At the NIH, the Office for Research Services (ORS), Division of Occupational Health and Safety (DOHS) is the organization responsible for ensuring the safe conduct of all intramural biological research in NIH facilities. The risk assessment review process begins with the mandatory registration of:
(1) research involving any human, animal or plant pathogens, and potentially pathogenic materials (human cell lines, Old-World NHP samples, etc.), acute biological toxins, and
(2) research with recombinant or synthetic nucleic acid molecules that falls under the
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules published by the
NIH Office of Science Policy
All Principal Investigators (PIs) are required to submit registrations describing their biological research projects for review and approval by the NIH
Institutional Biosafety Committee. Furthermore, PIs are primarily responsible for ensuring all associated researchers are aware of the potential risks associated with the described research.
To manage the biological registration program, DOHS now uses the Electronic Registration System (ERS). ERS is a custom-built, stand-alone biosafety registration platform that replaced PI-Dashboard starting after March 25, 2024. All approved registrations in the previous system, PI Dashboard, are still active and have been automatically transferred into ERS. This web-based system for submitting descriptive research registrations and amendments can be accessed securely from any NIH computer with a PIV card reader, as two-factor authentication is required. New with the ERS system, researchers can register work in a project-based format if they choose. As always, administrative changes to approved registrations can be done in real time with the ability to add and remove labs, associated personnel, and relevant linked registrations as needed without a formal amendment submission.
Select one of the links below for more information:
Biological material and rDNA registration
Amend an existing registration
Administrative Changes
Major Amendments
Dual-Use Concerns
Select Agent Program
Using ERS
Guide to the NIH Guidelines
Biological Material and rDNA Registrations
At the NIH, potential risks to laboratory and other personnel related to performing research with potentially harmful biological materials (such as unintended exposures), begins with submission and review of the Institutional Biosafety Committee (IBC) Registration form(s). All Principal Investigators (PIs) working with human, animal, or plant pathogens, potentially pathogenic materials including human blood, body fluids, tissues or cell lines, or the body fluids/tissues/cells of old-world non-human primate (NHP) species, or acute biological toxins, must submit a registration describing their work and procedures through the Electronic Registration System (ERS). These registrations are then formally reviewed and approved by the NIH IBC for work under particular safety levels and following necessary practices.
The initiation of any experiments involving recombinant or synthetic nucleic acid (e.g., rDNA) molecules that require review by an IBC, as described in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), must also be registered in the electronic system. PIs working with recombinant or synthetic nucleic acids must register their experiments using our electronic registration system which has been designed for project-based submissions with greater latitude than in the past. This system, with greater capacity for information and procedural details to be described together, is designed to simplify registrations, and reduce confusion across registrations.
The NIH IBC, whose functions are defined under the
NIH Guidelines, reviews and approves research protocols involving the use of rDNA techniques or potentially infectious/toxic materials. Additionally,
NIH policy describes requirements for registering work with and storage of potentially hazardous biological material. The IBC generally meets monthly;
refer to your local IBC schedule for specific meeting dates and deadlines or reach out to your local Biosafety Officer. The general schedule is:
Bethesda IBC – Meeting dates: First Wednesday of every month except January and July (second Wednesday). For August there is usually no scheduled IBC meeting.
Submission Deadline: Fourteen days before meetings, or greater over holidays.
Rocky Mountain Laboratories IBC - Meeting dates: Third Thursday of every month.
Submission Deadline: Ten days before meeting.
- Meetings may be rescheduled with little notice, so please verify meeting date(s) with your local BSO.
The NIH IBC determines the biosafety level based on a risk assessment of factors such as the agent in use, laboratory procedures, quantity of material being manipulated, etc. Guidance documents include, but are not limited to, the
NIH Guidelines and
Biosafety in Microbiological and Biomedical Laboratories (BMBL).
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Amend an Existing Registration
It is the responsibility of the PI to provide the IBC with updated research information, as well as other changes to laboratory location and research personnel. It is required that the PI review all of their registration documents on an annual basis to ensure current and accurate information regarding their research. Administrative updates (laboratories and personnel) are performed in real-time, and substantive changes are made via formal amendments to current registrations in
ERS.
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Administrative Changes
Administrative changes to personnel and laboratory location can be performed by the PI at any time without the need for an amendment using
ERS. Changes that are made are reflected immediately. To make these changes, PIs can review their registrations in the system and make changes to the personnel and laboratories associated with each. Personnel and laboratory location selections are made by searching, then selecting out of a pre-populated NIH database. If your laboratory or personnel are not listed or cannot be found, please contact your Safety and Health Specialist at (301) 496-2346.
