QI or research? How project review decisions work
You may describe your project as quality improvement, program evaluation, or research. That description does not replace the determination required by your institution and project site.
OHRP explains that some improvement activities are not research under the federal human subjects regulations, while other activities may involve both improvement and research. Intending to publish does not, by itself, settle the distinction. [1] Use the institutional review process rather than deciding that a familiar project label makes review unnecessary.
Describe the actual activities
The review office needs to understand what you will do, why you will do it, who will be involved, and what information you will access. A vague sentence such as “This is only QI” leaves those questions unanswered.
| Review consideration | Information to provide |
|---|---|
| Purpose | The local decision and any broader knowledge-generating aim. |
| Activities | The intervention, assignments or comparisons, assessments, and extra procedures. |
| People and data | Participants, records, identifiers, contact methods, and data access. |
| Risks and protections | Possible burden, privacy concerns, voluntariness, and safeguards. |
| Site and school requirements | The approvals or determinations each organization requires. |
This table is a preparation aid, not a self-scoring test for research status.
A familiar activity can raise different questions
Hypothetical example. A clinic reviews routine referral records to improve its local tracking process. A second proposal adds a new comparison procedure and extra participant assessments to answer a broader question. Both use the words “workflow improvement,” but the review office may need to consider them differently.
Neither the use of a survey nor a small number of participants automatically determines the outcome. Similarly, a finding that an activity is not regulated human subjects research does not remove every obligation concerning privacy, site access, student requirements, or ethical conduct.
Keep the determinations distinct
“Not research,” “not human subjects research,” and “exempt research” are not interchangeable labels. An exemption is not simply an informal way to say that no one needs to review the project. Follow the process your institution authorizes for making and documenting those decisions.
Obtain the required determinations and permissions before beginning the activities they govern, including recruitment and access to identifiable project data. Your faculty committee’s academic approval may not substitute for site authorization or institutional review, and the reverse is also true.
Your next decision
Prepare a brief activity summary and contact the designated institutional office, such as the human research protection program or IRB office, together with your site contact. Ask what determination is needed and retain it. When the intervention, data, or recruitment plan changes, ask whether an amendment or new review is required.
Scope note. This page provides educational orientation, not a regulatory determination. OHRP’s QI FAQ notes that it predates the revised Common Rule; current institutional procedures and applicable requirements control your project. [1]
Sources
[1] Office for Human Research Protections. (n.d.). Quality improvement activities FAQs.