New Registrations: The PI-Dashboard Electronic Submission System

The initiation of any experiment involving recombinant DNA (rDNA) molecules requires review by the NIH Institutional Biosafety Committee (IBC).  According to the NIH Guidelines for Research Involving Recombinant DNA Molecules, Principal Investigators (PIs) intending to work with rDNA must register their experiments with the NIH IBC via the IBC Executive Secretary/NIH Institutional Biological Safety Officer (BSO) in the Division of Occupational Health and Safety (Building 13, Room 3K04).

• The NIH IBC, whose functions are defined under the Guidelines, reviews and approves research protocols involving the use of rDNA techniques or potentially infectious/toxic materials. The IBC typically meets the first Wednesday of the month.
• The PI is responsible for compliance with the Guidelines in the conduct of rDNA research, and ensuring that appropriate reviews and approvals are obtained prior to initiation of experiments. All submissions, including amendments, are now being taken electronically using our web-based online submission system called PI-Dashboard.
• PI-Dashboard can be used securely from any computer with internet access.
• Streamlines the registration submission and update process by allowing PIs to add/delete laboratories associated with registrations; add/delete personnel associated with registrations; link related registrations; and amend existing registrations. 
• Simplifies a research submission involving the use of rDNA and potential pathogens.
• To contact or speak with a PI-Dashboard technical support representative, please e-mail support@healthrx.com or call (800) 690-3530.

Regulation of Recombinant DNA Material

The NIH Institutional Biosafety Committee determines the biosafety level based on a risk assessment including such factors as the agent in use, laboratory procedures, quantity of material being manipulated, etc.

• The NIH Guidelines for Research Involving Recombinant DNA Molecules
• Guide to the NIH Guidelines for Recombinant DNA Research NIH Intramural Investigators

Amending Existing Registrations 

It is the responsibility of the Principal Investigator to provide the IBC with updated research information, as well as other changes to laboratory location and research personnel. Amendments to ‘original paper-form’ registrations (those submitted prior to July 2009) can be done with PI-Dashboard, as records are maintained from these forms which are stored electronically as PDF files.

The RD/HPRD Dual Use-Screening Survey Form

A research project is considered dual-use in nature if the methodologies, materials or results could be used for malevolent purposes, including harm to humans, animals and/or the environment.

• To ensure research performed at the NIH is conducted and published in a timely manner with due consideration given to experiments potentially having dual-use concerns, completing RD/HPRD Dual-Use Screening Survey Form is part of the electronic registration process.
• An affirmative answer will not delay the progress of research, but indicates that further review and consideration may be warranted as the research advances.
• Become familiar with the "dual use" dilemma by completing a 30-minute module developed by the Southeast Regional Center of Excellence for Emerging Infections and Biodefense (SERB) found here.