Скачать или смотреть Alternatives to Traditional Informed Consent: Past & Current Examples (Research Committee Sponsored)

Presenters:

Peter C. Hou, MD
Joshua N. Goldstein, MD, PhD
Michael R. Filbin, MD, MS

Learning Objectives:
Upon completion of this session, participants should be able to:
Understand and describe examples of alternatives to traditional informed consent
Understand and describe the process of how to conduct a study using EFIC
Understand and describe the process of how to pivot a study from traditional consent to Deferred Consent

Informed consent to participate in research often use the ""reasonable patient standard"" because it focuses on what a typical patient would need to know to understand the decision at hand. However, it is the sole obligation of the provider to determine which approach is appropriate for a given situation. Traditionally, this required a hand-written signature from the research participant. With the pandemic requiring infectious precautions, electronic consent processes became prevalent and accepted. However, there are times when the patient is incapacitated, and the legal authorized representative is not available for consent to research participation. For certain emergency care research studies, alternatives to traditional informed consent are necessary due to the timeliness of the investigation as it relates to the biology and pathophysiology of the condition and disease process. The examples of alternative consent processes that will be presented are Exception for Informed Consent (EFIC) and Deferred Consent."