OBA Posts Frequently Asked Questions about Research Constituting a "Major Action" - Under Section III-A of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines), experiments involving the transfer of a drug resistance trait are considered "Major Actions" if the acquisition of the trait could potentially compromise the use of the drug in question to control disease agents in humans, veterinary medicine, or agriculture.  Notice of such experiments must be published in the Federal Register.  In order to proceed, the experiments must be reviewed by the RAC and specifically approved by the NIH Director.  If the NIH approves the experiment, the agency will specify appropriate biosafety containment.

OBA frequently receives questions about this provision of the NIH Guidelines, and has thus prepared a set of answers, now available on its Web site, to respond to the most frequently asked questions (FAQs).   The aim of the FAQs is to provide readily accessible information on the matters most commonly in need of clarification.  Institutional staff and investigators may also contact OBA directly by email or telephone with any additional questions they may have.  These questions may be directed to Gene Rosenthal, Ph.D., Biotechnology Program Advisor, NIH OBA, at 301-496-9838 or rosenthg@od.nih.gov. Written queries may also be sent to oba@od.nih.gov.
(Posted March 21, 2008)

Major Action Approved by the NIH Director – After a review of public comments and pursuant to the open deliberations of the NIH Recombinant DNA Advisory Committee (RAC), the NIH Director has approved two specific research proposals involving the deliberate transfer of a drug resistance trait to a microorganism.  NIH approval was required, because these experiments were considered “Major Actions” under Section III-A of the NIH Guidelines for Research Involving Recombinant DNA Molecules Molecules (NIH Guidelines).  Major Actions include experiments involving the transfer of a drug resistance trait, the acquisition of which could potentially compromise the use of the drug in question to control disease agents in humans, veterinary medicine, or agriculture.  The NIH Director’s approval allows Dr. Dan Rockey and Dr. Walter Stamm (at Oregon State University and the University of Washington, respectively) to transfer from Chlamydia suis (a swine pathogen) a gene encoding tetracycline resistance into C. trachomatis (a human pathogen).  This approval is specific to Drs. Rockey and Stamm and the particular research proposals in question, which may proceed only under the conditions outlined in NIH’s approval, as published in the October 31 Federal Register.  Other investigators intending to transfer tetracycline resistance to Chlamydia or to engage in other types of experiments fitting the characteristics of those described in Section III-A-1-a of the NIH Guidelines, must submit their proposals to NIH OBA for review and approval before these experiments can be initiated. 
(Posted November 1, 2007)

NIH Recombinant DNA Advisory Committee to Discuss Proposals to Transfer Chloramphenicol Resistance to Rickettsia typhi and Rickettsia conorii – At its September 17-18, 2007 meeting, the NIH Recombinant DNA Advisory Committee (RAC) will be discussing proposed experiments to transfer chloramphenicol resistance to Rickettsia typhi and Rickettsia conorii.  Initiation of these experiments would constitute a Major Action under the NIH Guidelines for Research Involving Recombinant DNA Molecules because they involve the transfer of a drug resistance trait to microorganisms, where the acquisition of that trait could possibly compromise the use of the drug to control disease caused by that microorganism in humans, veterinary medicine, or agriculture.  Notice of such experiments must be published in the Federal Register.  In order to proceed, the experiments must be reviewed by the RAC and specifically approved by the NIH Director. Appropriate biosafety containment will be specified if the proposals are approved by the NIH.   A notice has been published in the Federal Register regarding these experiments, proposed by Dr. David Walker, University of Texas Medical Branch, Galveston, and Dr. Abdu Azad, University of Maryland at Baltimore (copies of each proposal may be downloaded by clicking on the name of the respective investigator).  The public is encouraged to comment in writing and/or in person at the September RAC meeting.   Written comments can be sent to OBA's email inbox or to Dr. Eugene Rosenthal, Biotechnology Program Advisor, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985.  Written comments received by September 6, 2007 will be reproduced and distributed at the September RAC meeting. 
(Posted July 25, 2007)

NIH OBA to Conduct a Series of Training Sessions and Workshops – Staff from NIH OBA will be presenting on the NIH system of oversight of recombinant DNA research at a series of upcoming meetings sponsored by various professional associations. An investigator training session is being offered as a preconference educational event during the annual meeting of the American Society for Gene Therapy in Seattle, Washington on May 30, 2007. OBA staff will present on Institutional Biosafety Committees at a June 14-15, 2007 meeting of the Massachusetts Society for Medical Research. On September 17, 2007, OBA staff will conduct an "IBC Basics" course at a meeting sponsored by Public Responsibility in Medicine and Research. More information about these events can be obtained by clicking on the name of the sponsoring organizations.
(Posted May 15, 2007)

