Outcomes research that evaluates and documents the benefits of interventions


provided by the RDN can help you and your staff improve performance, gain respect, and increase funding and revenues, and it can advance the dietetics profession more generally. When conducting outcomes research, focus on measuring outcomes that can demonstrate the value of our profession to patients, payers, and administrators. Ideally, the evidence or data you collect should be used to ensure quality of care, patient safety, and/or cost savings. Outcomes research using an existing database, such as the electronic health


record (EHR), is a good way for a clinical dietitian or clinical nutrition manager (CNM) to begin participating in research activity. The EHR can help you learn about specific practice patterns (eg, initiation of enteral feedings in the ICU, or nutrition interventions used for patients with pressure ulcers or injuries). Ask your facility’s information technology personnel whether they can assist in building reports that capture the desired data. The Academy of Nutrition and Dietetics Health Informatics Infrastructure (ANDHII) is another option for RDNs interested in participating in outcomes research. More information about ANDHII and how to participate is available on the ANDHII website (www . ANDHII . org).28


involving human subjects or their records, requires approval from the institutional review board (IRB).


Institutional Review Board Process


Before you initiate any research study, you should understand its legal and ethical dimensions, including those related to the IRB process. In the United States, health care and medical research is regulated by the federal government through the De- partment of Health and Human Services and the US Food and Drug Administration. US regulations have established the IRB as one way to ensure the protection of the rights and welfare of human beings who participate in research.29-31


The principles


of the IRB’s work can be traced to the Nuremberg Code, developed in reaction to the coerced human experiments conducted by the Nazi party in World War II, and the Belmont Report, released in the 1970s, which declared that acceptable and eth- ical human research must embrace “respect for persons, beneficence, and justice.”29 To demonstrate respect for persons, researchers are obligated to ensure all study participants involved in research have voluntarily consented to participate and un- derstand the risks and benefits associated with the study. Researchers must also protect participants’ privacy and confidentiality and offer greater protections for vulnerable populations, such as children or those with disabilities. The application of beneficence requires that any possible benefits of research be maximized and that risks be minimized. Justice involves the equitable selection of subjects. As a CNM, you will need to understand whether it is mandatory for your pro-


posed research study to undergo the process of IRB approval. You will also need to ensure that any staff involved with the research study complete training on how to conduct research appropriately. The IRB will not grant study approval until all study personnel have completed the training. To achieve IRB approval of your study, seek out and collaborate with the IRB


staff at your organization. They can advise you about the IRB process and provide specific instructions and templates, which are often dictated by regulations, to assist you through the process. The IRB will typically have specific dates on which they


256 EFFECTIVE LEADERSHIP & MANAGEMENT IN NUTRITION & DIETETICS


This type of research, like any


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