{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T23:07:58Z","timestamp":1780441678847,"version":"3.54.1"},"reference-count":52,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"},{"start":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T00:00:00Z","timestamp":1759881600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Ethics"],"DOI":"10.1186\/s12910-025-01296-0","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T09:10:10Z","timestamp":1759914610000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Ethics review or compliance check? an empirical analysis of 6740 requests for information in Belgian clinical trial evaluations (2017\u20132024)"],"prefix":"10.1186","volume":"26","author":[{"given":"Audrey","family":"Van Scharen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Deneyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter","family":"Cornu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,10,8]]},"reference":[{"key":"1296_CR1","unstructured":"How many clinical. trials are conducted each year in the EU? [Internet]. Entry into application of the Clinical Trials Regulation. Available from: https:\/\/health.ec.europa.eu\/medicinal-products\/clinical-trials\/entry-application-clinical-trials-regulation_en#:~:text=7.-,How%20many%20clinical%20trials%20are%20conducted%20each%20year%20in%20the,two%20Member%20States%20on%20average"},{"key":"1296_CR2","unstructured":"Monitoring the European clinical trials environment A deliverable of the ACT EU Priority Action 2 [Internet]. 2024 [cited 2025 Jul 24]. Available from: https:\/\/accelerating-clinical-trials.europa.eu\/document\/download\/d9994d92-5b38-45fd-bba9-d211b4136705_en?filename=ACT%20EU%20KPI%20Report_Feb_2024.pdf"},{"key":"1296_CR3","unstructured":"European Medicines Agency. Clinical trials in human medicines [Internet]. [cited 2024 May 29]. Available from: https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/clinical-trials-human-medicines\/clinical-trials-regulation"},{"key":"1296_CR4","unstructured":"Regulation (EU). No 536\/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use [Internet]. Eur-Lex Jun 16, 2014. Available from: https:\/\/eur-lex.europa.eu\/eli\/reg\/2014\/536\/oj"},{"issue":"1","key":"1296_CR5","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1111\/bcp.14871","volume":"88","author":"S Tusino","year":"2022","unstructured":"Tusino S, Furfaro M. Rethinking the role of research ethics committees in the light of regulation (EU) 536\/2014 on clinical trials and the COVID-19 pandemic. Br J Clin Pharmacol. 2022;88(1):40\u20136.","journal-title":"Br J Clin Pharmacol"},{"issue":"8","key":"1296_CR6","doi-asserted-by":"publisher","first-page":"485","DOI":"10.1136\/medethics-2013-101686","volume":"39","author":"M Sheehan","year":"2013","unstructured":"Sheehan M. Do we need research ethics committees? J Med Ethics. 2013;39(8):485\u2013485.","journal-title":"J Med Ethics"},{"key":"1296_CR7","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1016\/j.socscimed.2017.10.013","volume":"194","author":"JT Clapp","year":"2017","unstructured":"Clapp JT, Gleason KA, Joffe S. Justification and authority in institutional review board decision letters. Soc Sci Med. 2017;194:25\u201333.","journal-title":"Soc Sci Med"},{"issue":"2","key":"1296_CR8","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1136\/qshc.2007.022756","volume":"17","author":"EL Angell","year":"2008","unstructured":"Angell EL, Bryman A, Ashcroft RE, Dixon-Woods M. An analysis of decision letters by research ethics committees: the ethics\/scientific quality boundary examined. Qual Saf Health Care. 2008;17(2):131\u20136.","journal-title":"Qual Saf Health Care"},{"issue":"1","key":"1296_CR9","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1186\/s12910-021-00605-7","volume":"22","author":"G Benfatto","year":"2021","unstructured":"Benfatto G, Regulatory Group, Longo L, Mansueto S, Gozzo L, Vitale DC, et al. Regulatory, scientific, and ethical issues arising from institutional activity in one of the 90 Italian research ethics committees. BMC Med Ethics. 2021;22(1):40.","journal-title":"BMC Med Ethics"},{"key":"1296_CR10","unstructured":"Wet betreffende klinische proeven met geneesmiddelen voor menselijk gebruik [Internet]. Staatsblad May 22. 2017. Available from: https:\/\/etaamb.openjustice.be\/nl\/wet-van-07-mei-2017_n2017012146"},{"key":"1296_CR11","unstructured":"Koninklijk besluit tot uitvoering van de wet van 7 mei 2017 betreffende klinische proeven met geneesmiddelen voor menselijk gebruik [Internet]. Staatsblad Nov 10. 2017. Available from: https:\/\/etaamb.openjustice.be\/nl\/koninklijk-besluit-van-09-oktober-2017_n2017013752.html"},{"issue":"4","key":"1296_CR12","doi-asserted-by":"publisher","first-page":"792","DOI":"10.1016\/j.socscimed.2007.03.046","volume":"65","author":"M Dixon-Woods","year":"2007","unstructured":"Dixon-Woods M, Angell E, Ashcroft RE, Bryman A. Written work: the social functions of research ethics committee letters. Soc Sci Med. 2007;65(4):792\u2013802.","journal-title":"Soc Sci Med"},{"issue":"4","key":"1296_CR13","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1177\/1556264615599685","volume":"10","author":"E Hemminki","year":"2015","unstructured":"Hemminki E, Virtanen JI, Regushevskaya E. Decisions by Finnish medical research ethics committees: a nationwide study of process and outcomes. J Empir Res Hum Res Ethics. 2015;10(4):404\u201313.","journal-title":"J Empir Res Hum Res Ethics"},{"issue":"6","key":"1296_CR14","doi-asserted-by":"publisher","first-page":"344","DOI":"10.1136\/jme.2003.007492","volume":"31","author":"R Dal-R\u00e9","year":"2005","unstructured":"Dal-R\u00e9 R, Ortega R, Morej\u00f3n E. Multicentre trials review process by research ethics committees in spain: where do they stand before implementing the new European regulation?? J Med Ethics. 2005;31(6):344\u201350.","journal-title":"J Med Ethics"},{"issue":"20","key":"1296_CR15","first-page":"770","volume":"123","author":"R Dal-R\u00e9","year":"2004","unstructured":"Dal-R\u00e9 R, Morej\u00f3n E, Ortega R. Nature and extent of changes in the patient\u2019s information sheets of international multicentre clinical trials as requested by Spanish research ethics committees. Med Clin (Barc). 2004;123(20):770\u20134.","journal-title":"Med Clin (Barc)"},{"issue":"3","key":"1296_CR16","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1177\/1747016121999935","volume":"17","author":"C Brandenburg","year":"2021","unstructured":"Brandenburg C, Thorning S, Ruthenberg C. What are the most common reasons for return of ethics submissions? An audit of an Australian health service ethics committee. Res Ethics. 2021;17(3):346\u201358.","journal-title":"Res Ethics"},{"key":"1296_CR17","doi-asserted-by":"crossref","unstructured":"O\u2019Reilly M, Armstrong N, Dixon-Woods M. Subject positions in research ethics committee letters: a discursive analysis. Clin Ethics. 2009;4(4).","DOI":"10.1258\/ce.2009.009027"},{"issue":"1","key":"1296_CR18","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-15-83","volume":"15","author":"M Van Lent","year":"2014","unstructured":"Van Lent M, Rongen GA, Out HJ. Shortcomings of protocols of drug trials in relation to sponsorship as identified by research ethics committees: analysis of comments raised during ethical review. BMC Med Ethics. 2014;15(1):83.","journal-title":"BMC Med Ethics"},{"issue":"1","key":"1296_CR19","doi-asserted-by":"publisher","first-page":"47","DOI":"10.1080\/08989620600588944","volume":"13","author":"MH Fitzgerald","year":"2006","unstructured":"Fitzgerald MH, Phillips PA. Centralized and non-centralized ethics review: a five Nation study. Acc Res. 2006;13(1):47\u201374.","journal-title":"Acc Res"},{"issue":"3","key":"1296_CR20","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1177\/1556264618812625","volume":"14","author":"HF Lynch","year":"2019","unstructured":"Lynch HF, Nicholls S, Meyer MN, Taylor HA, For the Consortium to Advance Effective Research Ethics Oversight (AEREO). Of parachutes and participant protection: moving beyond quality to advance effective research ethics oversight. J Empir Res Hum Res Ethics. 2019;14(3):190\u20136.","journal-title":"J Empir Res Hum Res Ethics"},{"key":"1296_CR21","doi-asserted-by":"crossref","unstructured":"Gouilhers S, Riom L. Observer l\u2019\u00e9thique en train de se faire pour une approche pragmatique des commissions d\u2019\u00e9thique de la recherche. Rev Anthropol Connaiss. 2019 Jun 1 [cited 2024 May 7];13(2). Available from: http:\/\/journals.openedition.org\/rac\/1210","DOI":"10.3917\/rac.043.0503"},{"issue":"1","key":"1296_CR22","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1186\/s12910-018-0339-5","volume":"20","author":"M Petrova","year":"2019","unstructured":"Petrova M, Barclay S. Research approvals iceberg: how a \u2018low-key\u2019 study in England needed 89 professionals to approve it and how we can do better. BMC Med Ethics. 2019;20(1):7.","journal-title":"BMC Med Ethics"},{"issue":"3","key":"1296_CR23","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1177\/1556264618804686","volume":"14","author":"MF Tsan","year":"2019","unstructured":"Tsan MF. Measuring the quality and performance of institutional review boards. J Empir Res Hum Res Ethics. 