Author

Resource Library

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.

Latest Posts by Michele

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.

Read Now

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.

Read Now

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.

Read Now

3 min. read

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.

Watch Now

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.

Read Now

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.

Read Now

4 min. read

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.

Read Now

3 min. read

Blog

IRB Review of Adaptive Design Studies

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

Read Now

3 min. read

Blog

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

Is there a difference between the terms sIRB and cIRB?

Read Now

2 min. read

Back 1 2

Back to Resources

Subscribe to our monthly email

Receive updates monthly about webinars for CEUs, white papers, podcasts, and more.

Community

Reviews

Consulting

Professional Services

Training

Services for

Ready to Increase Your Research Productivity?

Solutions for Need

Research Site Cloud

Life Sciences Cloud

Not Sure Where To Start?

Resource Library

About Advarra

Join Advarra

Michele Russell-Einhorn, JD

Latest Posts by Michele

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

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

ICH-GCP Guidelines and Research Conducted in the US

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

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

Non-English Speaking Research Subjects: What’s in the Regs?

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

IRB Review of Adaptive Design Studies

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

Ready to Advance Your Clinical Research Capabilities?

Subscribe to our monthly email