Use of Electronic Informed Consent – Questions and Answers
This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human...
Use of Electronic Informed Consent: Questions and Answers
2016年12月15日 · This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations ...
Frequently Asked Questions About Electronic and Remote Consent
Electronic consent (e-consent) is a method of obtaining informed consent through the use of an electronic system instead of a paper consent form, e.g. in REDCap or DocuSign. Not all e-consent systems contain the ability to document legally effective signatures.
NYU Langone Health permits reseachers to use electronic processes to consent participants. There are two types of. e-Consent: in-person or remote. In-person e-Consenting uses an electronic device such as a tablet or a computer when …
Back to basics: What is electronic informed consent (eConsent)
Electronic consent offers patients a more engaging experience. Videos, images, audio, charts, and diagrams help guide patients through the informed consent process, helping them understand the study’s design and research objectives as well as what is …
The eIC must contain all elements of informed consent required by HHS and/or FDA regulations (45 CFR 46.116 and 21 CFR 50.25). eIC is simply another modality for executing the exact same process.
Informed Consent | New England Journal of Medicine
2017年3月2日 · Information technology may provide new opportunities to implement informed consent with minimal intrusion. Digital technology has transformed how people communicate, learn, and work;...
Informed Consent - StatPearls - NCBI Bookshelf
2024年10月15日 · Informed consent ensures that patients understand the risks, benefits, alternatives, and potential consequences of medical interventions, allowing them to weigh their options and participate actively in their treatment plans.
Electronic consent in clinical care: an international scoping review
2023年7月9日 · Through an international, systematic scoping review, we identified and assessed all published findings on clinical e-consent in the scholarly and grey literatures, including consents for telehealth encounters, procedures and health information exchanges.
eConsent
We encourage researchers to use evidence-informed practices when designing their eConsent processes. What is eConsent? eConsent involves using electronic devices (e.g., computer, tablet, phone) to obtain consent from a potential participant or legally authorized representative.