Research vs. QI/QA activities – Do I need IRB approval?
As an academic institution, ETSU and its affiliated clinical partners are required to continually evaluate and improve our clinical care, training activities, and organizational operations through activities such as needs assessments, quality assurance, and quality improvement projects. The ETSU IRB recognizes that it can be challenging to determine if an activity is Human Subjects Research (HSR) or Quality Improvement (QI). ETSU IRB policy, consistent with federal regulations, requires IRB approval prior to initiating any human subject research project, but some QI/QA activities do not qualify as research and do not require IRB approval.
What is Quality Improvement (QI)?
There is no regulatory definition for QI. Generally, QI/QA activities are designed to continuously evaluate and improve performance in a clinical or operational area using best practices or evidence-based approaches. Quality Improvement can be defined as systematic, data-guided activities, designed to bring about immediate improvements in particular settings, processes, or practices. Initiators of QI projects identify promising improvements, implement small scale changes, monitor results, and decide about additional changes and wider implementation. Quality improvement is a core function of good clinical care and organization operations.
Examples of QI that are likely not HSR:
- Implementing a practice to improve the quality of patient care or customer service provided
- Teaching evaluations or customer satisfaction surveys
- Measuring and reporting performance data for clinical, practical, or administrative uses such as annual reports and accreditation processes
- Measuring or evaluating the effectiveness of a specific program in meeting the intended goals of the program
What is Human Subject Research (HSR)?
ETSU defines human subject and research using the DHHS definitions published in the Common Rule. First, you must determine if the activity qualifies as research. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A systematic investigation generally means use of the scientific method to follow a protocol, or predetermined method of investigation, to test a hypothesis, theory, or research question.
If an activity is considered research according to the definition above, then you
must determine if it involves human subjects. A human subject is a living individual about whom an investigator (whether a profession or student/trainee) conducting research (1)
obtains information or biospecimens through intervention or interaction with the individual,
and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses,
studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Interaction not only includes in-person but also includes virtual or remote interactions
such as email correspondence, online surveys, and zoom interviews. Intervention includes
physical procedures such as blood draws or MRI as well as manipulation of the subjects
or their environment for research purposes such as educational presentations, simulations,
or medical procedures.
Examples of QI that are likely also HSR:
- Testing a new intervention to improve patient care in order to establish scientific evidence to support the intervention’s effectiveness
- Developing or validating new quality assessment or measurement tools
- Using identifiable patient data to develop new clinical treatment guidelines
- Implementation of a novel approach that has not been extensively studied
Overlap of QI and Research
QI/QA activities are an important component of organizational operations. Because QI activities are data-driven and may involve human participants, it can overlap with methodologies common to research. If an activity is both QI and research, or if an investigator decides to conduct research using QI data, ETSU IRB approval is required prior to initiating the research activities.
What if I want to publish or present the data?The federal agency overseeing human subject research (OHRP) has stated that publication or presentation of QI activities does not change its classification to research. As noted in the table above, dissemination of QI results is not uncommon and can help to provide relevant benchmarks or to suggest effective strategies for others seeking to implement similar evidence-based approaches.
What if my activity is sponsored or funded?The determination about whether an activity is QI and/or research may depend on how the activity is funded. If the QI activities are being conducted as dictated by a protocol supported by a research grant or contract, IRB approval may be required for the funded research activities pursuant to the sponsored agreement.
Are there other considerations?If the activity involves randomization, is not part of usual care, or increases risks to patients or participants, the activity likely will be considered research. If the activity is not based on sufficient existing evidence, and the implementation is meant to test, prove, or establish guidelines in an unproven or untested setting, the activity will likely be considered research. If the activity is supported by evidence and is being adopted locally as clinical practice, it is likely not research and clinical consent/HIPAA would cover those activities.
How do I obtain a determination from the IRB?Unless you are certain that your activity is not human subject research, you should submit to the ETSU IRB for a formal determination. Determinations are made on a case-by-case basis. Please refer to the IRB website here for information about how to obtain a determination. QI projects must be endorsed by the clinic, facility, organization, etc. where it is implemented, so a letter of support is required with all determination requests.