• The Ethical Tech Project: https://www.ethicaltechproject.org/ 
• CITI Program’s Tech Ethics training solution: https://about.citiprogram.org/solutions/tech-ethics/ 

 
Our guests today are Christina Kuhn and Olivia Dworkin from the law firm Covington. Christina advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products. Olivia minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. 
 

Additional resources: 

• FDA’s Clinical Decision Support Software guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software 
• FDA’s General Wellness: Policy for Low Risk Devices guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices 
• 5 Key Takeaways from FDA’s Revised Clinical Decision Support (CDS) Software Guidance: https://www.cov.com/news-and-insights/insights/2026/01/5-key-takeaways-from-fdas-revised-clinical-decision-support-cds-software-guidance 
• FDA Issues Revised Guidance on General Wellness Products: https://www.cov.com/en/news-and-insights/insights/2026/01/fda-issues-revised-guidance-on-general-wellness-products 
• Covington Digital Health Blog and Resources: https://www.cov.com/en/practices-and-industries/industries/digital-health 
• CITI Program’s Essentials of Software as a Medical Device and Clinical Decision Support Systems: https://about.citiprogram.org/course/essentials-of-software-as-a-medical-device-clinical-decision-support-systems/ 
•  CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

 
Our guest today is Danielle Louder, who serves as the Co-Director of MCD Global Health’s U.S. Programs and the Director of the Northeast Telehealth Resource Center. In these roles, she is responsible for advancing the use of digital health strategies to improve health access and outcomes. 
 

Additional resources: 

• National Consortium of Telehealth Resource Centers: https://telehealthresourcecenter.org/ 
• National Telehealth Technology Assessment Resource Center: https://telehealthtechnology.org/ 
• Northeast Telehealth Resource Center: https://www.netrc.org/ 
• U.S. Department of Health and Human Services: https://telehealth.hhs.gov/ 
• Center for Connected Health Policy: https://www.cchpca.org/ 
• National Digital Inclusion Alliance: https://www.digitalinclusion.org/ 
• National Digital Equity Center: https://digitalequitycenter.org/ 
• DiMe Digital Health Series: https://about.citiprogram.org/series/dime-digital-health-series/ 
• TelehealthVillage @UVA: https://about.citiprogram.org/series/teleheatlhvillage-uva/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

 
Our guest today is Yael Bensoussan, who is an Assistant Professor of Otolaryngology at the University of South Florida Health Morsani College of Medicine and a fellowship-trained laryngologist. She is also the principal investigator of the Bridge2AI-Voice project, a multi-institutional endeavor funded by the National Institutes of Health to fuel voice as a biomarker of diseases. 
 

Additional resources: 

• Bridge2AI-Voice: https://b2ai-voice.org/ 
• Voice AI Symposium: https://b2ai-voice.org/voice-ai-symposium/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

• KavAI: https://www.kavai.com/ 
• What is Active Physical Intelligence?: https://www.kavai.com/dev/active-physical-intelligence 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

• CMS fact sheet: https://www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-and-ambulatory-surgical 
• Impact of Recent CMS Rule on Site Neutrality and 340B Programs—Implications for Oncology Services: https://www.blankrome.com/publications/impact-recent-cms-rule-site-neutrality-and-340b-programs-implications-oncology
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

Our guests today are from MIT Critical Data, which develops local AI capacity in healthcare by building open data and software, fostering community engagement through datathons, and advocating for AI equity in research. 

