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Registrations

The Division of Occupational Health and Safety (DOHS) is the organization responsible for the mandatory registration of research involving human pathogens and recombinant nucleic acid molecules within the NIH intramural program. Principal Investigators (PIs) are responsible for registering bacteria, virus, toxins of biological origin, and/or recombinant DNA.  

To manage the registration program, DOHS utilizes PI-Dashboard. PI-Dashboard is a web-based system for submitting required research registrations and amendments. PI-Dashboard can be used securely from any computer with internet access. Through the PI-Dashboard system, researchers are able to register work with new material, amend approved registrations with the ability to add and remove labs, associated personnel, relevant linked registrations, and administrative details as needed.

 Additional Information  

Biological Material Registrations

At the NIH, exposure information for laboratory personnel is gathered with the Human Pathogen Registration Document (HPRD) form. All Principal Investigators (PIs) working with human pathogens; human blood, body fluids, or tissues; biological toxins; and the blood, tissues, or body fluids of old-world non-human primate (NHP) species must submit a registration through PI-Dashboard. The registration will be reviewed by the NIH Institutional Biosafety Committee (IBC)Exit arrow

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Recombinant DNA Registrations

The initiation of any experiment involving recombinant DNA (rDNA) molecules requires review by the NIH IBC . PIs intending to work with rDNA must register their experiments through PI-Dashboard before experiments begin.

The NIH IBC, whose functions are defined under the Guidelines Exit arrow, reviews and approves research protocols involving the use of rDNA techniques or potentially infectious/toxic materials. The IBC generally meets the first Wednesday of each month except for August. Refer to their schedule for specific meeting dates and deadlines.

The NIH IBC 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. based on guidelines developed by the NIH Office of Biotechnology Activities Exit arrow. A condensed version of these guidelines is available through this link Exit arrow.

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Amending Existing Registrations 

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 highly recommended that the PI review all of their registration documents on an annual basis to ensure current and accurate information regarding their research. Amendments to current registrations and registrations submitted prior  to July 2009 can be performed with PI-Dashboard.

Administrative Changes

Administrative changes to personnel and laboratory location can be performed by the PI using PI-Dashboard. Changes that are made are reflected immediately.  To make these changes PIs can highlight one of their registrations in their ‘My Research’ folder (shown on the left side of the page), and make changes to personnel, laboratory or associated registrations by right-clicking in the ‘Linked Records’ section on the right side of the page. 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 specialist through DOHS. 

Major Amendments

Amendments to existing RD and HPRD registrations  such as adding new rDNA for a particular study, adding an Animal Study Proposal (ASP) to an existing RD, or updating the dual-use questionnaire, may also be performed under the ‘My Research’ folder by highlighting the registration in question, right-clicking and selecting the option ‘amend registration’. This process will create a time-stamped amendment file located in the ‘draft research registrations’ heading shown on the left hand side of the page.

The amendment page allows the PI to clearly describe the requested changes in a brief but complete narrative. 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 and submitted in the area at the bottom of the first page. Please keep in mind, the RD/HPRD Dual-Use Screening Survey must be submitted with all such amendment requests and is located on the second page of the amendment request. In cases of ‘Joint Registrations’, where pathogenic agents are being used to perform rDNA experiments, only an amendment to the RD registration is necessary.  'Stand-alone’ HPRD registrations (not associated with rDNA work) are amended when the nature of work with that agent changes (i.e., using the agent in a new study, adding an ASP, etc.).

For more information, please contact your Safety and Health Specialist at (301) 496-2346.

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Dual-Use

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 Download Adobe Reader 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 (SERCEB) found here Exit arrow.

 
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Registrations for FDA Personnel

Employees from the FDA need to request a username and password from PI-Dashboard. They are unable to access the system with their username and password. To request a username and password, contact customer support at 1-800-690-3530 or support@healthrx.com.

 

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Using PI-Dashboard

To access PI-Dashboard visit HealthRx. Log in securely from any computer using your NIH username and password. Detailed instructions  for how to submit registrations, submit amendments, and add registration proxies are located in the “Support section”. Additionally, you can contact support personnel at 1-800-690-3530 or support@healthrx.com

 

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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 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 be conducted. However, only the IBC can establish the containment level. 
RD - Registration Document For Recombinant DNA Experiments
For copies of the “RD” registration form and the NIH Guidelines, click on the links. For advice on how to complete the registration form or clarification of the Guidelines, contact the safety specialist for your particular Institute or Center (301-496-2346).
Relevant section(s) of “NIH Guidelines”
Examples of recombinant DNA research
Level of review
PI Action Required
III – A
Experiments that compromise the control of disease agents in medicine through deliberate transfer of a drug resistant trait into microorganisms not known to acquire the trait naturally (III-A-1-a)
IBC, RAC review, and NIH Director review and approval
Submit RD application to IBC. Await authorization to begin experiments
III – B
·   Cloning of DNA encoding molecules toxic to vertebrates that have an LD50 <100ng/kg  body weight (III-B-1)
·   Experiments conducted with a recombinant DNA modified restricted agent in a whole animal
IBC approval and NIH review for containment determinations
Submit RD application to IBC Await authorization to begin experiments
III – C
·   Experiments involving the deliberate transfer of recombinant DNA into one or more human research participants (III-C-1)
IBC and IRB approval and NIH review before research participant enrollment
Submit RD application to IBC. Await authorization to begin experiments
III - D
·   Experiments involving the introduction of recombinant DNA into Risk Group 2, Risk Group 3, Risk Group 4, or Restricted agents (RG2: III-D-1-a; RG3: III-D-1-b; RG4: III-D-1-c; Restricted Agent: III-D-1-d)
·   Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4, or Restricted agents is cloned into non-pathogenic prokaryote or lower eukaryote host-vector systems (RG2, RG3, RG4: III-D-2-a; Restricted Agent: III- D-2-b [case-by-case review])
·   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 (RG2: III-D-3-a; RG3: III-D-3-b; RG4: III-D-3-c; infectious or defective restricted poxviruses: III-D-3-d; other agents not covered above: III-D-3-e)
·   Experiments involving whole animals. Recombinant DNA, or DNA or RNA molecules derived therefrom (from any source except > 2/3rds of eukaryotic viral genome) transferred to any non-human vertebrate or any invertebrate organism (III-D-4)
IBC approval before initiation
Submit RD application to IBC. Await authorization to begin experiments
III – E
·   Creating stable germline alterations of rodents using recombinant DNA (from any source except > 2/3rds of eukaryotic viral genome) when these experiments only require BSL-1 containment
IBC notice at initiation
Submit RD application to IBC simultaneously with commencement of experiments
III - F
·   Purchase or transfer of transgenic organisms (III-F-6, Appendix C-VI)
·   Cloning of all other DNA in E. coli K-12 (III-F-6, Appendix C-II), S. cerevisiae or S. uvarum (III-F-6, Appendix C-III), and B. subtilis or B. licheniformis (III-F-6, Appendix C-IV) host-vector systems (with the exception of DNA from Risk Group 3 or 4, or restricted organisms)
Exempt from NIH Guidelines. IBC registration not required if experiment not covered by Sections III-A, III-B, or III-C *
 
Contact NIH BSO to discuss whether the experiments may be exempt from the guidelines
 * NOTE: There are exceptions to the exemptions e.g., large scale experiments (>10 liters of culture), production of molecules toxic to vertebrates as a result of the deliberate cloning and expression of toxin molecule genes, etc. (consult guidelines for complete listing).