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<ul><li><p>CLINICAL RESEARCH BOOTCAMP: EMORY IRB OVERVIEW Clifford Gunthel, MD, IRB Co-Chair Rebecca Rousselle, CIP, IRB Director </p></li><li><p>Co-Chairs </p><p>2 </p><p>Cliff is Associate Professor of Infectious Disease at SOM, and </p><p>chairs Committee B1. </p><p>Aryeh is Professor of Global Health at RSPH and chairs Committee Q (compliance). </p></li><li><p>3 </p><p>Jill Perry-Smith, PhD Sociobehavioral VC </p><p>Larry Tune, MD Comedian, Psychiatrist </p><p>Susan Ray, MD Infect. Disease </p><p>Amy Langston, MD Hem/Onc </p><p>Ann Haight, MD Hem/Onc Peds </p><p>Carlton Dampier, MD Pediatric Hematology </p></li><li><p>How the IRB Staff Help We know the regulations </p><p> Q&amp;A </p><p> Do you need IRB review? We can tell you. </p><p> Gets study in good shape for review </p><p> Outreach/education, and quality assurance </p><p>4 </p></li><li><p>Because people do not always do the right thing; and its hard to know in the moment what the right thing is Nazi Doctors: Obviously, pathologically, not right </p><p> 1947 Nuremburg Code required informed consent Henry Beecher 1961 NEJM article: </p><p> The physicians thought they were right but werent in hindsight. Science is not the highest value to which all other orders of values should be subordinated (Pope Pius IV, cited in Beecher) </p><p> Consent in any fully informed sense may not be obtainable. Nevertheless it remains a goal toward which one must strive There is no choice in the matter. </p><p> An experiment is ethical or not at its inception. It cannot become ethical post-hoc ends do not justify means. </p><p> 1971-1991: Tuskegee surfaces, Belmont Reports Three Principles, national atonement for studies gone wrong. Led to IRB model for one-site studies, federal regulations </p><p> 1990s 2000s: Rise of multi-site studies, transnational research, shut-downs; more studies gone wrong </p><p>5 </p></li><li><p>Belmont Report Principles Respect for persons </p><p>Informed, comprehending consent assuming rational autonomy; safeguards for those with limited autonomy </p><p> Beneficence </p><p>Minimize risk, maximize benefit </p><p>Justice Ensure fairness of subject selection, balancing of burdens </p><p>and benefits </p><p>6 </p></li><li><p>7 </p><p>Shared Oversight </p><p>HHS FDA </p><p>Cooperative trial group </p><p>Institution &amp; IRB </p><p>PI </p></li><li><p>5 Points to Get an IRB Application Approved </p><p> Put yourself in the reviewers shoes. What is being </p><p>done with Human Subjects, and why? 1. The science must be sound 2. State the obvious: What is investigational about this </p><p>study? 3. Define the study population 4. The description of the risks must be complete 5. Have an appropriate data and safety monitoring plan </p><p>8 </p></li><li><p>IRB Triage Questions Is it research? Is it human subjects? </p><p> Is it exempt human subjects research? </p><p> Is it expeditable HSR? </p><p> Must it go to a full board meeting? </p><p>9 </p></li><li><p>What is Research? IRB jurisdiction is limited to research (with human </p><p>subjects) Contact the IRB at to talk with an analyst </p><p>about your project Our first question is: is it research? See handout If it isnt research, no IRB review needed IRB will give you a letter for your records </p><p>10 </p><p></p></li><li><p>Research or Not? Generalizable knowledge is information gathered to draw general conclusions beyond the study population. The researcher approaches the project with the intention of extrapolating from the chosen sample to generate knowledge about a larger reference group. </p><p> By contrast, non-research projects gather information about a chosen sample to describe a local phenomenon, or draw conclusions that are intended to be used for the benefit of that local sample alone. </p><p>11 </p></li><li><p>Research or Not? </p><p>Not Research Some education activities Quality improvement, assurance, assessment studies </p></li><li><p>Human Subjects or Not? A living individual about whom an investigator </p><p>conducting research obtains data through intervention or interaction