THE IMPORTANCE OF ELECTRONIC CONSENT FORMS IN CLINICAL RESEARCH
Keywords:
Clinical research
Abstract
Clinical research, a cornerstone of medical progress, is an intricate and dynamic field aimed at advancing our understanding of diseases, developing innovative treatments, and improving overall healthcare outcomes. The background of clinical research is deeply rooted in the pursuit of knowledge and the desire to enhance medical practices. Historically, clinical research has been driven by the need to address unanswered questions in medicine and to find effective interventions for various health conditions.
References
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2. 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, and repealing Directive 2001/20/EC. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.
3. Signant Health. State of eConsent 2020: insights from our industry global experience survey; 2020. https://www.signanthealth.com/wp-content/uploads/2021/06/eConsent-Survey-2020.pdf.
4. 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). https://eur-lex.europa.eu/eli/reg/2016/679/oj.
5. Kadam RA. Informed consent process: a step further towards making it meaningful! Perspect Clin Res. 2017;8(3):107–112. doi: 10.4103/picr.PICR_147_16.
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7. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14:28. doi: 10.1186/1472-6939-14-28.
8. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–435. doi: 10.1016/j.amjsurg.2009.02.010.
9. Lalova T, Negrouk A, Deleersnijder A, Valcke P, Huys I. Conducting non-COVID-19 clinical trials during the pandemic: can today’s learning impact framework efficiency? Eur J Health Law. 2020;27(5):425–450. doi: 10.1163/15718093-BJA10031.
2. 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, and repealing Directive 2001/20/EC. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.
3. Signant Health. State of eConsent 2020: insights from our industry global experience survey; 2020. https://www.signanthealth.com/wp-content/uploads/2021/06/eConsent-Survey-2020.pdf.
4. 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). https://eur-lex.europa.eu/eli/reg/2016/679/oj.
5. Kadam RA. Informed consent process: a step further towards making it meaningful! Perspect Clin Res. 2017;8(3):107–112. doi: 10.4103/picr.PICR_147_16.
6. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Integrated addendum to ICH E6 (R1): guideline for Good Clinical Practice E6 (R2). 2016.
7. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14:28. doi: 10.1186/1472-6939-14-28.
8. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–435. doi: 10.1016/j.amjsurg.2009.02.010.
9. Lalova T, Negrouk A, Deleersnijder A, Valcke P, Huys I. Conducting non-COVID-19 clinical trials during the pandemic: can today’s learning impact framework efficiency? Eur J Health Law. 2020;27(5):425–450. doi: 10.1163/15718093-BJA10031.
Published
2024-01-30
How to Cite
Kavyashree, D., Reddy, V. S., & Manogna, K. (2024). THE IMPORTANCE OF ELECTRONIC CONSENT FORMS IN CLINICAL RESEARCH. Central Asian Journal of Medical and Natural Science, 5(1), 437-447. https://doi.org/10.17605/cajmns.v5i1.2347
Section
Articles
