Informed Consent
Unique First-in-Human Phase I IRB Considerations you Might not Know About
An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.
Developing and Implementing a Successful eConsent Process
As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.
Why Now is the Right Time to Adopt eConsent
A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.
How to Optimize Your sIRB Experience
Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.
Why Keep HIPAA Separate from the Informed Consent Form
HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Informed Consent Writing Tip Sheet
Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it.
Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
Enhancing Research Conduct Using eConsent
The Belmont Report established informed consent parameters in 1976, but there are no federal regulations surrounding electronic consent.
Short Form Consents and the Unexpected Non-English Speaking Participant
What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?
Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents
Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools
Becoming Your Own Best Advocate Through Patient Empowerment
In this episode, we discuss clinical trial patient empowerment and advocacy. We dive into health literacy and the informed consent process.
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