NIH Recombinant DNA Advisory Committee to Discuss Proposals to Transfer Tetracycline Resistance to Chlamydia trachomatis  – At its June 19-21, 2007 meeting, the NIH Recombinant DNA Advisory Committee (RAC) will be discussing proposed experiments to transfer tetracycline resistance to Chlamydia trachomatis.  Initiation of these experiments would constitute a Major Action under the NIH Guidelines for Research Involving Recombinant DNA Molecules because they involve the transfer of a drug resistance trait to microorganisms, where the acquisition of that trait could possibly compromise the use of the drug to control disease caused by that microorganism in humans, veterinary medicine, or agriculture.  Notice of such experiments must be published in the Federal Register.  In order to proceed, the experiments must be reviewed by the RAC and specifically approved by the NIH Director. Appropriate biosafety containment will be specified if the proposals are approved by the NIH.   A notice has been published in the Federal Register and copies of the proposed protocols are available by clicking here. The public is encouraged to comment in writing and/or in person at the June RAC meeting.  Written comments can be sent to OBA's email inbox or to Dr. Eugene Rosenthal, Biotechnology Program Advisor, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985. The NIH will consider all comments submitted by June 15, 2007. Written comments received by May 24, 2007 will be reproduced and distributed at the June RAC meeting. 
(Posted May 9, 2007)

NIH OBA Staff to Teach "IBC Basics" Course at the March PRIM&R IACUC Meeting - On March 25, staff from OBA will be participating in an IBC training workshop being held by Public Responsibility in Medicine and Research (PRIM&R).  Titled “IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research,” the workshop will take place on March 25, 2007 at the Town and Country Resort and Convention Center in San Diego California. "IBC Basics" is intended for IBC members and staff who have an interest in the oversight of recombinant DNA research, as well as research administrators, biological safety officers, regulatory affairs officers, and the members and staff of other institutional oversight committees such as IACUCs and IRBs. For registration and further information please visit the PRIM&R Web site.
(Posted February 20, 2007)

Guidance on Biosafety Considerations with Research Involving Lentiviral Vectors -- OBA often receives questions regarding the biosafety considerations of using lentiviral vectors in research. The NIH Guidelines for Research Involving Recombinant DNA Molecules do not directly address the use of lentiviral vectors. Consequently, OBA put this matter on the agenda of the March 15, 2006 meeting of the Recombinant DNA Advisory Committee (RAC), which discussed the conduct of risk assessments and determination of containment for lentiviral vector research.  To provide additional guidance to Institutional Biosafety Committees and investigators, OBA organized a working group of RAC members and ad hoc reviewers with virology and biosafety expertise. They were charged with developing some general criteria to be considered when conducting risk assessments for research involving lentiviral vectors.  The RAC discussion, as well as the report of the working group, is now available as a resource to the research community on the OBA Web site.
(Posted December 1, 2006)

Now Available: Information on Upcoming OBA Presentations and Workshops of Interest to IBCs and Others  -- OBA has added to the IBC page of its Web site information on upcoming events where OBA will be conducting workshops and training sessions of interest to IBCs and others with responsibility for the conduct and oversight of recombinant DNA research.  Connect to the IBC page and scroll down to the heading "Meetings and Conferences."  Training materials from prior OBA workshops are also available from this section of the OBA Web site. 
(Posted September 1, 2005)

NIH OBA Presentations from "IBC Basics" Course Now Available   The NIH Office of Biotechnology Activities partnered with Public Responsibility in Medicine and Research (PRIM&R), the Applied Research Ethics National Association (ARENA), and the NIH Office of Laboratory Animal Welfare to sponsor a one-day educational workshop on the roles and responsibilities of Institutional Biosafety Committees (IBCs). The workshop, titled “IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research,” took place on March 13, 2005 prior to the PRIM&R and ARENA Annual Institutional Animal Care and Use Committee (IACUC) Conference. 

Presentations by NIH OBA staff at the course are now available on the NIH OBA Web site. These materials may be of interest to IBC staff and others who wish to conduct training locally on the NIH system of oversight of recombinant DNA research. To download these materials, connect to the IBC page of OBA's web site and scroll down to "Meetings and Conferences."
(Posted April 25, 2005)

Safety Considerations in Recombinant DNA Research with Pathogenic Viruses Resource Now Available - A resource page has been developed for IBCs, investigators, and others with responsibility for research involving recombinant DNA and pathogenic viruses. The page was developed in follow up to the Safety Symposium held on September 21-22, 2004 and includes slides and a videocast of the proceedings of that event. Frequently Asked Questions (FAQs) about this type of research, as well as links to many pertinent resources, are also included. 
(Posted February 1, 2005)

