10-0398

Research Protocol Safety Survey

Agency
VA
Revision
August 2026
Fillable fields
627
Pages
12
Official source
VA form page
Checked
October 20, 2026
Fill 10-0398 online
Page 1 of form 10-0398

VA Form 10-0398: Research Protocol Safety Survey (RPSS)

VA Form 10-0398 is the U.S. Department of Veterans Affairs Research Protocol Safety Survey (RPSS). VA's form page lists it under VHA. It describes a research project's hazards, work spaces, staff training and safety controls so the SRSS can review the hazard risks, and it records whether the project also needs Institutional Biosafety Committee (IBC) review.

Each page is identified by the principal investigator's name and the IRBNet number. Section G says the document is submitted for review on the VA Innovation and Research Review System (VAIRRS-IRBNet). The form covers initial submissions, amendments and continuing or annual reviews, and says an ORD companion document gives guidance on completing it.

The PDF has 12 pages: administrative and umbrella project details, Sections A to G, and addendum pages for longer answers and extra table rows. It is used for VA research projects, not for Veteran benefits. You can fill out the PDF free in your browser on this page and download the result without an account.

Top of page 1 of VA Form 10-0398: Research Protocol Safety Survey (RPSS), as printed by VA

What's on VA Form 10-0398

Administrative and umbrella information

Principal investigator, whether it is an umbrella protocol, project title, IRBNet number and local board number, plus every IRBNet number an umbrella project covers.

Section A: exemption review

A choice between 1A, exempt from SRSS and IBC review, and 1B, requires SRSS review and/or IBC registration, with the examples the form gives for each.

Section B: general project information

Type of submission, an amendment summary, continuing review questions on changes, incidents and inspection findings, a plain-language purpose, a procedures overview, the personnel and training table and the location of VA and off-site spaces.

Section C: hazards used

Chemical hazards, including volatile anesthetics, formaldehyde, xylene or benzene and controlled substances; biological hazards, from recombinant nucleic acids and specimens to select agents and live animals; then radiation and physical hazards, with controls and PPE.

Sections D and E: shipping, risk and international work

Whether specimens are transported or shipped, whether a PPE risk assessment has been completed and reviewed, and whether data or specimens come from or go outside the United States.

Sections F and G and addenda

Additional local information, the acknowledgement of responsibility and knowledge, continuation pages for Section B items 4 and 5, and an additional addendum for table rows.

How to complete VA Form 10-0398

  1. 1

    Fill in the administrative information

    Enter the principal investigator, project title, IRBNet number and umbrella details. Pages 2 to 12 repeat the investigator name and IRBNet number.

  2. 2

    Check Section A

    If 1A applies, the form says the project is exempt and to follow local policy for SRSS exempt projects. If 1B applies, it says to complete the form and contact the IBC coordinator.

  3. 3

    Describe the project and staff

    Complete Section B: the type of submission, the purpose in non-technical language, the procedures, the personnel table and every space where the work takes place.

  4. 4

    Mark hazards and controls

    Answer the Section C tables and questions. If the project involves no work with chemical, biological, physical or radiological hazards, the form says to skip to Section D.

  5. 5

    Finish Sections D to F and attach records

    The form allows attaching an inspection report with action plans, a complete list of hazardous chemicals for initial reviews, a local spill procedure and off-site inspection reports.

  6. 6

    Submit on VAIRRS-IRBNet

    Section G says submitting the document for review on VAIRRS-IRBNet is the investigator's certification of compliance and staff training.

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Where it goes

Submission

Section G says the document is submitted to be reviewed on the VA Innovation and Research Review System (VAIRRS-IRBNet). The form prints no mailing address.

Guidance

The form says an ORD companion document provides guidance to complete it. Several items say local policy decides details, such as how the training table is completed.

Edition

The current edition is dated AUG 2026, and VA's form page lists its revision date as August 2026.

Related forms

Who uses VA Form 10-0398?

  • Principal investigators

    Item 1 names the principal investigator. In Section G the investigator certifies that the research will be conducted in compliance with Federal, State and local policies, regulations and CDC-NIH Guidelines.

  • Project personnel

    Section B, item 6 lists each person involved in the project, their safety, BBP and rDNA training and the hazards each one encounters.

  • The SRSS

    The form asks for enough information for the SRSS to review hazard risks, and says the SRSS reviews laboratory inspection reports from approved off-site spaces annually under VHA Directive 1200.08.

  • Institutional Biosafety Committee

    Section A says work with an experimental drug or device containing or derived using recombinant or synthetic nucleic acid technology may need IBC registration, and to contact the IBC coordinator for instructions.

  • Safety officers and committees

    Items point to the Chemical Hygiene Officer for chemical inventories, the Radiation Safety Committee for isotopes and radiation-generating equipment, and the IACUC for work with live animals.

  • Exempt projects

    Section A says research done exclusively in clinical areas, or that exclusively involves chart review or data analysis without the listed hazards, is exempt from SRSS and IBC review and follows local policy.

The form names the investigator who completes it and the reviewers it goes to.

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Questions about Form 10-0398

What is VA Form 10-0398 used for?

It gives the SRSS enough information about a research project's procedures, hazards, spaces and training to review the hazard risks, and shows whether IBC review is also needed.

Which projects are exempt from SRSS and IBC review?

Section A says research done exclusively in clinical or patient care areas, clinical laboratories or clinical offices, or research that exclusively involves chart review or data analysis without the listed hazards, is exempt. It says to follow local policy for those projects.

Does the form cover amendments and annual reviews?

Yes. Section B asks the type of submission, with item 2A for amendments and items 3A to 3D for continuing or annual reviews.

Where is VA Form 10-0398 submitted?

Section G says it is submitted to be reviewed on the VA Innovation and Research Review System (VAIRRS-IRBNet).

What if a project uses no hazards?

Section C has a box for a project that involves no work with chemical, biological, physical or radiological hazards, and says to skip to Section D.

What if an answer does not fit?

Section B items 4 and 5 continue on pages 10 and 11, and page 12 is an additional addendum for further information on a table earlier in the form.