Research Compliance
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.
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.
Q&A – Study Startup Success for the New Generation of Genetically Engineered Vaccines
Daniel Eisenman answers questions from his latest webinar Study Startup Success for the New Generation of Genetically Engineered Vaccines.
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.
Is GDPR Coming to the US? CCPA and Its Impact on Research
New California regulations apply to companies who have information about CA residents regardless of where the company is located. Read more:
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:
Getting “Engaged” in the Time of COVID
When using remote sites to perform clinical trial procedures, keep in mind things like whether remote sites are considered "engaged" in research. Read more:
Community Consultation in the Time of COVID-19
COVID-19 complicates traditional models of community consultation. How should sites conducting planned emergency research approach community consultation?
How Oncology Research Is Advancing Better Research
Innovations in oncology have sparked advancements in the clinical trial industry and empowered COVID-19 research. Read more:
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