with individuals or obtains identifiable private information </p><p> About a living person (at time of collection) Intervention/interaction in person, phone, internet Identifiers Private vs public </p><p> 45 CFR 46.102(F) </p><p>13 </p></li><li><p>Publishing I want to publish, so its research, right? Common misconception </p><p> One can publish works that meet - or do not meet - the IRB </p><p>definition of research. </p><p> Publishing is simply sharing information with an external audience. </p><p> The Emory IRB can give you email or letter with determination, for </p><p>publishers. </p><p> If not research, publication should not attempt to generalize conclusions. Should report on what you did and how well it worked youre mileage may vary. </p><p>14 </p></li><li><p>What is exempt? Most common types of exempt research: </p><p> Surveys, interviews and focus groups of adults Public observation of adults and of children (but only if </p><p>investigators do not intervene at all) Fewer approval criteria based on Emory policy </p><p> CITI training General sniff-test Adequate informed consent </p><p>15 </p></li><li><p>What is expeditable? Non-exempt HSR that is: </p><p> Minimal risk AND Falls in certain categories set by federal regs </p><p> Most common expeditable research: </p><p> Medical record reviews Blood, urine, hair, saliva samples Non-invasive biometric measurements </p><p> More than minimal risk: goes to full board meeting. </p><p>16 </p></li><li><p>Create Study </p><p>Dept Review </p><p>CTRC review </p><p>(if cancer-related) </p><p>IRB staff screening Change </p><p>request loop </p><p>IRB Review Change request </p><p>loop Ancillary reviews </p><p>Final Approval! </p><p>Protocol Amendments </p><p>Annual Renewal </p><p>Close Out </p><p>17 </p></li><li><p>Review Outcomes Approved Approved pending minor modifications Deferred to another meeting (full board only) </p><p> Major issues, or missing information Disapproved (very rare) must be done by full </p><p>board Tabled (lack of quorum, immature application) </p><p>18 </p></li><li><p>How are ongoing studies reviewed? Investigator/sponsor responsibilities </p><p> Safety reports Monitoring visits DSMB reports Document Document Document (subject binders, study </p><p>binders, logs, AE worksheets) IRB responsibilities </p><p> Unanticipated problems Noncompliance reviews and corrective/preventive </p><p>action plans Review of study at least annually </p><p>19 </p></li><li><p>Visit our Website </p><p> </p><p>eIRB ( </p><p>20 </p></li><li><p>Time What turnaround can you expect? Here are AVERAGES </p><p>(vary according to quality of submissions, staffing, novel issues, COIs, etc.) </p><p> Full board new: app. 3-8 weeks til IRB meeting FB Amendments: 3 weeks til IRB meeting All Continuing reviews: before expiration if not submitted late </p><p> Expedited new: app. 2-8 weeks Expedited Amendments: 2-4 weeks </p><p> No review needed and exemption determinations: 2-4 weeks </p><p>21 </p></li><li><p>The Stick The IRB may: </p><p> Suspend enrollment Suspend approval of a study Terminate a study Bar an investigator from conducting HSR or certain kinds of HSR (e.g., more than minimal risk) </p><p>22 </p></li><li><p>Why we all do this </p><p>23 </p><p>Community trust in research Willing subjects Continued funding </p></li><li><p>Contact the Emory IRB Main email: </p><p> Rebecca Rousselle, CIP </p><p> (404)712-0785 </p><p> Main line: (404) 712-0720 </p><p> IRB website: </p><p> Dr. Gunthel </p><p> </p><p>24 </p><p>mailto:IRB@emory.edumailto:Rebecca.Rousselle@emory.edu</p><p>Clinical Research Bootcamp:Emory IRB OverviewCo-ChairsSlide Number 3How the IRB Staff HelpBecause people do not always do the right thing; and its hard to know in the moment what the right thing isBelmont Report PrinciplesSlide Number 75 Points to Get an IRB Application ApprovedIRB Triage QuestionsWhat is Research?Research or Not?Research or Not?Human Subjects or Not?PublishingWhat is exempt?What is expeditable?The FlowReview OutcomesHow are ongoing studies reviewed?Visit our WebsiteTimeThe StickWhy we all do thisContact the Emory IRB</p></li></ul>