Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations
Olga Marius Peycheva, Lydia R Ainsworth, Galina Fujimori-Petrikova, Wai Theng Lee Solutions OP Ltd, Dover, UKCorrespondence: Olga Marius Peycheva, Solutions OP Ltd, 74 Pencester Road, Dover, CT16 1BW, UK, Email olga.peycheva@solutionsop.co.ukAbstract: Many developers of medical devices face a new re...
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| Language: | English |
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Dove Medical Press
2025-07-01
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| Series: | Medical Devices: Evidence and Research |
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| Online Access: | https://www.dovepress.com/enhancing-informed-consent-forms-for-medical-devices-international-reg-peer-reviewed-fulltext-article-MDER |
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| author | Peycheva OM Ainsworth LR Fujimori-Petrikova G Lee WT |
| author_facet | Peycheva OM Ainsworth LR Fujimori-Petrikova G Lee WT |
| author_sort | Peycheva OM |
| collection | DOAJ |
| description | Olga Marius Peycheva, Lydia R Ainsworth, Galina Fujimori-Petrikova, Wai Theng Lee Solutions OP Ltd, Dover, UKCorrespondence: Olga Marius Peycheva, Solutions OP Ltd, 74 Pencester Road, Dover, CT16 1BW, UK, Email olga.peycheva@solutionsop.co.ukAbstract: Many developers of medical devices face a new reality with the increasing demand for clinical evidence that is generated by clinical investigations. This affects biotechnology companies, start-ups and academic research centres. The participants’ informed consent form (ICF), which includes the participant information sheet (PIS), is among the critical documents that are part of the clinical investigation. While many countries around the world follow the principles of good clinical practice (GCP), there are country-specific variations of the ICF requirements. In addition, many of the country guidelines are focused on medicinal products rather than medical devices. Clinical investigations involving medical devices have their unique challenges and need additional guidance to help developers improve the ICF and PIS content. This review provides information on the latest regulatory recommendations from Europe, USA and Asia regarding the content of the ICF and offers practical advice from professionals experienced in preparing ICFs. It also includes some ethical considerations that must be taken into account.Keywords: informed consent, medical devices, GCP |
| format | Article |
| id | doaj-art-e3700b07869041ccaee15d8567fda2e7 |
| institution | Kabale University |
| issn | 1179-1470 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Medical Devices: Evidence and Research |
| spelling | doaj-art-e3700b07869041ccaee15d8567fda2e72025-08-20T03:56:49ZengDove Medical PressMedical Devices: Evidence and Research1179-14702025-07-01Volume 18Issue 1397411105184Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical RecommendationsPeycheva OM0Ainsworth LRFujimori-Petrikova G1Lee WTNot applicableNot applicableOlga Marius Peycheva, Lydia R Ainsworth, Galina Fujimori-Petrikova, Wai Theng Lee Solutions OP Ltd, Dover, UKCorrespondence: Olga Marius Peycheva, Solutions OP Ltd, 74 Pencester Road, Dover, CT16 1BW, UK, Email olga.peycheva@solutionsop.co.ukAbstract: Many developers of medical devices face a new reality with the increasing demand for clinical evidence that is generated by clinical investigations. This affects biotechnology companies, start-ups and academic research centres. The participants’ informed consent form (ICF), which includes the participant information sheet (PIS), is among the critical documents that are part of the clinical investigation. While many countries around the world follow the principles of good clinical practice (GCP), there are country-specific variations of the ICF requirements. In addition, many of the country guidelines are focused on medicinal products rather than medical devices. Clinical investigations involving medical devices have their unique challenges and need additional guidance to help developers improve the ICF and PIS content. This review provides information on the latest regulatory recommendations from Europe, USA and Asia regarding the content of the ICF and offers practical advice from professionals experienced in preparing ICFs. It also includes some ethical considerations that must be taken into account.Keywords: informed consent, medical devices, GCPhttps://www.dovepress.com/enhancing-informed-consent-forms-for-medical-devices-international-reg-peer-reviewed-fulltext-article-MDERinformed consentmedical devicesGCP |
| spellingShingle | Peycheva OM Ainsworth LR Fujimori-Petrikova G Lee WT Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations Medical Devices: Evidence and Research informed consent medical devices GCP |
| title | Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations |
| title_full | Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations |
| title_fullStr | Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations |
| title_full_unstemmed | Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations |
| title_short | Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations |
| title_sort | enhancing informed consent forms for medical devices international regulatory guidance and ethical recommendations |
| topic | informed consent medical devices GCP |
| url | https://www.dovepress.com/enhancing-informed-consent-forms-for-medical-devices-international-reg-peer-reviewed-fulltext-article-MDER |
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