2019;14(3):187\u20139.","journal-title":"J Empir Res Hum Res Ethics"},{"issue":"1","key":"1296_CR24","doi-asserted-by":"publisher","first-page":"117","DOI":"10.1186\/1471-2288-13-117","volume":"13","author":"NK Gale","year":"2013","unstructured":"Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(1):117.","journal-title":"BMC Med Res Methodol"},{"issue":"2","key":"1296_CR25","doi-asserted-by":"publisher","first-page":"52","DOI":"10.7748\/nr2011.01.18.2.52.c8284","volume":"18","author":"J Smith","year":"2011","unstructured":"Smith J, Firth J. Qualitative data analysis: the framework approach. Nurse Res. 2011;18(2):52\u201362.","journal-title":"Nurse Res"},{"key":"1296_CR26","unstructured":"Audrey Van Scharen. A national EC or harmonisation and education, the better solution? In 2023. Available from: https:\/\/barec.be\/barec-symposium-09-december-2023\/"},{"key":"1296_CR27","unstructured":"Audrey Van Scharen. Ethics evaluations in pilots CTR and MDR. In Brussels, Belgium. 2022. Available from: https:\/\/barec.be\/barec-symposium\/"},{"key":"1296_CR28","doi-asserted-by":"crossref","unstructured":"Braun V, Clarke V. Thematic analysis: A practical guide. Sage; 2022.","DOI":"10.1007\/978-3-319-69909-7_3470-2"},{"key":"1296_CR29","unstructured":"Audrey Van Scharen. Final Analyses on How Medical Research Ethics Committees (MRECs). Have Evaluated CTR Trials (2017\u20132024), Numbers, Evolutions, and Recommendations. In 2024. Available from: https:\/\/barec.be\/save-the-date-symposium-2024\/"},{"key":"1296_CR30","unstructured":"College Board. Recommendations of the College Board to reduce the number of RFIs raised during the assessment of a clinical study [Internet]. 2025 [cited 2025 Mar 9]. Available from: https:\/\/consultativebodies.health.belgium.be\/sites\/default\/files\/documents\/advice_for_ecs_recommendation_to_reduce_number_of_rfi_v2_20250125_6.pdf"},{"issue":"8","key":"1296_CR31","doi-asserted-by":"publisher","first-page":"e011973","DOI":"10.1136\/bmjopen-2016-011973","volume":"6","author":"M Dixon-Woods","year":"2016","unstructured":"Dixon-Woods M, Foy C, Hayden C, Al-Shahi Salman R, Tebbutt S, Schroter S. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project. BMJ Open. 2016;6(8):e011973.","journal-title":"BMJ Open"},{"issue":"10385","key":"1296_CR32","doi-asserted-by":"publisher","first-page":"1339","DOI":"10.1016\/S0140-6736(23)00463-4","volume":"401","author":"M Al","year":"2023","unstructured":"Al M, Levison S, Berdel WE, Andersen DZ. Decentralised elements in clinical trials: recommendations from the European medicines regulatory network. Lancet. 2023;401(10385):1339.","journal-title":"Lancet"},{"issue":"3\u20134","key":"1296_CR33","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1177\/1747016116656912","volume":"13","author":"SM Happo","year":"2017","unstructured":"Happo SM, Halkoaho A, Lehto SM, Ker\u00e4nen T. The effect of study type on research ethics committees\u2019 queries in medical studies. Res Ethics. 2017;13(3\u20134):115\u201327.","journal-title":"Res Ethics"},{"issue":"2","key":"1296_CR34","doi-asserted-by":"publisher","first-page":"107","DOI":"10.1177\/1556264618824921","volume":"14","author":"B Silaigwana","year":"2019","unstructured":"Silaigwana B, Wassenaar D. Research ethics committees\u2019 oversight of biomedical research in South africa: a thematic analysis of ethical issues raised during ethics review of non-expedited protocols. J Empir Res Hum Res Ethics. 2019;14(2):107\u201316.","journal-title":"J Empir Res Hum Res Ethics"},{"key":"1296_CR35","unstructured":"Permissible Medical Experiments. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg October 1946. 1949;2:181\u20132."},{"issue":"20","key":"1296_CR36","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","volume":"310","author":"World Medical Association","year":"2013","unstructured":"World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191.","journal-title":"JAMA"},{"key":"1296_CR37","unstructured":"BAREC statement race and ethnicity [Internet]. Belgian Association for Research Ethics Committees (BAREC). 2024. Available from: https:\/\/barec.be\/barec-statement-race-and-ethnicity\/"},{"key":"1296_CR38","unstructured":"Farkas L, Analysis. and comparative review of equality data collection practices in the European Union Data collection in the field of ethnicity [Internet]. EC, Directorate-General for Justice and Consumers; 2017. Available from: https:\/\/commission.europa.eu\/system\/files\/2021-09\/data_collection_in_the_field_of_ethnicity.pdf"},{"key":"1296_CR39","doi-asserted-by":"publisher","unstructured":"European Commission. Directorate General for Justice and Consumers. Guidance note on the collection and use of equality data based on racial or ethnic origin. [Internet]. LU: Publications Office. 