APMA News - September/October 2016 - S4

SUPPLEMENT TO APMA NEWS YOUR APMA / PAGE 4 DOES YOUR RESEARCH NEED AN INSTITUTIONAL REVIEW BOARD? By Adam E. Fleischer, DPM, MPH, and Patrick A. DeHeer, DPM You are preparing to start a new research project. Do you need to obtain approval from an institutional review board (IRB) before you get started? This article provides some basic information.* When is IRB review needed? IRB review is required by law in the following two instances: * Your research receives federal funding, directly or indirectly, from the Department of Health and Human Services, including NIH ("The Common Rule," 45 CFR 46, 1991) * Your research is subject to FDA regulation (21 CFR 50 and 56, 1981) However, many institutions that receive federal funding also extend their federalwide assurance to cover all human subjects research. In these instances, any human research conducted under the auspices of the institution will be required to undergo IRB review. Examples of FDA-regulated research include: evaluating the efficacy of a nonFDA-approved drug, evaluating the efficacy of an approved drug for an off-label use, and evaluating the value of a non-marketed medical device. In line with these regulations, the APMA Code of Ethics states, "The podiatrist shall not subject any patient to an experimental diagnostic modality or treatment method without prior review of the experiment protocol by their peers and with full disclosure to the patient" (ME7.12). Keep in mind that many high-impact journals (e.g., Journal of Biophysics and Structural Biology, American Journal of Sports Medicine, etc.) also require proof of IRB review for submission to their journals. What type of activity does an IRB review? IRBs only review human subjects research. So ask yourself: * * Is it research? Research is defined as "a systematic investigation designed to develop or contribute to generalizable knowledge" (45 CFR 46). Case reports with only one or a few subjects and that do not involve a data analysis or systematic investigation usually do not require IRB review. Similarly, most quality assurance and quality improvement activities usually do not require IRB review. A good test to identify what qualifies as research is to ask yourself, "Will the knowledge gained be generalizable, as opposed to specific only to my site?" or "Will the findings be publishable and/or presented outside of my institution?" If the answer is 'yes,' then the project is research. Does it involve human subjects? A human subject is defined as "a living individual about whom an investigator conducting research obtains either: 1) data through intervention with the individual; or 2) identifiable private information" (45 CFR 46). Hence, studies using cadavers or systematic reviews/meta-analyses would be examples of projects that do not require IRB review. to Chart 2.) Many retrospective studies (where the data is already in existence) fit into this category. When applying to an IRB for exempt determination, be sure to also apply for a waiver of research consent and waiver of HIPAA authorization. Remember that patients' authorization to use their protected health information for treatment does not mean that they have authorized its use for research. Where do I find an IRB if I'm in private practice? You can find any one of a number of independent, private, or central IRBs online. Popular examples include WIRB and Quorum. Working with these IRBs is not cheap, however. Another option is to find a hospital or other institution that is willing to extend IRB review services to you. There is no law prohibiting this practice and many will do so for loosely affiliated and sometimes even unaffiliated physicians. *The statements contained herein represent generalizations. If you are in doubt, please check with your institution's human research protections committee. What if my project is "exempt" from IRB review? The Common Rule recognizes several categories of research that qualify for "exempt determination," meaning IRB oversight is not needed; however, the initial determination must be made by the IRB and not the investigator. (For a list of these categories, visit www.hhs.gov/ohrp/policy/ checklists/decisioncharts.html and refer APMA gratefully acknowledges the support of PICA, founding sponsor of the Young Physicians' Program. http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

Table of Contents for the Digital Edition of APMA News - September/October 2016