AAALAC VISN contractors to review: Safety Security Others EPA You will probably have facility groups that want to perform inspections or walk-throughs: Annual Workplace Evaluation (AWE) Environmental Rounds Safety ISO IT or IRM Controlled Substance Space Hardly a week will go by during which you are not coordinating, or participating, in some type of research program review. You may need to help coordinate the submission of documents for the review. These would include minutes, agendas, SOPs, and reports. You may need to help set the agenda for the inspection and coordinate the people needed to be in attendance. In some instances, you will be asked to help with hotel reservations, meals/restaurant locations, and transportation for the visiting inspection staff. Remember, you are not alone! There are many other people who are responsible for the success and compliance of the research program. As the AO, you have an enormous role in this but, the ACOS/R&D, RCO, and committees are – responsible entities, as well. SECTION 22 IBC Registration and Annual Reporting – Institutional Biosafety Committee If your research program is engaged in research involving recombinant DNA then you will need to have committee oversight from an Institutional Biosafety Committee (IBC) which is registered with the Office of Biotechnology Affairs (OBA) at the NIH. Some facilities have their safety committees function as the IBC. The IBC will need to have and follow an SOP for how to function and document its activities. You may use the affiliate’s IBC if your MOU with the affiliate university allows for it. The research program will need to name a Biological Safety Officer (BSO), who will be a member of the IBC. The BSO will also be responsible for performing periodic inspections of areas involving rDNA research to ensure that lab standards are rigorously followed.
AAALAC VISN contractors to review: Safety Security Others EPA You will probably have facility groups that want to perform inspections or walk-throughs: Annual Workplace Evaluation (AWE) Environmental Rounds Safety ISO IT or IRM Controlled Substance Space Hardly a week will go by during which you are not coordinating, or participating, in some type of research program review. You may need to help coordinate the submission of documents for the review. These would include minutes, agendas, SOPs, and reports. You may need to help set the agenda for the inspection and coordinate the people needed to be in attendance. In some instances, you will be asked to help with hotel reservations, meals/restaurant locations, and transportation for the visiting inspection staff. Remember, you are not alone! There are many other people who are responsible for the success and compliance of the research program. As the AO, you have an enormous role in this – but, the ACOS/R&D, RCO, and committees are responsible entities, as well. SECTION 22 – IBC Registration and Annual Reporting Institutional Biosafety Committee If your research program is engaged in research involving recombinant DNA then you will need to have committee oversight from an Institutional Biosafety Committee (IBC) which is registered with the Office of Biotechnology Affairs (OBA) at the NIH. Some facilities have their safety committees function as the IBC. The IBC will need to have and follow an SOP for how to function and document its activities. You may use the affiliate’s IBC if your MOU with the affiliate university allows for it. The research program will need to name a Biological Safety Officer (BSO), who will be a member of the IBC. The BSO will also be responsible for performing periodic inspections of areas involving rDNA research to ensure that lab standards are rigorously followed.
AO_ACOS_Manual.docx