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The Agenda for
Effective IBCs: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research
September 21, 2010
[To see the agenda for 3 I's: Ethics and Community, click here.]
1:00 – 1:15 Welcome and Introduction
1:15 – 1:45 Introduction to the National Institutes of Health Office of Biotechnology Activities and to the History of the NIH System of Recombinant DNA Oversight
A discussion of the responsibilities and activities of the NIH Office of Biotechnology Activities. An overview of the origins of the current system of oversight and its scientific and philosophical basis.
1:45 – 2:30 Overview of the Current NIH Guidelines for Research Involving Recombinant DNA Molecules
A discussion of the key elements of the NIH Guidelines and their application to basic and clinical recombinant DNA research. An overview of sections of the NIH Guidelines.
2:30 – 3:00 Requirements for IBCs in the NIH Guidelines
The need for, and expected characteristics of, IBCs. Registering an IBC with NIH OBA. General responsibilities of IBCs in the review of research involving recombinant DNA.
3:00 – 3:15 Questions and Open Discussion
An opportunity to ask questions and exchange information and ideas.
3:15 – 3:30 Break
3:30 – 4:15 Role of the Recombinant DNA Advisory Committee and the Protocol Review Process
An overview of the RAC and its major responsibilities as a key federal advisory committee. A discussion of the requirements of Appendix M and protocol submission to NIH.
4:15 – 4:45 AM The NIH Site Visit Program
What to expect if your institution is selected for a site visit. Observations including best practices, areas where improvement is needed, and common compliance challenges will be discussed
4:45 – 5:00 Questions and Open Discussion
An opportunity to ask questions and exchange information and ideas.
5:00 Adjournment
Policies
Cancellations and Refunds: Conference fees will be reimbursed in full minus a $25 service charge until August 21, at which time no refunds will be made. No on-site registration will be available.
Questions? Call Lynne Walsh @ 978-251-1556 or email: msmr@att.net
CONFERENCE REGISTRATION |
| Effective IBC's only- $195 |
Non-Members |