On Research - with CITI Program

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-fda-guidance-documents/exception-informed-consent-requirements-emergency-research 
• NIH Resources about EFIC studies - https://www.ninds.nih.gov/current-research/trans-agency-activities/office-emergency-care-research/research-involving-exception-informed-consent 
• Learn more about CITI Program at about.citiprogram.org  
• Learn more about HRP Consulting at HRP Consulting Group (thehrpconsultinggroup.com). 

Guest Bio: Mike Linke is a scientist, researcher, and IRB Chair. He has been in the research industry for 30 years and serves as the StrokeNet IRB Chair and the SMART IRB Program Director for Education. Mike has extensive experience working with Exception from Informed Consent (EFIC) studies.  

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 over 25 years. He started out as a research coordinator, then manager. He moved into project management at a CRO, then operations director at a central IRB and currently serves as the Vice President, Research Site Services at a phase 1-4 multi-specialty clinical research site. 


Additional Resources: 

• Interested in participating in a clinical research study? - Sign up with CTI: https://www.ctifacts.com/research-center/participate-in-a-clinical-research-study 
• Developing Clinical Trial Budgets, Considerations, and Best Practices: pharmanewsintel.com
• Learn more about CITI Program at: about.citiprogram.org.  

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 Guidance with 7 Elements https://oig.hhs.gov/compliance/compliance-guidance/  
• HCCA Conference 2024 Events - hcca-2024-conferences-1pgad.pdf (hcca-info.org)  
• Learn more about CITI Program at about.citiprogram.org

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 President of Content and Education; Cid Gomes, Senior Director of Information Technology; and Gina Sullivan, Director of Sales and Marketing. The panel shares their personal reflections and observations gained from the conference. Stay tuned to hear about emerging hot topics and key takeaways. We also cover tips for getting the most out of your conference attendance.

To learn more about CITI Program please visit: https://about.citiprogram.org/

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 views and opinions expressed are those of Dr. Jans and not the Centers for Disease Control and Prevention or the National Center for Health Statistics.

Survey research is a dynamic method that transforms curiosity into actionable insights. Utilizing carefully crafted questionnaires, it navigates the intricate terrain of public opinion, illuminating trends and attitudes. A powerful tool in social sciences and business, surveys enable the systematic collection of data, providing a quantitative understanding of diverse subjects. From gauging customer satisfaction to unraveling societal trends, each survey is a snapshot capturing the nuances of human perspectives. Methodical and versatile, survey research is a compass, guiding decision-makers toward informed choices. With its ability to distill complex data into comprehensible patterns, survey research is a cornerstone in evidence-based decision-making.

If you found the survey research insights in this episode interesting and want to learn more about this topic, check out CITI Program’s online course, Survey Research: Design, Planning, Implementation, and Ethics, authored by Dr. Matt Jans and Zoe Padgett. This comprehensive resource offers an in-depth exploration of survey research design, implementation, analysis, and ethical considerations.

Learn more about CITI Program:
- https://about.citiprogram.org/
- https://about.citiprogram.org/course/survey-research-design-planning-implementation-and-ethics/

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 views and opinions expressed are those of Dr. Jans and not the Centers for Disease Control and Prevention or the National Center for Health Statistics.

Survey research is a dynamic method that transforms curiosity into actionable insights. Utilizing carefully crafted questionnaires, it navigates the intricate terrain of public opinion, illuminating trends and attitudes. A powerful tool in social sciences and business, surveys enable the systematic collection of data, providing a quantitative understanding of diverse subjects. From gauging customer satisfaction to unraveling societal trends, each survey is a snapshot capturing the nuances of human perspectives. Methodical and versatile, survey research is a compass, guiding decision-makers toward informed choices. With its ability to distill complex data into comprehensible patterns, survey research is a cornerstone in evidence-based decision-making.

If you found the survey research insights in this episode interesting and want to learn more about this topic, check out CITI Program’s online course, Survey Research: Design, Planning, Implementation, and Ethics, authored by Dr. Matt Jans and Zoe Padgett. This comprehensive resource offers an in-depth exploration of survey research design, implementation, analysis, and ethical considerations. 

Learn more about CITI Program:
- https://about.citiprogram.org/ 
- https://about.citiprogram.org/course/survey-research-design-planning-implementation-and-ethics/

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 resources, and workers’ compensation and leave team. Tanya has a Bachelor’s of Arts in Social Sciences with a minor in Psychology from the University of Arizona and a Master’s of Science in Human Resources Strategic Management from Bellevue University.

The Family and Medical Leave Act (FMLA) is of paramount importance in a research setting. Researchers often face demanding workloads and unique challenges, and FMLA ensures they can balance their professional commitments with personal needs. This legislation grants eligible employees up to 12 weeks of unpaid, job-protected leave, enabling them to address critical family or health issues without risking their careers. In a research environment, where project continuity is essential, FMLA helps maintain ongoing work, minimizes disruptions, and fosters a more inclusive, supportive atmosphere. It promotes work-life balance, ensuring the well-being and productivity of researchers, thus contributing to the overall success of research endeavors.

Learn more about CITI Program: https://about.citiprogram.org/

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 as an unaffiliated IRB member is a challenging and rewarding experience.

Additional Resources: 

• 45 CFR 46 – Protection of Human Subjects (https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46) 
• TCPS 2 (2002) – Chapter 1: Ethics Framework (https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter1-chapitre1.html#a)
• CITI Program module - I Have Agreed to be an IRB Community Member, Now What? (https://about.citiprogram.org/course/biomedical-biomed-basic/)
• Evolving Concern: Protection for Human Subjects (http://www.youtube.com/watch?v=_8Ku4b1fW18) 
• Institutional Review Boards (http://www.youtube.com/watch?v=U8fme1boEbE)

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, development of strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training/mentoring of IRB staff. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs nationwide.

According to the Food and Drug Administration, the purpose of clinical trials is to study medical products in people. In doing so, consent is critical in clinical trials for these people to understand they are the research subjects and not imply a patient. Consent within research ensures individuals have an informed choice on whether they want to participate in a research study. Informed consent within research is meant to protect human subjects from harm that could occur from participating in research and should always be voluntary.

Resources: 

• https://www.niaid.nih.gov/research/dmid-protocols-informed-consent
• https://www.nsf.gov/bfa/dias/policy/docs/45cfr690.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5980471/
• https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials

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, development of strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training/mentoring of IRB staff. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs nationwide.

Informed consent is critical and a main principle of research ethics in a research study. Consent within research ensures individuals have an informed choice on whether they want to participate in a research study. Informed consent applies to research in the social-behavioral, physical, and medical sciences. Informed consent within research is meant to protect human subjects from harm that could occur from participating in research and should always be voluntary.

Learn more about CITI Program: https://about.citiprogram.org/

Resources: 

• https://www.niaid.nih.gov/research/dmid-protocols-informed-consent
• https://www.nsf.gov/bfa/dias/policy/docs/45cfr690.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5980471/