On Research - with CITI Program

Access to research is a complicated but essential area of growing concern in the research industry. As technology advances, many smaller research sites and rural areas can’t compete or keep up. By narrowing the field of eligible research participants, we lose important patient populations. Jessica Rowe, the Director of Quality and Education at the Yale Cancer Center and the current President of th...

Research security is about protecting the means, know-how, and products of U.S. research and development until they are ready to be shared. In 2021, the government issued a national presidential memorandum with updated requirements for institutions around research. Emily Bradford joins us to explain these new research security requirements and suggests how to grow or build a program to meet these...

A growing area of research involves exception from informed consent. In an emergency setting, participants can be enrolled in a trial without their consent. Mike Linke joins On Research to discuss the regulations and ethical considerations around this important area of research.      Additional Resources:  FDA Guidance Document for EFIC studies - https://www.fda.gov/regulatory-information/search-f...

A discussion about research site operations. We talk about the different types of sites, different recruitment strategies, how DCTs impact dedicated research sites, and the financial impact technology brings to sites. Adam Roth, the Vice President of Site Services at CTI, shares his experience and insights into the site world.   Guest Bio: Adam Roth has been in the clinical research industry for o...

Our guest this month is Kate Cohen, the Chief Compliance Officer at SIU Medicine in Illinois. Kate breaks down the concept of research compliance, sharing best practices and practical guidance. We dive into essential elements of a compliance research program, as well as how someone new to this side of the industry can take steps to break in and learn more.    Additional Resources:   Updated OIG Gu...

This is a special edition of On Research with CITI Program. Guest hosted by Margaret Rankovic, Director of Content and Education at CITI Program, this podcast provides a recap, insights, and key takeaways from the recently concluded PRIM&R 2023 conference. The panel includes the following from CITI Program leadership team: Bharat Krishna, SVP & Managing Director; Jaime Arango, Vice Preside...

Dr. Matt Jans has been conducting and innovating surveys for almost 25 years. He is currently Lead Statistician for the National Health and Nutrition Examination Survey (NHANES) at the National Center for Health Statistics (NCHS).* His survey experience spans academic, government, and private sectors. He is an active member of the American Association for Public Opinion Research (AAPOR). *The view...

Dr. Matt Jans has been conducting and innovating surveys for almost 25 years. He is currently Lead Statistician for the National Health and Nutrition Examination Survey (NHANES) at the National Center for Health Statistics (NCHS).* His survey experience spans academic, government, and private sectors. He is an active member of the American Association for Public Opinion Research (AAPOR).  *The vie...

Tanya Brown is the Senior Director, HR Consulting, Employee and Labor Relations at Vanderbilt University. She has 15 years of experience in Human Resources in many industries including the private sector, public sector, and higher education. Tanya currently leads a team of HR Consultants, who are the primary contact for leaders and employees across the university for matters related to human resou...

In this special edition of the On Research with CITI Program podcast, we speak to Sally Mann about her role as an unaffiliated IRB member. Regulations in the U.S. and Canada include requirements associated with the membership of Institutional Review Boards (IRBs)/Research Ethics Boards (REBs). Both regulations require at least one member not to be otherwise affiliated with the institution. Serving...

Linda Reuter has been involved with IRB Administration in various capacities for over 30 years, currently serving as the Sr. Director for BRANY IRB. Responsibilities include supervising the IRB staff, maintaining compliance with the IRB SOPs and applicable regulations, supervising pre and post-IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education,...

Linda Reuter has been involved with IRB Administration in various capacities for over 30 years, currently serving as the Sr. Director for BRANY IRB. Responsibilities include supervising the IRB staff, maintaining compliance with the IRB SOPs and applicable regulations, supervising pre and post-IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education,...

This episode discusses the impact of online bots on survey research, ethical considerations and implications of using bots in survey research, and potential benefits and unintended consequence. Myra Luna-Lucero, EdD, is the Research Compliance Director at Columbia University’s Teachers College. She spearheaded the College’s “Ethics & Safety Amid Uncertainty” initiative and co-chaired the Resea...

Ross Hickey is the Assistant Provost for Research Integrity at the University of Southern Maine (USM.) Ross is the Director of the Maine Regulatory Ethics and Training Center (MeRTEC) at USM. He is an attorney in Maine. His office serves institutions throughout the United States. Ross developed and teaches in the Regulatory Ethics undergraduate program at USM. He helped to develop and teaches in t...

Cecilia Brooke Cholka serves Weill Cornell Medicine as a Human Research and QA Manager and consultant for the PEER Consulting Group. She works to demystify IRB processes and expectations so that researchers and the IRB can work together collaboratively to ensure ethical conduct of research. An Institutional Review Board or IRB is commonly found at institutions that conduct or participate in resear...

Chirag Shah, Ph. D.,  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 with a focus on fairness and transparency. Artificial intelligence, or AI, is utilized more and m...

Lou Kavar is a faculty member in psychology at Capella University where he is the lead faculty member for qualitative research and teaches doctoral-level graduate courses in psychology. Lou has taught in higher education at the graduate level for over thirty years. His personal research interest is the integration of spirituality and psychology. He lives in Atlanta, GA. For more information on Lou...

Elizabeth Waddell, has over 20 years in the clinical research industry and is the owner of The CRA Helper. Elizabeth began her clinical research career as an in-house Clinical Research Associate (CRA) and later transitioned to an on-site CRA. Later in her career, she moved into a Line Manager role that focused on training new CRAs prior to launching her own company, The CRA Helper. What is a Clini...