Academic Journal
Privacy rights and improving knowledge are not hierarchical needs: data protection and good epidemiologic standard (DP_GOES) checklist for retrospective observational studies using secondary data.
| Τίτλος: | Privacy rights and improving knowledge are not hierarchical needs: data protection and good epidemiologic standard (DP_GOES) checklist for retrospective observational studies using secondary data. |
|---|---|
| Συγγραφείς: | Corrao G; Emeritus Professor in Medical Statistics, University of Milano-Bicocca, Milan, Italy.; National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy.; Operative Centre for Health Data, Welfare Department, Lombardy Region, Milan, Italy., Greco M; European Patients' Forum, Brussels, Belgium., Leoni O; Operative Centre for Health Data, Welfare Department, Lombardy Region, Milan, Italy., Franchi M; National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy. matteo.franchi@unimib.it.; Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy. matteo.franchi@unimib.it.; Dipartimento di Statistica e Metodi Quantitativi, Università degli Studi di Milano-Bicocca, Via Bicocca degli Arcimboldi, 8, Edificio U7, Milano, 20126, Italy. matteo.franchi@unimib.it. |
| Πηγή: | BMC medical research methodology [BMC Med Res Methodol] 2026 Mar 06; Vol. 26 (1). Date of Electronic Publication: 2026 Mar 06. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968545 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2288 (Electronic) Linking ISSN: 14712288 NLM ISO Abbreviation: BMC Med Res Methodol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : BioMed Central, [2001- |
| Ιατρικοί όροι (MeSH): | Checklist*/standards , Checklist*/methods , Confidentiality*/standards , Observational Studies as Topic*/standards , Observational Studies as Topic*/methods , Computer Security*/standards , Privacy*, Humans ; Retrospective Studies ; Secondary Data Analysis |
| Περίληψη: | Starting with the Nuremberg Code in 1947, several guidelines were developed to formulate rules to guide research on humans and safeguard the rights and well-being of subjects participating in clinical research. In recent years, retrospective observational studies based on disease and drug registries, surveillance systems, hospital-based data lakes and platforms, and unstructured data have gained progressively greater attention in the medical literature. Although several guidelines and checklists are currently available to develop and evaluate a protocol for observational studies, issues concerning ethical considerations, data protection and data access have been often ignored. We propose the Data Protection and Good Epidemiologic Standard (DP_GOES) checklist for the development and evaluation of the protocol of observational, retrospective studies based on secondary data. The checklist is divided into four parts, 9 sections and 68 items, and should help to verify whether the study protocol respects the constraints of the regulatory requirements and provisions of data protection authorities, while ensuring that the study may generate robust evidence potentially useful to promote health, supplying more effective healthcare, and guaranteeing system sustainability. The DP_GOES checklist represents a novel and integrative contribution, as it systematically combines epidemiological research standards with data protection principles. Its practical value lies in offering a structured and operational tool that supports both researchers and evaluators in conducting and assessing retrospective observational studies based on secondary data in a rigorous, transparent, and ethically accepted manner. (© 2026. The Author(s).) |
| Competing Interests: | Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: GC received research support from the European Community (EC), the Italian Agency of Drugs (AIFA), and the Italian Ministry for University and Research (MIUR). He took part in a variety of projects that were funded by pharmaceutical companies (i.e. Novartis, GSK, Roche, AMGEN and BMS). He also received honoraria as a member of the advisory board to Roche. The other authors do not report any competing interest. |
