Nonprofits and agencies ask us this all the time. You are running a program, you want to know if it works, and you plan to survey or interview the people involved. Does that need IRB approval?
The honest answer is: sometimes. It depends on whether your evaluation counts as research under federal rules.
What counts as research
Under the Common Rule (45 CFR 46), research is “a systematic investigation… designed to develop or contribute to generalizable knowledge.” The key word is generalizable. The question is not whether you are collecting data from people. It is what you plan to do with what you learn.
- Usually not research: an evaluation designed to improve your own program, report back to your board, or meet a funder’s reporting requirements, where the findings stay inside the organization.
- Usually research: an evaluation designed to test whether an approach works in general, with plans to publish, present at conferences, or share findings so other programs can use them.
If your evaluation is research and it involves living people you interact with or collect identifiable information about, it is human subjects research. That is when IRB review comes in.
Signs your evaluation probably needs review
- You plan to publish the results in a journal or present them as findings others should apply
- The evaluation uses a comparison or control group to test an approach
- Your funder requires IRB approval or an exemption determination
- You are collecting sensitive information, such as mental health, substance use, or legal history
- Your participants include children or other groups that need added protections
- An outside evaluator plans to use the data for their own research
Signs it probably does not
- The goal is internal improvement or accountability for one program
- Results go only to your staff, board, and funder
- You are using routine program data you would collect anyway
- No one plans to publish or generalize the findings
Plans change, though. If an internal evaluation later turns into a paper or conference presentation, you may need a review before using the data that way.
Who makes the call
It is tempting to decide on your own that an evaluation is not research. Funders and journals often want more than that. A written determination from an IRB, saying the project either is not human subjects research or qualifies as exempt, is much easier to defend later.
If it does need review, it is often exempt
Many program evaluations involve minimal risk. Surveys, interviews, and analysis of existing program records often qualify for exempt review, which is the lightest level. Exempt review is also common for nonprofits that need a determination to satisfy a federal grant. You can read more about the levels in our post on exempt, expedited, and full board review.
Good practice either way
Even when an evaluation is not research, the same ethics apply. Tell participants what you are collecting and why, make participation voluntary, keep data secure, and report results in ways that do not identify individuals.
How TIER can help
TIER does both sides of this work. Our program evaluation services help organizations design and run evaluations, and our independent IRB can review the study or issue a determination when one is needed. If you are not sure whether your evaluation needs review, get in touch and we will help you figure it out.
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