VA Form 10-0398: Research Protocol Safety Survey Guide

VA Form 10-0398: Research Protocol Safety Survey Guide – The VA Form 10-0398, officially titled the Research Protocol Safety Survey, is a critical document used in the U.S. Department of Veterans Affairs (VA) research ecosystem. It helps ensure the safe conduct of research involving potential hazards at VA facilities. Whether you’re a principal investigator (PI), research coordinator, or part of a VA Institutional Review Board (IRB) or Subcommittee on Research Safety (SRS), understanding this form is essential for compliance.

Download the official VA Form 10-0398 PDF here: VA Form 10-0398 Research Protocol Safety Survey

What Is VA Form 10-0398?

VA Form 10-0398 is a standardized safety survey required for many VA research protocols. First issued in its current form around May 2002 (with local updates and a “2.0” version discussed in recent webinars), it collects detailed information about potential hazards in research projects.

The form supports the VA’s commitment to protecting research personnel, veterans participating in studies, and the environment by identifying and mitigating risks from biological, chemical, radiological, and physical hazards. It aligns with federal guidelines from the CDC, NIH, and other agencies.

Purpose of the Research Protocol Safety Survey

The primary purpose of VA Form 10-0398 is to facilitate a documented safety review by the local Subcommittee on Research Safety (SRS) before research activities begin. It ensures:

  • Proper identification of hazards (e.g., pathogens, recombinant DNA, chemicals, radiation).
  • Implementation of appropriate containment, training, and monitoring procedures.
  • Compliance with VHA Handbook 1200.08 and related policies on personnel safety in research.

This form is typically required for VA-funded projects and must often accompany submissions to the IRB, IACUC (for animal research), or R&D Committee. It promotes a culture of safety in VA medical centers nationwide.

Who Needs to Complete VA Form 10-0398?

  • Principal Investigators (PIs) conducting research at VA facilities.
  • Research teams working with biological materials, chemicals, controlled substances, or radiation.
  • Studies involving human subjects, tissues, animals, or lab-based hazards.

Even if no high-risk hazards are involved, a documented review by the local SRS may still be required. The form must be signed by the PI, a Safety Officer, and relevant committee chairs.

Key Sections of VA Form 10-0398

The form is structured to systematically assess risks:

1. Initial Hazard Screening

Investigators answer yes/no questions about:

  • Biological hazards (pathogens, toxins, select agents).
  • Human or non-human cell/tissue samples.
  • Recombinant DNA.
  • Chemicals (toxic, flammable, carcinogenic, etc.).
  • Controlled substances.
  • Ionizing and non-ionizing radiation.

2. Detailed Biological Hazards Section

For any “yes” answers, provide details on agents, biosafety levels (BSL-2/3), containment equipment, and personnel health monitoring.

3. Cells and Tissue Samples

Covers work with blood, fluids, organs, or cell lines and required precautions.

4. Recombinant DNA Procedures

References NIH Guidelines; requires classification and description of procedures.

5. Chemicals, Controlled Substances, Radiation, and Physical Hazards

Includes inventories, storage details, approvals, and training confirmations.

6. Certifications and Signatures

PI acknowledgment of responsibility, Safety Officer review, and final approvals from SRS Chair, R&D Committee, and others as applicable.

How to Complete and Submit VA Form 10-0398

  1. Download the latest version from the official VA site.
  2. Fill out all applicable sections completely. Attach chemical inventories where required.
  3. Consult local SRS or Research Office for facility-specific instructions (some locations use updated Word versions or appendices).
  4. Submit alongside your protocol to the IRB, SRS, and other committees.
  5. Retain records per VA policies.

Recent updates (e.g., “Research Protocol Safety Survey 2.0”) may offer more flexibility in certain VA facilities—check with your local Research Service.

Pro Tip: Always verify requirements with your VA facility’s Research and Development Office, as processes can vary slightly by location.

Why Safety Compliance Matters in VA Research?

VA research directly benefits veterans by advancing treatments for conditions prevalent in the veteran population. Strict safety protocols via forms like 10-0398 protect everyone involved, maintain public trust, and ensure studies meet the highest ethical and regulatory standards. Non-compliance can delay approvals or halt projects.

For the most current information, visit the official VA Forms page or contact your facility’s Research Office.

This article is for informational purposes and is based on publicly available VA resources. Always consult official VA channels and your local research administrators for guidance specific to your project.