Research and quality improvement activities: when is institutional review board review needed?
Role of the IRB
An IRB, also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review research involving humans with the aim to protect the safety, rights, and welfare of the research subjects (Amdur & Bankert, 2002). In the United States, the Food and Drag Administration and Department of Health and Human Services (DHHS) regulations have empowered IRBs to approve, require modifications, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
The history of human subjects research is filled with examples of what happens when investigators fail to respect the rights of subjects. Even after the Nuremberg trials exposed the Nazi war crimes and the Nuremberg Code provided a clear statement of standards for research on human subjects, unethical research programs continued to be designed and conducted. In the United States, the Willowbrook study of hepatitis transmission in a hospital for children with mental impairment and the Tuskegee syphilis study are only two of the many infamous examples of unethical research designed and conducted long after the institution of the Nuremberg Code. In each of these studies, investigators were confident that the ends of research justified the means (Moon & KhinMaung-Gyi, 2009).
Institutional review boards ensure that human subject research is carried out in an ethical manner. The Nuremberg Code, the Declaration of Helsinki (World Medical Association, 2000), and the Belmont Report (Department of Health, Education, and Welfare, 1979) represent the evolving acceptance of ethical principles in research worldwide. These documents provide the basis for voluntary informed consent, prior and ongoing approval of research by independent ethical review committees, and the basic principles in any research activity: respect for persons (the recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy), beneficence (the obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm), and justice (fairness in the distribution of research benefits and burdens).
In the United States, regulations protecting human subjects first became effective in 1974 by the Department of Health, Education, and Welfare (later named the Department of Health and Human Services). These regulations are enforced by the Office for Human Research Protections (OHRP) and establish the IRB as one mechanism through which human subjects are protected. Specifically, DHHS regulations at 45 CFR Part 46, Subpart A (DHHS, 2005) constitute the Federal Policy (Common Rule) for the protection of human subjects. Other federal agencies, such as the Food and Drug Administration, have incorporated DHHS research regulations and expanded them to codify informed consent and research involving medications and devices. IRBs are then responsible for creating policies and procedures that ensure that research activities are compliant with these federal regulations.
What Constitutes Research Activities?
Research is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (DHHS, 2005). Ultimately, there are two key components to research: (a) The project involves a systematic investigation, and (b) the design of the project (i.e., the goal, purpose, or intent) is to develop or contribute to generalizable knowledge. If an activity has only one of these properties, the activity is not considered research (DHHS, 2005).
The term systematic investigation refers to the fact that research activities are carefully designed to limit sources of error and to control for extraneous or confounding variables, thus increasing internal validity (Polit & Beck, 2008). Research activities are based on specific study aims, a structured study protocol, standardized and valid tools for data collection, and predetermined sample sizes for statistical analyses. Statistical analysis of research data is structured around these study aims and allows the investigator to explore relationships among study variables to identify correlations and often infer causation (Polit & Beck, 2008).
The purpose of research activities is to create and disseminate new knowledge about a phenomenon (i.e., a disease process, treatments, and characteristics of those with the disease) (Beyea & Nicoll, 1998; Reinhardt & Ray, 2003). This purpose guides the study aims and design because researchers design projects based on a thorough review of the literature, identifying gaps in knowledge about the phenomenon. The research study aims then address these knowledge gaps and contribute to what is known through dissemination of the findings. In the beginning design of any research project, there is the plan to share study findings with a wider audience once the project is complete.
After establishing if a project is research, the next step is to determine whether the project involves "human subjects." A human subject means a living individual about whom the investigator obtains (a) data through intervention or interaction with the individual or (b) identifiable private information. Human subject research always requires IRB review and approval. The OHRP has a decision chart available online which can be used when making these determinations (DHHS, OHRP, 2004).
What Constitutes QI Activities?
