JUL-AUG 2019

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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Page 37 of 68 | JULY/AUGUST 2019 35 © GETTY IMAGES "[Staying active in research] reminds me to examine results and outcomes objectively, which ultimately makes me a better physician overall," says Joely Kaufman-Janette, MD, a dermatologist at Skin Associates of South Florida in Coral Gables. "It also allows me to see and use new devices and medications before they come to the market, giving me clini- cal experience I could not get otherwise." FINDING YOUR FOCUS Before you get involved in clinical research, you must fi rst examine your mentality and motivations. "You need to be curious and open-minded," says Omar A. Ibrahimi, MD, PhD, founder and medical director of the Connecticut Skin Insti- tute. "It is so important to conduct the research in as impartial and nonbiased a fashion as possible." Often, you'll be inspired to conduct an investigation because of a question or hypothesis that comes up in your practice. Or, you may look at what other researchers or companies are doing and wonder if you can come up with a better approach. "Occasionally, I have a clinical problem without an obvious solution," says Karol A. Gutowski, MD, a Chicago-based board-certifi ed plastic surgeon who transi- tioned into doing research in private practice after being in academics for eight years. "So I begin to think, what would happen if I did something different? Then I look around to see what is available. If I think a product or device could have a new application, I approach the company or study it myself." GETTING THE GO-AHEAD Once you've formulated your question, you'll need to develop a study design to objectively answer it—however, all research involving human subjects requires Institutional Review Board (IRB) approval. Studies must also be conducted in accordance with Good Clinical Practice (GCP) standards and U.S. Food & Drug Administration (FDA) regulations governing clinical trials. Because of these requirements, it's a good idea to connect with companies and individuals who have experience and contacts. Large clinical research centers typically have their own IRBs, while practices that are just get- ting started can hire a commercial IRB to review their study protocol—or they can partner with a local institution that has its own IRB.

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