• Sebastian Cajas Senior is an AI scientist at CeADAR with expertise in generative AI, quantum machine learning, and responsible AI. Sebastian is a former fellow in computer science at Harvard University, leading projects in multimodal AI, AI safety, and federated learning. Sebastian is passionate about applying AI to healthcare, education, and high-impact societal challenges. 
• Leo Anthony Celi is the principal investigator behind the Medical Information Mart for Intensive Care (MIMIC) and its family of databases. With close to 100k users worldwide, an open codebase, and close to 10k publications in Google Scholar, the datasets have shaped the course of machine learning in healthcare. 
• Meskerem Kebede is a research officer at the London School of Economics and Political Science. Meskerem has previously worked as a clinician and lecturer at the ENT surgery department at Addis Ababa University, Ethiopia. She is passionate about strengthening surgical systems in low- and middle-income countries and has a special interest in health workforce development in East Africa. 
• Hyunjung Gloria Kwak is an assistant professor at Emory University’s School of Nursing, with a PhD in Computer Science. She researches bias-aware modeling, social determinants of health, and simulation-based studies, integrating large-scale EHRs and multimodal data to improve decision-making, and leads interdisciplinary projects on predictive analytics, representation, and real-world AI evaluation in healthcare. 
   

Additional resources: 

• MIT Critical Data: https://criticaldata.mit.edu/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

Our guest today is Lynn Sessions, the lead of the Healthcare Privacy and Compliance team and co-lead of the national Healthcare Industry team at BakerHostetler. Lynn focuses her practice on healthcare privacy and data security, breach response, regulatory defense, and Health Insurance Portability and Accountability Act (HIPAA) compliance. 
 

Additional resources: 

• BakerHostetler Data Counsel: https://www.bakerdatacounsel.com/ 
• Health Care Compliance Association: https://www.hcca-info.org/ 
• American Health Law Association: https://www.americanhealthlaw.org/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

• The Hastings Center for Bioethics – https://www.thehastingscenter.org/ 
• The American Journal of Bioethics – https://www.tandfonline.com/journals/uajb20 
• Bioethics Today – https://bioethicstoday.org/ 
• Bioethics in the Margins – https://bioethicsinthemargins.org/ 
• Bioethics for the People – https://www.bioethicsforthepeople.com/ 
• CITI Program’s Bioethics course – https://about.citiprogram.org/course/bioethics/ 
• CITI Program’s Healthcare Ethics Committee course – https://about.citiprogram.org/course/healthcare-ethics-committee/ 

Our guest today is Dr. Yauheni Solad who is a Managing Partner at Dalos Partners, leading healthcare AI strategy and validation. Dr. Solad is a research affiliate at Yale University and a board-certified physician in clinical informatics. He formerly led digital health innovation at UC Davis Health and Yale, advancing FHIR interoperability, telemedicine, and responsible AI standards. 
 

Additional resources: 

• ReAligned Healthcare podcast: https://realignedhealthcare.com/ 
• Journal of the American Medical Informatics Association: https://academic.oup.com/jamia 
• The Lancet Digital Health: https://www.thelancet.com/journals/landig/home 
• Deep Medicine: https://dl.acm.org/doi/10.5555/3350442 
• Request for Information on the Development of an AI Action Plan: https://www.federalregister.gov/documents/2025/02/06/2025-02305/request-for-information-on-the-development-of-an-artificial-intelligence-ai-action-plan 
• WHO Harnessing AI for Health: https://www.who.int/teams/digital-health-and-innovation/harnessing-artificial-intelligence-for-health 
• National Academy of Medicine AI and Emerging Technology: https://nam.edu/our-work/key-issues/artificial-intelligence-and-emerging-technology/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

This episode is co-hosted by Eric D. Kupferberg, PhD, Associate Director of Clinical Research Education at CITI Program. 
 

Additional resources: 

• ICH E6(R3): https://www.ich.org/page/efficacy-guidelines#6-2 
• CITI Program’s ICH E6(R3): An Introduction course: https://about.citiprogram.org/course/ich-e6r3-an-introduction/ 

Our guest today is Sarah Florini who is an Associate Director and Associate Professor in the Lincoln Center for Applied Ethics at Arizona State University. Sarah’s work focuses on technology, social media, technology ethics, digital ethnography, and Black digital culture. Among other things, Sarah is dedicated to fostering critical AI literacy and ethical engagement with AI/ML technologies. She founded the AI and Ethics Workgroup to serve as a catalyst for critical conversations about the role of AI models in higher education. 

