TAG ARCHIVES FOR electronic informed consent

12
May2022

Years ago, I attended a conference and was handed a small button that read "I (heart symbol) Paper." Nothing resonated more deeply with me at that moment! Technology and automation may pose an inherent element of fear and unfamiliarity. The concept of change may be especially challenging to the deep-rooted paper trail practices in the field of research, no matter the phase. Read more

25
Aug2021

As hospitals have become essential treatment centers for COVID-19 patients, clinical trial participants have become increasingly averse to attending check-ups and monitoring visits at these sites. Telemedicine is now being recognized not only as an option for those who do not have convenient access to healthcare, but also as a means by which clinical trials can be accomplished. Read more

5
Apr2017

In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and [...] Read more