Research studies involving human subjects require IRB review. Evaluative studies and activities do not. It is not always easy to distinguish between these two types of projects and projects frequently have elements of both. Therefore, the decision about whether review is required should be made in concert with the IRB.
If you think that your project is limited to evaluative activities and therefore not subject to IRB oversight, please contact the IRB office at 6-8802 to discuss.
Research studies are defined by Federal Regulation as:
Systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Evaluative studies are defined as:
Systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development.
Below are elements that are common to evaluation and research projects. This list is not intended to be comprehensive and not all elements are required in order for a project to be considered research or evaluation. Rather, this list of elements can be used to assist faculty in determining whether an activity involves research requiring IRB review.
|Determines merit, worth, or value||Strives to be value-free|
|Assessment of how well a process, product, or program is working||Aims to produce new knowledge within a field(designed to develop or contribute…)|
|Focus on process, product, or program||Focus on population (human subjects)|
|Designed to improve a process, product, or program and may include:
-process, outcome, or impact evaluation
-cost-benefit or cost-effectiveness analyses
|May be descriptive, relational, or causal|
|Designed to assess effectiveness or a process, product, or program||Designed to be generalized to a population beyond those participating in the study or contribute broadly to knowledge or theory in a field of study (designed to develop or contribute to generalizable knowledge)|
|Assessment of program or product as it would exist regardless of the evaluation||May include an experimental or non-standard intervention|
|Rarely subject to peer review||Frequently submitted for peer review|
|Activity will rarely alter the timing or frequency of standard procedures||Standard procedures or normal activities may be altered by an experimental intervention|
|Frequently, the entity in which the activity is taking place will also be the funding source||May have external funding|
|Conducted within a setting of changing actors, priorities, resources, and timelines||Controlled setting (interaction or intervention) or natural setting (observation which may or may not include interaction or intervention)|
Coffman, J. (2003). Ask the Expert: Michael Scriven on the Differences Between Evaluation and Social Science Research. The Evaluation Exchange, 9(4). Retrieved January 8, 2012 from http://www.hfrp.org/evaluation/the-evaluation-exchange/issue-archive/reflecting-on-the-past-and-future-of-evaluation/michael-scriven-on-the-differences-between-evaluation-and-social-science-research
National Center for Justice Planning. (2012) Research and Evaluation Overview. Retrieved on November 28, 2012 from http://www.ncjp.org
National Institutes of Health (2012). Evaluation Basics. Retrieved on November 28, 2012 from http://www.nigms.nih.gov/Research/Evaluation/
Oklahoma State University Institutional Review Board. IRB Toolbox. Program Evaluation: When is it Research? Retrieved on November 28, 2012 from https://compliance.vpr.okstate.edu/irb/irb-toolbox.aspx
Patton, M. Q. (1997). Utilization focused evaluation: The new century text. Thousand Oaks, CA: Sage.
Scriven, M. (1991). Evaluation thesaurus (4th ed.). Newbury Park, CA: Sage.
U.S. Government Accountability Office. (2005). Performance Measurement and Evaluation. Retrieved January 8, 2012 from http://www.gao.gov/special.pubs/gg98026.pdf
Source material for this policy guidance was provided by Oregon State University. The UConn IRB gratefully acknowledges this support.