This episode is co-hosted by Alexa McClellan, MA, Associate Director of Research Foundations at CITI Program. 
 

Additional resources: 

• Distributed AI Research Institute: https://www.dair-institute.org/ 
• Mystery AI Hype Theater 3000: https://www.dair-institute.org/maiht3k/ 
• Tech Won’t Save Us: https://techwontsave.us/ 
• CITI Program’s Essentials of Responsible AI course: https://about.citiprogram.org/course/essentials-of-responsible-ai/ 

Our guest today is Katrina Destrée who is a globally experienced privacy and sustainability professional. Katrina’s work in privacy and sustainability focuses on privacy programs, ESG reporting, awareness and training, and strategic communications. 
 

Additional resources: 

• International Association of Privacy Professionals (IAPP): https://iapp.org/ 
• ISACA: https://www.isaca.org/ 
• Global Enabling Sustainability Initiative (GeSI): https://www.gesi.org/ 
• Agréa Privacy & ESG: https://agreaprivacyesg.com/ 
• CITI Program’s “GDPR for Research and Higher Ed” course: https://about.citiprogram.org/course/gdpr-for-research-and-higher-ed/  
• CITI Program’s “Big Data and Data Science Research Ethics” course: https://about.citiprogram.org/course/big-data-and-data-science-research-ethics/ 
• CITI Program’s “Essentials of Responsible AI” course: https://about.citiprogram.org/course/essentials-of-responsible-ai/ 

Our guest today is Lisa Rasmussen who is a Professor in the Department of Philosophy at the University of North Carolina Charlotte and Editor-in-Chief of the journal Accountability in Research. Lisa has been a principal investigator or co-principal investigator on over $1 million in National Science Foundation awards and serves as a Co-Editor of the book series Philosophy and Medicine and an Associate Editor of the publication Citizen Science: Theory and Practice.  

Additional resources: 

• Association for the Advancement of Participatory Sciences: https://participatorysciences.org/ 
• Citizen Science: Theory and Practice: https://theoryandpractice.citizenscienceassociation.org/ 
• Citizen Science: How Ordinary People are Changing the Face of Discovery: https://scistarter.com/cooper 
• SciStarter: https://scistarter.org/ 

Our guest today is Megan LaFollette, who is the Executive Director at The 3Rs Collaborative, where she advances better science for both people and animals. She received her PhD and Master of Science in Animal Behavior & Welfare from Purdue University. She is an expert in advancing the implementation of practical, impactful, and evidence-based 3Rs techniques. 

Additional resources: 

• The 3Rs Collaborative: https://3rc.org/ 
• The 3Rs Collaborative Initiatives: https://3rc.org/workstreams/ 
• CITI Program ACU Core Courses: https://about.citiprogram.org/series/animal-care-and-use-acu/ 
• CITI Program ACU Advanced Courses: https://about.citiprogram.org/series/animal-care-and-use-acu-advanced/ 

• Consumer Reports: https://www.consumerreports.org/issue/data-privacy
• Electronic Frontier Foundation: https://www.eff.org/
• Family Educational Rights and Privacy Act (FERPA): https://about.citiprogram.org/course/family-educational-rights-and-privacy-act-ferpa/ 
• Health Insurance Portability and Accountability Act (HIPAA): https://about.citiprogram.org/series/health-insurance-portability-and-accountability-act-hipaa/ 
• Human Subjects Research (HSR): https://about.citiprogram.org/series/human-subjects-research-hsr/ 

Our guest today is Dennis L. Shung, MD, MHS, PhD, an Assistant Professor of Medicine at Yale School of Medicine and Director of Digital Health in Digestive Diseases. He leads the Human+Artificial Intelligence in Medicine lab, which focuses on enhancing human presence with AI. Dennis is also involved in multiple gastroenterology AI initiatives and research.  

