Essential Training for IRB Members and Staff

Overview:

Institutions/organizations that are responsible for the operation of the IRB have the responsibility for ensuring that its IRB administrators/staff and IRB members have adequate training and knowledge to review the research it approves. With turnover of IRB staff and IRB members, this responsibility must be constantly addressed.

This webinar serves will provide substantive training of the criteria for IRB approval for new IRB members/staff who have less than three years of experience.

Why should you Attend:

Is your IRB in compliance? Are you concerned about your next FDA or OHRP audit of your IRB? What criteria should be applied to the review of studies? When do evaluations or quality assurance efforts require IRB approval? How can an IRB appropriately protect vulnerable subjects in research? To what degree should risks be minimized in research studies?

These and other related questions for IRB review of human subjects research will be explored in this webinar. Department of Health and Human Services (HHS) regulations (45 CFR 46) for the protection of human subjects provide definitions of "human subjects" and "research". FDA regulations (21 CFR 56) for IRB review differ in the applicability of their regulations and therefore have different definitions.

Both sets of regulations provide similar criteria for IRB approval. Yet there is significant lack of clarity regarding certain activities involving human subjects (e.g., evaluations, quality assurance/improvement, public health, etc.) and whether such activities require IRB approval. Once an IRB has made the appropriate determination of whether a study requires IRB approval, there are many regulatory requirements that must be considered prior to approval of a study.

Areas Covered in the Session:

• Applicability of HHS and FDA regulations for the protection of human subjects
• Important definitions every IRB administrator/member must know
• How to identify and minimize potential risks in a research study
• IRB's role to determine that risks are reasonable in relation to anticipated benefits
• IRB's review of protocols to ensure equitable selection of subjects
• Focused review of the criterion for obtaining legally-effective consent
• When and how to require documentation of informed consent for different types of studies
• IRB review of safety monitoring plans
• How to protect confidentiality of research data and minimize potential breaches of confidentiality
• Consideration of additional safeguard for the protection of vulnerable subjects

Who Will Benefit:

• IRB Members
• IRB Administrators
• IRB Managers

Speaker Profile

George Gaspar is has over 35 years of experience in the administration or conduct of human subjects research. Prior to founding “PEER”, he served as the Asst. VP and Sr. Asst. Dean for Research Ethics at Columbia University (CU), CU Medical Center (CUMC) from 2003-12, where he directed the IRB Office and compliance team. He worked at the Office for Human Research Protections (OHRP) for seven years and served as the Director, Division of Assurances and Quality Improvement from 2000-03, where he led the development of the OHRP QI Program and electronic submission of the Federalwide Assurance (FWA). He has also served as the Director, The George Washington University Medical Center (GWUMC) IRB and Research Pharmacy after serving as a Data Manager for over 40 clinical trials at GWUMC.