10/9/2012. Alicia Joy, IRB. Wednesday October 10, Please be sure to sign in and take copies of each handout.

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1 Wednesday October 10, 2012 Please be sure to sign in and take copies of each handout. 1 Alicia Joy, IRB 2 FH Office of Research Administration Christina Jackson, BSN, RN, CCRC, CHRC 1

2 ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. ClinicalTrials.gov It is a web based resource that provides patients, their family members, health care professionals, researchers, and the public with information on clinical studies. The web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH) US Congress, FDA Modernization Act For serious or life-threatening diseases & conditions National Library of Medicine launches ClinicalTrials.gov As a public database of clinical trial protocols International Committee of Medical Journal Editors (ICMJE) Mandates protocol registration for Phase II-IV interventional clinical trials as a requirement for manuscript publication 2007 Formalizes & expands clinical trial registration & results reporting requirements of Phase II-IV interventional clinical trials. 2

3 Law Interventional studies of drugs, biologics, and/or devices (some exceptions) Federally funded studies Journal Publication ICMJE has a clinical trials registration requirement for publication The Study Sponsor (IND/IDE holder, NIH Grantee, or the initiator of the trial ) OR The sponsor designated PI (PI responsible for conducting the trial, has access to and control over the data, has the right to publish the results, and has the ability to meet all of these requirements) If it is a multi-site study, then the primary PI would be the responsible party for ensuring it is registered. It would only be registered once. It would not be registered by each individual site. We have an Organization account with ClinicalTrials.gov Organization name = Florida Hospital PRS Administrator for our account is identified as Christina Jackson Everyone conducting research under the auspices of FH should use our organization account 3

4 Complete an online Administrator Contact Request Form The Organization s PRS Administrator will receive an to set up your user account You will receive your account login information via See the FH ORA website and ClinicalTrials.gov for more information and further instructions regarding registration CT.gov has a Help section containing links to Quick Start Guide & User s Guide After you enter your clinical trial information, your PRS Administrator will receive an from CT.gov The PRS Administrator will review the information submitted and release it for publication on the CT.gov site Once released, it will receive an NCT (National Clinical Trial) number 2-5 days after it is released, you can view, edit, and add results On August 2, 2012, a US Representative introduced a bill for the Trial Experimental Studies Transparency (TEST) Act The Office of the Inspector General (OIG) has begun including clinical trial data disclosure requirements in corporate integrity agreements. According to the September 26, 2012 edition of Federal Register , the DHHS has delegated authority to the FDA to vet clinical trial information submitted to ClinicalTrials.gov 4

5 Information: Case Report Forms (new class) October 2012 Biostatistics and Epidemiology new class starting January

6 Conflict of Interest We currently have 731 COI forms and 473 researchers (65 %) have also completed their educational requirement. 6

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10 October 2012 Town Hall IRB UPDATES Non-English Speaking Participants General Requirements for Informed Consent according to 21 CFR and 45 CFR The information to be given to the participant or the participant s legally authorized representative will be in language understandable to the participant or representative

11 Non-English Speaking Participants Who are you targeting? Non-English Speaking population: Use of the full consent form (regular IRB template) in that language. Unexpected Encounter: Use of a short consent form (oral presentation followed by signature on the short form documenting that the elements of consent have been presented orally.) Notify IRB at Continuing Review If three or more subjects require translation into the same language, a full consent form in that language must be submitted for IRB approval. 31 Consent Form - HIPAA Language Please use the HIPAA language provided in the consent form template. Approved by our legal department Review to ensure it matches your study Certain sections indicate changes are allowed i.e. Government agencies in other countries may not be relevant to your research 32 Marketing Your Studies Remind your PIs Investigators should contact the IRB before pursuing marketing tactics - articles, interviews, related to procedures/drugs/ medical devices considered new, innovative, or part of a clinical trial. IRB approval letters will post a reminder IRB Office works together with Marketing Contact the IRB if you are unsure 33 11

12 IRB to Streamline Processes Coming soon to an IRB near you! WHY? Consistency / IRB Determinations / Documentation Wondering about recent IRB Office Requests? Protocols for Investigator Initiated Studies Your input is valuable to us! 34 Happening NOW Credentialing CITI REFRESHER Requirement Every three (3) years for ALL researchers Includes the CV submission CVs no longer need to be signed/dated Melissa Palazzolo will work to revise expirations dates IRB Office open Fridays 35 OHRP Regional Conference

13 Michelle McKinney, IRB

14 Michelle McKinney, IRB and Michelle Kilponen, ORA 40 Christina Jackson, ORA Thank you for coming! Please be sure you ve signed in! 41 14