Additional resources: 

• NSF Program Solicitation on Mathematical Foundations of Digital Twins: https://new.nsf.gov/funding/opportunities/math-dt-mathematical-foundations-digital-twins/nsf24-559/solicitation 
• AI models collapse when trained on recursively generated data: https://www.nature.com/articles/s41586-024-07566-y 
• Synthetic data in machine learning for medicine and healthcare: https://www.nature.com/articles/s41551-021-00751-8 
• Synthetic data in medical research: https://bmjmedicine.bmj.com/content/1/1/e000167 
• Harnessing the power of synthetic data in healthcare: innovation, application, and privacy: https://www.nature.com/articles/s41746-023-00927-3 
• Essentials of Responsible AI: https://about.citiprogram.org/course/essentials-of-responsible-ai 
• Big Data and Data Science Research Ethics: https://about.citiprogram.org/course/big-data-and-data-science-research-ethics/ 

Our guest today is Shelly Simana, an assistant professor at Boston College Law School. Before joining BC, she was a fellow at Stanford Law School’s Center for Law and the Biosciences and a doctoral candidate at Harvard Law School. Her scholarship lies at the intersection of law and bioethics. 

Additional resources: 

• Shelly Simana: https://www.bc.edu/bc-web/schools/law/academics-faculty/faculty-directory/shelly-simana.html 
• National Human Genome Research Institute: https://www.genome.gov/
• Technology, Ethics, and Regulations: https://about.citiprogram.org/course/technology-ethics-and-regulations/
• Bioethics: https://about.citiprogram.org/course/bioethics/ 

Our guest today is Natalie Rubio, the executive director of the Cellular Agriculture Commercialization Laboratory at Tufts University, who is working to convert early-stage innovations to impactful technologies to reduce costs, increase scale, and improve the quality of cellular agriculture products. Previously, Natalie worked at New Harvest, Perfect Day Foods, and Ark Biotech. 
 

Additional resources: 

• Tufts University Center for Cellular Agriculture: https://cellularagriculture.tufts.edu/ 
• New Harvest: https://new-harvest.org/ 
• Good Food Institute: https://gfi.org/ 
• CITI Program’s “Technology, Ethics, and Regulations” course: https://about.citiprogram.org/course/technology-ethics-and-regulations/ 

• Center for Open Science: https://www.cos.io/ 
• The Open Science Framework: https://www.cos.io/products/osf 
• FORRT (Framework for Open and Reproducible Research Training): https://forrt.org/ 
• The Turing Way: https://book.the-turing-way.org/  
• CITI Program’s “Preparing for Success in Scholarly Publishing” course: https://about.citiprogram.org/course/preparing-for-success-in-scholarly-publishing/ 
• CITI Program’s “Protocol Development and Execution: Beyond a Concept” course: https://about.citiprogram.org/course/protocol-development-execution-beyond-a-concept/ 
• CITI Program’s “Technology Transfer” course: https://about.citiprogram.org/course/technology-transfer/ 

Our guest today is Junfeng Jiao, an Associate Professor in the Community and Regional Planning Program at the University of Texas at Austin. He is the founding director of the Urban Information Lab, Texas Smart Cities, the UT Ethical AI program, and a founding member of UT Austin's Good Systems Grand Challenge. His research focuses on smart cities, urban informatics, and ethical AI. 
 