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Major Amendments
Amendments to existing registrations such as adding new rDNA for a particular study, adding an Animal Study Proposal (ASP), or updating the dual-use questionnaire may be performed by selecting the option to submit an amendment.
The amendment process allows the PI to clearly describe the requested changes and give an overview of the request. All of the relevant aspects of the requested amendment should be discussed and all necessary documents (ASPs, amendments to ASPs, copies of vector maps, etc.) should be uploaded (PDF preferred) and included with the submission. Please keep in mind, the Dual-Use Questionnaire must be submitted with all amendment requests. Although this process has been optimized to save time, PIs are asked to give due consideration to these potential Dual-Use elements each time.
For more information, please contact your Safety and Health Specialist at (301) 496-2346.
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Dual-Use Concerns
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 a dual-use questionnaire is part of the electronic registration process. An affirmative answer to one of the listed research effects and considerations will not delay the progress of research but indicates that further review and consideration may be warranted as the research advances.
The Dual-Use Research of Concern (DURC) potential for research is determined through a series of questions included in every registration and referred to the NIH DURC-IRE (Institutional Review Entity) if necessary.
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Using ERS
You may log into ERS securely from any NIH computer with a PIV card reader for dual authentication and if working remotely, using the VPN. Detailed instructions for how to submit registrations, submit amendments, and make administrative changes are located within the system, and resources are available at our Sharepoint site. Additionally, you can contact institute-assigned support personnel at any time.
The DOHS
Health and Safety Application Resources SharePoint site contains information about the ERS application, step-by-step instructional videos, pre-recorded walk-throughs, and live recorded webinars. Users may also schedule time directly with the Biosafety Officers through the site.
Access the Health and Safety Application Resources SharePoint site at
https://nih.sharepoint.com/sites/ORS-ORF-HealthandSafetyApplicationResources.
Your feedback on the ERS application is welcome and encouraged. We hope that you will find the ERS application efficient and easy to use. Please contact
nihbso@mail.nih.gov if you have any questions about ERS.
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Guide to the NIH Guidelines for Recombinant DNA Research NIH Intramural Investigators
This outline is intended only to serve as a guide to the NIH Guidelines for Recombinant DNA Research. It is the responsibility of each NIH investigator to make sure that his/her laboratory is in compliance. Note that the vast majority of experiments involving recombinant DNA require registration and formal IBC approval prior to, or simultaneous with, initiation (see below). A small number of experiments are exempt from registration, BUT only the IBC can determine whether experiment(s) fall into this category. It is useful to consider the relevant section of the Guidelines under which your experiment(s) fall and review the recommendation for the appropriate biosafety level under which the experiment(s) would usually be conducted. However, only the IBC can establish the containment level after a proper risk assessment is performed.
For advice on how to complete the registration form or clarification of the Guidelines, contact your Safety and Health Specialist at (301) 496-2346.
Non-Exempt Categories of rDNA Experiments
All experiments under NIH Guidelines Sections III A, B, C, D, and E require a rDNA Registration prior to the initiation of work.
Section III-A & B – Experiments that require registration and NIH and IBC approval PRIOR to initiation:
1. Deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally if such acquisition could compromise the use of the drug to control disease or cloning of toxin genes with LD50 of less than 100 ng/kg body weight.
Section III-C – Experiments that require IBC and IRB approvals PRIOR to research participant enrollment:
- Experiments Involving the transfer of recombinant DNA or RNA derived from rDNA, into one or more human research participants.
Section III-D – Experiments that require registration & IBC approval PRIOR to initiation:
- Experiments using Risk Group 2, 3, or 4 agents as host-vector systems.
- Experiments in which DNA from Risk Group 2, 3, or 4 agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
- Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus in tissue culture systems.
- Experiments involving whole animals (with the exception of transgenic rodents requiring BSL-1 containment).
- Experiments involving whole plants that require BSL-2+ (enhanced) or higher containment.
- Experiments involving more than 10 liters of culture.
- Experiments involving human influenza strains H2N2, 1918 H1N1, and/or highly pathogenic H5N1.
Section III-E – Experiments that require IBC notice by registration simultaneous with initiation:
- Experiments involving the formation of rDNA molecules containing no more than two-thirds of the genome of any eukaryotic virus.
- Cloning in non-pathogenic prokaryotes and non-pathogenic lower eukaryotes.
- Generation by embryo injection of transgenic rodents requiring BSL-1 containment.
- Breeding 2 different transgenic strains of rodents to generate novel transgenic strains requiring only BSL-1 containment.
- Experiments involving whole plants that require BSL-1 or BSL-2 containment.
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