IRB Basics: Intermediate
One day program
Program Description
The Intermediate IRB Basics program is ideal for researchers, IRB staff and IRB professionals who have completed the Introductory IRB Basics Course or who already have baseline knowledge of the issues related to human subject protections and desire to advance that knowledge through an exploration of advanced topics. This intermediate course will delve into more complicated issues related to clinical research and the protection of human subjects. It will include a comprehensive overview of 1) Conflict of Interest 2) Research with Vulnerable Populations 3) Recruitment Issues 4) IRB Audits 5) Ethical Dilemmas in Research and 5) Quality Improvement vs. Research. Various case studies will be included to allow for a practical application of the course content.Program Objectives
- Provide an Overview Conflict of Interest Issues in Research (Current Regulations, Types of Conflicts, Current Guidance, Potential Problems, Recent Headlines)
- Provide a Comprehensive Overview of Issues Related to Research with Vulnerable Populations (Research with Children, Decisionally Impaired, Elderly, Students, Employees, Emergency Research)
- Discuss Recruitment Issues (Optimizing the Informed consent process, advertising, sponsor issues)
- Provide an Overview of the Audit Process (FDA Audits, For-Cause Internal Audits, Random internal audits)
- Discuss Complicated Ethical Situations and Special Topics in Research (Controversial research, difficult research)
- Quality Improvement vs. Research (Overlap of quality improvement/quality assurance and research)
- Case Studies and Discussion (to braid together the course content with real-life work experiences)
Program Schedule and Location
Date: Available upon requestTime: 9:30am - 4:30pm
Place: 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042
Instructor
Linda Reuter, MS, CIPCost
$800 per person(10% group discount for two or more attending from the same office)
Refreshments
Breakfast, lunch, and snacks will be provided for programs conducted at BRANY.------------------------------------------------------------------------------------
Linda Reuter, MS, CIP
Ms. Reuter is currently working at the North Shore - Long Island Jewish Health System (NSLIJHS) as Director of the Huntington Hospital Institutional Review Board. Ms. Reuter has extensive experience in education and training related to IRBs and the protection of human subjects in research. She has over 15 years experience in the field of clinical research and IRB oversight and has trained many individuals in matters related to IRB regulations and oversight, informed consent, historical perspectives of IRB development, HIPAA, research ethics, compliance, etc. Her audiences appreciate her ability to take complex regulatory information and present it in an engaging and understandable manner.
Ms. Reuter has a B.S. in Biological Science and also graduated with top honors from SUNY Stony Brook with a MS in Health Sciences Research and an Advanced Certificate in Health Care Management. She currently serves on two local IRBs and has presented at a number of different workshops for research professionals. She is a certified IRB Professional (CIP).