Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors. The federal definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.” This is an important distinction to make because it determines whether IRB review and oversight of a project is needed because IRB oversight is limited to human subjects research.
The IRBs Office is frequently asked to make a formal determination that a project falls outside of the federal definition of research. Often, IRB review of these projects isn’t required; however, formal IRB determinations that the projects do not require IRB oversight are requested in anticipation of such documentation being required for journals, conferences, funding sources and others.
The materials below are intended to assist study teams in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected. To address the issue of documentation, the IRBs Office also has developed a tool that can provide self-certification that the project does not require IRB review and oversight.
IRB QI/Program Evaluation Self-Certification Tool
This tool allows study teams to make the decision about whether their project constitutes the definition of research under the Common Rule (45 CFR 46) independent of the IRB. The tool is designed to help determine whether the project constitutes research or whether it is quality improvement or program evaluation, such that IRB review isn’t required.
NOTE: This tool is not designed to determine all of the cases when a project falls outside of the IRB’s purview. This tool is only for determining if a project is QI/Program Evaluation, rather than research. The tool should not be used for public health surveillance projects, as these projects require consultation with the IRBs Office Director. The IRBs Office has additional resources that can help determine the need for IRB review based on inclusion of human subjects, as well as qualification for exemption.
For assistance answering the questions in the IRB QI/Program Evaluation Self-Certification Tool, please review the following: HS QI/Program Evaluation Self-Certification Tool Guidance
This Decision tree provides an additional resource for assistance in determining whether a project constitutes human subjects research (and subsequently requires IRB review) or quality improvement/program evaluation. The decision tree forms the basis for the questions in the IRB QI/Program Evaluation Self-Certification Tool (see above), but it does not provide a certification upon completion.
This table is intended to help in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected. Please contact the IRBs Office with any questions or for assistance in making a determination.
Please note, HIPAA Privacy and Security Rule Regulations may still apply to your project even though IRB review isn’t required. If you have questions or concerns about IRB review requirements after reviewing the above materials, please contact the HS IRBs Office for additional assistance.
For assistance answering the questions in the IRB QI/Program Evaluation Self-Certification Tool, please review the following: ED/SBS QI/Program Evaluation Self-Certification Tool Guidance