Additional resources: 

• Texas Smart Cities: https://smartcity.tacc.utexas.edu/pages/index.html 
• Texas Smart Cities Events: https://smartcity.tacc.utexas.edu/events#E282128843 
• Urban Information Lab: https://sites.utexas.edu/uil/ 
• Big Data and Data Science Research Ethics Course: https://about.citiprogram.org/course/big-data-and-data-science-research-ethics/ 

• Biotility: https://biotility.research.ufl.edu/ 
• BACE: https://biotility.research.ufl.edu/bace/ 
• Biotility Courses Available on CITI Program: https://about.citiprogram.org/series/biotility-at-the-university-of-florida/ 
• InnovATEBIO: https://innovatebio.org/ 
• Biotech Careers: https://www.biotech-careers.org/careers 
• Bio-Rad Biotechnology Textbook & Program: https://www.bio-rad.com/en-us/a/edu/biotechnology-textbook-program 

Our guests today are Mike Steele and Emily Bradford. Mike is an Expert in the Office of the Chief of Research Security Strategy and Policy at the National Science Foundation, where he supports efforts to develop research security training and the office’s global outreach efforts. Emily is the Assistant Director of Research Compliance at the University of Kentucky. Under the Office of Sponsored Projects, she oversees conflicts of interest, research security, export controls, and some aspects of clinical trial compliance. 
 

Additional resources: 

• CITI Program Research Security Training: https://about.citiprogram.org/series/research-security/ 
• National Science Foundation Research Security (including the JASON studies and resources): https://new.nsf.gov/research-security 
• National Science Foundation Research Security Training: https://new.nsf.gov/research-security/training 
• Council on Governmental Relations Science and Security Resources: https://www.cogr.edu/cogrs-resource-page-science-and-security 

Our guest today is César de la Fuente who is a Presidential Assistant Professor at the University of Pennsylvania. César’s research focuses on using computational approaches to accelerate discoveries in biology and medicine. Specifically, he pioneered the development of the first computer-designed antibiotic with efficacy in animal models, demonstrating the application of AI for antibiotic discovery and helping launch this emerging field. 
 

Related publications: 

• Pioneering study describing an antibiotic designed by AI with efficacy in preclinical mouse models: https://www.nature.com/articles/s41467-018-03746-3 
• First exploration of the human proteome as a source of antibiotics, yielding numerous preclinical candidates: https://www.nature.com/articles/s41551-021-00801-1 
• First therapeutic molecules (i.e., antibiotics) identified in extinct organisms, launching the field of molecular de-extinction: https://www.cell.com/cell-host-microbe/pdfExtended/S1931-3128(23)00296-2 
• Relevant review in Science with the Collins Lab covering this emerging field: https://www.science.org/doi/10.1126/science.adh1114 

Related media coverage: 

• STAT - “Giant sloths and woolly mammoths: Mining past creatures’ DNA for future antibiotics:” https://www.statnews.com/2023/10/25/antibiotics-resistance-ancient-dna-cesar-de-la-fuente/ 
• Vox - “Using AI, scientists bring Neanderthal antibiotics back from extinction:” https://www.vox.com/future-perfect/23811682/ai-neanderthal-antibiotics-extinction 
• CNN - “Why ‘resurrection biology’ is gaining traction around the world:” https://www.cnn.com/2023/12/26/world/resurrection-biology-extinct-species-virus-scn/index.html 

Additional resources: 

• De La Fuente Lab: http://delafuentelab.seas.upenn.edu/ 
• LinkedIn: https://www.linkedin.com/in/cesardelafuentenunez/ 
• X: https://twitter.com/delafuenteupenn 
• CITI Program’s Bioethics course: https://about.citiprogram.org/course/bioethics/ 
• CITI Program’s Technology, Ethics, and Regulations course: https://about.citiprogram.org/course/technology-ethics-and-regulations/ 

Our guest today is David Chadwick who is the Founder and CEO of RealResponse.

Additional resources:

·         RealResponse: https://www.realresponse.com/

·         On Campus with CITI Program: https://www.buzzsprout.com/1896915

·         CITI Program’s Safe Research Environments course: https://about.citiprogram.org/course/safe-research-environments/

Our guest today is Stephanie Kukora who is a neonatologist and bioethicist at Children’s Mercy Kansas City, where she serves as core faculty in the Certificate Program in Pediatric Bioethics. She conducts research related to shared decision-making, global health, and education targeting communication skills for clinicians. 
 

