Human Research Protection Program

Social and Behavioral Human Subjects Research vs. Program Evaluation

Distinguishing between simple program evaluation and human subjects research can sometimes be difficult. While the federal regulations use the term "evaluation" in their definition of research, most program evaluations do not, in fact, fall under this definition.

The chart below lists some features that are common to each type of project and is intended to help investigators determine whether their project requires review by the Human Research Protection Program and/or the Institutional Review Board. Note that not all projects will fall squarely into one column or the other; if in doubt, always contact the HRPP for guidance.

Feature Social and Behavioral Human Subjects Research Program Evaluation
Purpose
  • To test a hypothesis or answer a research question
  • To advance general knowledge in the academic, scientific or
    professional community
  • To fill gaps in current literature
  • To improve a program, practice or process
  • To judge a program’s effectiveness
  • To judge a program’s merit or worth
  • To provide information for and about a specific program
Motivation
  • Intellectual curiosity
  • To answer scientific questions
  • To advance broad knowledge and theory
  • To portray individuals, groups or societies involved
  • Program mandate
  • Program decision-making
Initiator Investigator/scientist Program stakeholders
Study Question How does it work? How well does it work?
Focus On subjects On program
Results
  • Not generally expected to directly or immediately affect subjects
  • Generate new research questions
  • Expected to directly affect program practice or conduct
  • Identify improvements
Dissemination of Results
  • Expectation to present or publish in scholarly forum or publication
  • Present to program stakeholders
  • May present or publish widely to suggest potentially effective models and strategies, or provide benchmarks