IRB
Institutional Responsibilities Under a Federalwide Assurance (FWA)
When institutions are engaged in non-exempt human subjects research supported or conducted by a Common Rule department or agency, they are required to provide written assurance that they will abide the requirements of the Common Rule.
Evaluating Payment to Participate in Research: Ethical and Regulatory Issues
In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical framework for evaluating offers of payment and applies it to case studies to yield guidance on challenging ethical and regulatory issues involved in paying research subjects.
Q&A – Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
Our experts answered some of the most popular questions from "Racial Diversity in Clinical Trials: Building Trust in Participant Engagement."
Ethical Challenges in Clinical Research During the COVID-19 Pandemic
Luke Gelinas, Advarra IRB Chairperson, co-authored the article “Ethical Challenges in Clinical Research During the COVID-19 Pandemic” in Journal of Bioethical Inquiry.
Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA)
Checking the box is still an option on the FWA. At this time, institutions must carefully consider whether it makes sense to check the box.
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
On October 22, 2020, the FDA's VRBPAC met to discuss the development, authorization, and licensure of vaccines to prevent COVID-19.
Ethical and Practical Concerns About IRB Restrictions on the Use of Research Data
Judith Carrithers co-authored the article Ethical and Practical Concerns About IRB Restrictions on the Use of Research Data in Ethics & Human Research.
By the Numbers: Our Response to COVID-19
See the data points in our infograhpic to find out how Advarra helps keep research moving forward.
Beginner’s Guide to Investigator-Initiated Trials
In investigator-initiated trials, an investigator takes on the clinical study as both the sponsor and investigator. Learn more about IITs impact on the clinical research industry.
Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
Find out more about what to report to whom--and when--in the Q&A blog follow-up to our recent webinar. Read the answers to popular audience questions:
Racial Diversity in Clinical Trials: Building Trust in Participant Engagement
COVID-19 has focused the importance of diversity, equity, and inclusion considerations in clinical trial enrollment. How can the research community address the root causes for lack of diversity? What actions ...
Global CRO Drives Study Startup Efficiency by Converting Local IRB Sites to Central IRB Review
Research sites that rely on a local IRB typically take at least twice as long to activate than sites that rely on the study’s single central IRB. Utilizing the central ...
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