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Michele Russell-Einhorn, JD

Chief Compliance Officer and Institutional Official, Advarra

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.

Michele Russell-Einhorn

Latest Posts by Michele

 
Webinar

Ask Advarra Live: The Real-World Impact of COVID-19 on Research

April 2, 2020

The unprecedented COVID-19 pandemic has quickly changed how we live and work. This extraordinary situation has resulted in a significant impact on IRB-approved protocols and research yet to go through ...

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News

Bloomberg Law Features Advarra Chief Compliance Officer on New Ethics for Fitbit Data

Advarra Chief Compliance Officer and Institutional Official Michele Russell Einhorn was recently featured in Bloomberg Law on Your Fitbit Data Means New Ethics Conundrums for Clinical Trials.

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Webinar

Making Mobile Clinical Trials a Reality

In this webinar hosted by Advarra, presenters will share findings, recommendations, and resources from four projects in CTTI’s MCT program: Novel Endpoints, Mobile Technologies, Decentralized Trials, and Stakeholder Perceptions.

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Blog

After the Compliance Date: Revised Common Rule FAQs (Or: Why We Cancelled Our February Webinar)

We have cancelled our webinar “After the Compliance Date: Revised Common Rule FAQs,” which was originally scheduled for February 28.

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Blog

ICH-GCP Guidelines and Research Conducted in the US

Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.

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3 min. read
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Webinar

Making a List, Checking It Twice… The Revised Common Rule Is Coming to Town!

Judith Carrithers and discuss a checklist of action items to consider and complete prior to the revised Common Rule compliance date.

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Abstract

Shifting Sands: The Complexities and Uncertainties of the Evolving US Regulatory, Policy, and Scientific Landscape for Biospecimen Research

Michele Russell-Einhorn co-authored Shifting Sands: The Complexities and Uncertainties of the Evolving US Regulatory, Policy, and Scientific Landscape.

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Blog

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 in clinical studies.

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4 min. read
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Blog

Component Analysis: Analyzing Benefits and Risks of Individual Interventions to Ensure Appropriate Research Participant Protections

A major element of any IRB review is the examination of potential benefits and risks to study participants.

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3 min. read
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Blog

IRB Review of Adaptive Design Studies

Learn why the popularity of adaptive design in clinical research is continuing to grow!

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3 min. read
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Blog

“Single IRB” vs “Central IRB” – What’s the Difference?

Is there a difference between the terms sIRB and cIRB?

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2 min. read
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