On Differing Approaches to Measuring and Ensuring IRB Effectiveness

Holly A. Taylor, PhD, MPH, is a member of the faculty of the Department of Bioethics at the Clinical Center of the National Institutes of Health. She is a nationally recognized expert on the review and oversight of human subject research and on research ethics consultation. She co-leads two national collaboratives dedicated to advancing knowledge and practice in these areas: the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org) and the Clinical Research Ethics Consultation Collaborative (www.iths.org/CRECC). Dr. Taylor conducts quantitative and qualitative research in the field of research ethics, including informed consent for research participation and subject selection, as well as the review and oversight of research and research ethics consultation. She also has longstanding interests in public health ethics issues related to infectious disease and has published on HIV, pandemic preparedness, Ebola, and Covid-19. She also has served on multiple institutional review boards and data monitoring committees.

Rachel Lally, MPH, CIP is an Assistant Vice President for Research at the Pennsylvania State University. She is responsible for overseeing compliance programs related to IRB, IACUC and safety within Penn State’s Office for Research Protections. Rachel completed her undergraduate degree in Behavioral Neuroscience and Education at Colgate University, earned a Master's degree from Columbia’s Mailman School of Public Health, and has over 20 years of experience working in clinical research and research administration, with an expertise in human subjects research. Rachel worked with a number of IRBs in New York City before landing at Penn State and has participated in many local and national meetings related to improving the way IRBs do their work, with a focus on protecting human subjects while moving science forward.

Nichelle Cobb, PhD, CIP, is the Senior Advisor for Strategic Initiatives for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and previously a site visitor for AAHRPP and member of AAHRPP’s Council on Accreditation. Prior to joining AAHRPP, she was the Director of the Health Sciences Institutional Review Boards (IRBs) for 16 years at the University of Wisconsin-Madison and has worked with IRBs for 20+ years. Nichelle has been involved in single IRB work for more than a decade and was instrumental in the development of the SMART IRB Reliance Agreement and serves as a Senior Advisor and Ambassador for SMART IRB, a federally funded project to support the implementation of single IRB. In addition, Nichelle is a member of the SMART IRB Harmonization Steering Committee and has co-led working groups to harmonize IRB and Human Research Protection Program (HRPP) practices, such as for reportable events, ancillary reviews, continuing review, and local context. Nichelle also has been a member and co-chair of human subjects research content planning committees for the Public Responsibility in Medicine and Research (PRIM&R) annual Advancing Ethics in Research Conference, contributed to IRB Management and Function, 3rd Edition, authored academic articles on single IRB and informed consent, and developed and taught PRIM&R courses for new IRB administrators and about the Common Rule. She has been invited to many regional and national meetings to speak on issues affecting HRPPs and especially IRBs.

Ben Mooso, MS, CCRP, is the current director for the Office of IRB Administration at UC San Diego where he has served for three years and is a co-chair for the Executive Committee of the Consortium for Applied Research Ethics Quality (CARE-Q) developed by the University of California and Stanford. Ben began his career as a basic and animal researcher studying genitourinary cancers at UC Davis and the VA in Sacramento, eventually becoming involved with the VA IRB. Ben parlayed these experiences into a role in clinical research administration at UC Davis’ Emergency Medicine Department before joining the UC Davis IRB and eventually leading the UC San Diego IRB. Ben has been described as a “policy nerd” by his colleagues and enjoys the challenge of making IRBs more efficient without sacrificing subject protections. Ben appreciates any opportunity to work with colleagues on advancing the national discussion around IRB efficiencies and efficacy.

Luke Gelinas, PhD, is the Senior IRB Chair Director at Advarra, where he provides analysis and guidance on complex ethical issues arising in the course of clinical research study design and human participant protection. Previously, Luke led collaborative and multi-stakeholder projects addressing foundational and practical issues in research ethics including social media use, clinical trial priority-setting, and has explored the ethical and regulatory parameters paying research participants. His written work has appeared in leading medical and bioethics journals, and frequently lectures on various issues surrounding research ethics and human participant protection. Luke holds a PhD in Philosophy with a concentration in Ethics from the University of Toronto and an MA in Religion from Yale Divinity School.

Laura Stark, PhD, is Associate Professor at Vanderbilt University’s Department for Medicine, Health, and Society.

She is author of Behind Closed Doors: IRBs and the Making of Ethical Research, which was published in 2012 by University of Chicago Press. She has published several other works on the history of medicine, morality, and the modern state, and pieces on social theory. Her second book, The Normals: A People’s History is under contract with Chicago Press. This book explores the lives of “normal control” research subjects enrolled in the first clinical trials at the US National Institutes of Health after World War II. Laura received her PhD from Princeton University, was a Postdoctoral Fellow in Science in Human Culture at Northwestern University and held a Stetten Fellowship at the Office of NIH History at the National Institutes of Health. She was on faculty at Wesleyan University before joining Vanderbilt in 2012.