Additional resources: 

• “Ethical challenges in first-in-human trials of the artificial placenta and artificial womb: not all technologies are created equally, ethically:” https://www.nature.com/articles/s41372-023-01713-5 
• CITI Program’s Bioethics course: https://about.citiprogram.org/course/bioethics/ 
• CITI Program’s Healthcare Ethics Committee course: https://about.citiprogram.org/course/healthcare-ethics-committee/ 

Our guest today is Mihaela Popescu who is a Professor of Digital Media in the Department of Communication Studies at California State University, San Bernardino (CSUSB) and the Faculty Director of CSUSB's Extended Reality for Learning Lab (xREAL). She holds a Ph.D. in Communication from the University of Pennsylvania. 

Additional resources: 

• Educause: https://www.educause.edu/ 
• Electronic Frontier Foundation: https://www.eff.org/ 
• CITI Program’s Technology, Ethics, and Regulations course: https://about.citiprogram.org/course/technology-ethics-and-regulations/ 

Our guest is Myra Luna-Lucero, EdD, the Research Compliance Director at Columbia University’s Teachers College. She spearheaded the College’s “Ethics & Safety Amid Uncertainty” initiative and co-chaired the Research Compliance & Safety Committee. She has also recently launched the “Research Writing & Ethics” internship program and oversaw an extensive transformation of the College’s IRB website. She regularly offers seminars and workshops on research compliance and IRB leadership. A researcher and teacher herself, Dr. Luna-Lucero has studied and published on student motivation in STEM fields, barriers to accessing education for students in rural communities, and community activism. 
 

Additional resources: 

• CITI Program’s Essentials of Responsible AI course: https://about.citiprogram.org/course/essentials-of-responsible-ai/ 
• CITI Program’s Technology, Ethics, and Regulations course: https://about.citiprogram.org/course/technology-ethics-and-regulations/ 

Our guest today is Mohammad Hosseini who is an Assistant Professor at Northwestern University. Mohammad’s work explores a broad range of research ethics issues, such as recognizing contributions in academic publications, citations and publication ethics, gender issues in academia, and employing artificial intelligence and large language models in research.

Additional resources:

· “How ChatGPT is transforming the postdoc experience” (Nordling 2023): https://www.nature.com/articles/d41586-023-03235-8

· “An exploratory survey about using ChatGPT in education, healthcare, and research” (Hosseini et al. 2023): https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292216

· CITI Program’s Essentials of Responsible AI course: https://about.citiprogram.org/course/essentials-of-responsible-ai/

Our guest today is Karen Maschke, a Senior Research Scholar at The Hastings Center and editor of The Hastings Center’s journal Ethics & Human Research. Her work focuses on ethical, regulatory, and policy issues associated with developing and using new biotechnologies.

Additional resource:

· The Hastings Center “Ethical and Policy Guidance for Translational Xenotransplantation Clinical Trials:” https://www.thehastingscenter.org/who-we-are/our-research/current-projects/ethical-and-policy-guidance-for-translational-xenotransplantation-clinical-trials/

Additional resources:

• Jones Day “Autonomous Vehicles: Legal and Regulatory Developments in the United States” white paper: https://www.jonesday.com/en/insights/2021/05/autonomous-vehicles-legal-and-regulatory-developments-in-the-us
• SAE International: https://www.sae.org/ 
• National Highway Traffic Safety Administration: https://www.nhtsa.gov/
• Ferris State University’s School of Automotive and Heavy Equipment: https://www.ferris.edu/CET/auto-heet/homepage.htm

Our guest today is Tom Salazar, the Chief Research Oversight and Compliance Officer at Travis Air Force Base in Northern California. Tom’s areas of expertise include bioethics and research compliance in topics such as psychedelic drugs, neuroscience, artificial intelligence, and space research.

