Most medical schools, as part of the graduate medical curriculum, require residents to conduct at least one research project. These projects are designed to give clinicians early in their career an opportunity to manage a project, understand the importance of well-designed clinical research and to improve their communication skills. This may be the first time a resident goes through the entire process of writing a clinical research protocol that must undergo the rigorous review by their superiors and the IRB. Some institutions provide the resident with a mentor, or preceptor. But in some cases, the resident must rely on other sources for assistance, such as fellows or the medical librarian.<\/p>\n
A successful residency research project starts with a strong, well-developed protocol. This article will highlight the key elements of a research protocol and the common pitfalls to avoid.<\/p>\n
Start with a good idea<\/strong><\/p>\n This is easier than it sounds, and is often where a less experienced researcher may stumble. Consider a question that may come up in everyday practice or on clinical rounds with patients. It\u2019s best to brainstorm more than one question to ensure existing literature hasn\u2019t already addressed it. Even if there are published studies addressing the question, there may be additional questions that warrant further study.<\/p>\n Challenge your idea <\/strong><\/p>\n Ask why is it important to conduct this particular research. Good ideas are feasible, interesting to the researcher and ethical. They should also be novel, and the resulting answer should be relevant and useful to future researchers and clinicians.<\/p>\n Feasibility is an important consideration for residents, since their projects are typically for one year. While the gold standard of clinical research is a prospective, randomized and controlled trial, these take much longer and require significant resources to complete. By default, then, many residency research projects are retrospective or non-interventional studies.<\/p>\n Consider your hypothesis<\/strong><\/p>\n This idea needs to be expressed in the form of a question, which then leads to a hypothesis. The hypothesis should be an educated, testable prediction about what will happen in the \u201cexperiment.\u201d A well written and defined hypothesis is the key to developing a research protocol. With a strong hypothesis, the investigator can then define specific objectives that will answer the research question.<\/p>\n Review existing research<\/strong><\/p>\n The importance of reviewing the literature can not be overemphasized. In combing the literature, you may find many studies similar to yours have already been conducted. Medical librarians can offer significant support in researching the vast databases available. The results of this work can lead to a clearer research question, the foundation of a strong protocol.<\/p>\n Write a clear protocol<\/strong><\/p>\n The protocol will guide the researcher throughout the research project. As the building block of all research, it facilitates the effective processes that are required to answer the research question. Additionally, a well-written protocol complies with regulatory requirements, including the review by the IRB.<\/p>\n Federal regulatory agencies have encouraged the use of a standardized approach to writing research protocols. While it is not essential that the researcher follow these in a residency project, it can be helpful to establish a well-organized and methodical process to ensure all the important elements of the project are addressed.<\/p>\n Additionally, establishing a habit of a systematic approach early in one\u2019s research career will make it easier to apply for grants and other funding later.<\/p>\n A protocol should include these key elements:<\/p>\n <\/p>\n