Research, Quality Improvement, and Institutional Review Boards: What's The Deal?
Article Outline
Linda J. Scheetz, EdD, RN, FAEN, Monroe, NY
Kathy Oman, RN, PhD, CEN, FAEN, Aurora, Colo
Scenario 2: “I have a great idea! Let's do a survey to find out what emergency nurses think about involving families in our new case management program. We'll write a paper describing our results and submit it to JEN.”
What's wrong with this picture? Well, it depends; maybe nothing, maybe many things. Perhaps you'll recall those discussions in your psychology or research classes about the infamous Tuskegee Syphilis Study, the Nazi experimentation at Nuremberg, the Willowbrook study of hepatitis transmission in mentally retarded children, the Jewish Chronic Disease Hospital's (JCDH) cancer study, or the US military's Cincinnati Project testing radiation dose tolerance in humans. These and other studies conducted throughout the history of modern medicine have resulted in physical or psychologic harm, even death, to participants. So, you ask, “What does this have to do with JEN?”
Fortunately we've learned valuable lessons from the tragedies at Nuremberg, Tuskegee, JCDH, Cincinnati, Willowbrook, and other studies that have exploited humans in the name of research. As JEN's editors, we have the responsibility for assuring our audience that the research we publish adhered to accepted ethical standards for the protection of human subjects. So, what does this mean and how does that impact the way we receive and review manuscripts?
The US Department of Health & Human Services established regulations for conducting research, detailed in Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects (45 CFR 46).1., 2. These regulations evolved from lessons of the past—human experimentation that exploited, maimed, and killed people. The Belmont Report,2 written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research describes ethical principles for the conduct of research on humans. Three ethical principles detailed in the Belmont Report are autonomy, beneficence, and justice. Autonomy is respect for persons, including personal self-determination. This means that all persons who are asked to participate in research have the right to decide if they wish to do so without undue influence or coercion. The second principle, beneficence, means to do no harm. In other words, maximize the benefits of the research, and minimize the risks. Justice, the third principle, implies fairness with regard to the distribution of benefits and risks of the research. In the case of Scenario 1, the nurses AND patients are research participants; the nurses because they will be doing something to influence patient satisfaction, and the patients because they are the recipients of whatever the nurses are doing. As for Scenario 2, sometimes a survey is just a survey! Or, it might be a quality improvement (QI) project or case management research. If it's research, the nurses who are asked to complete the survey are the research participants. In either research scenario, participants' rights must be protected.
To comply with 45 CFR 46 regulations, all staff, patients, families, significant others, and anyone else who is asked to participate in a study (as a research subject) must be informed of the context of the research, the purpose, risks, and benefits of the study so that they can make an informed decision about whether or not they wish to participate. And, they have the right to refuse participation without any repercussions regarding their employment (nurses) or care (patients). The Principal Investigator (PI) who conducts the research must assure that participation is voluntary and free from undue influence or coercion.1
The 45 CFR 46 regulations, including the principles described in the Belmont Report, apply to any research conducted or supported by the government. Many non-governmental organizations, agencies, and private foundations that provide research funding, including the Emergency Nurses Foundation, also require assurance of compliance with the 45 CFR 46 regulations. This assurance is accomplished through Institutional Review Board (IRB) review. Hospital and university IRBs review proposals to conduct research, grant approval for research, and monitor compliance with 45 CFR 46 regulations for studies in progress. Nurses, physicians, and other healthcare researchers are bound by these regulations throughout the duration of the study. The IRB will make determinations regarding the level of review: exempt from full IRB review, meets the requirements for expedited IRB review, or requires full IRB review.1 Most studies that involve more than minimal risk require full review and written informed consent from participants. Certain studies that meet criteria for exemption from full IRB review also may meet criteria for waiving the informed consent requirement.
Is It QI Or Research?
Although there is a distinct difference between QI and research, the boundaries are at times unclear. QI is a clinical and management tool or activity designed to make changes in the delivery of healthcare in a particular setting.3 Research, on the other hand, is a systematic investigation designed to develop or contribute to generalizable knowledge.4 Research contributes to the growing body of evidence that helps us set standards and develop practice protocols.
