An IRB application is not required. The Self-Certification Tool can be used if the project may be quality improvement or program evaluation. For other projects that don’t fit into those two categories or for multi-site not research projects, a Not Research Exemption application can be submitted; an application may also be necessary when an official determination letter is required to meet funding, departmental requirements, or other reasons.

The IRBs Office must determine whether a project that does not constitute research involving human subjects. An IRB application is necessary when receiving data or biological specimens for secondary analysis research. The only exceptions:

• Data:
  • Use of publicly available data 
    • If the data is publicly available, it is usually not considered human subjects research. However, data mining raises the potential for partial identifiers to be combined and individuals recognized. Multiple data sets may be aggregated and analyzed, yielding novel information. Given this, it would be appropriate to submit an application for review so the IRB can make a determination about whether individuals may be readily identifiable and whether the data would be considered private information based on the details of the data mining you intend to do.
  • Use of data from decedents only.
• Specimens:
  • Samples acquired from a commercial source, or
  • Specimens are from decedents only. Note: HIPAA applies if samples are identifiable. See: Certification for Research on the Protected Health Information of Decedents

To request certification that a project does not constitute human subjects research, the requestor must complete a non-protocol-based application: Exemption, request a review as a not human subjects research project, and provide any relevant information/documents in support of the request.

See HRP-310 - Human Research Determination.

1. If the assigned IRBS determines during pre-review that the application does not qualify for NHSR, the assigned IRBS will request that the study team change the application type as needed.
2. After the study team has responded to the pre-review issues and the assigned IRBS determines that pre-review is complete, the assigned IRBS will complete HRP-401 and 402.
   • If the project was determined to be not research and further clarification may be needed to explain the determination, if the IRBS will include a statement in the comments section of 402 describing why the submission was found to be not research. The description can range from a brief statement to a detailed description of the determination, based on the nature of the submission and the complexity of the determination. The following are examples of statements that can be included in the comments section:
     • "This submission does not fall under the federal definition of research because the primary intent is a quality improvement projects." 
     • "This submission does not fall under the federal definition of research because it is designed as a program evaluation project."
3. After completing the checklist, draft correspondence using the Edit Letter to Study Team activity and select the appropriate letter template (NHSR) using the drop-down menu. Complete Send Correspondence to Study Team activity to send the notice to the study team.

Note: If the application qualifies for NHSR and falls under VA purview, the application is NOT sent to the VA Research & Development Committee (VA R&DC) for review. The assigned IRBS should add the following language when editing the Not Human Subjects Research letter: "You must obtain VA Research & Development Committee approval prior to beginning any activities."

If a certification request is granted, the study team need have no further contact with the IRB about the project in question unless the project changes such that the certification no longer applies.

In the case of NHSR certifications, the ARROW application cannot be updated with a change of protocol, so the following steps must be followed if a change or update is necessary:

• The ST must email the original analyst. The email correspondence should contain the IRB number, a brief summary of the procedures that were approved, a description of the desired change, and any applicable supporting documents.
• The IRBS must evaluate the proposed change in comparison to the original ARROW application, keeping in mind the original criteria upon which the NHSR determination was based.
  • If the proposed change is minor and clearly adheres to the basis upon which the NHSR determination was made, then a new application is not required and the staff reviewer can confirm that the change does not affect the NHSR status via email correspondence and that the ST must retain a copy of the email with their records. The IRBS should log a private comment in ARROW indicating that the IRB was notified of the change, include a brief description of the change or uploading a copy of the email correspondence.
  • If the proposed change clearly violates the criteria of the current determination, such that the study no longer qualifies for a NHSR determination, a new application is required. If the PI is changing, a new application should be submitted. In both cases, the IRBS must inform the ST via email that a new application is required.

Closure reports are not expected to be submitted for NHSR applications.

For submissions Certified as not research, the following apply: 

• Unless the project entails research that does not include human subjects, the project should not be referred to as “research.” Instead, the project should be referred to as an evaluation/quality improvement/etc. for its life course.
• The project should not use consent forms presenting the project as research.
• Personnel should not state that they have IRB approval; the project falls outside IRB purview.

If reviewing a Not Research application that includes statements/materials that go against any of the above, advise the project personnel accordingly and request the application be modified.

Human subjects training and PI status are not required for NHSR/NR applications.

The difference between a stakeholder and subject depends on 1) the kind of information collected, and 2) how it will be used. Stakeholder engagement is limited to gathering feedback on an intervention or tool (i.e., does the tool make sense, are the questions clear, etc.). If participants are not providing information about themselves that will be used as research data, we wouldn't consider them subjects.