Ochsner J. 2020 Spring; 20(1): 56–61. Background: Before undertaking a research project, investigators must determine if the planned activity is human subjects research or a quality improvement project because specific regulations govern the conduct of human subjects research. Making this determination, however, can
be confusing because human subjects research and quality improvement projects share similar characteristics. Methods: The definitions, questions, and examples provided in this article will help investigators decide between quality improvement projects and human subjects research or determine when to seek regulatory guidance. Results: While quality improvement and human subjects research are both rigorous processes and at times
involve similar methods, the two types of studies have distinctly different overall aims. Quality improvement projects use data-driven methods to improve health delivery and quality. Such projects examine changes in human behavior and are largely experiential learning processes. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. Conclusion: In most instances, the goals of human subjects research and quality
improvement projects do not intersect, and quality improvement projects are generally not subject to US Department of Health and Human Services (HHS) regulatory protections. However, some projects are both quality improvement and human subjects research, and sometimes, a quality improvement project develops into a human subjects research project. Investigators must be aware of the criteria defining human subjects research to ensure that HHS regulations for the protection of human subjects are
applied when necessary. Keywords: Quality improvement, quality of healthcare, research subjects Improving the quality of care is intrinsic to the daily activities of any good practitioner of medicine. Imagine the following primary care practice scenarios: You want to reduce vaccination errors. You decide to implement a no-interruption process
during vaccination preparation and administration. You notice that diabetic patients on a certain combination treatment plan develop arthritis more commonly than patients receiving an alternative therapy. After finding little information about this scenario in the medical literature, you decide to test a specific exercise regimen to determine if it decreases arthritis symptoms in these patients. In both instances, you want to share the results of your
project locally and at a regional professional meeting. Are these activities quality improvement or human subjects research? The investigator must determine the appropriate classification for a project because specific protection regulations apply to human subjects research.1 Making this determination, however, can be confusing because human subjects research and quality improvement
projects share similar characteristics.2 They both ask clinically important questions use patient and hospital data involve analysis of data collected as part of a project may involve direct interactions with patients seek to improve patient care or experience for patients and providers While
quality improvement and human subjects research are both rigorous processes and at times involve similar methods, quality improvement and human subjects research have distinctly different overall aims. Quality improvement projects use data-driven methods to improve health delivery and quality. These projects examine changes in human behavior and are largely experiential learning processes. Research is a systematic investigation designed to develop or contribute to generalizable knowledge. The following questions can help an investigator determine if a particular activity is human subjects research and therefore subject to human subjects protection regulations3: Does the activity involve research according to definitions outlined in the Code of Federal Regulations at 45 CFR §46.102(d)? Are human subjects involved as defined in 45 CFR §46.102(f)? Does the research qualify for an exemption under 45 CFR §46.101(b)? Is the project nonexempt human subjects research supported by the US Department of Health and Human Services (HHS) or otherwise covered by an institution's Federalwide Assurance (the required federal documentation of an institution's commitment to comply with federal regulations and maintain policies and procedures for the protection of human participants)? If an investigator can clearly answer yes to the preceding questions, the project is most likely subject to the human subjects research regulations of HHS. However, most quality improvement activities will not meet these criteria, and the information in this article will help the investigator decide between quality improvement projects and human subjects research or determine when to seek regulatory guidance. HUMAN SUBJECTS RESEARCH DEFINEDWhether a project involves human subjects should be the first question a researcher asks. A human subject is defined in 45 CFR §46.102 as a “living individual about whom an investigator, whether professional or student, conducting research:
Research is defined by federal regulations in 45 CFR §46.102 as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”1 Research projects involving human subjects require review by an institutional review board (IRB). Medical research is generally designed to test a hypothesis and follows a formal protocol. A research project has at least one objective, and the investigator outlines a set of procedures that are strictly followed to achieve that objective. The researcher is often seeking to generalize findings to a specific population beyond the specific patients or institution where the research is performed. The researcher is bound by regulatory policies and must obtain informed consent from participants or a waiver of consent from the IRB. QUALITY IMPROVEMENT DEFINEDQuality improvement, also sometimes referred to as quality assurance, is also systematic, but the goal is to improve care, processes, or outcomes in an organization. A straightforward definition of quality improvement is “a systematic, data-guided activity designed to bring about immediate improvement in a local setting.”4 Quality improvement is not defined in the Federal Policy for the Protection of Human Subjects—the Common Rule—but the Centers for Medicare and Medicaid Services (CMS) defines quality improvement in 42 CFR §480.101 as “an assessment, conducted by or for a quality improvement organization, of a patient care problem for the purpose of improving patient care through peer analysis, intervention, resolution of the problem and follow-up.”5 CMS further elaborates in 42 CFR §476.1: “Quality improvement initiative means any formal activity designed to serve as a catalyst and support for quality improvement that uses proven methodologies to achieve these improvements. The improvements may relate to safety, health care, health and value and involve providers, practitioners, beneficiaries, and/or communities.”5 Quality improvement projects commonly involve the implementation and testing of new processes using the Plan-Do-Study-Act (PDSA) process. As the PDSA cycle is repeated, changes are made to continue to improve the outcome. DISTINGUISHING BETWEEN HUMAN SUBJECTS RESEARCH AND QUALITY IMPROVEMENT PROJECTSWhile identifying a quality improvement project may be straightforward, determining if a project is both quality improvement and human subjects research is more challenging. The Table lists common descriptions and characteristics that may help with this determination.4–7 Table.Comparison of Human Subjects Research and Quality Improvement Projects4–7
