Research is subject to the HRPP when it includes activities that are research involving human subjects as defined by either DHHS or FDA regulations. WMed becomes “engaged” in human subjects research, and therefore bears responsibility for protecting participants involved in the research, when its employees or agents intervene or interact with living individuals or obtain individually identifiable private information for research purposes. The university is also engaged in human subjects research whenever it receives a direct DHHS award to support the research. For more information, see the WMed HRPP and IRB Handbook.
- What is “Human Subjects Research”?
To determine whether an activity is research and whether that research involves human subjects, one must consider the regulatory definitions of “research” and “human subject.
The Common Rule defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” (45 CFR 46.102(d)).
The FDA uses the term “clinical investigation” instead of research and defines it is as “any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit” (21 CFR 50.3(c)).
A human subject as defined by the Common Rule is “a living individual about whom an investigator… conducting research obtains (1) data through intervention or interaction with the individual or (2) through identifiable private information” (45 CFR 46.102(f)).
Note: Human subjects may or may not be patients; for example, if your activity includes intervening with or gathering information about providers, the providers may be subjects. Similarly, in educational research sometimes both students and faculty would be considered subjects using these definitions.
Intervention means “both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.”
Interaction means “communication or interpersonal contact between investigator and subject.”
Note: Gathering data via questionnaires, surveys, diaries, etc. is considered interaction.
Private information means “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).”
Individually identifiable information is information for which “the identity of the subject is or may readily be ascertained by the investigator or associated with the information.”
For research covered by FDA regulations, “human subject means an individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A subject may be in normal health or may have a medical condition or disease” (21 CFR 50.3(g)). In the case of a medical device, a human subject also includes any individual whose tissue specimen an investigational device is used or tested (21 CFR 812.3(p)).
Research involving human subjects must be reviewed and approved by the IRB, or determined to qualify for exempt status by the IRB Chair or designee, before it can begin.
- What is “Quality Assurance” and “Quality Improvement”?
There are no regulatory definitions of quality assurance and quality improvement, but generally quality assurance can be described as a comparison of performance or outcomes against a standard. In addition, quality improvement can be described as systematic, data-guided activities to bring about prompt positive changes in the delivery of health care and involve deliberate actions to improve care. Depending on the activity, QA/QI can look like practical problem solving, an evidence-based management style or the application of a theory-driven science of how to bring about system change.
- What are some examples of QA/QI?
Implementation of an evidence-based standard to achieve a:
- Reduction of morbidity and mortality
- Reduction in in-patient admissions and length of stay
- Reduction in ER visits
- Improvement of overall quality of life
- What are some differences between QA/QI and human subjects research?
RESEARCH QA/QI Purpose Test a hypothesis, establish standards where none are accepted, or advance knowledge in an academic, scientific, or professional community. To assess or improve a program or system (e.g., care delivery); compare or improve performance to accepted standards Benefit Designed to contribute to generalizable knowledge and may or may not benefit subjects. Most patients are expected to benefit from the quality improvement initiative. Risk May impose risk or burden on subjects. By design, does not increase patients' risk, with exception of possible privacy/confidentiality concerns. Design Testing/Analysis Leads to scientifically valid findings (control groups, random subject selection, statistical tests) Established quality assurance or quality improvement methods (e.g., PDSA design cycle) aimed at evaluating performance or producing change; does not typically include sufficient research design elements to support scientifically valid findings.
- When does QA/QI require IRB review?
While many QA/QI initiatives, program evaluations, and healthcare innovations do not meet the regulatory definition of human subjects research under the Common Rule or FDA and do not require WMed IRB review, some projects may.
Because the line between quality and research can easily be blurred, an evaluation should be made on a case-by-case basis for each project using the regulations and guidance provided below. When a person engaging in an activity is unsure whether a project requires IRB review, is using coded private information or specimens, or is seeking a formal determination, they should submit to the IRB Office for a determination. Human Subject Research is governed by regulations and requires IRB review or determination of exemption by the IRB.
When the QA/QI activity is designed to accomplish a research purpose as well as the purpose of assessing or improving the quality of care or evaluating the success or value of a program or system, IRB review is required.
In addition, when QI initiatives lack a sufficient evidence base, you are engaging in the development of evidence and conducting research. The only time these activities may not be research is when the results are dependent on a set of characteristics unique to the organization or unit and the results are unlikely reproducible in another setting (i.e., not generalizable).
- When does healthcare innovation require IRB review?
The Belmont Report (Section A. Boundaries Between Practice and Research) provides the following guidance to help distinguish between practice and research:
“For the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. By contrast, the term "research' designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).”
Because research and medical practice often go hand-in-hand, it can be difficult to identify when innovation is or should be research. Generally, “[a] practitioner should move an innovation practice into formal research if the innovation represents a significant departure from standard practice, if the innovation carries unknown or potentially significant risks, or if the practitioner’s goal is to use data from the innovation to produce generalizable knowledge.”
- When do educational activities or assessments require IRB review?
Educational activities or assessments undertaken as part of the normal education or training process for practitioners, staff, or trainees, will ordinarily not require IRB review. However, if the intent is to compare the effectiveness of educational practices, or to collect data to support the development of new or refined practices, the activities are likely to meet the definition of human subjects research and IRB review may be required. In such cases, you should confer with the IRB Office for a determination.
- What if I intend to publish or present my results?
The intent to publish is an insufficient criterion for determining whether a QA/QI activity involves research. When QA/QI is published or presented, the intent is usually to discuss potentially effective models, strategies, assessment tools or to provide benchmarks, rather than to establish scientific evidence or otherwise develop or contribute to ‘generalizable’ knowledge. Conversely, an activity may involve research even if there is no intent to publish the results (e.g., the data may be used to develop or inform research).
- What if I am receiving funding for my project?
Funding may make a difference in distinguishing between QA/QI and research. For example, when the grant type is for research, the grant application describes the activity as research, or the activity is described as research in a notice of award, terms of a grant, or in a contract, it is unlikely that WMed could issue a determination that an activity is not research.
- What if I need to access PHI?
Use of PHI for QA/QI is permissible under HIPAA as health care operations thus there is no requirement to obtain HIPAA authorization or a waiver of authorization for such uses. However, if the quality activity is also research, then authorization or a waiver is required.
- What if I don’t know if my project requires IRB review?
WMed IRB Policies and Procedures state, “Because investigators are held responsible if the determination is not correct, investigators are urged to request confirmation that an activity does not constitute human subject research from the HRPP.”
A request for a Human Subjects Research (HSR) Determination should be made prior to beginning the activity or research. The IRB Office will provide a letter documenting the outcome of the determination. If it is determined that your project does not require IRB review, the determination letter can be provided to publications or for a conference presentation, if such documentation is requested.
- How do I submit for a Human Subjects Research Determination?
HSR Determinations should be submitted to the IRB Office. “The request may be made by email or in writing. All requests must include sufficient description of the activity and the rationale for the investigator’s initial determination.”
Determinations whether an activity constitutes human subject research are made according to the definitions in Section 1.3 using the Human Subject Research Determination Checklist. Determinations are made by the IRB chair or vice chair, who may refer the determination request to the convened IRB.”
A project summary should be included if you feel additional information may be helpful in the reviewer’s assessment. Please note that CITI training and a Conflict of Interest review are not required for HSR Determinations, and no review fee applies.