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(PMID: 15994364173418010.1136/jme.2004.010447) Malone M, Ferguson P, Rogers A, Mackenzie IS, Rorie DA, MacDonald TM. When innovation outpaces regulations: The legal challenges for direct-to-patient supply of investigational medicinal products. Br J Clin Pharmacol. 2022;88:1115–42. (PMID: 3439002210.1111/bcp.15040) European Commission. Directorate General For Health And Food Safety. Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation. Available from: https://health.ec.europa.eu/document/download/c3042973-b36d-4094-a1fb-a6fc980f065e_en . Last accessed on 2024 Nov 21. Haendel MA, Chute CG, Robinson PN. Classification, Ontology, and Precision Medicine. N Engl J Med. 2018;379:1452–62. (PMID: 30304648650384710.1056/NEJMra1615014) Nardini C, Osmani V, Cormio P, Frosini A, Turrini M, Lionis C, et al. The evolution of personalized healthcare and the pivotal role of European regions in its implementation. 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Sci Rep. 2023;13:14419. (PMID: 376601351047506210.1038/s41598-023-41475-w) Chakraborty G, Pagolu M, Garla S. Text mining and analysis practical methods, examples, and case studies using SAS<sup>®</sup>. Cary, North Carolina, USA: SAS Institute Inc.; 2013. Kuznetsov V, Lee HK, Maurer-Stroh S, Molnár MJ, Pongor S, Eisenhaber B, et al. How bioinformatics influences health informatics: usage of biomolecular sequences, expression profiles and automated microscopic image analyses for clinical needs and public health. Health Inf Sci Syst. 2013;1:2. (PMID: 25825654433611110.1186/2047-2501-1-2) Cheung CC, Krahn AD, Andrade JG. The emerging role of wearable technologies in detection of arrhythmia. Can J Cardiol. 2018;34:1083–7. (PMID: 30049358) Cheong SHR, Ng YJX, Lau Y, Lau ST. Wearable technology for early detection of COVID-19: a systematic scoping review. Prev Med 2022;162107170. Quantin C, Jaquet-Chiffelle DO, Coatrieux G, Benzenine E, Allaert FA. 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A guide to sharing open healthcare data under the General Data Protection Regulation. Sci Data. 2023;10:404. (PMID: 373557511029065210.1038/s41597-023-02256-2) Wirth FN, Meurers T, Johns M, Prasser F. Privacy-preserving data sharing infrastructures for medical research: systematization and comparison. BMC Med Inf Decis Mak. 2021;21:242. (PMID: 10.1186/s12911-021-01602-x) Brandt M, Franconi L, Guerke C, Hundepool A, Lucarelli M, Mol J et al. Last accessed on. Guidelines for the Checking of Output Based on Microdata Research, 2010. Available at: https://uwe-repository.worktribe.com/output/983615/guidelines-for-the-checking-of-output-based-on-microdata-research . 2024 Nov 21. Desai T, Ritchie F, Welpton R. Five Safes: designing data access for research. University of the West of England. Faculty of Business and Law. Economics Working Paper Series 1601. Available at: https://www2.uwe.ac.uk/faculties/BBS/Documents/1601.pdf . Last accessed on 2024 Nov 21. Grimes DA, Schulz KF. 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| Contributed Indexing: | Keywords: Checklist; Data protection; Good practice; Observational studies; Privacy-by-design; Retrospective; Secondary data |
| Entry Date(s): | Date Created: 20260305 Date Completed: 20260710 Latest Revision: 20260710 |
| Update Code: | 20260726 |
| PubMed Central ID: | PMC13077908 |
| DOI: | 10.1186/s12874-026-02818-z |
| PMID: | 41787337 |
| Βάση Δεδομένων: | MEDLINE |
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| Items | – Name: Title Label: Title Group: Ti Data: Privacy rights and improving knowledge are not hierarchical needs: data protection and good epidemiologic standard (DP&#95;GOES) checklist for retrospective observational studies using secondary data. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Corrao+G%22">Corrao G</searchLink>; Emeritus Professor in Medical Statistics, University of Milano-Bicocca, Milan, Italy.; National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy.; Operative Centre for Health Data, Welfare Department, Lombardy Region, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Greco+M%22">Greco M</searchLink>; European Patients' Forum, Brussels, Belgium.<br /><searchLink fieldCode="AU" term="%22Leoni+O%22">Leoni O</searchLink>; Operative Centre for Health Data, Welfare Department, Lombardy Region, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Franchi+M%22">Franchi M</searchLink>; National Centre for Healthcare Research and Pharmacoepidemiology, University of Milano-Bicocca, Milan, Italy. matteo.franchi@unimib.it.; Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy. matteo.franchi@unimib.it.; Dipartimento di Statistica e Metodi Quantitativi, Università degli Studi di Milano-Bicocca, Via Bicocca degli Arcimboldi, 8, Edificio U7, Milano, 20126, Italy. matteo.franchi@unimib.it. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22100968545%22">BMC medical research methodology</searchLink> [BMC Med Res Methodol] 2026 Mar 06; Vol. 26 (1). <i>Date of Electronic Publication: </i>2026 Mar 06. