On Research - with CITI Program

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 progra

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-informati

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

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:�

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 Aran

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 (A

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 (A

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 relate

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 insti

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, conti