Summer 2012 eNewsletter

Summer 2012 eNewsletter

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Latest News from the Office of Sponsored Projects

Office of Sponsored Projects (OSP) Listserv Announcement

Carilion Clinic OSP distributes a list of new and current grant opportunities. This list includes new opportunities from federal agencies, as well as grant announcements from foundations and other organizations. Notices from federal agencies on e-submission, compliance or other subjects are also included in the e-mail.

If you are interested in subscribing to funding opportunities and announcement e-mail list, please e-mail research@carilionclinic.org with "subscribe to OSP listserv" in the subject line.

Dr. Michael Boyd is warded grant from the Commonwealth Health Research Board

Four thousand Virginians die from lung cancer each year. Much of the current knowledge regarding lung cancer biology is based on molecular studies utilizing early staged tumors that had been removed from the patient. Recently, minimally invasive biopsies from advanced lung cancers were demonstrated to provide sufficient genetic material for molecular studies. A greater understanding of the genetic abnormalities associated with advanced lung cancer could improve current therapies and outcomes.

Michael Boyd, MD, Department of Medicine, Pulmonary, Critical Care, Environmental and Sleep Medicine, is studying this promising avenue of lung cancer research. In June, Dr. Boyd was awarded a $200,000 grant from the Commonwealth Health Research Board. The goal of this two-year project, Genetic Reassessment after Induction in Advanced Non-Small Cell Lung Cancer, is to achieve a greater understanding of the molecular biology of non-small cell lung cancer, a disease which afflicts a significant number of people within the Commonwealth of Virginia. By doing this, current therapies and outcomes can be improved.

Carilion Medical Center is partnering with Virginia Tech on this pilot research project. The team's research will establish the first advanced non-small cell lung cancer (NSCLC) specimen repository in Virginia. The work will confirm the presence of genetic drift in advanced NSLC after induction therapy utilizing a DNA microarray and MIBS, and identify unique genetic derangements which will assist in predicting patient responsiveness to current therapies. They also plan to identify potential targets for future cellular biology research and pharmaceutical development. As a result, the overall impact of this study will result in improved quality of life, outcomes and/or survival of Virginians afflicted with advanced non-small cell lung cancer.

The Commonwealth Health Research Board was established in 1997 to provide financial support for human health research in the Commonwealth. The boards' primary responsibility is to make grants for human health research, especially for those efforts that have the potential of maximizing human health benefits for citizens of the Commonwealth.

Carilion New River Valley Medical Center and Partners Receive Award from the Center for Medicare and Medicaid Innovation

In June 2012, Carilion New River Valley Medical Center, in partnership with Virginia Commonwealth University School of Pharmacy, Aetna Healthcare and CVS/Caremark, has been selected to receive a $4.1 million award from the Center for Medicare and Medicaid Innovation.

The program, Improving Health for At-Risk Rural Patients (IHARP), will improve medication therapy management for Medicare and Medicaid beneficiaries and other patients in 23 underserved rural counties in southwest Virginia through a collaborative pharmacist practice model. Their care delivery model, involving six rural hospitals and 17 primary care practices, will train pharmacists in transformative care and chronic disease management protocols. Through care coordination and shared access to electronic medical records, the project will enable pharmacists to participate in improving medication adherence and management, resulting in better health, reduced hospitalizations and emergency room visits, and fewer adverse drug events for patients with multiple chronic diseases.

The award is part of CMS’s Health Care Innovation Challenge, a $1 billion fund to support initiatives that have the potential to improve care and lower the overall cost of healthcare. With the funds, CNRVMC will launch a three-year program to improve the health of patients in the rural parts of our state through better management of their medications.

Three Clinical Research Nurses Join the Office of Sponsored Projects

The Office of Sponsored Projects (OSP) welcomed three new clinical research nurses: Karen Baker, Karen Buchanan and Charlene Viers.

Research nurses manage the clinical trial from start to finish. An important part of their management is to work closely with investigators to ensure the confidentiality and safety of research subjects, make sure trials are compliant, and serve as the liaison between the sponsor, OSP and the research team.