Quality improvement activities are defined as an activity "specifically initiated with the goal of improving the performance of institutional practice in relationship to an established standard" (Amdur & Bankert, 2002, p. 102). The purpose of QI activities is to improve internal organizational processes, and there is no intent at the onset of the project to disseminate findings outside the institution. Because of this, the design of QI projects is typically not as rigorous as research designs, and because concerns about internal validity are not addressed, there is no control for confounding variables, and there is no randomization of subjects or strict sampling criteria (Kring, 2008). QI projects do not introduce novel therapies or interventions but rather integrate interventions based on best practice recommendations and gather data to determine if they improve internal outcomes or processes. As a result, patient identifying information is not usually gathered; rather, data are recorded and presented in aggregate form. Inferential statistics to infer correlations and causations are not conducted with QI data. Instead, findings are only disseminated internally as a means for evaluating care processes and outcomes.
With a move toward quality care, improved patient outcomes, and benchmark reporting, there are more publications in scholarly journals that report the findings of QI projects, which raises the question of dissemination of findings. Occasionally, findings from a QI project may be profound and worthy of disseminating to a larger audience outside of the institution. If this is the case, certain criteria should be used when disseminating the information (Davidoff & Batalden, 2005). Specifically, the article title and purpose should clearly indicate that the publication is a QI article, not research. In the article, the QI processes, setting, and type of aggregate analyses should be described. In addition, limitations should include the lack of generalizability of the reported findings (Davidoff & Batalen, 2005). Many institutions may also require approval by either a privacy or risk management committee or retrospective IRB review prior to publishing hospital data that were originally gathered solely for internal use. However, it should be noted that the initial intent when designing a QI project should not be to disseminate the information to a larger audience. If this is the case, then the purpose is no longer to improve internal processes but rather to contribute to generalizable knowledge and thus should be treated as a research activity.
When Does the IRB Need to Be Involved?
Although definitions of research and QI activities aid in differentiating between the two activities, it is inevitable that questions remain, particularly as QI activities evolve and become more complex. Several checklists and tables have been devised to help determine if a project is research or QI (Beyea & Nicoll, 1998; Johnson, Vermeulen, & Smith, 2006; Newhouse, Pettit, Poe, & Rocco, 2006; Reinhardt & Ray, 2003; Vogelsang, 1999). These checklists essentially center on three key aspects to determine if a project is research or QI: (a) the purpose, (b) the design, and (c) generalizability. Listed below are questions related to these three points that the investigator should ask at the onset of any project.
1. Is the purpose of the project to gain more information or fill a knowledge gap about a specific phenomenon, group of patients, or disease process or treatment?
1. Does your project involve the evaluation of a specific drug or device?
2. Does your project involve the use or acquisition of protected health information, including patient name, date of birth, or medical record numbers?
3. If your project evaluates a change in nursing practice or care process, will this change be applied to some patients and not others?
4. Does your project involve comparisons of one or more interventions that are given to some patients and not others?
5. Are you delivering an intervention that is less than the standard of care?
6. Does the project impose risks or burdens that are beyond standard practice?
1. Do you intend to disseminate information from your project at a conference or in a publication?
A "yes" answer to any of the above questions indicates that the project likely involves research activities and should undergo review by the IRB. Many institutions have a system or policy in place to determine if a project is research or QI, and many of these policies include review by a quality committee either in isolation or in conjunction with the institutional IRB (Johnson et al., 2006). Additional circumstances which may warrant IRB review include if the project involves greater-than-minimal risk, if a new intervention is introduced and is not part of usual care or best practice, and if outcomes are not viewed as having any potential benefit to patients (Lo & Groman, 2003).