OBA Reminds Grantees of Importance and Necessity of Biosafety Review and Oversight - Grantee institutions receiving NIH funding for recombinant DNA research are reminded in a December 6, 2004 memorandum of the importance of complying with the NIH Guidelines for Research Involving Recombinant DNA Molecules, including establishing and registering with NIH an Institutional Biosafety Committee.
(Posted December 7, 2004)  

New Qs&As on Convening Institutional Biosafety Committee Meetings Available - OBA has received a number of queries concerning acceptable ways in which to convene Institutional Biosafety Committees (IBCs).  To assist institutions in developing policies and practices that are in keeping with the intent of the NIH Guidelines for Research Involving Recombinant DNA Molecules and that are acceptable to the NIH, OBA has prepared two "Questions and Answers" on this topic that have now been added to the IBC page of the OBA Web site.  They are included as Questions 5 and 6 in the set of questions available at: http://www4.od.nih.gov/oba/IBC/IBCrole.htm (Posted August 10, 2004)  

 Questions and Answers Concerning Institutional Biosafety Committee (IBC) Meeting Minutes - The NIH Office of Biotechnology Activities (OBA) has received a number of queries concerning the preparation of, and access to, minutes of IBC meetings.  To assist institutions in developing policies and practices for IBC minutes that are in keeping with the intent of the NIH Guidelines for Research Involving Recombinant DNA Molecules, OBA has prepared a set of questions and answers.   
(Posted May 15, 2004)

NIH and FDA Launch a New Human Gene Transfer Research Data System - The NIH Office of Biotechnology Activities (OBA) and the FDA Center for Biologics Evaluation and Research (CBER) have launched  a new Genetic Modification Clinical Research Information System (GeMCRIS) - a Web-accessible database of human gene transfer trials that the two agencies developed collaboratively.  GeMCRIS's adverse event reporting module provides a convenient, secure, and instantaneous means of conveying safety information to the NIH.  In addition, GeMCRIS enables patients, research participants, scientists, sponsors, and the public at large to become better informed about human gene transfer research.  Through drop-down menus and preformatted reports, individuals can easily navigate the GeMCRIS site to view information on particular characteristics of clinical gene transfer trials.  Individuals interested in using GeMCRIS as an information resource about gene transfer trials should connect to the public Web site at http://www.gemcris.od.nih.gov/  Investigators, study coordinators, and sponsors who wish to use GeMCRIS to report adverse events will need to access the secure Web site by obtaining a User ID and password.  To learn about adverse event reporting through GeMCRIS, connect to: http://www4.od.nih.gov/oba/rac/gemcris/gemcris_PI.htm 

(Posted March 26, 2004)   

IBCs and a New Federal Biosecurity Initiative - Many individuals are interested in whether the roles and responsibilities of IBCs have changed with the announcement of new Federal biosecurity initiatives, including the establishment of a National Science Advisory Board on Biosecurity (NSABB) and a proposed role for IBCs in the review of "dual-use" research.   

The roles and responsibilities of IBCs have not changed.  For the time being, IBCs should continue to carry out the duties outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules.  The Federal government has proposed a future role for IBCs in the review of "dual use" research, or legitimate research that nonetheless has the potential to be misused in ways that could threaten public health. 

Once NSABB members are appointed and the Board is convened, it will embark upon a process of developing guidelines that will eventually define a role for IBCs in the oversight of this arena of research.  IBCs and other stakeholders will have a voice in the development of these guidelines.  The IBC community will be notified directly of any future changes in their responsibilities.  In addition, any relevant developments will be posted on this Web site. 
(Posted March 4, 2004)

New Informed Consent Resource Available - OBA is pleased to offer on its Web site a new resource on informed consent in gene transfer research.  Developed by the Informed Consent Working Group of the Recombinant DNA Advisory Committee (RAC) with participation from OHRP and FDA, this resource is intended to educate investigators about the many facets of the informed consent process and help optimize communication about risks and benefits.  It will also be of interest to IRBs, IBCs, potential research participants, and others interested in human gene transfer research.
(Posted February 24, 2004)

Letter to Principal Investigators Conveying RAC Recommendations Regarding Adverse Events in a Gene Transfer Trial Studying X-linked SCID  
(Posted March 20, 2003)

Frequently Asked Questions (FAQs) on the NIH review process for human gene transfer trials, a useful educational tool for gene transfer investigators, institutional administrators, and others who wish to learn more about the process and its requirements.
(Posted September 15, 2002)

Reminder to recipients of NIH grants and contracts of need to comply with the NIH Guidelines (includes notice of safety data and Institutional Biosafety Committee reporting requirements).
(Posted May 8, 2002)

Announcement of January 24, 2002 effective date of new safety reporting requirements under the NIH Guidelines.
(Posted May 24, 2002)

RAC Future Meeting Dates with Protocol Submission Deadlines for Public Review.