Michele Russell-Einhorn, JD
Michele Russell-Einhorn has over 30 years of professional experience, including service as the conflicts of interest attorney for the National Institutes of Health (NIH) and Director of Regulatory Affairs for the US Department of Health and Human Services Office for the Protection from Research Risks and its successor office, the Office for Human Research Protections. Russell-Einhorn is also a co-chair of a DHHS subcommittee related to human research protections and a founder and leader of the IRB Directors Group within the National Comprehensive Cancer Network.
Latest Posts by Michele Russell-Einhorn
Short Form Consents and the Unexpected Non-English Speaking Participant
Short form consents provide a crucial bridge for unexpected non-English speaking participants, ensuring informed consent...
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Common Elements of IRB Assessments
Like every institutional review board (IRB) – commercial or local – Advarra is subject to...
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Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of...
Read More...Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
In a recent webinar, Advarra regulatory experts discussed the must-haves of FDA and Common Rule...
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Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution
In Advarra’s recent virtual symposium, experts from industry and academia met to discuss how oncology...
Read More...Q&A – The New Normal: Considerations for Restarting Research
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider...
Read More...Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research
Experts from Advarra and Johns Hopkins University School of Medicine provided practical guidance on the...
Read More...After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)
The bad news is we cancelled our webinar on the revised Common Rule. The good...
Read More...ICH-GCP Guidelines and Research Conducted in the US
When research is being conducted in multiple countries, determining which regulations apply to which country’s...
Read More...Non-English Speaking Research Subjects: What’s in the Regs?
Recently, the clinical research community has been making efforts to include more diverse subject populations...
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