At a basic level, research is about the discovery of new information, while quality improvement primarily emphasizes the application of known knowledge.7 One of the principal distinguishing differences between quality improvement and human subjects research is exposure to risk. With the exception of loss of privacy and confidentiality, quality improvement projects should not expose patients to more than minimal risk. The assumption is that quality improvement activities are at least as safe as routine care.2 On the other hand, risk to human subjects is approved by the IRB and outlined in the informed consent document, giving potential research participants the opportunity to decide if they wish to enroll in the study or not. IRB review demonstrates to the medical community that the project is thoughtful and well designed, the risks are reasonable in relation to the anticipated benefits, and the knowledge expected to result from the study is important.2 Some research projects may qualify for an IRB exemption, some projects definitely require full IRB review, and some projects may not meet the criteria for human subjects research. Projects That May Qualify for Institutional Review Board ExemptionOnly the IRB is allowed to decide if a project is exempt. If a project is exempt, certain federal regulations such as annual continuing review and IRB notification of study closure do not apply. Examples of exempt human subjects research are projects that use or focus on the following:
In the healthcare setting, examples of human subjects research projects that require IRB review but may qualify for an exemption include the following:
Projects That Are Human Subjects ResearchProjects that do not meet one of the exemption criteria are human subjects research and require IRB review. Examples include the following:
Projects That Are Not Human Subjects ResearchExamples of studies that are not human subjects research and may not require IRB review include the following8:
As noted previously, quality improvement projects are generally not considered human subjects research unless the intent to contribute to generalizable knowledge is clear. Examples of quality improvement projects and activities that are not likely to meet the definition of human subjects research include the following:
PROJECTS THAT ARE BOTH QUALITY IMPROVEMENT AND HUMAN SUBJECTS RESEARCHProjects can sometimes both be quality improvement and human subjects research. Examples include the following4,6:
PROJECTS THAT BEGIN AS QUALITY IMPROVEMENT BUT BECOME HUMAN SUBJECTS RESEARCHWhen an investigator designs a quality improvement project with the idea that the activity is also human subjects research, the investigator should submit a protocol for IRB review before initiating the project. However, an investigator may realize after initiating or completing a quality improvement project that further study would make the results generalizable. Cases such as this generally require submission to the IRB for a secondary use of data. Examples include the following:
QUESTIONS TO HELP WITH THE DECISIONBy applying the following questions, investigators can assess if a project is human subjects research, a quality improvement project, or both4,6,9:
Chapter 9, Ethical, Legal, and Regulatory Framework for Human Subjects Research, in the book Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century10 and the article “Quantitative Research Versus Quality Assurance, Quality Improvement, Total Quality Management, and Continuous Quality Improvement”11 provide additional information about human subjects research and quality improvement. CONCLUSIONCircling back to the two scenarios provided at the beginning of this article, the reader has likely determined that the immunization project is a quality improvement project and the study to determine if exercise reduces arthritis symptoms is human subjects research even though both projects seek to improve care. By applying the concepts and questions provided in this article, teams should be able to determine if their project is human subjects research, a quality improvement project, or both. ACKNOWLEDGMENTSThe authors have no financial or proprietary interest in the subject matter of this article. This article meets the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties Maintenance of Certification competencies for Patient Care, Medical Knowledge, and Systems-Based Practice. REFERENCES2. Morris PE, Dracup K.. Quality improvement or research? The ethics of hospital project oversight. Am J Crit Care. 2007. September;16(5):424-426. [PubMed] [Google Scholar] 4. Lynn J, Baily MA, Bottrell M, et al.. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007. May 1;146(9):666-673. doi: 10.7326/0003-4819-146-9-200705010-00155. [PubMed] [CrossRef] [Google Scholar] 6. Baily MA, Bottrell M, Lynn J, Jennings B Hastings Center The ethics of using quality improvement methods to improve health care quality and safety. Hastings Cent Rep. 2006. Jul-Aug;36(4):S1-S40. doi: 10.1353/hcr.2006.0054. [PubMed] [CrossRef] [Google Scholar] 7. Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface between research and quality improvement. Ann Fam Med. 2005. May-Jun;3 Suppl 1:S12-S20. doi: 10.1370/afm.303. [PMC free article] [PubMed] [CrossRef] [Google Scholar] 9. Grady C. Quality improvement and ethical oversight. Ann Intern Med. 2007. May 1;146(9):680-681. doi: 10.7326/0003-4819-146-9-200705010-00156. [PubMed] [CrossRef] [Google Scholar] 11. Vogelsang J. Quantitative research versus quality assurance, quality improvement, total quality management, and continuous quality improvement. J Perianesth Nurs. 1999. April;14(2):78-81. doi: 10.1016/s1089-9472(99)80021-5. [PubMed] [CrossRef] [Google Scholar] Articles from The Ochsner Journal are provided here courtesy of Ochsner Clinic Foundation What is considered research by IRB?Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A project requires IRB review if it includes both research and human subjects.
What studies must be reviewed by an IRB?The Regulations
IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
What things is the IRB looking for in a research proposal?IRB Proposal Creation Guidelines. Purpose of investigation and procedures.. Anticipated risk and potential benefits to participants.. Steps taken to protect the participants.. Manner of obtaining participants.. What does IRB look at?The IRB reviews the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects. The IRB has the authority to approve, disapprove or require modifications of these projects.
|