs may both be used. We will get your permission before using a quote from you or a photograph of you. After the project has ended, we intend to archive the interviews at …. Then the interview data can be disseminated for reuse by other researchers, for research and learning purposes. The interviews will be archived at ……. and disseminated so other researchers can reuse this information for research and learning purposes:  I agree for the audio recording of my interview to be archived and disseminated for reuse  I agree for the transcript of my interview to be archived and disseminated for reuse  I agree for any photographs of me taken during interview to be archived and disseminated for reuse In practice: wording in consent form / information sheet Y N In practice: wording in consent form / information sheet UK Data Archive model consent form ukdataservice.ac.uk/manage-data/legal-ethical/consent-data-sharing/consent-forms.aspx Any personal information that could identify you will be removed or changed before files are shared with other researchers or results are made public. Anonymising research data • Direct identifiers – often not essential research info • Indirect identifiers • Remove direct identifiers (or replace with pseudonyms) e.g. names, address, institution, photo • Reduce precision/detail through aggregation e.g. birth year vs. date of birth, occupational categories, area rather than village • Generalise meaning of detailed text e.g. occupational expertise • Restrict upper lower ranges to hide outliers e.g. income, age Anonymising qualitative data • Remove direct identifiers, or replace with pseudonyms – often not essential research info • Avoid blanking out; use pseudonyms or replacements • Identify replacements, e.g. with [brackets] • Plan or apply editing at time of transcription • Avoid over-anonymising – removing information in text can distort data, make them unusable, unreliable or misleading; so balance anonymisation with the need to preserve context • Consistency within research team and throughout project. • Keep anonymisation log of replacements or removals made – keep separate from anonymised data files In practice: example anonymisation In practice: example anonymisation Managing access to data • available for download/online access under open licence without any registration Open • available for download/online access to logged-in users who have registered and agreed to an End User Licence Safeguarded • available for remote or safe room access to authorised and authenticated users whose research proposal has been and who have received training Controlled Can such research data be open ? • ESRC research data policy: • Publicly-funded research data are a public good, produced in the public interest, which shall be made openly available and accessible with as few restrictions as possible in a timely and responsible manner that meets a high ethical standard and does not violate privacy or harm intellectual property. • Openly available research data, with as few restrictions as possible, means in the ESRC context that research data will be made available for re-use free of charge, as open data, safeguarded data or controlled data; the access category being selected to minimise the risk of disclosing personal information Open about data with restricted access Publish: • Which data exist • Where data are kept, e.g. which repository • Who can access them • For which purpose can they be used • Under which conditions In practice: data with access conditions Health and Social Consequences of the Foot and Mouth Disease Epidemic in North Cumbria, 2001-2003 (study 5407 in UK Data Archive collection) by M. Mort, Lancaster University, Institute for Health Research. • Interviews (audio + transcript) and written diaries with 54 people • 40 interview and diary transcripts are archived and available for re- use by registered users • 3 interviews and 5 diaries are embargoed until 2015 • audio files archived and only available by permission from researchers discover.ukdataservice.ac.uk/catalogue/?sn=5407 doc.ukdataservice.ac.uk/doc/5407/mrdoc/pdf/q5407userguide.pdf In practice: access conditions ReShare In practice: access conditions ReShare In practice: access conditions ReShare In practice: access conditions ReShare Questions ? • Veerle Van den Eynden • veerle@essex.ac.uk