Editing Informed consent (section)

===Obtaining informed consents===

To document that informed consent has been given for a procedure, healthcare organisations have traditionally used paper-based consent forms on which the procedure and its risks and benefits are noted, and is signed by both patient and clinician. In a number of healthcare organisations consent forms are scanned and maintained in an electronic document store. The paper consent process has been demonstrated to be associated with significant errors of omission,<ref>{{Cite journal | last1 = St John | first1 = ER. | last2 = Scott | first2 = AJ. | last3 = Irvine | first3 = TE. | last4 = Pakzad | first4 = F. | last5 = Leff | first5 = DR. | last6 = Layer | first6 = GT. | doi =10.1016/j.surge.2015.11.004 | title = Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms. | journal = The Surgeon | volume = 15 | issue = 4 | pages = 190–195 | year = 2017 | pmid = 26791394}}</ref><ref>{{Cite journal | last1 = St John | first1 = ER. | doi =10.1093/bjs/znaa119 | title = Assessment of the introduction of semi-digital consent into surgical practice | journal =  British Journal of Surgery|  year = 2021 | volume = 108 | issue = 4 | pages = 342–345 | pmid = 33783479}}</ref> and therefore increasing numbers of organisations are using digital consent applications where the risk of errors can be minimised, a patient's decision making and comprehension can be supported by additional lay-friendly and accessible information, consent can be completed remotely, and the process can become paperless.  One form of digital consent is [[dynamic consent]], which invites participants to provide consent in a granular way, and makes it easier for them to withdraw consent if they wish.

Patient satisfaction in the context of novel forms of informed consent has been a topic in scientific research. Visual and auditory components in video-assisted informed consent<!--Q106414852--> and digital informed consent have proved to lead to higher patient satisfaction.<ref>{{Cite journal |last1=Schulz |first1=Alexandra |last2=Bohnet-Joschko |first2=Sabine |date=2024-08-02 |title=Enhancing patient informed consent in elective skin cancer surgeries: a comparative study of traditional and digital approaches in a German public hospital |journal=BMC Health Services Research |volume=24 |issue=1 |pages=879 |doi=10.1186/s12913-024-11225-3 |doi-access=free |issn=1472-6963 |pmc=11295654 |pmid=39095856}}</ref> Integrating patients into treatment decisions ([[Shared decision-making in medicine|shared decision-making]]) and increasing transparency leads to better overall treatment adherence.<ref>{{Cite journal |last1=Bernat |first1=James L. |last2=McQuillen |first2=Michael P. |date=2021 |title=On Shared Decision-making and Informed Consent |journal=Neurology. Clinical Practice |volume=11 |issue=2 |pages=93–94 |doi=10.1212/CPJ.0000000000000823 |issn=2163-0402 |pmc=8032407 |pmid=33842060}}</ref>

Electronic consent methods have been used to support indexing and retrieval of consent data, thus enhancing the ability to honor to patient intent and identify willing research participants.<ref name="healthsciencessc">{{cite web|url=http://www.healthsciencessc.org/IT.asp|title=Health Sciences South Carolina|publisher=healthsciencessc.org|access-date=14 September 2014|url-status=dead|archive-url=https://web.archive.org/web/20141011200835/http://healthsciencessc.org/IT.asp|archive-date=11 October 2014}}</ref><ref>{{Cite journal | last1 = Chalil Madathil | first1 = K. | last2 = Koikkara | first2 = R. | last3 = Gramopadhye | first3 = A. K. | last4 = Greenstein | first4 = J. S. | title = An Empirical Study of the Usability of Consenting Systems: IPad, Touchscreen and Paper-based Systems | doi = 10.1177/1071181311551168 | journal = Proceedings of the Human Factors and Ergonomics Society Annual Meeting | volume = 55 | pages = 813–817 | year = 2011 | s2cid = 62362166 }}</ref><ref>{{Cite journal | last1 = Chalil Madathil | first1 = K. | last2 = Koikkara | first2 = R. | last3 = Obeid | first3 = J. | last4 = Greenstein | first4 = J. S. | last5 = Sanderson | first5 = I. C. | last6 = Fryar | first6 = K. | last7 = Moskowitz | first7 = J. | last8 = Gramopadhye | first8 = A. K. | doi = 10.1016/j.ijmedinf.2013.04.008 | title = An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting | journal = International Journal of Medical Informatics | volume = 82 | issue = 9 | pages = 854–863 | year = 2013 | pmid = 23757370 | pmc =3779682 }}</ref><ref>{{Cite journal | last1 = Sanderson | first1 = I. C. | last2 = Obeid | first2 = J. S. | last3 = Madathil | first3 = K. C. | last4 = Gerken | first4 = K. | last5 = Fryar | first5 = K. | last6 = Rugg | first6 = D. | last7 = Alstad | first7 = C. E. | last8 = Alexander | first8 = R. | last9 = Brady | first9 = K. T. | last10 = Gramopadhye | first10 = A. K. | last11 = Moskowitz | first11 = J. | doi = 10.1177/1740774513491338 | title = Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents | journal = Clinical Trials | volume = 10 | issue = 4 | pages = 604–611 | year = 2013 | pmid = 23785065 | pmc = 4213063}}</ref> More recently, [[Health Sciences South Carolina]], a statewide research collaborative focused on transforming healthcare quality, health information systems and patient outcomes, developed an open-source system called Research Permissions Management System (RPMS).<ref name="github">{{cite web|url=https://github.com/HSSC/RPMS|title=HSSC/RPMS · GitHub|date=31 March 2014|publisher=github.com|access-date=14 September 2014}}</ref><ref name="healthsciencessc2">{{cite web|url=http://www.healthsciencessc.org/rpms/index.asp|title=Health Sciences South Carolina|publisher=healthsciencessc.org|access-date=14 September 2014|url-status=dead|archive-url=https://web.archive.org/web/20141011221421/http://healthsciencessc.org/rpms/index.asp|archive-date=11 October 2014}}</ref>