May-June, 2014 Re-Envisioning Research at HHC Exciting changes are occurring at all levels of the research endeavor that are designed to foster highquality, patient-centered research across the entire Hartford HealthCare system. These include the newly formed TIGER working group which is providing a forum for investigators from many departments to discuss how best to drive interdisciplinary research efforts. In addition, Departmental Research Councils will guide the research coming from each department and encourage the development of strong, coherent research visions. Finally, the Research Committee and Research Department can reach across and between departments to foster broad initiatives, and to ensure that the best ideas have a fertile home at HHC. All of these efforts are supported by the staff of the Research Department. Introducing iRIS: Our New Research Protocol Management Tool The Research Department recognized an urgent need to update the system used to guide research proposals through the oversight committees. In response, we are in the process of implementing a new research protocol management system, known as iRIS, which will support clinical research including submissions to the IRB/HRPP and IACUC. The iRIS system will replace Trintech for both clinical and pre-clinical research protocols. A number of factors were considered in this changeover including the need for an integrated system to manage research studies from submission to HRPP for regulatory approval to final submission to IRB. We also needed a system that could accommodate investigators from multiple locations, is web-based, and provides investigators a central site to store research documents. There will be a blackout period between May 23rd and June 4th. No new protocols (either IRB or IACUC) will be accepted through Trintech after May 23; iRIS goes live June 4. The entire Research Department is committed to providing the resources, tools and consultations needed to strengthen and support the clinical and pre-clinical research that drives advances in medical care and enhances patient safety. We anticipate that iRIS will be an important tool in these endeavors. In this Issue: • Overview of Research at HHC • Introduction to iRIS • Request for Proposals for in-house grants • SoCRA Exam for Clinical Research Professionals • “Lunch & Learn” Research Administration Topics • Recent Publications from HHC investigators • Important Links Learning iRIS: In order to ensure that all users have the opportunity to become familiar with the functionality of iRIS, several types of training are being developed. Most users will be able to learn the key elements of creating a protocol in iRIS by viewing a webinar; the link to the webinar will be posted on the Research Administration Website as soon as it has been completed. More in-depth, hands-on training sessions are available to all users and these sessions will be given throughout the summer. Finally, we are working to ensure that each department has at least one member of their administrative staff that has completed a more extensive training and thus can become a departmental resource or “super user”. You can register for classes that cover all aspects of using iRIS at: https://myhhc.hhchealth.org/sites/sandbox/JosephTortora/SitePages/iRIS%20Training%20Sign%20Ups.aspx Additional Modules We have purchased the eProposal Assistant (Grants Management) module for iRIS and will be merging it with the IRB/IACUC management module in the coming months. This upgrade will allow users to track their grant applications from application to the IRB through to the grant award. In addition, eProposal interfaces with Grants.gov to track the submission status of specific grants and also allows for dynamic budget generation. We anticipate that this upgrade will substantially streamline the grant submission and tracking process for HHC’s investigators. Internal Research Funding Program Update Funds for pilot studies are available again through the HHC Internal Funding Program through a gracious gift from the Hartford Hospital Medical Staff and Research Endowment Funds. The Research Committee will provide funding for scientifically sound research, including hypothesis-testing investigations, new pilot projects, feasibility studies and projects that forward the institution’s quality, safety and educational goals; the maximum award will be $10,000. In addition, funds will be set aside for small ($2,000) proposals. For all submissions, preference will be given to those proposals that address the hospital’s priorities related to patient safety, quality of care and personalized medicine, as well as to those demonstrating a strong potential for future external funding. More information about this funding program can be found at: http://www.harthosp.org/research/FundingOpportunities/InternalFundingOpportunities/default.aspx The intent of the Research Committee is to support as many projects as possible; therefore, budgets should be streamlined and designed to cover essentials only. The Research Committee will evaluate the