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Webinar: (07-2022) Who's Around the IRB Table? Considering Diversity, Expertise, and Lay Perspectives in IRB Decision-Making

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Contributors

  • Kim Serpico, MEd, CIP, EdD Candidate

    Kim Serpico is the assistant director of IRB operations for the Harvard Longwood Campus (HLC) Schools, including Harvard TH Chan School of Public Health, Harvard Medical School, and Harvard School of Dental Medicine. Kim holds a BS in psychology, an MEd in higher education administration, a graduate certificate in legal studies, and is currently working on her doctoral degree in education at Vanderbilt University. Her professional areas of expertise are the ethical conduct and regulatory compliance of human subjects research, and protection of the rights and welfare of participants involved in biomedical and social-behavioral research. Additionally, she serves as co-chair of the Harvard Catalyst Emerging Technologies, Ethics, and Research subcommittee where she co-leads a federally funded committee dedicated to enhancing data security and human subjects research involving novel technologies (i.e. cloud platforms, apps, smart devices). She is also a Certified IRB Professional (CIP).

  • Holly Fernandez Lynch, JD, MBE

    Holly Fernandez Lynch is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania. Her scholarly work focuses primarily on the ethics and regulation of research with human subjects and related areas, including payment to research participants, research with biospecimens, the use of social media in research settings, patient-engaged research, research risks to bystanders, and the quality of Institutional Review Board oversight of research. She was named a Greenwall Faculty Scholar in 2019 to examine the ethics of health care gatekeeping, with an emphasis on access to investigational therapies outside clinical trials. In the context of COVID-19, she has applied her expertise to the ethical conduct of research, drug and vaccine development and FDA oversight, and allocation of scarce investigational products during a pandemic. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise (MIT Press 2008), as well as the co-editor of seven books.

    Professor Fernandez Lynch is the founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), established in 2018. She served as member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019. She currently serves as a board member of the American Society of Law, Medicine, and Ethics. Professor Fernandez Lynch joined PRIM&R's Board of Directors in 2020 and co-chairs the Public Policy Committee.

    Prior to joining Penn, Professor Fernandez Lynch was Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She has worked as an attorney in private practice focused on pharmaceuticals regulation and as a bioethicist at the NIH’s Division of AIDS and President Obama's Commission for the Study of Bioethical Issues. She attended college at Penn, was a Levy Scholar in Law and Bioethics at Penn Law, and earned a Master of Bioethics also from Penn.

  • Stuart Nicholls, BSc(Hons), MSc, MRes, PhD

    Stuart Nicholls is the Strategy for Patient-Oriented Research (SPOR) Program Facilitator in the Office for Patient Engagement in Research Activities (OPERA) at the Ottawa Hospital Research Institute, Canada. He obtained his PhD in Social Statistics (Lancaster University, UK), and has an MRes in Social Statistics, an MSc in Healthcare Ethics, and a BSc (Hons) in Genetics. Using empirical approaches to explore ethical issues he has has published on topics including quality assessment in ethics review, progress in human research regulation, public attitudes to population screening, stakeholder perspectives on the ethical challenges in pragmatic clinical trials, and the development of core outcome sets. Dr. Nicholls is a member of the AEREO Consortium and is leading research to explore how non-scientist and unaffiliated members of IRBs are recruited and supported. He was a member of the Canadian Clinical Trials Coordinating Centre (CCTCC)/Health Canada working group reviewing the potential for a pan-Canadian accreditation system for Research Ethics Boards. He is also a member of the Health Canada/Public Health Agency of Canada Research Ethics Board. He holds Associate Editor positions for the journals Research Ethics, Journal of Empirical Research on Human Research Ethics, and Clinical Trials.

July 19, 2022
Tue 1:00 PM EDT

Duration 1H 15M

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