Yvonne Higgins, CIP
Quality Assurance Advisor, Compliance
Biography
Yvonne has contributed to the cause of ethics and responsibility in human research for more than 20 years. During that time, she has served as Vice President of Quality Management for Copernicus Group IRB, Executive Director of the human research protections program (HRPP) and Institutional Review Boards (IRBs) at the University of Pennsylvania, Co-Chair of the workshop and didactic planning committee for PRIM&R’s Advancing Ethical Research annual conference, and Public Health Analyst within the US Department of Health and Human Services Office for Human Research Protections (OHRP).
Latest insights by Yvonne
WCG Clinical | Insights
Do all subjects need to be reconsented with the revised consent form?
Blog Posts
WCG Clinical | Insights
Is informed consent needed for post-market patient registry?
Blog Posts
WCG Clinical | Insights
Does the IRB need to approve doctor-to-doctor letters?
Blog Posts
WCG Clinical | Insights
Ask the Experts: When Do I Report a Protocol Deviation to the IRB? Do I Need To Report a Summary of Deviations at the Time of Continuing Review?
Blog Posts
WCG Clinical | Insights
What ethical safeguards are needed for research involving observation of group behavior?
Blog Posts
WCG Clinical | Insights
Questions on Using Generic Recruitment Flyers at Clinical Trial Sites
Blog Posts
WCG Clinical | Insights
Guidance on genomic research with deceased patients
Blog Posts
WCG Clinical | Insights
What are the IRB Reporting Requirements for Adverse Events?
Blog Posts
WCG Clinical | Insights
Questions on regulations for process development and purchased human cells
Blog Posts
WCG Clinical | Insights