Clearly differentiating between research and QI activities is not an easy task, but there are resources in the literature and within individual institutions to help determine when review by an IRB is necessary. Both research and QI activities are important to ensuring that the highest quality of care is delivered to patients. It is equally important that nurses are involved in these activities because they have a unique perspective on patient care and hospital processes and are best positioned to lead activities aimed at improving patient outcomes. Therefore, nurses must be knowledgeable about when IRB review may be necessary in order to protect the rights and safety of patients and remain in compliance with federal regulations. The goal of the institutional IRB is to protect these same patients who may be involved in research activities. As such, the IRB is a valuable resource to all investigators and should be consulted if there is ever a question about whether or not a project involves research activities. Additional resources on the differences between QI and research activities are provided by DHHS on the OHRP website (DHHS, OHRP, 2009).
Amdur, E. A., & Bankert, R. J. (2002). Institutional review board: Management and function. Boston: Jones & Bartlett.
American Nurses Credentialing Center. (2005). Magnet recognition. Silver Spring, MD: Author.
Beyea, S. C., & Nicoll, L. H. (1998). Is it research or quality improvement? AORN Journal, 68(1), 117-119.
Davidoff, F., & Batalden, R (2005). Toward stronger evidence on quality improvement. Draft publication guidelines: The beginning of a consensus project. Quality and Safety in Health Care, 14, 319-325.
Department of Health and Human Services. (2005). Code of federal regulations. Title 45A, part 46: Protection of human subjects'. Retrieved July 3, 2009, from http://www. hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Department of Health and Human Services, Office for Human Research Protections. (2004). Human subject regulations decision charts. Retrieved July 3, 2009, from http://www. hhs.gov/ohrp/humansubjects/guidance/decisioncharts. htm#c1
Department of Health and Human Services, Office for Human Research Protections. (2009). OHRP quality improvement activities frequently asked questions. Retrieved July 3, 2009, from http://www.hhs.gov/ohrp/qualityfaq.html
Department of Health, Education, and Welfare. (1979). The Belmont report. Retrieved July 3, 2009, from http://www. hhs.gov/ohrp/humansubjects/guidance/belmont.htm
Johnson, N., Vermeulen, L., & Smith, K. M. (2006). A survey of academic medical centers to distinguish between quality improvement and research activities. Quality Management in Health Care, 15(4), 215-220.
Kring, D. L. (2008). Research and quality improvement: Different processes, different evidence. MedSurg Nursing, 17(3), 162-169.
Lo, B., & Groman, M. (2003). Oversight of quality improvement: Focusing on benefits and risks. Archives of Internal Medicine, 163(12), 1481-1486.
Moon, M. R., & Khin-Maung-Gyi. (2009). The history and role of institutional review boards. Virtual Mentor, 11(4), 311-321.
Newhouse, R. E, Pettit, J. C., Poe, S., & Rocco, L. (2006). The slippery slope: Differentiating between quality improvement and research. Journal of Nursing Administration, 36(4), 211-219.
Polit, D. F., & Beck, C. T. (2008). Nursing research: Generating and assessing evidence for nursing practice (8th ed.). Philadelphia: Lippincott Williams & Wilkins.
Reinhardt, A. C., & Ray, L. N. (2003). Differentiating quality improvement from research. Applied Nursing Research, 16(1), 2-8.
Vogelsang, J. (1999). Quantitative research versus quality assurance, quality improvement, total quality management, and continuous quality improvement. Journal of Perianesthesia Nursing, 14(2), 87-81.
World Medical Association. (2000). Declaration of Helsinki: Recommendations guiding medical doctors in biomedical research involving human subjects. Retrieved July 3, 2009, from http://www.wma.net/e/policy/pdf/17c.pdf
Questions or comments about this article may be directed to Molly McNett, PhD RN, at email@example.com. She is a senior nurse researcher and member of the institutional review board at the MetroHealth Medical Center, Cleveland, OH.
Kathleen Lawry, MSSA CIP CIM, is an institutional review board manager and an assistant director, Research Administration-Compliance, MetroHealth Medical Center, Cleveland, OH.
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|Title Annotation:||Ethicolegal Perspectives|
|Author:||McNett, Molly; Lawry, Kathleen|
|Publication:||Journal of Neuroscience Nursing|
|Date:||Dec 1, 2009|
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