Yvonne Higgins | Quality Assurance Advisor, Compliance

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).

  • What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?

    What documentation is needed to prove a parent’s legal authority to consent for a child’s participation in research?

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  • What are the regulations for training home health individuals who are working remotely to collect study data?

    What are the regulations for training home health individuals who are working remotely to collect study data?

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  • What ethical safeguards are needed for research involving observation of group behavior?

    What ethical safeguards are needed for research involving observation of group behavior?

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  • Questions regarding the definition of "human subject"

    Questions regarding the definition of "human subject"

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  • Questions on Using Generic Recruitment Flyers at Clinical Trial Sites

    Questions on Using Generic Recruitment Flyers at Clinical Trial Sites

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  • Guidance on genomic research with deceased patients

    Guidance on genomic research with deceased patients

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  • Is IRB review required for publication of a case study?

    Is IRB review required for publication of a case study?

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  • What are the IRB Reporting Requirements for Adverse Events?

    What are the IRB Reporting Requirements for Adverse Events?

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  • Is IRB review required for a research study conducted by a high school student?

    Is IRB review required for a research study conducted by a high school student?

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  • Question: Does the Common Rule apply to Medicare-covered investigational device studies?

    Question: Does the Common Rule apply to Medicare-covered investigational device studies?

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  • Questions on regulations for process development and purchased human cells

    Questions on regulations for process development and purchased human cells

    Do the FDA and federal regulations apply to activities such as process development activities that are privately funded? For federally funded research, if the sponsor purchases human cells or specimen

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  • Question: What training documentation is required for conducting clinical research studies?

    Question: What training documentation is required for conducting clinical research studies?

    For initial protocol training, do both the trainee and the trainer need to sign as being trained or can we only have the PI sign confirming that training was done with date trained and who was...

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  • Question: How to resolve irregularities in the documentation of informed consent?

    Question: How to resolve irregularities in the documentation of informed consent?

    Our site recently concluded a clinical trial enrolling 2,500 subjects across several clinical sites. Upon review of our information we are seeing improper informed consent documentation...

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  • Question: What are the requirements for submitting protocol deviations?

    Question: What are the requirements for submitting protocol deviations?

    Some deviations from the IRB approved protocol are planned while others are unintentional or unplanned. The FDA and HHS (45 CFR §46.103(b)(4) and 21 CFR §56.108(a)(4)), position is that...

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  • Question: Can we transfer patient data from our CTMS to our parent medical practice?

    Question: Can we transfer patient data from our CTMS to our parent medical practice?

    Our research site is a subsidiary of a medical practice. The financial controller, who works for both the practice and the research site, wants to export data from our clinical trial management system

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  • Question: What elements of Informed Consent must we include when pre-screening?

    Question: What elements of Informed Consent must we include when pre-screening?

    We want to create a “pre-screening protocol” to screen patients for a specific mutation, with permission to recontact them when we have a study open for people with that mutation. Does the informed..

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  • Question: Does the IRB need to review news stories?

    Question: Does the IRB need to review news stories?

    The local newspaper is planning to run a story on a new clinical trial that will highlight the development of an exciting new drug and the work done by our principal investigator...

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  • Question: When can research participants be paid?

    Question: When can research participants be paid?

    As a sponsor, what do the regulations say about paying research subjects? What are acceptable practices for compensating subjects for participating in a clinical trial?

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