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
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?
Common Elements of IRB Assessments
Like other IRBs, Advarra is subject to inspections from time to time. What standards are we measured against?
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.
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.
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:
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 ...
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:
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 ...
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.
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:
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:
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 ...