budget of each proposal as well as the scientific merit, originality, and relationship to the specific goals of the HHC research enterprise. Based on these discussions, the Research Committee may approve funding levels lower than those requested. All investigators must notify Dr. Ilene Staff ([email protected]) of their intent to submit a proposal by June 16 2014. The notification must be via email and must include a full letter of intent and include an estimated budget total. The letter of intent should include a description of the problem that the project will address and the hypotheses that will be tested, if applicable. Include a brief description of the planned project and describe its relevance to patient safety, quality or personalized medicine. The letter of intent should be no more than two pages using 11 point font and one inch margins. Applicants will be notified by July 15th if they are invited to submit a full 10 page proposal. These full proposals will be due by August 18, with funding decisions made by September 30th. Important Dates: June 16, 2014, 6:00 p.m. – Letter of Intent due June - July 2014: Research Committee members review LOIs July 15, 2014: Investigators will be notified of whether they have been invited to submit a full proposal August 18, 2014 at 6:00 p.m. – Full Application/Proposal due September 30, 2014: Research Committee funding decisions made and funds encumbered for new proposals SoCRA Certification Exam for Researchers and Research Administrators Hartford Hospital will be hosting the Society of Clinical Research Associates (SoCRA) certification exam on Monday September 29th from 1:00-5:00 PM, in JB 118 (Jefferson Building). This is a wonderful opportunity to become a Certified Clinical Research Professional (CCRP) without the usual travel expenses. The SoCRA exam is appropriate for both investigators and research staff (i.e. coordinators, RA’s). You must apply on-line by August 18th at http://www.socra.org/certification/ccrp-certification-exam/applicationprocedure-how-to-apply/ in order to be eligible to take the exam at Hartford Hospital. Coming Attractions: Quality Improvement Presents “Lunch & Learn” this Fall We will be offering the opportunity for investigators and research staff to learn about various aspects of conducting research at HHC in an informal setting. The majority of topics discussed will be geared for research staff and residents; however Principal Investigators are always welcome and encouraged to attend. The meetings will be held from 12:00-1:00 in the main Hartford Hospital cafeteria. A list of topics will be provided soon. The 1st half of the meeting will focus on a specific topic, with the 2nd half of the meeting dedicated to answering questions about the topic along with open discussions on any emerging issues or problems with which individuals are grappling. Possible topics include: Details of the IRB review process; Regulatory and Source Documentation: What documents do I need? Recruitment and Retention: Tips for finding patients and keeping them. Please direct any questions about the SoCRA exam or the “Lunch & Learn” initiative to Pamela Johnson: [email protected]; (860) 545-0141. Shout Outs: Recent Publications by Hartford HealthCare Investigators: Dager AD, Anderson BM, Rosen R, Khadka S, Sawyer B, Jiantonio-Kelly RE, Austad CS, Raskin SA, Tennen H, Wood RM, Fallahi CR, Pearlson GD. Functional magnetic resonance imaging (fMRI) response to alcohol pictures predicts subsequent transition to heavy drinking in college students. Addiction. 2014 Apr;109(4):585-95. Martin ST, Cardwell SM, Nailor MD, Gabardi S. Hepatitis B reactivation and rituximab: a new boxed warning and considerations for solid organ transplantation. Am J Transplant. 2014 Apr;14(4):788-96. Connors KP, Housman ST, Pope JS, Russomanno J, Salerno E, Shore E, Redican S, Nicolau DP. Phase I, open-label, safety and pharmacokinetic study to assess bronchopulmonary disposition of intravenous eravacycline in healthy men and women. Antimicrob Agents Chemother. 2014 Apr;58(4):2113-8. . Rizvi AA, Margey R. PFO and ASD Closure in Adulthood: Where Do We Stand? Curr Treat Options Cardiovasc Med. 2014 Apr;16(4):295. Macvane SH, Tuttle LO, Nicolau DP. Impact of extended-spectrum β-lactamase-producing organisms on clinical and economic outcomes in patients with urinary tract infection. J Hosp Med. 2014 Apr;9(4):232-8. Fears SC, Service SK, Kremeyer B, Araya C, Araya X, Bejarano J, Ramirez M, Castrillón G, Gomez-Franco J, Lopez MC, Montoya G, Montoya P, Aldana I, Teshiba TM, Abaryan Z, Al-Sharif NB, Ericson M, Jalbrzikowski M, Luykx JJ, Navarro L, Tishler TA, Altshuler L, Bartzokis G, Escobar J, Glahn DC, Ospina-Duque J, Risch N, Ruiz-Linares A, Thompson PM, Cantor RM, Lopez-Jaramillo C, Macaya G, Molina J,Reus VI, Sabatti C, Freimer NB, Bearden CE. Multisystem component phenotypes of bipolar disorder for genetic investigations of extended pedigrees. JAMA Psychiatry. 2014;71(4):375-87. Veltmeijer MT, Pluim B, Thijssen DH, Hopman MT, Eijsvogels TM.Thermoregulatory responses in wheelchair tennis players: a pilot study. Spinal Cord. 2014 Mar 25. Perola E, Stamos D, Grillot AL, Ronkin S, Wang T, Letiran A, Tang Q, Deininger DD, Liao Y, Tian SK, Drumm JE, Nicolau DP, Tessier PR, Mani N, Grossman TH, Charifson PS. Successful application of serum shift prediction models to the design of dual targeting inhibitors of bacterial gyrase B and topoisomerase IV with improved in vivo efficacy. Bioorg Med Chem Lett. 2014 Mar 19. pii:S0960-894X(14)00238-8. Maglio D, Sun HK, Patel T, Banevicius MA, Nightingale CH, Arya A, Wang G, ChenZ, Phan LT, Nicolau DP. Pharmacodynamic profiling of modithromycin: Assessment in a pneumococcal murine pneumonia model. Int J Antimicrob Agents. 2014 Mar 19. pii:S0924-8579(14)00058-2. Hammond MD, Taylor RA, Mullen MT, Ai Y, Aguila HL, Mack M, Kasner SE,McCullough LD, Sansing LH. CCR2+Ly6Chi Inflammatory Monocyte Recruitment Exacerbates Acute Disability Following Intracerebral Hemorrhage. J Neurosci. 2014 Mar 12;34(11):3901-9. doi: 10.1523/JNEUROSCI.4070-13.2014. Fernandez AB, Thompson PD. Detection of Cardiac Abnormalities in Elite Black and White Athletes: Still Not Black and White. Circulation. 2014 Mar 11.PubMed PMID: 24619465. Corbera S, Ikezawa S, Bell MD, Wexler BE. Physiological evidence of a deficit to enhance the empathic response in schizophrenia. Eur Psychiatry. 2014 Mar 11.pii: S0924-9338(14)00007-8. doi: 10.1016/j.eurpsy.2014.01.005. Herbst MK, Rosenberg G, Daniels B, Gross CP, Singh D, Molinaro AM, Luty S,Moore CL. Effect of Provider Experience on Clinician-Performed Ultrasonography for Hydronephrosis in Patients With Suspected Renal Colic. Ann Emerg Med. 2014 Mar 10. pii: S0196-0644(14)00073-0. doi: 10.1016/j.annemergmed.2014.01.012. Sankaranarayanan J, Murante LJ, Moffett LM. A Retrospective Evaluation of Remote Pharmacist Interventions in a Telepharmacy Service Model Using a Conceptual Framework. Telemed J E Health. 2014 Mar 10. Gipson KE, Rosinski DJ, Schonberger RB, Kubera C, Mathew ES, Nichols F, Dyckman W, Courtin F, Sherburne B, Bordey AF, Gross JB. Elimination of gaseous microemboli from cardiopulmonary bypass using hypobaric oxygenation. Ann Thorac Surg. 2014 Mar;97(3):879-86. doi: 10.1016/j.athoracsur.2013.08.074. Epub 2013 Nov 6. Housman ST, Crandon JL, Nichols WW, Nicolau DP. Efficacies of ceftazidime-avibactam and ceftazidime against Pseudomonas aeruginosa in a murine lung infection model. Antimicrob Agents Chemother. 2014 Mar;58(3):1365-71. MacVane SH, Kuti JL, Nicolau DP. Clinical pharmacodynamics of antipseudomonal cephalosporins in patients with ventilator-associated pneumonia. Antimicrob Agents Chemother. 2014 Mar;58(3):1359-64. doi: 10.1128/AAC.01463-13 Rosenfeld ES, Pearlson GD, Sweeney JA, Tamminga CA, Keshavan MS, Nonterah C, Stevens MC. Prolonged hemodynamic response during incidental facial emotion processing in inter-episode bipolar I disorder. Brain Imaging Behav. 2014 Mar;8(1):73-86. Castelluccio BC, Meda SA, Muska CE, Stevens MC, Pearlson GD. Error processing in current and former cocaine users. Brain Imaging Behav. 2014 Mar;8(1):87-96.doi: 10.1007/s11682-013-9247-y. Dooley C, Kaur R, Sobieraj DM. Comparison of the efficacy and safety of low molecular weight heparins Research FAQs and Important Links for venous thromboembolism prophylaxis in Contact information can be found on our website at medically ill patients. Curr Med Res Opin. 2014 http://www.harthosp.org/research/IRB/default.aspx Mar;30(3):367-80. Vafaii P, Digiuseppe JA. Detection of B-cell populations New Protocol and Training Requirements: with monotypic light chain expression in Are all members your staff CITI Compliant? Check here: cerebrospinal fluid specimens from patients with http://www.harthosp.org/research/IRB/TrainingRequirements/d multiple sclerosis by polychromatic flow cytometry. efault.aspx Cytometry B Clin Cytom. 2014 Mar;86(2):106-10. doi: 10.1002/cyto.b.21099. Epub 2013 Jul 1. Brazell HD, Patel M, O'Sullivan DM, Mellen C, LaSala CA. The impact of pessary use on bowel symptoms: oneyear outcomes. Female Pelvic Med Reconstr Surg. 2014 Mar-Apr;20(2):95-8. doi: 10.1097/SPV.0000000000000060. The HHC Research Department offers the following services to assist investigators and research staff in preparing their research protocols and grant proposals: Proposal Design and Statistical Analysis Assistance with general IRB and IACUC issues Budgets Coordination of investigator- or industry-sponsored clinical trials Database Design Grant writing assistance Weekly NIH Funding Updates Available Individuals who are interested in receiving weekly funding updates via email from NIH may register for the NIH weekly listserv at http://grants.nih.gov/grants/guide/index.htm _____________________________________________________________________________________________________ Hartford HealthCare Research News is published by Research Administration at Hartford Healthcare. If you would like to contribute to this publication research-related news to share (e.g., new grant awards, publications, honors, recognitions), please contact Joe ([email protected]) or Anne ([email protected]) for more info.