Research vs. Quality Assurance/Improvement

Federal regulations require human subject research to be reviewed and approved by the Institutional Review Board (IRB), while strictly Quality Assurance/Quality Improvement (QA/QI) activities do not require IRB oversight. However, some QA/QI activities may also be research and therefore need IRB approval. Review the following guidance and use the Office of Human Research Protections (OHRP) decision tool to determine whether an activity meets the criteria for human subjects research (HSR) or a QA/QI initiative BEFORE the activity is initiated.

Definitions

• Research is a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)).
• Human Subject is a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(f)(1)(2)).

Generally, activities that are designed solely for internal purposes, with no external application or generalization, usually do not constitute human subject research and usually do not require IRB review or exemption. 

Examples:

• A project limited to implementing a practice to improve the internal quality of a program or offering and collecting data regarding the implementation of the practice for internal programmatic or administrative purposes.
• A project limited to implementing a practice to improve the quality of patient care and collecting patient or provider data regarding the implementation of the practice for clinical or administrative purposes.
• The goal of the project is to improve outcomes, a program, or service at the local site with no intention of creating generalizable knowledge.
• A project involving the collection of data to assess a process, program, or system as judged/measured by established/accepted standards for internal or administrative purposes.
• A project involving the collection of data on a standard, established, and validated program (not new or novel) recently instituted at Ohio State as standard practice to share institution-specific, factual outcomes data with internal administration and perhaps at a regional best practices conference. No intent to generalize findings, to draw generalizable conclusions, or to answer a hypothesis.

QA/QI activities constitute human subject research and require IRB review or exemption when they are also designed or intended to develop or contribute to generalizable knowledge.

Examples:

• A project designed to test a hypothesis or to establish practice standards where no standards are already accepted.
• A project involving the introduction of a new, untested intervention for the purposes of not only improving internal quality, but also collecting information about outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results.
• One of the main goals of the project is to advance general knowledge in the academic, scientific, or professional community.
• The project will be conducted using a design that will lead to scientifically valid findings (e.g., control group, randomization, sample design, etc.).
• The project involves the manipulation or implementation of activities that may be considered other than standard of care or standard practice.

Projects conducted by Ohio State faculty or staff as part of a work-for-hire contract do not require human subjects review if ALL the following conditions are true: 

• The project is directed/required by the sponsor/organization/company for internal reporting/quality purposes and is not designed for research purposes (i.e., it is not “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”). 
• The work is performed under a contract without the mention of human subjects research or using the data for future research purposes. 
• The sponsors/funders and collaborators do not consider the project to be human subjects research requiring IRB review. 
• Ohio State personnel do not have control over any other/future data uses (all data and internal reports reside with the hiring entity).

Given the duty to safeguard human subjects and the potential regulatory repercussions for failing to secure appropriate review, it is advisable for investigators to exercise caution and seek guidance from the Office of Responsible Research Practices (ORRP) when unsure whether a study qualifies as human subjects research necessitating review. If an investigator is unsure, email ORRPDeterminations@osu.edu to request a determination. In the request, provide the research protocol and relevant participant materials for a determination to be made. Within five business days, ORRP will notify the investigator with one of the following determinations:

1. the proposed activity is not regulated research involving human subjects and may be conducted without further IRB review or exemption; or
2. the proposed activity is regulated research involving human subjects and meets the criteria for exempt review; or
3. the proposed activity is research involving human subjects and requires IRB review.

Projects determined to be research involving human subjects require application submissions and documentation of IRB approval or exemption before any research activities can begin (including advertising, recruitment, data access, and pilot studies).