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

Blog

Short Form Consents and the Unexpected Non-English Speaking Participant

What happens when an unexpected non-English speaking participant shows up, and there isn’t enough time to obtain a translated study consent?

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3 min. read

Blog

Common Elements of IRB Assessments

Like other IRBs, Advarra is subject to inspections from time to time. What standards are we measured against?

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5 min. read

Blog

Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect

Q&A from our 4/21 webinar outlining what to expect in an FDA inspection and how to have a more positive experience.

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5 min. read

Webinar

FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect

A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance.

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Blog

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:

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6 min. read

Webinar

Racial Diversity in Clinical Trials: Building Trust in Participant Engagement

October 9, 2020

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 ...

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Blog

Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution

How has the COVID-19 pandemic changed oncology research--and research in general? Read more for the follow-up blog to our recent symposium:

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5 min. read

Webinar

The Must-Haves of FDA and Common Rule Reporting Requirements

September 14, 2020

The Food and Drug Administration (FDA) regulations governing Investigational New Drug (IND) applications contain specific reporting requirements. Similarly, the Common Rule (i.e., the federal policy for the protection of human ...

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Virtual Event

The New Urgency of Clinical Trials: How Oncology Leads the Evolution

August 17, 2020

Join colleagues from the research community for a discussion on the evolution of clinical trials and how oncology research has influenced agility in clinical trial design.

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Blog

Q&A – The New Normal: Considerations for Restarting Research

Experts answer some of the most popular audience questions from the recent webinar The New Normal: Considerations for Restart Research. Read more:

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7 min. read

Blog

Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research

We have addressed the most popular Q&A topics from our recent webinar on the research impact of COVID-19 in this blog post. Read more:

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6 min. read

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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Michele Russell-Einhorn, JD

Latest Posts by Michele

Short Form Consents and the Unexpected Non-English Speaking Participant

Common Elements of IRB Assessments

Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect

FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect

Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements

Racial Diversity in Clinical Trials: Building Trust in Participant Engagement

Q&A – The New Urgency of Clinical Trials: How Oncology Leads the Evolution

The Must-Haves of FDA and Common Rule Reporting Requirements

The New Urgency of Clinical Trials: How Oncology Leads the Evolution

Q&A – The New Normal: Considerations for Restarting Research

Q&A – Ask Advarra Live: The Real-World Impact of COVID-19 on Research

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

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