Research Ethics and Legal Compliance: Informed Consent and Data Licensing This work is licensed under Creative Commons Namensnennung 4.0 International Lizenz. Sebastian Netscher CESSDA Training at the Data Archive for the Social Sciences GESIS - Leibniz Institute for the Social Sciences @CESSDA_Data Informed Consent Research Study planning Data collectionData analysis Archiving & registering Informed Consent • Obtaining agreement from your participants to participate in your study • Weak consent will lead to poorer data because participants may try to protect themselves ⇒ causes item (sensitive data) or even unit non-response Image: CC-0 EU-Directive 1995/46/EC • Participants in research have the right to – withdraw from participation – access their data – get information about the use of their data • Personal data need special protection – have to be stored in the EU – have to be anonymized Image by P. Hochstenbach ( CC-by) Elements of Consent Forms • Informed consent includes information on: – project and the researcher(s) – participation in the study – use of information within and beyond the project – protection of personal data – right to withdraw • Can be given written form (favourable) or verbally ⇒ always obtain informed consent Image: CC-0 Anonymization Research Study planning Data collectionData analysis Archiving & registering Anonymization • Strategy to protect the identity of participants – legal requirements, e.g. EU-Directive 1995/46/EC – ethical reasons (protection from harm) • Identifying participants – direct identifiers, e.g. names, addresses, pictures etc. – indirect identifiers, i.e. combination of different information in the data • Anonymization is an early task (study planning) – types of data to collect – data protection laws Anonymization Strategies • Direct identifiers – keep sensitive data on separate files – use meaningful pseudonyms and replacements – remove variables with sensitive data – voice alteration or image blurring • Indirect identifiers – restrict upper and lower ranges of variables – low-level aggregation of data Anonymization: Keep in Mind • Document anonymization and changes undertaken • Avoid – inconsistency – over-anonymization • If anonymization is impossible – obtain informed consent for using and sharing non-anonymous data – control access and regulate reuse – place confidential data under embargo Image by A. Herrema & H. Bouwteam (CC-by) Data Licensing Research Study planning Data collectionData analysis Archiving & registering • Intellectual Property Rights (IPR) – cover scientific work – do neither extend to an idea nor subsist in facts but to an organized collection of data • IPRs are not universal – vary from country to country – are territorial ⇒ it matters where they are applied not where they originate Intellectual Property Rights Reusing Data • Copyright – assigns the owner of IPR protects against unauthorized copies or derivatives of work • The right of usage – defines conditions of reused ⇒ reusing data, clarify conditions, first Image by A. Herrema & H. Bouwteam (CC-by) Licensing Data • Give permission to someone else to reuse data • To license data – clarify who owns the data, first – check for template license of your institute of funder • Licenses can be – irrevocable and – not suitable for third party licensing or for confidential, sensitive objects etc. Image by A. Herrema & H. Bouwteam (CC-by) What Licenses Look Like • Licenses define conditions of reuse • Extract of UKDA end user license http://ukdataservice.ac.uk/get-data/how-to-access/conditions – not to use the data for commercial purposes … – …no transfer of any interest in intellectual property – …without warranty or liability of any kind – …abide by any further conditions notified to you – …ensure that the means of access … are kept secure – …use the correct methods of citation … in publications + access conditions for weakly anonymized data Further Readings • ANDS Guides (2012): Ethics, Consent & data Sharing. Available at: http://www.ands.org.au/guides/ethics-working-level.pdf. • Ball, Alex (2014): How to License Research Data. Available at: http://www.dcc.ac.uk/resources/how-guides/license-research-data. • Creative Commons. Available at https://creativecommons.org/. • Directive 95/46/EC of the European Parliament and of the Council, 24 October 1995. Available at: http://eur- lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:EN:NOT. • Lagoze, C., Block, W.C., Williams, J., Abowd, J. and Vilhuber, L. (2013): Data Management of Confidential Data. doi:10.2218/ijdc.v8i1.259 . Available at: http://www.ijdc.net/index.php/ijdc/article/view/8.1.265. • McGeever, Mags (2007): IPR in Databases. Available at http://www.dcc.ac.uk/resources/briefing-papers/legal-watch-papers/ipr-databases#top. • Open Data Commons. Available at http://opendatacommons.org/. • UK Data Service: Consent for data sharing: http://ukdataservice.ac.uk/manage-data/legal- ethical/consent-data-sharing/consent-forms [Examples on various consent forms]. DMP Section 4: Ethics and …  work in 2-4 groups,  time: about 30 minutes  choose one of the following topics DMP Sections 4: Ethics and … a) informed consent (Section 4.1) ⇒ outline the process of obtaining informed consent … … how you gained consent (for data sharing and preservation) … how you handle sensitive data and how protect participants’ identity b) Intellectual Property Rights (Section 4.2) ⇒ reusing data of others, under which conditions ⇒ processing data, consider … … who is the owner … will the data be licensed … the conditions of reuse DMP Sections 4.1: Informed Consent • seek informed consent in written form • outline – aim of your project as well as name of primary researcher(s) and institute(s) – importance and implication of participation – use of data within the project as well as beyond the project (archiving and sharing) – protection of sensitive information, e.g. via anonymization – right to withdraw, access the data etc. ⇒get the consent form signed and hand over a copy DMP Sections 4.2: Intellectual Property Rights • re-using data from others, consider … …who is the copyright holder and who needs to be cited …what are the conditions of reuse ⇒ better seek for permission than for forgiveness • licensing data for the reuse of others, consider … …how sensitive your data are … if and how you have to control access … if your data need additional protection, e.g. being accessible only via a Secure Data Center ⇒ archive your data to control access and use