ARTICLE
16 October 2023

FDA Issues Guidance On Informed Consent For IRBs, Clinical Investigators, And Sponsors (Podcast)

KG
K&L Gates LLP

Contributor

At K&L Gates, we foster an inclusive and collaborative environment across our fully integrated global platform that enables us to diligently combine the knowledge and expertise of our lawyers and policy professionals to create teams that provide exceptional client solutions. With offices worldwide, we represent leading global corporations in every major industry, capital markets participants, and ambitious middle-market and emerging growth companies. Our lawyers also serve public sector entities, educational institutions, philanthropic organizations, and individuals. We are leaders in legal issues related to industries critical to the economies of both the developed and developing worlds—including technology, manufacturing, financial services, healthcare, energy, and more.
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA's latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent...
United States Food, Drugs, Healthcare, Life Sciences
K&L Gates LLP are most popular:
  • within Immigration topic(s)

In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA's latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators, and sponsors.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

[View Source]

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More