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
Regulatory Compliance
Guidance on genomic research with deceased patients
Blog Posts
Clinical Trial Safety
What are the IRB Reporting Requirements for Adverse Events?
Blog Posts
Questions on regulations for process development and purchased human cells
Blog Posts
Regulatory Compliance
What training documentation is required for conducting clinical research studies?
Blog Posts
What are ethical considerations for a trial with a pre-study washout period?
Blog Posts
Regulatory Compliance
How to resolve irregularities in the documentation of informed consent?
Blog Posts
What are the requirements for submitting protocol deviations?
Blog Posts
Regulatory Compliance
Can we transfer patient data from our CTMS to our parent medical practice?
Blog Posts
What elements of Informed Consent must we include when pre-screening?
Blog Posts
Ethics in Clinical Research