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Workshops, Safety Symposia and Policy Conferences
   Upcoming Meetings  
   Safety and Scientific Symposia  
   Scientific Symposium - December 9-10, 2010
NIH RAC and CliniGene Scientific Symposium on "Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design"
 
   Safety Symposium - June 15, 2010
Gene-Modified T Cells: Challenges in Clinical Trial Design
 
   Safety Symposium on a Serious Adverse Event on OBA Protocol 705  
   Safety Symposium - March 15, 2005
Current Perspectives on Gene Transfer for X-SCID
 
   Safety Symposium - September 21-22, 2004
Safety Considerations in Recombinant DNA Research with Pathogenic Viruses
 
   Safety Symposium - March 7, 2001
Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials
 
   Safety Symposium - December 14, 2000
Safety Considerations in Cardiovascular Gene Transfer Clinical Research
 
   Safety Symposium - March 8, 2000
Internally Deleted, Helper-Dependent Adenoviral Vectors
 
   Biosafety Considerations for Research with Lentiviral Vectors  
   Policy Conferences  
   Gene Transfer and Rare Diseases Workshop (September 13, 2012)  
   RNA Oligonucleotides: Emerging Clinical Applications (December 15-16,2011)  
   Sham Neurological Procedures in Clinical Trials for Neurodegenerative Diseases: Scientific and Ethical Considerations (June 30, 2010 - July 1, 2010)  
   NIH Public Consultation on Proposed Changes to the NIH Guidelines for Synthetic Nucleic Acids (June 23, 2009)  
   Summaries and Reports of the Gene Therapy Policy Conferences (1998-Present)  
   IBCs in a Changing Research Landscape: A Policy Conference  
   Past Professional Development Conferences, Workshops, and Training Sessions  
   Institutional Biosafety Committees: Promoting Optimal Practice Now and in the Future  
   The NIH System of Oversight of Human Gene Transfer Research: Optimizing Science, Safety and Ethics  
   IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research  
   The Future Face of IBCs: Evolving Roles and Responsibilities, Upcoming Challenges and Opportunities  
 

Upcoming Meetings  
  Events of Interest to IBCs and Others  
  OBA will be participating in several key meetings in the next few months, sponsoring exhibits and training sessions that will offer information about the oversight of recombinant DNA research, as well as promote awareness about dual use life sciences research. Please take note of the following events:  
 
   University of Minnesota - OBA will be conducting a full-day IBC training workshop on September 20, 2012, at the University of Minnesota. Further information can be found here.  
 
   USDA - OBA will be participating in an IBC training event that will take place September 25-26, 2012, at the USDA/ARS National Animal Disease Center in Ames, IA. For further information contact Vicki Jones or call 515-337-7285 for registration information.  
 
   Massachusetts Society for Medical Research - OBA staff will be presenting at the conference "IACUCs, IBCs & IRBs: Harmonization, Integration & Implementation", which will be held October 1-2, 2012, in Wellesley, MA. OBA staff will also be available during the conference to answer questions on the revised NIH Guidelines and dual use life science research oversight. Further information can be found at: Massachusetts Society for Medical Research.  
 
   American Biological Safety Association - OBA will be conducting a half day pre-conference class, "Case Studies in Recombinant DNA and Dual Use Research of Concern" at the Annual ABSA Conference in Orlando, FL on October 20, 2012, from 8:00 am - 12:00 pm. OBA staff will also be available to answer questions at an exhibit booth during the conference. The exhibit will display educational material relating to the oversight of research involving recombinant DNA, as well as information on the oversight of dual use life science research. For more information about this event, visit: American Biological Association.
 
 

Policy Conference - September 13, 2012:  
  Gene Transfer and Rare Diseases Workshop  
  The NIH Office of Biotechnology Activities and Office of Rare Disease Research, NCATS, co-sponsored a workshop to discuss the advances in and challenges of gene transfer for rare diseases. There have been recent promising clinical successes in gene transfer protocols for rare diseases, such as retinal degeneration, hemophilia, and immune disorders. Investigators discussed their results to date and opportunities and challenges for extending these successes to other similar rare diseases. The panel discussions focused on strategies for maximizing opportunities for data sharing or platform development.  
   Agenda (with links to briefings)   
   Webcast   

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Policy Conference - December 15-16, 2011:  
  RNA Oligonucleotides: Emerging Clinical Applications  
   Agenda (with links to briefings)    
   Webcast- December 15, 2011 - Day 1    
   Webcast- December 16, 2011 - Day 2    

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Scientific Symposium - December 9-10, 2010:  
  NIH RAC and CliniGene Scientific Symposium on "Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design"  
   Agenda (with links to briefings)    
   Webcast- December 9, 2010 - Day 1    
   Webcast- December 10, 2010 - Day 2    

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Safety Symposium - June 15, 2010:  
  Gene-Modified T Cells: Challenges in Clinical Trial Design  
   Agenda    
   Participant List    
   Webcast    
   RAC Points to Consider   
   Meeting Publication: Cancer Research   
   Reference Materials    

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Safety Symposium  
  Safety Symposium on a Serious Adverse Event on OBA Protocol 705:  
  A Phase I/II Study of Repeat Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:FC Fusion Gene in Inflammatory Arthritis with and without Concurrent TNF-a Antagonist  
   Safety Symposium on a Serious Adverse Event on OBA Protocol 705  

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Safety Symposium - March 15, 2005:  
  Current Perspectives on Gene Transfer for X-SCID  
   Webcast - Morning session before break   
   Webcast - Morning session after break   
   Webcast - Afternoon session before break   
   Webcast - Afternoon session after break   
   Current Perspectives on Gene Transfer for X-linked Severe Combined Immunodeficiency Disease (X-SCID)  

