VA Northern California Health Care System
Subcommittee for Research Safety
- Instructions for Completion of Research Protocol Safety Survey
- Definitions of Hazard Categories
- SRS Research Protocol Safety Survey VA Form 10-0398
- Basic Science Animals Bench Studies
- Instructions for Basic Science Animal Bench Studies
- Ammendment Form
- Protocol Closure Application
Responsibilities of the SRS
Ensuring personnel safety in Veterans Affairs (VA) research laboratories is of primary importance. The VA Northern California Health Care System (VANCHCS) Subcommittee for Research Safety (SRS) reviews all research proposals that involve safety hazards related to the research environment for compliance with all applicable directives pertinent to research security as well as biological, chemical, physical, and radiation hazards. This includes all research proposals to be conducted at the VANCHCS or by VANCHCS personnel off-site. All protocols submitted to the VANCHCS Research Office need to be reviewed by the SRS.
The SRS holds a meeting once a month (usually on the second Monday of the month). Regulatory processes at the Research Office require that applications be submitted at least 6 weeks prior to the day of the meeting in order to be considered for a particular meeting. Once approved by the SRS, the protocol then goes on to the R&DC, if it also has the approval of the other subcommittees as necessary.
Protocols are thoroughly reviewed by the SRS Executive Secretary, the Chair and the Primary Reviewer before the protocol is presented to the full committee. Despite this, sometimes, minor errors are detected at the meeting itself. Studies that require minor corrections are given conditional approval contingent upon the correction of the errors. These contingent approvals will not hold up the timely presentation of the protocols to the R&DC meeting. Protocols that require major corrections will be “tabled” until the next meeting. To avoid such an incidence, please ensure that the protocol reaches the Research Office with sufficient time for a complete pre-review to avoid errors.
The following documents must be submitted to the Research Service office for an SRS review (together with other regulatory documents):
- Project Data Sheet, VA Form 10-1436
- Research Protocol Safety Survey (RPSS) (VA Form 10-0398). Instructions for completing this form may be found at the top of this page.
- Conflict of Interest Statement (VA Form 10-1313) (Required for all personnel on this research study.)
- Application for Basic Science and Animal Studies. Instructions for completing this form may be found at the top of this page. (Required for studies which have animal or bench components.)
Initial Reviews are conducted when the protocol is being submitted to the SRS for the first time. Initial Reviews will be conducted by the full SRS. The SRS will review the risk assessment of the facilities, level of containment, laboratory procedures, chemicals, practices, training and expertise of personnel involved in the specific research being conducted. The SRS will identify if the proposed research involves the use of select agents, toxins, radioactive compounds, ionizing radiation, and storage of tissue samples.
Continuing Reviews are conducted for each subsequent submission of a protocol to the SRS. Continuing reviews will be conducted annually based on the date of the most recent SRS approval. Continuing reviews may be expedited by the SRS chair if the answers to all 11 questions on page 2 of the RPSS form were either NO or there has been no change in the protocol since the previous review.
Animal and Bench protocols will be reviewed by the SRS. In addition to the process for initial review, the SRS will review these protocols for the following:
- scientific merit,
- meeting the definition of VA engagement,
- meeting relevance to the mission of the VA,
- security of VA data/sensitive information,
- conflict of interest,
- adequate resources
Amendments: Changes to the original research protocol must accompany all amendment forms and must be documented on an amended RPSS form and Application for Basic Science and Animal Studies as necessary. These forms must be submitted to, and reviewed by, the SRS prior to implementation of the changes.
If there is an allegation or other evidence that there has been a violation of safety policies or procedures, the SRS will conduct an audit. The SRS has authority to examine all records that have a direct impact on safety. If non-compliance is confirmed, the SRS will consider the non-compliance to be Serious if it involves an immediate threat to the safety or health of animals, research participants or staff. The SRS will consider the non-compliance continuing if the Principal Investigator has failed to take corrective action after a previous finding of non-compliance for the same violation or if there have been more than 3 consecutive findings of non-compliance for the same Principal Investigator.
If the SRS determines that the non-compliance is Serious or Continuing, the SRS may recommend that the R&DC suspend or terminate the project. Reports of Serious or Continuing non-compliance to external agencies will be made by the R&DC.
For further information on administrative matters, please contact the SRS Coordinator:
VANCHCS Research Service
10535 Hospital Way, Bldg 650, Rm 2B010
Mather, CA 95655