Karen Baker has worked in clinical research since 2006 and joined OSP in late 2011 as a clinical research nurse, primarily for infectious disease. Karen earned certifications in clinical research from the Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SOCRA). Karen received her RN degree from Jefferson College of Health Sciences and is currently working on her MSN at Western Governors University. Before working in research, she worked as a critical care nurse at Carilion.

Karen Buchanan joined OSP in April 2012 as a cardiology clinical research nurse. She earned a Bachelor of Science degree in nursing from Jefferson College of Health Sciences. Before joining OSP, Karen worked in the cath lab holding area and was a certified nephrology nurse in dialysis for 18 years.

Charlene Viers joined OSP in May 2012 as a clinical research nurse. She has been a nurse for 20 years with 18 years experience in oncology and seven years experience in clinical research. She holds certifications as an oncology certified nurse (OCN) and certified clinical research professional (CCRP). Prior to joining OSP, Charlene was a senior quality and compliance auditor for McKesson Specialty Health. She has a BSN from Virginia Commonwealth University/Medical College of Virginia and has recently been accepted into the graduate nursing program at Old Dominion University.

OSP is pleased to welcome these highly qualified and talented individuals.

Changes to the QA/QI & Internal Research Application and Approval Process

Beginning this summer the Office of Sponsored Projects (OSP) and the Institutional Review Board (IRB) will modify the process for submitting QA/QI applications as well as internally-sponsored (department funded) research applications.

Currently, the process is for the principal investigator (PI) to complete the Application to Conduct Research or QA/QI form and submit this to OSP. Requirements associated with this form include signatures (PI, his/her department chair/VP and the chair/VP of any investigators outside of the PI’s department), an abstract and disclosure of any outside entities working with the PI on the project. OSP will then review the application and either approve via a letter or contact the PI with additional questions. The IRB application is submitted by the PI after the Application to Conduct Research or QA/QI form is submitted to OSP.

The new process includes additional disclosures to ensure all patient protections are met, as well as ensuring Carilion and its employees are protected when outside interests are involved. The new process should also improve communication between OSP and IRB, thus resulting in a faster turn-around time.

The revised procedure for applying to conduct a QA/QI project or an internally-funded research project will be:

  1. Principal investigator will complete the revised Application to Conduct Research or QA/QI form. This form will instruct the PI on what to do should the project involve outside groups or non-Carilion employees (including VTCSOM students). It will also instruct the PI on what to do should the project involve accessing protected health information.
  2. OSP will review the form. If the PI indicates outside entities or individuals are involved, OSP will begin the process of securing the appropriate executed agreements. If the PI indicates protected health information is required, OSP will direct them to the appropriate forms/contacts.
  3. OSP will send the PI a letter that must be included in the IRB application. This alerts the IRB that OSP has reviewed the application and is working on additional conditions. IRB review can then occur concurrently. Please note that even if IRB approval is given, the PIs project cannot begin until the additional conditions in the OSP letter have been fully met.
  4. If there are no additional concerns, OSP will issue an approval letter to the PI and this letter should be included in the IRB application.

Detailed instructions on the revised Application to Conduct Research or QA/QI form as well as a basis for the requirements of agreements with outside entities and individuals will be available on the OSP webpage this summer. Please contact OSP 540.985.8510 or research@carilionclinic.org if you would like additional information.

Mission Model Agreements & Guidelines International (MAGI) Conference

MAGI is standardizing best practices for clinical research operations, business and regulatory compliance. Approximately 600 participants representing over 350 international organizations attended the May 2012 conference. Nancy Gentry, the OSP financial services manager spoke at the MAGI conference. Nancy shared her expertise regarding Medicare billing compliance in practice, which is of great concern to any organization conducting research. She outlined how Carilion has implemented new processes and tools (EPIC and BioOptronics Clinical Conductor) to help ensure billing compliance for clinical research trials.

Carilion’s Active Clinical Trials’ List

For a snapshot view of all Carilion’s active clinical trials, we have developed an Active Clinical Trials Index. This index can be found by going to the Carilion Clinic homepage, select Education and Research, Research at Carilion, then looking at the left-hand side of the page, you will find Active Clinical Trials Index as the first item “In This Section.”