Additional resources:

• Tom Salazar’s email: trssalazar@ucdavis.edu
• The Outer Space Treaty of 1966: https://www.unoosa.org/oosa/en/ourwork/spacelaw/treaties/introouterspacetreaty.html
• Code of Conduct for the International Space Station Crew (14 CFR 1214.403): https://www.ecfr.gov/current/title-14/chapter-V/part-1214/subpart-1214.4/section-1214.403

Our guest is Nicholas Proferes, an Assistant Professor at Arizona State University’s School of Social and Behavioral Sciences. His research interests include users’ understanding of socio-technical systems such as social media, societal discourse about technology, and issues of power and ethics in the digital landscape.

Additional resources:

•  Coalition for Independent Technology Research: https://independenttechresearch.org/
• The Citizens and Technology (CAT) Lab at Cornell University: https://citizensandtech.org/ 
• Knight First Amendment Institute at Columbia University: https://knightcolumbia.org/
• “Twitter’s plan to cut off free data access evokes ‘fair amount of panic’ among scientists:” https://www.science.org/content/article/twitters-plan-cut-free-data-access-evokes-fair-amount-panic-among-scientists
• “What the end of Twitter’s free API means for research:” https://www.nature.com/articles/d41586-023-00480-9

Our guest is Sara Meeder, who is the Director of Human Research Protections at Maimonides Medical Center in Brooklyn, New York, where she works on ethics and infrastructure for mobile health research, pain management studies, and AI in healthcare. Previously, she served as the Director of Research Compliance & Ethics for The Human Project at New York University, helping to define the ethical and regulatory processes for big data and emerging technologies studies. Sara specializes in the intersection between research ethics, regulations, infrastructure, and mobile health research.

Additional resources:

• CITI Program’s Big Data and Data Science Research Ethics course: about.citiprogram.org/course/big-data-and-data-science-research-ethics
• CITI Program’s Technology, Ethics, and Regulations course: about.citiprogram.org/course/technology-ethics-and-regulations
• Public Responsibility in Medicine and Research: primr.org
• Digital Medicine Society (DiMe): dimesociety.org

Our guest is Katie Shilton, Ph.D. who is an associate professor in the College of Information Studies at the University of Maryland, College Park. She is the principal investigator (PI) of the PERVADE project, a multi-campus collaboration focused on big data research ethics. She is also a co-PI of the NSF Institute for Trustworthy Artificial Intelligence in Law & Society (TRAILS). She is the founding co-director of the University of Maryland’s undergraduate major in social data science.

Additional resources:

· PERVADE Data Ethics Tool: https://pervade.umd.edu/pervade-data-ethics-tool/
· PERVADE Selected Publications: https://pervade.umd.edu/selected-publications/
· CITI Program Big Data and Data Science Research Ethics course: https://about.citiprogram.org/course/big-data-and-data-science-research-ethics/

Our guest is Myra Luna-Lucero, EdD, the Research Compliance Director at Columbia University’s Teachers College. She spearheaded the College’s “Ethics & Safety Amid Uncertainty” initiative and co-chaired the Research Compliance & Safety Committee. She has also recently launched the “Research Writing & Ethics” internship program and oversaw an extensive transformation of the College’s IRB website. She regularly offers seminars and workshops on research compliance and IRB leadership. A researcher and teacher herself, Dr. Luna-Lucero has studied and published on student motivation in STEM fields, barriers to accessing education for students in rural communities, and community activism.

Our guest is Eric Wagner, Ph.D., JD who is the Director, Legal Affairs in Duke University’s Office for Translation and Commercialization (OTC). His responsibilities include preparing and prosecuting patent applications, assisting OTC staff regarding patent and licensing matters, and managing intellectual assets owned by Duke University.

