What's the difference between evaluation and research for IRB purposes?
For IRB purposes, the difference between evaluation and research is whether the work is designed to contribute to generalizable knowledge, beyond understanding and improving this one program. The federal rule for protecting human subjects in research (45 CFR 46) defines research as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." So the word "evaluation" on a project doesn't settle the question. An evaluation designed to help one program understand what's working and improve is in a different position from a study designed to produce knowledge that applies to other programs and settings.
A plan to publish the findings, or to use the data in a broader study, can change the answer. If anyone on the project team hopes to publish, there's nothing wrong with that. Tell the IRB about it when you first contact them, so the review covers what the project intends to do with the information.
What is an IRB determination?
An IRB determination is the IRB's decision about whether, and how, the project has to be reviewed. Depending on what the evaluation involves, the IRB may decide that it doesn't meet the federal definition of human subjects research, that it qualifies for one of the rule's exemptions, or that it needs review.
The exemptions are specific. The federal rule lists categories that include research on normal educational practices in established educational settings, and some research that only involves surveys, interviews, educational tests, or observation of public behavior, under conditions the rule spells out. Whether one of them applies to your evaluation is the IRB's call, made through your institution's own process.
Should the evaluator be listed on our IRB application?
Whether the evaluator should be listed on your IRB application depends on the evaluator's role and your institution's rules, so ask your IRB and settle it before data collection starts. For example, an evaluator who will ask participants questions directly may be in a different position from one who only works with information the project team collects.
The evaluator's role also decides what data agreements you need. If the evaluator will receive participant or institutional data, your institution may require a data use agreement, a data sharing agreement, or a confidentiality agreement, and a project that involves more than one institution may need additional approvals. At Grantibly, we ask project teams to identify their IRB contact before the kickoff meeting, and we discuss the appropriate IRB approach together during project planning. We've received notice that our project was funded. When do I need to get my evaluator involved? lays out where the IRB fits in the first weeks of a funded project.
The Grantibly perspective
Lauren's perspective
Grant-funded projects, particularly those housed in colleges and universities, sometimes begin to treat evaluation like an academic research study. There can certainly be overlap, and rigorous methods matter in both. But the purposes are different. Research generally seeks to generate knowledge that extends beyond a particular program or setting. Evaluation primarily seeks to understand and improve a specific program, initiative, organization, or investment.
We help clients distinguish between what they need to know to evaluate the project well and what would be interesting to study. Both can be worthwhile. They simply may not belong in the same scope of work, and a plan to study something beyond the program is exactly what your IRB will want to hear about early.
