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IBC News

New Study Team Lookup Tool

Wed, 23rd September, 2015

A new tool is available for researchers to check that study team members have completed the requirements for human, animal, and biosafety research.  “Study Team Lookup” displays an individual’s training information, PI eligibility status, and currently approved studies.  The tool also allows users to store team member profiles.  Study Team Lookup can be accessed from the ORRP website, Buck-IRB and e-Protocol workspaces, and at: http://go.osu.edu/studyteamlookup.

 

— > Contact: John Yocom at 688-8673 or yocom.9@osu.edu

Category : IACUC / IBC / IRB / ORRP

IBC Protocols Changing to 5 year Review Cycle

Fri, 29th May, 2015

Beginning August 2015, the IBC will be changing to a 5 year review cycle for IBC protocols.  Previously approved protocols will be transitioned to the new review cycle over the next few years.  Notices will begin going out in June for protocols that require a renewal protocol rather than an annual review of the protocol.  For more information see the letter from the IBC Chair.

Contact Helen O’Meara or Jen Spohn in the ORRP IBC office at IBCinfo@osu.edu.

Category : IBC / ORRP

New Lentiviral Safety Training Requirement by IBC

Tue, 9th December, 2014

Over the past year, the Institutional Biosafety Committee has seen an increase in the number of protocols submitted requesting to use lentiviral vectors as part of the research.   Many researchers are proposing to use these vectors for the first time.  To fulfill our responsibilities of verifying our research staff is aware of and understand the potential hazards of the material they are working with, the IBC is now offering a new Lentiviral Safety Training, available on the Environmental Health & Safety training website (https://ehs.osu.edu/secure/apps/ ).   The training was developed by The University of Cincinnati and has been reviewed and approved by the OSU IBC for use.

Beginning January 1, 2015 all investigators, co-investigators and study team listed on IBC protocols using lentivirus will need to complete this one-time training program prior to protocol approval.   It is recommended that individuals on currently approved protocols take the training, however it will not be a retroactive requirement for previous approvals.

Contact Tina M. Bogac at  bogac.1@osu.edu or 614-292-2950

Category : IBC / ORRP / Training

Updated IBC Training Requirements

Fri, 17th January, 2014

Institutional Biosafety Committee (IBC) has updated the training requirement for personnel working with recombinant or synthetic nucleic acids.

The IBC now requires all study team members to complete the appropriate web-based training for NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines).

Previously, only PIs involved with this type of research were required to take the on-line course, but all members were to be trained on the NIH Guidelines by the PI.  This new requirement provides documentation that all members working with recombinant or synthetic nucleic acid have received the training.  Information on all the training requirements is available at http://orrp.osu.edu/ibc/training-requirements/ .

This requirement does not include personnel working with protocols that are indicated as being exempt. The IBC will be confirming this training has been completed during protocol or annual reviews.

Category : IBC / ORRP / Training

News from the NIH Office of Biotechnology Activities – False Positive HIV PCR Test Result on a Lentiviral Trial

Mon, 2nd December, 2013

In the spring of 2013, OBA became aware of an individual who had an unexpected false positive HIV polymerase chain reaction (PCR) test result while participating in a human gene transfer trial for X-linked severe combined immunodeficiency (SCID-X1). The research participant had received CD34+ cells transduced with a lentiviral vector. The details of this and another participant’s false positive result were presented at the September 2013 meeting of the NIH Recombinant DNA Advisory Committee (RAC).

After conducting multiple assays to rule out HIV infection or replication competent lentivirus, the trial investigators determined that the HIV test being used appeared to detect sequences present in the vector proviral genome in gene-modified cells.

OBA believes that IBCs and investigators should be aware of these findings since they raise the possibility that research participants in other lentiviral vector gene transfer trials may receive false positive HIV test results if tested with a PCR test that recognizes a part of the HIV genome retained in the lentiviral vector.

If you conduct these types of trials, please discuss this finding with your Institutional Review Board regarding how to best inform potential subjects and those in long-term follow-up about these findings.

For additional information, please contact NIH Office of Biotechnology Activities, by email at oba@od.nih.gov or by telephone at 301-496-9838.

 

 

Category : IBC / ORRP

NIH revises guidelines

Fri, 10th May, 2013

Information, including a summary of the changes and FAQs, is available at the NIH website at http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines.

FAQs provide answers to why the NIH guidelines have been updated and definition of a synthetic nucleic acid molecule.

Category : IBC

How to change study team

Wed, 11th January, 2012

As of January 2012, any study team member currently listed on an approved IACUC or IBC protocol may initiate a new eProtocol action “PROPOSE STUDY TEAM CHANGE.” The Principal Investigator can complete the request by executing “SUBMIT STUDY TEAM CHANGE” to confirm the proposed change(s).  This new, two-step system enhancement allows members of the study team to help manage a protocol’s personnel list – previously, only a PI could enter changes to the study team in eProtocol.

All individuals listed on the Submit Study Team Change activity must be current in all required training (and financial conflict of interest disclosure) before study team changes are finalized.  If any individual (newly added or already on the protocol) does not have all training completed, an error message will be displayed and the request will not be finalized.

NOTE:  Only individuals who are registered in eProtocol will be displayed in the personnel drop-down list.  Registration can be completed at http://eprotocol.osu.edu.

 

Category : IBC

Annual eCOI Disclosure Reminder

Mon, 12th December, 2011

Category : IBC

Judith Neidig, RN, PhD retires as Office of Responsible Research Practices Director; Karen Hale, RPh, MPH, CIP named Interim Director

Fri, 2nd September, 2011

Dr. Judith Neidig, Director of the Office of Responsible Research Practices (ORRP), retires August 31, 2011. Karen Hale, Director of Ohio State’s electronic Institutional Review Board (e-IRB) initiative, has been appointed Interim Director of ORRP effective September 1, 2011. See http://research.osu.edu/2011/08/hale-named-interim-director-of-orrp

Category : IACUC / IBC / IRB / ORRP

New Online IBC rDNA Training Requirement

Thu, 21st October, 2010

The Ohio State University receives funding from the National Institutes of Health. As such, OSU is required to ensure that the research community working with recombinant DNA receive training regarding The NIH Guidelines for Research Involving  Recombinant DNA Molecules. Consequently, the University is requiring all Principal Investigators working with rDNA to complete a web-based training course that covers the NIH Guideline Basics. This requirement will be required beginning November 1, 2010 and will be checked at time of IBC submissions.

Category : IBC