Additional Resources:

· AUTM provides various resources on working with technology transfer offices: https://autm.net/

· The American Intellectual Property Law Association provides information on ongoing intellectual property matters, such as Section 101 of the Patent Act: https://www.aipla.org/detail/news/2022/10/21/aipla-comments-to-uspto-on-subject-matter-guidance

· More information on Amgen v. Sanofi can be found online

· CITI Program provides an online course on technology transfer: https://about.citiprogram.org/course/technology-transfer/

Our guest is Josephine Johnston, LLB, MBHL who is the Director of Research and a Research Scholar at The Hastings Center, and a Lecturer at The University of Otago’s Bioethics Centre. Her research addresses ethical, legal, and policy issues in medicine and science, with a focus on emerging biotechnologies in human reproduction and genetics.

Additional Resources:

· Research report discussed in this podcast: https://www.thehastingscenter.org/centerreports/clarifying-the-ethics-and-oversight-of-chimeric-research/

· The National Academies guidelines for human embryonic stem cell research: https://www.nationalacademies.org/our-work/guidelines-for-human-embryonic-stem-cell-research

· The National Academies consensus report on the emerging field of human neural organoids, transplants, and chimeras: https://www.nationalacademies.org/our-work/ethical-legal-and-regulatory-issues-associated-with-neural-chimeras-and-organoids

· The International Society for Stem Cell Research guidelines for stem cell research and clinical translation: https://www.isscr.org/guidelines

· CITI Program provides an online module on human-animal chimera research: https://about.citiprogram.org/course/technology-ethics-and-regulations/

Our guest is Chirag Shah, Ph.D. Chirag is a Professor of Information and Computer Science at the University of Washington. He is the Founding Director of InfoSeeking Lab and Founding Co-Director of the Center for Responsibility in AI Systems & Experiences (RAISE). He works on intelligent information access systems focusing on fairness and transparency.

Additional Resources:

· InfoSeeking Lab: https://infoseeking.org/
· RAISE: https://www.raise.uw.edu/
· “Situating Search” by Chirag Shah and Emily M. Bender: https://dl.acm.org/doi/fullHtml/10.1145/3498366.3505816

For more information about CITI Program, please visit: https://about.citiprogram.org/

Our guest is Tamiko Eto, MS, CIP who manages research compliance at the Division of Research at Kaiser Permanente. Tamiko also serves on the AI Ethics Advisory Board for Northeastern University’s Institute of Experiential AI.

Additional Resources:

• HHS definitions of human subject and research: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102
• Nils Nilsson definition of AI: https://ai.stanford.edu/~nilsson/QAI/qai.pdf
• Joanna Bryson and Jeremy Wyatt definition of AI: http://www.cs.bath.ac.uk/~jjb/web/whatisai.html
• OHRP list of ethical codes and research standards: https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html
• SACHRP considerations for IRB review of research involving AI: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-e-july-25-2022-letter/index.html
• FDA guidance: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
• OSTP blueprint for AI bill of rights: https://www.whitehouse.gov/ostp/ai-bill-of-rights/
• EU proposed AI Act: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206
• CITI Program AI content: https://about.citiprogram.org/course/technology-ethics-and-regulations/
• PRIM&R webinars: https://primr.org/online-learning/webinars
• IRB reviewer checklist and decision tree: https://etohconsulting.com/wp-content/uploads/2021/12/ai-hsr-irb-reviewer-checklist-with-decision-tree.pdf
• White paper on IRB review of AI HSR: https://techinhsr.com/2022/08/25/how-to-conduct-an-effective-irb-review-of-artificial-intelligence-human-subjec/

Additional Resources:

· Share ideas for topics to cover on the podcast and nominate guests using this nomination form - https://about.citiprogram.org/nominate-author-or-peer-reviewer/
· Learn more about CITI Program at https://about.citiprogram.org/  
· Follow CITI Program on social media (LinkedIn, Twitter, Facebook).