JEN publishes 1 or 2 research studies in each issue. Recently we have experienced an upsurge in the number of research manuscript submissions and with it, a growing concern about the sometimes fuzzy boundary delineating research and QI activities,4., 5., 6. and more recently, concerns about research ethics. Although both research and QI reports are published in JEN, research reports must conform to the 45 CFR 46 regulations. Research manuscripts must include a statement that IRB approval was granted before conducting the study or that the study was exempted from full IRB review based on specific 45 CFR 46 criteria for exemption. Although most QI projects do not require IRB review, manuscripts reporting these projects should be reviewed by someone in authority in the author's institution before submission to JEN if the hospital will be named and data will be published. Some hospitals require IRB review for any QI project that will provide institutional data that will be published; however, this is not the standard.
Why Does It Take So Long for Manuscript Review?
Once the manuscript is submitted to JEN, the managing editor assigns it to a senior clinical or section editor. This editor is responsible for the peer review process and the final publication decision. Peer review is a crucial characteristic of quality publications and the cornerstone of scholarly work. The blinded manuscript (no author identification) is sent to a panel of 3 reviewers, selected on the basis of their content expertise. The reviewers use a standardized review tool to help them arrive at a recommendation for disposition of the manuscript. Manuscripts may be accepted, returned to the author for revisions, or rejected. Reasons for rejection of research manuscripts include: poor study design or methods, failure to protect human subjects' rights (including the lack of IRB review or approval), duplicate publication, plagiarism, or other reasons that are less obvious. Occasionally the timing just isn't good; we may have just accepted or published a similar manuscript or our reviewers believe that reader interest in this topic would be low. Sometimes manuscripts just don't fit the journal's target audience and the editor may suggest a more appropriate journal for publication. If the manuscript is returned for revisions, the author will receive feedback from the editor with the reviewers' comments, and then must decide if she or he wants to put forth the effort and time required to revise the manuscript. The author works with the editor during this process until the manuscript is accepted for publication or rejected. Recent changes to our online submission process require evidence of IRB approval at the time of submission. Authors must submit a copy of the IRB approval letter along with the manuscript. The review process will not move forward until this letter is received.
In our most recent electronic survey of JEN readers, 87% indicated interest in reading research. We hope this strong interest continues and that our colleagues who are engaged in research continue to submit reports of their studies to us. We will continue to promote high standards for the publication of research findings so that you may consider these findings in your practice. Be assured that studies published in JEN will have had IRB approval or documented exemption, and participants will have granted written informed consent to participate when indicated. Additional information about the 45 CFR 46 regulations and the Belmont Report can be found on the websites listed in the Table.
Table. Websites with additional information about research integrity
| Office for Human Research Protection (OHRP), US Department of Health & Human Services | http://www.hhs.gov/ohrp |
| NIH Office of Human Subjects Research | http://ohsr.od.nih.gov/about/index.html |
| Belmont Report | http://ohsr.od.nih.gov/guidelines/belmont.html |
| Office of Research Integrity (ORI), US Department of Health & Human Services | http://ori.hhs.gov/ |
| Teaching the Responsible Conduct of Research in Humans | http://ori.hhs.gov/education/products/ucla/default.htm |
| Ethical and Regulatory Aspects of Clinical Research | http://www.bioethics.nih.gov/hsrc/index.shtml |
| 45 CFR 46 Regulation | http://www.access.gpo.gov/nara/cfr/waisidx_99/45cfr46_99.html |
| Human Participant Protections Education for Research Teams (free) | http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp |
| HRSA Protecting Human Subjects Training (free) | http://www.hrsa.gov/humansubjects/ |
| Collaborative Institutional Training Initiative (CITI) | http://www.citiprogram.org/ |
References
- . Institutional review board management and function. Sudbury, MA: Jones and Bartlett Publishers; 2002;
- . Office of Human Subjects Research. Bethesda, MD, 2007. Available at: http://ohsr.od.nih.gov/index.htmlAccessed October 7, 2007
- . The ethics of using QI methods to improve healthcare quality and safety. J Nurs Care Qual. 2007;22:97–101
- . The slippery slope: differentiating between quality improvement and research. J Nurs Admin. 2006;36:211–219
- . The ethics of using QI methods to improve health quality and safety. Hastings Cent Rep. 2006;36:S1
- . Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications. JAMA. 2000;283:2275–2280
Linda J. Scheetz and Kathy Oman are Senior Research Editors for JEN.
PII: S0099-1767(07)00583-1
doi:10.1016/j.jen.2007.10.006
© 2008 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved.