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Safety Symposium - September 21-22, 2004:  
  Safety Considerations in Recombinant DNA Research with Pathogenic Viruses  
  On September 21-22, 2004, NIH OBA held a safety symposium in conjunction with the meeting of the Recombinant DNA Advisory Committee (RAC). The symposium addressed safety considerations for recombinant DNA research with pathogenic viruses, focusing on containment issues for research with such viruses as 1918 influenza virus, highly pathogenic avian influenza viruses, and SARS Co-V. A major goal of the symposium was to develop a Points to Consider document and other resources to assist IBCs in conducting risk assessments and determining appropriate containment.  
   Agenda and Participant List   
   Webcast - Day one - Morning session before break   
   Webcast - Day one - Morning session after break   
   Webcast - Day one - Afternoon session before break   
   Webcast - Day one - Afternoon session after break   
   Reference Information  
   Frequently Asked Questions - Risk Assessment and Determining Containment  

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Safety Symposium - March 7, 2001:  
  Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials  
   Transcript   

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Safety Symposium - December 14, 2000:  
  Safety Considerations in Cardiovascular Gene Transfer Clinical Research  
   Transcript   

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Safety Symposium - March 8, 2000:  
  Internally Deleted, Helper-Dependent Adenoviral Vectors  
   Transcript   
   Summary   

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Summaries and Reports of the Gene Therapy Policy Conferences (1998-Present)  
  Prenatal Gene Therapy: Scientific, Medical, & Ethical Issues - January 7-8, 1999  
   Full Report   
   Summary   
   RAC Statement Regarding In Utero Gene Transfer Research   
  Lentiviral Vectors for Gene Delivery - March 9, 1998  
   Summary   
   Preclinical Safety Evaluation of Lentivirus Vectors: FDA Regulatory Expectations - Anne M. Pilaro, Ph.D.   

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"IBCs in a Changing Research Landscape: A Policy Conference"  
  Bethesda, Marriott, December 7-8, 2001  
   Conference Summary   
   Webcasts Day 1  
   Welcome   
   Session 1   
   Session 2   
   Session 3   
   Session 4   
   Webcasts Day 2  
   Morning Session   
   Afternoon Session   
  Note:  For reasons beyond the control of the NIH and the host of these video pages (Webconferences.com), the color quality in this video product is not optimal. Webconferences.com was not responsible for the video recording onsite, nor for the encoding for the web, of these files.  
   Presentation Information  

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Institutional Biosafety Committees: Promoting Optimal Practice Now and in the Future  
  Hyatt Regency Crystal City, Arlington, Virginia, June 24-26, 2009  
   The NIH Office of Biotechnology Activities and the Eagleson Institute, with the participation of the American Association for Laboratory Animal Science, American Biological Safety Association, American Society for Microbiology, and Public Responsibility in Medicine and Research, cosponsored a professional development conference for Institutional Biosafety Committee members and staff. The agenda and slide presentations from this event are accessible from the Eagleson Institute Web site.  

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The NIH System of Oversight of Human Gene Transfer Research: Optimizing Science, Safety and Ethics  
  Washington State Convention and Trade Center, Seattle, Washington, May 30, 2007  
   Segment I - The Fundamentals of Oversight: NIH and Local Review  
   Introduction to the NIH Office of Biotechnology Activities and the Resources OBA Offers Investigators   
   Overview of the Policy and Biosafety Framework for Human Gene Transfer Research: The NIH Guidelines for Research Involving Recombinant DNA Molecules   
   Institutional Biosafety Committees (IBCs): The Linchpin of Local Oversight   
   The "What, When and How" of Submitting Human Gene Transfer Protocols to the NIH OBA for Review by the Recombinant DNA Advisory Committee (RAC)   
   Safety and Annual Reporting; What to Report and How to Get the Most out of GeMCRIS, NIH OBA's Electronic Safety Reporting System   
   Segment II - Views from the Field  
   An Investigator's Perspective: How to Prepare for RAC Review   
   Informed Consent in Human Gene Transfer Trials   

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"IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research"  
  Town and Country Resort Hotel, San Diego, California, March 12, 2005  
   NIH OBA presentations  
   Introduction to the NIH Office of Biotechnology Activities   
   The NIH Guidelines and IBC Responsibilities   
   The Recombinant DNA Advisory Committee   

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"The Future Face of IBCs: Evolving Roles and Responsibilities, Upcoming Challenges and Opportunities"  
  Town and Country Resort, San Diego, California  
  Training session for new IBC members and staff, February 20, 2003;  
   Webcasts  
   Welcome and Introduction to the National Institutes of Health Office of Biotechnology Activities   
   History and Evolution of IBCs: Asilomar to the Present    
   Overview of the Current NIH Guidelines   
   Requirements for IBCs in the NIH Guidelines   
   Review of the Recombinant DNA Advisory Committee and the Protocol Review Process   
   Ask the Faculty: Open Forum for Questions   
   Presentation Information  
  Main conference event, February 21-22, 2003  
   Webcasts Day 1  
   Welcome from the Conference Organizers    
   Keynote Presentation: At the Cutting Edge of Biotechnology: Emerging Promises, and New Oversight Challenges, Theodore C. Friedmann, M.D.   
   Panel I: Biodefense Research, Select Biological Agents and Toxins, and IBCs   
   Luncheon Address - Today's IBC: A Report on a National Survey of IBCs   
   Panel II - When You've Seen One IBC, You've Seen One IBC: A Roundtable Discussion to Various Approaches to Review and Oversight   
   Webcasts Day 2  
   Opening Address - Managing Biosafety Concerns in Human Gene Transfer Research    
   The Ethics of Preclinical Recombinant DNA Research   
   Ethical Consideration in Human Gene Transfer Research   
   Presentation Information  

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