QA, QI, and Human Subjects Research
The following sections provide regulatory definitions as well as OSU-specific definitions and policies to consider when determining whether your Quality Improvement or Quality Assessment project involves regulated human subjects research (in other words, research that requires an exempt application or IRB application at Ohio State).
In addition, the federal Office of Human Research Protections provides a decision chart. In light of the responsibility to protect human subjects and the potential regulatory consequences of not obtaining proper review, investigators should err on the side of caution and consult with the Office of Responsible Research Practices (ORRP) when uncertain whether a study constitutes human subjects research requiring review.
Is it Regulated Research?
DHHS regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)).
Does it Involve Human Subjects?
A human subject is defined by DHHS regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information” (45 CFR 46.102(f)(1)(2)).
- Living individual refers to data/specimen(s)/information collected from or about living subjects. Cadavers, autopsy specimens, or information about deceased individuals are not human subjects.
- Intervention includes physical procedures, manipulations of the subject or the subject’s environment for research purposes.
- Interaction refers to communication between the investigator and the subject. This includes face-to-face, mail, and phone interactions, as well as other modes of communication.
- Systematic Investigation: A planned scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or answer a question.
- Generalizable Knowledge: Information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.
- Individually identifiable means the identity of the subject is or may be readily ascertained by the investigator or the investigator’s staff, or is associated with the information.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Examples of private information include medical or academic records or personal journals.
Additional information and examples can be found in the HRPP policy, Research Involving Human Subjects.
Please note that FDA definitions and requirements can vary—contact ORRP for guidance if you suspect FDA regulations may apply to your project.
Does my QA/QI project constitute human subjects research requiring review?
- QA/QI 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.
- 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.
Does the intent to publish make my quality improvement project fit the regulatory definition of research?
No. The intent to publish does not necessarily dictate whether a quality improvement activity involves research—the project must meet the definition of research involving human subjects.
From OHRP guidance:
Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results (http://answers.hhs.gov/ohrp/questions/7286).
Examples of activities that normally fall into one category or the other:
|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 (nothing new or novel) recently instituted at OSU as standard practice in order 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.||
|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.||
How do I get a written determination about the review requirements necessary for my research?
If an investigator is unsure of their project’s review requirements, the PI should request a determination from ORRP; investigators will be instructed to provide sufficient materials to allow a determination to be made (generally a copy of the research protocol, and any participant materials developed). ORRP staff will make one of three determinations and will notify the PI as follows:
- The proposed activity is not regulated research involving human subjects and may be conducted without further IRB review or exemption; or
- The proposed activity is regulated research involving human subjects and meets the criteria for Exempt from IRB review; or
- The proposed activity is research involving human subjects and requires IRB review.
Upon receipt of complete information, determinations regarding review requirements are usually made within five business days. Projects determined to be regulated 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).
- HRPP Policies
- Office Hours & Education/help sessions
- CITI – All Ohio State investigators and key personnel must fulfill the University’s requirement for education in human subjects protection by taking the web-based course licensed by the Collaborative IRB Training Initiative.
- COI – Investigators & key personnel are also required to meet additional compliance requirements, including conflict of interest (COI) requirements.
Quality Improvement Specialist | Regulatory & Exempt Determinations
614.688.0389 | firstname.lastname@example.org
Quality Improvement Specialist | Exempt and IRB Review
614.688.0389 | email@example.com