IRB Basics
One day program
Program Description
The IRB Basics program is ideal for IRB staff and IRB professionals. This program will provide a comprehensive overview of
- The History of Federal Regulations that Govern Human Subject Research
- Research Ethics
- Federal and State Regulations
- OHRP and FDA Documents
- Institutional Review Board Functions and Operations
- Informed Consent
Various case studies will be included to allow for a practical application of the course content.
Program Objectives
- Provide a Historical Perspective of the Development of the IRB System and Federal Regulations (Nuremberg, Thalidomide Tragedy, Study of Untreated Syphilis, Milgram Study, Human Radiation Experiments, Gene Transfer, Current Headlines, Upcoming Technology and Related Ethical Considerations)
- Discuss the Relevant Ethical Principles and their Application (Belmont Report, Nuremberg Code, Declaration of Helsinki, ICH Guidelines, Conflict of Interest, Research Design issues)
- Thoroughly cover all Federal and State Regulations (DHHS, FDA, HIPAA)
- Analyze guidance documents (OHRP, FDA and more)
- Provide an overview of IRB functions and operations (exempt/expedited/convened review, IRB requirements, risk/benefit analysis, vulnerable populations, subject recruitment, advertising)
- Explore Informed Consent (required elements, practical considerations, proper documentation, helpful hints, common errors)
- Case Studies and Discussion (to braid together the course content with real-life work experiences)
Program Schedule and Location
Date: May 19, 2010 (Wednesday)
Time: 9:30am - 4:30pm
Place: 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042
Instructor
Linda Reuter, MS, CIP
Cost
$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).