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
Series: Ask the IRB & IBC Experts
Adults with Limited Capacity to Consent to Research
Blog Posts
FDA & ICH
Do all subjects need to be reconsented with the revised consent form?
Blog Posts
Series: Ask the IRB & IBC Experts
Is informed consent needed for post-market patient registry?
Blog Posts
Participant Recruitment
Does the IRB need to approve doctor-to-doctor letters?
Blog Posts
Ethics in Clinical Research
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
FDA & ICH
When should a child assent form be used in a pediatric clinical trial?
Blog Posts
Series: Ask the IRB & IBC Experts
What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?
Blog Posts
Hybrid & Decentralized Trials
What are the regulations for training home health individuals who are working remotely to collect study data?
Blog Posts
What ethical safeguards are needed for research involving observation of group behavior?
Blog Posts