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article – Name: Language Label: Language Group: Lang Data: English – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central%22">BioMed Central </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>100968545 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1471-2288 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2214712288%22">14712288 </searchLink><i>NLM ISO Abbreviation: </i>BMC Med Res Methodol <i>Subsets: </i>MEDLINE – Name: PublisherInfo Label: Imprint Name(s) Group: PubInfo Data: <i>Original Publication</i>: London : BioMed Central, [2001- – Name: SubjectMESH Label: MeSH Terms Group: Su Data: <searchLink fieldCode="MM" term="%22Checklist%22">Checklist*</searchLink>/<searchLink fieldCode="MM" term="%22Checklist+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Checklist%22">Checklist*</searchLink>/<searchLink fieldCode="MM" term="%22Checklist+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Confidentiality%22">Confidentiality*</searchLink>/<searchLink fieldCode="MM" term="%22Confidentiality+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Observational+Studies+as+Topic%22">Observational Studies as Topic*</searchLink>/<searchLink fieldCode="MM" term="%22Observational+Studies+as+Topic+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Observational+Studies+as+Topic%22">Observational Studies as Topic*</searchLink>/<searchLink fieldCode="MM" term="%22Observational+Studies+as+Topic+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Computer+Security%22">Computer Security*</searchLink>/<searchLink fieldCode="MM" term="%22Computer+Security+standards%22">standards</searchLink> <br /><searchLink fieldCode="MM" term="%22Privacy%22">Privacy*</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Retrospective+Studies%22">Retrospective Studies</searchLink> ; <searchLink fieldCode="MH" term="%22Secondary+Data+Analysis%22">Secondary Data Analysis</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Starting with the Nuremberg Code in 1947, several guidelines were developed to formulate rules to guide research on humans and safeguard the rights and well-being of subjects participating in clinical research. In recent years, retrospective observational studies based on disease and drug registries, surveillance systems, hospital-based data lakes and platforms, and unstructured data have gained progressively greater attention in the medical literature. Although several guidelines and checklists are currently available to develop and evaluate a protocol for observational studies, issues concerning ethical considerations, data protection and data access have been often ignored. We propose the Data Protection and Good Epidemiologic Standard (DP&#95;GOES) checklist for the development and evaluation of the protocol of observational, retrospective studies based on secondary data. The checklist is divided into four parts, 9 sections and 68 items, and should help to verify whether the study protocol respects the constraints of the regulatory requirements and provisions of data protection authorities, while ensuring that the study may generate robust evidence potentially useful to promote health, supplying more effective healthcare, and guaranteeing system sustainability. The DP&#95;GOES checklist represents a novel and integrative contribution, as it systematically combines epidemiological research standards with data protection principles. Its practical value lies in offering a structured and operational tool that supports both researchers and evaluators in conducting and assessing retrospective observational studies based on secondary data in a rigorous, transparent, and ethically accepted manner.<br /> (© 2026. The Author(s).) – Name: Abstract Label: Competing Interests Group: Ab Data: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: GC received research support from the European Community (EC), the Italian Agency of Drugs (AIFA), and the Italian Ministry for University and Research (MIUR). He took part in a variety of projects that were funded by pharmaceutical companies (i.e. Novartis, GSK, Roche, AMGEN and BMS). He also received honoraria as a member of the advisory board to Roche. The other authors do not report any competing interest. – Name: Ref Label: References Group: RefInfo Data: Nuremberg Military Tribunal. Nuremberg Code JAMA. 1996;276:1691.<br />Krugman S. The Willowbrook hepatitis studies revisited: Ethical aspects. Rev Infect Dis. 1986;8:157–62. (PMID: <searchLink fieldCode="PM" term="%22395242310%2E1093%2Fclinids%2F8%2E1%2E157%22">395242310.1093/clinids/8.1.157)</searchLink><br />Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274:1354–60. 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