Research Project Hazard Assessment

What is the RPHA Form? How do I Submit the RPHA? What is the new process? Why the New RPHA Form? Expiration Date Changes to Research Questions?

Effective July 1, 2009, the new RPHA form must be submitted to register your research.

What is the RPHA Form?

The Research Project Hazard Assessment (RPHA) form is the primary tool for the EH&S Research and Biological Safety Office (RBSO) to gather information about hazardous materials used in research projects. The RPHA form must be submitted if your work involves the following:

• Recombinant DNA
• Genetically engineered cells
• Transgenic plants or animals
• Infectious agents (e.g. viruses, microorganisms, human cells)

Submitting the RPHA form will register your research with EH&S RBSO and initiate the approval process which is required for the above agents.

How do I Submit the RPHA?

If mailed or faxed send to Environmental Health and Safety, Attention UW Biosafety Officer. The signature on pg. 1 can be e-mailed electronically, or pg 1 can be mailed or faxed.

What is the New Biological Use Approval Process?

When the EH&S Research and Biological Safety Office (RBSO) receives your completed RPHA form, the review process will begin. An Institutional Biosafety Committee (IBC) member and/or an EH&S Biosafety Officer will be assigned to your project and will work with you to obtain approval. All IBC members will have the opportunity to review your RPHA form. As part of the review process a Biosafety Officer must inspect your lab to confirm to the IBC that your laboratory and practices are in compliance with the biocontainment requirements for your research. Once your research has been approved, you will receive notification from EH&S RBSO.

Why the New RPHA Form?

Following a not-for-cause site visit by the NIH Office of Biotechnology Activities, the University of Washington is revising and expanding the oversight of recombinant DNA and biohazardous research regardless of the funding source. As a response to the site visit the RPHA form has been expanded to capture additional information regarding the use of recombinant DNA (section G). One specific addition addresses the NIH Office of Biotechnology Activities directive that the Principle Investigator must identify the section of The NIH Guidelines for Research Involving Recombinant DNA Molecules that applies to their research (NIH guidelines (external link)). There are several different levels of oversight required for research with recombinant DNA depending on the agents and procedures in your specific research project. Thus, it is critical that the PI makes the initial assessment of oversight required for approval. Much of the research with recombinant DNA that occurs at the University of Washington, such as use of viral vectors, falls under Section III D. Projects that fall under this section of the guidelines will not be able to begin until the Principal Investigator obtains approval from the IBC.

In order to expedite the approval process the new RPHA captures additional information such as equipment use (section J), and general biosafety lab practices (section K). It is critical that the RPHA is completed entirely for IBC members to review your research. If you do not fully complete the RPHA describing your research, it will be returned to you to re-submit. This could potentially delay IBC review and approval until the following month when the full committee meets again.

Expiration Date for Biological Use Approvals:

As projects with biological agents are approved with the new process they will begin receiving expiration dates. Approvals will generally be given for a three year period. Any research performed on a project with biological agents after the expiration date will be out of compliance with the NIH Guidelines. This is a reportable incident to the NIH Office of Biotechnology Activities, which oversees the NIH Guidelines.

To renew your approval you must re-submit an RPHA form in sufficient time to obtain IBC approval before your expiration date. You will receive email notification of your impending expiration 2 months prior to remind you of your need to resubmit if you plan to continue your research.

Changes to Currently Approved Research

Principle Investigators may request changes to their current approval (e.g. new agent, location, or procedure). In certain situations, the EH&S RBSO will be able to make the change administratively. In others, review and approval from the IBC will be required. To request a change, submit a detailed email to rbso @u.washington.edu. A Biosafety Officer will work with you to update your approval.

Questions?

Contact a UW Biosafety Officer at the EH&S, Research and Biological Safety Office: