SAVE THE DATE - Genesis Health System
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Who we are… Genesis Health System Office of Research and Grants Administraon is here to help you. If you need assistance please contact us. Sarah Castro Research Support Liaison (563) 421-7957 [email protected] Joy Lemmon Research Program Coordinator (563) 421-7956 [email protected] Genesis Health System Research Promoon Fund To make a request to use the monies in the Research Promoon Fund, go to www.genesishealth.com/ research and fill out the online applicaon. You can also contact the Office of Research and Grants Administraon for a copy of the applicaon. Once the Research Promoon Fund Commiee receives a completed form, the commiee does it's best to respond to applicaons within two weeks. If you have quesons about the Genesis Health System Research Promoon Fund, please direct them to Sarah Castro at [email protected]. SAVE THE DATE Trainings Scheduled For New Research Policy Changes On January 19, 2018, revisions to the Federal Policy for the Protecon of Human Subjects (the Common Rule) will go into effect. This is the first significant research policy change at the federal level since the Common Rule was originally published in 1991. Changes to the Common Rule will affect many researchers at Genesis and significantly change the process in which studies are reviewed by the Genesis Instuonal Review Board. In order to ensure all researchers at Genesis are fully informed about the Common Rule changes and how that will affect processes at Genesis, the Research Department will be holding two trainings in November. TRAINING SCHEDULE If you have any quesons about these trainings or the upcoming changes to the research policies, please contact Sarah Castro at [email protected] or 563- 421-7957. Date Time Locaon Wednesday, November 8 12:00—1:30 pm Adler 1 Genesis East Campus Thursday, November 9 5:00—6:30 pm Interconnect Lounge Medical Office Building 1 Genesis East Campus
Transcript of SAVE THE DATE - Genesis Health System
Who we are…
Genesis Health System Office of Research and Grants Administration is here to help you. If you need assistance please contact us.
Sarah Castro Research Support Liaison (563) 421-7957 [email protected]
Joy Lemmon Research Program Coordinator (563) 421-7956 [email protected]
Genesis Health System Research Promotion Fund To make a request to use the monies in the Research Promotion Fund, go to www.genesishealth.com/research and fill out the online application. You can also contact the Office of Research and Grants Administration for a copy of the application.
Once the Research Promotion Fund Committee receives a completed form, the committee does it's best to respond to applications within two weeks.
If you have questions about the Genesis Health System Research Promotion Fund, please direct them to Sarah Castro at [email protected].
SAVE THE DATE Trainings Scheduled For New Research Policy Changes
On January 19, 2018, revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) will go into effect. This is the first significant research policy change at the federal level since the Common Rule was originally published in 1991. Changes to the Common Rule will affect many researchers at Genesis and significantly change the process in which studies are reviewed by the Genesis Institutional Review Board. In order to ensure all researchers at Genesis are fully informed about the Common Rule changes and how that will affect processes at Genesis, the Research Department will be holding two trainings in November.
TRAINING SCHEDULE
If you have any questions about these trainings or the upcoming changes to the research policies, please contact Sarah Castro at [email protected] or 563-421-7957.
Date Time Location
Wednesday, November 8 12:00—1:30 pm Adler 1 Genesis East Campus
Thursday, November 9 5:00—6:30 pm Interconnect Lounge Medical Office Building 1
Genesis East Campus
The Office of the Federal Register published the long-anticipated revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) on January 19, 2017. The U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies have announced revisions to modernize, strengthen and make more effective the Common Rule, which was originally published in 1991. Most provisions in the new rule will go into effect in 2018.
Genesis Research Inquirer July/August 2017
Research Policy Change Trainings What to Expect
The November research trainings will cover the following topics important to researchers at Genesis:
National Institutes of Health (NIH) Policy on the Use of a Single IRB Another federal policy change will be taking place about the same time as the Common Rule revisions. Effective January 25, 2018, all sites participating in multi-site studies involving human subjects research funded by the NIH will be required to use a single Institutional Review Board (sIRB) to conduct the ethical review of the study. This policy is intended to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as swiftly as possible without compromising ethical principles and protections for human research participants. This policy applies to all United States sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards. To ensure compliance with this policy, the Genesis Research Department is in the process of creating a new External IRB Policy and IRB Reliance Agreement template to clearly assist researchers that are participating in multi-site research covered by this policy.
Topic Details
Exempt Research New categories of research exempt from IRB review Limited IRB review New Exempt Research Application
Continuing Review of a Research Study
Types of research no longer requiring continuing review by the IRB Process for tracking studies that don’t require continuing review
Informed Consent New required “key information” section New required content Changes to Waiver of Informed Consent criteria Changes to vulnerable populations Broad Consent
Single IRB for Multi-Site Research
Research subject to Single IRB requirements IRB Reliance Agreements New External IRB Policy
Genesis IRB Documents Revised application forms Revised Standard Operating Procedures Revised tools and templates
Research Summit Presentation Slides Available Update—Conflicts of Interest in Research
Did you miss the Research Summit? Was there one relevant presentation you would like to see again? Do you wish you could see all the presentations again?
You’re in luck! The Research Summit presentation slides are available on the Genesis Research website at
www.genesishealth.com/research—Click on the “2017 Genesis Research Summit” on the left-hand side of the screen.
Genesis Research Inquirer July/August 2017
New Research Subcommittee
The Therapy Orthopedic Quality Committee has recently added a new Research Subcommittee that will focus on increasing therapist-led research at Genesis. The goal for the committee in the first year is to increase therapists’ awareness of research opportunities and knowledge of research in order to maximize the quality of patient care. Members of the Research Subcommittee include: Justine Uhl (Chair) Tara Rudolphi, Jennifer Petersen, Jordan Gillund and Sarah Castro. The creation of this subcommittee illustrates the importance Genesis places on using evidence-based practices and creating new evidence regarding the most effective methods for treating patients. In the past year, there have been five active therapy studies in the areas of physical therapy, occupational therapy and speech therapy. With this new subcommittee, the support for research will increase and the number and quality of studies completed by therapists at Genesis will continue to grow!
Studies in Development The Genesis Research Department is currently working with a number of different individuals and departments at Genesis on new research studies. Many are being developed by Genesis employees! Below is a sneak peak at just a few of the many upcoming studies.
Title Purpose
Birth Center Childbirth Satisfaction Study To examine the role of pain, pain relief methods and other factors in childbirth satisfaction among mothers at Genesis Medical Center, Davenport.
Plagiocephaly Study To examine the effectiveness of cupping as a treatment option for babies with plagiocephaly.
Human Milk Fortifier Study To examine the relationship between the use of powdered human milk fortifier, liquid human milk fortifier and diaper dermatitis among NICU babies at Genesis Medical Center, Davenport.
Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial
To determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg is effective in improving survival free from ischemic vascular events at 90 days when subjects are randomized within 12 hours of time last known free of new ischemic symptoms in patients receiving aspirin 50-325 mg/day.
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke (ARCADIA)
To test the hypothesis that apixaban is superior to aspirin for reducing the rate of recurrent stroke or death in patients with cryptogenic stroke and evidence of atrial cardiopathy.
IRB Approved New Projects: July - August, 2017 Care Optimization Through Patient and Hospital Engagement Clinical Trial For Heart Failure—CONNECT HF Principal Investigator: Dr. Vijay Rajendran Rationale and Purpose: The purpose of this study is to find out if adding a hospital improvement program to the usual care that is given to patients with heart failure, changes health outcomes and the costs of providing that care one-year after leaving the hospi-tal.
Completed Studies —Seven Studies in July - August, 2017 ECOG-ACRIN E7208: A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy Principal Investigator: Dr. George Kovach CTSU E3A06: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma Principal Investigator: Dr. George Kovach SWOG 1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer Principal Investigator: Dr. George Kovach CTSU E3A06: Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma Principal Investigator: Dr. George Kovach S1400 Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Principal Investigator: Dr. Shobha Chitneni ECOG-ACRIN 4512 A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein Principal Investigator: Dr. Shobha Chitneni A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) Principal Investigator: Dr. Shobha Chitneni
Genesis Research Inquirer July/August 2017
Summary of Genesis Health System IRB Activity July - August, 2017
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July 11, 2017 0 0 4 3 0 3 1 1 4
July 25, 2017 0 1 3 3 0 4 1 0 0
August 8, 2017 1 1 5 0 0 0 3 2 4
Total 1 2 12 6 0 7 5 3 8
% Expedited
Year-To-Date Total 18 13 39 20 1 25 24 34 42
% Expedited Year-To-Date 96%
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34% 59%
33% 38%
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