2021 [cited 2025 Mar 8]. Available from: https:\/\/data.europa.eu\/doi\/https:\/\/doi.org\/10.2838\/06180","DOI":"10.2838\/06180"},{"key":"1296_CR40","unstructured":"Regulation (EU). 2016\/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95\/46\/EC (General Data Protection Regulation). OJ L May 4, 2016 pp. 1\u201388."},{"issue":"1","key":"1296_CR41","doi-asserted-by":"publisher","first-page":"51","DOI":"10.1186\/s12910-021-00616-4","volume":"22","author":"A Ferretti","year":"2021","unstructured":"Ferretti A, Ienca M, Sheehan M, Blasimme A, Dove ES, Farsides B, et al. Ethics review of big data research: what should stay and what should be reformed? BMC Med Ethics. 2021;22(1):51.","journal-title":"BMC Med Ethics"},{"issue":"6","key":"1296_CR42","doi-asserted-by":"publisher","first-page":"e390","DOI":"10.1016\/S2589-7500(23)00052-3","volume":"5","author":"E Vayena","year":"2023","unstructured":"Vayena E, Blasimme A, Sugarman J. Decentralised clinical trials: ethical opportunities and challenges. Lancet Digit Health. 2023;5(6):e390-4.","journal-title":"Lancet Digit Health"},{"issue":"2","key":"1296_CR43","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1136\/jme.2008.025940","volume":"35","author":"E Angell","year":"2009","unstructured":"Angell E, Dixon-Woods M. Do research ethics committees identify process errors in applications for ethical approval? J Med Ethics. 2009;35(2):130\u20132.","journal-title":"J Med Ethics"},{"key":"1296_CR44","unstructured":"Model ICF. for interventional clinical trials with an investigational medicinal product on adult patients. Available from: https:\/\/consultativebodies.health.belgium.be\/en\/ICF-template-interv-trial-adult-patient-EN"},{"issue":"1","key":"1296_CR45","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1177\/09697330211003252","volume":"29","author":"J Morton","year":"2022","unstructured":"Morton J. Ethics review, reflective equilibrium and reflexivity. Nurs Ethics. 2022;29(1):49\u201362.","journal-title":"Nurs Ethics"},{"key":"1296_CR46","unstructured":"About us. [cited 2025 Mar 8]. Available from: https:\/\/barec.be\/objectives\/"},{"key":"1296_CR47","unstructured":"Compensation contraception. 2024 [cited 2025 Mar 8]. Available from: https:\/\/barec.be\/compensation-contraception\/"},{"key":"1296_CR48","unstructured":"Guidance on Compensation of Clinical Research Participants . 2024 [cited 2025 Mar 8]. Available from: https:\/\/barec.be\/guidance-on-compensation-of-clinical-research-participants\/"},{"key":"1296_CR49","unstructured":"Belgian Association of Research Ethics Committees (BAREC). Statement on decentralized trials . 2024 [cited 2025 Mar 8]. Available from: https:\/\/barec.be\/statement-on-decentralized-trials\/"},{"key":"1296_CR50","unstructured":"ICF \u2013 Trial at a glance. 2020. Available from: https:\/\/barec.be\/icf-trial-at-a-glance\/"},{"key":"1296_CR51","unstructured":"Insurance Coverage \u2013 Clinical Trials. 2018. Available from: https:\/\/barec.be\/1-insurance-coverage-clinical-trials\/"},{"key":"1296_CR52","unstructured":"Guidance for sponsors on the use of. electronic informed consent in interventional clinical trials in Belgium. 2022 [cited 2025 Mar 8]. Available from: https:\/\/consultativebodies.health.belgium.be\/en\/e-ICF%20guidance%20Belgium_30-09-2020"}],"container-title":["BMC Medical Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-025-01296-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12910-025-01296-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-025-01296-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T09:10:27Z","timestamp":1759914627000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedethics.biomedcentral.com\/articles\/10.1186\/s12910-025-01296-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,8]]},"references-count":52,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["1296"],"URL":"https:\/\/doi.org\/10.1186\/s12910-025-01296-0","relation":{},"ISSN":["1472-6939"],"issn-type":[{"value":"1472-6939","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,8]]},"assertion":[{"value":"14 May 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 September 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 October 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"NA","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"NA","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"129"}}