On Tech Ethics with CITI Program

Examines the requirements and various considerations for research security training. 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 

Discusses the use of artificial intelligence (AI) to accelerate antibiotic discovery. 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/ 

Discusses RealResponse, which is a platform that helps create safe, ethical, and inclusive educational and workplace environments.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/

Discusses artificial placenta and womb technologies, including some ethical considerations for first-in-human clinical trials. 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/ 

Discusses privacy and other ethical considerations for extended reality settings. 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/ 

Discusses considerations for using artificial intelligence in Institutional Review Board operations. 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/ 

Discusses recent developments in the regulation of artificial intelligence.Our guest today is Brenda Leong who is a Partner at Luminos.Law and an adjunct faculty member teaching privacy and information security at George Mason University.Additional resources:· White House Fact Sheet on the Executive Order on Safe, Secure, and Trustworthy AI: https://www.whitehouse.gov/briefing-room/statements-releases/2023/10/30/fact-sheet-president-biden-issues-executive-order-on-safe-secure-and-trustworthy-artificial-intelligence/ · European Union AI Act overview: https://www.europarl.europa.eu/news/en/press-room/20231206IPR15699/artificial-intelligence-act-deal-on-comprehensive-rules-for-trustworthy-ai · The Bletchley Declaration: https://www.gov.uk/government/publications/ai-safety-summit-2023-the-bletchley-declaration/the-bletchley-declaration-by-countries-attending-the-ai-safety-summit-1-2-november-2023 · G7 Guiding Principles and Code of Conduct for AI: https://digital-strategy.ec.europa.eu/en/library/g7-leaders-statement-hiroshima-ai-process · Luminos.Law: https://luminos.law/· CITI Program’s Essentials of Responsible AI course: https://about.citiprogram.org/course/essentials-of-responsible-ai/

Discusses the impact of generative artificial intelligence on research integrity.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/

Discusses ethical and policy considerations for xenotransplantation clinical trials.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/

Our guest today is Patrick English, a Professor of Automotive Engineering Technology at Ferris State University. He teaches both the engineering aspects and the service of advanced vehicles. Dr. English has two technical associates, a BS in vocational industrial education, a master’s degree in workforce education development, and a PhD in technology management.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-usSAE 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

Addresses human subjects research in space, including the unique ethical and regulatory considerations.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.eduThe Outer Space Treaty of 1966: https://www.unoosa.org/oosa/en/ourwork/spacelaw/treaties/introouterspacetreaty.htmlCode 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

Discusses how the recent changes to the social media landscape may affect researchers and society.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

Discusses some of the unique ethical, logistical, and regulatory issues associated with big health data research.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-ethicsCITI Program’s Technology, Ethics, and Regulations course: about.citiprogram.org/course/technology-ethics-and-regulationsPublic Responsibility in Medicine and Research: primr.orgDigital Medicine Society (DiMe): dimesociety.org

Discusses key considerations for data science researchers regarding ethical data and participant awareness.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/

Discusses the impact of bots on online survey research, what Institutional Review Board (IRB) members should look for when reviewing related protocols, and how IRB members can proactively help researchers mitigate the impact bots may have on their research.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.

Discusses common technology transfer issues that university faculty and staff should be mindful of when developing technology that may be commercialized, ways to navigate those issues, current events they should be paying attention to, and additional resources they can utilize to navigate the commercialization of technology.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/

Discusses chimeric research, why it is important to scientific progress, and current recommendations for addressing the ethical and policy issues raised by chimeric research.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/

Discusses the impact of AI on academic integrity, with a focus on ChatGPT.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/10.1145/3498366.3505816For more information about CITI Program, please visit: https://about.citiprogram.org/

Welcome to On Tech Ethics – With CITI Program, a podcast series about all things tech ethics. Through conversations with experts, you will learn about different technologies, the associated ethical issues, and other important considerations. Learn more in this introductory episode.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).

Covers the challenges that Institutional Review Board (IRB) members face when reviewing research protocols that involve artificial intelligence (AI), strategies for addressing those challenges, current events and trends that may impact human subjects research involving AI, and additional resources that you can utilize if you are involved in this space.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#46.102Nils Nilsson definition of AI: https://ai.stanford.edu/~nilsson/QAI/qai.pdfJoanna Bryson and Jeremy Wyatt definition of AI: http://www.cs.bath.ac.uk/~jjb/web/whatisai.htmlOHRP list of ethical codes and research standards: https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.htmlSACHRP considerations for IRB review of research involving AI: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-e-july-25-2022-letter/index.htmlFDA guidance: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samdOSTP 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%3A52021PC0206CITI Program AI content: https://about.citiprogram.org/course/technology-ethics-and-regulations/PRIM&R webinars: https://primr.org/online-learning/webinarsIRB reviewer checklist and decision tree: https://etohconsulting.com/wp-content/uploads/2021/12/ai-hsr-irb-reviewer-checklist-with-decision-tree.pdfWhite 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/