CRCN meeting tomorrow, July 1: eIRB Upgrade demo

Please join the Clinical Research Coordinator Network in a special IRB presentation on the new eIRB upgrade, Wednesday, July 1. This demonstration of the new eIRB system will include a presentation of the new processes for initial submissions, modifications and CRQs, and the new Reportable New Information (RNI) system. This presentation will be followed by a Q&A session and networking.

CRCN Quarterly Meeting: eIRB Upgrade demo
Wednesday, July 1
11 a.m. to 12 p.m.

Mackenzie Hall 1168

The Clinical Research Coordinator Network fosters networking, professional development, and learning opportunities for clinical research coordinators at OHSU and associated institutions by acting as a platform for sharing information, ideas, and best practices among coordinators and other research staff.

If you have questions about this presentation or would like to get involved, please visit the CRCN Bridge Site or contact the Clinical Research Coordinator Network at askastudycoordinator@ohsu.edu.

New VA undersecretary for health appointed

Last week the Senate approved President Obama’s nominee, David Shulkin, M.D., current president of Morristown Medical Center in New Jersey, to oversee the health care arm of the Department of Veteran’s Affairs. Shulkin will assume the role of managing a troubled health care system responsible for 9 million veterans in nearly 1,000 VA facilities nationwide.

David Shulkin, M.D.

David Shulkin, M.D.

Carolyn Clancy, M.D., has been serving as interim undersecretary for health since Robert Petzel, M.D., stepped down in the wake of a 2014 scandal that exposed improper scheduling practices. These practices resulted in over year-long waits  for veterans seeking care at various sites and records were falsified to make it appear patients were receiving treatment in a timely manner. These long wait times contributed to as many as 40 patient deaths, according to VA officials. Public outrage over these revelations eventually led to the resignation of Veterans Affairs Secretary Eric Shinseki.

Shulkin is a nationally recognized authority on hospital management with specific expertise in integrated delivery systems, quality and safety, error reduction, patient/physician satisfaction improvement, and strategic issues in healthcare.

 

 

InfoEd upgrade July 20; booster sessions offered for current users

OHSU’s grant proposal and submission system, InfoEd, is getting a welcome upgrade this summer! System downtime is scheduled for July 20, after which, you’ll see significant improvements concerning the budgeting and personnel sections.

To help current users adjust to these changes, we are offering InfoEd Booster sessions. One of these sessions will be recorded and posted online via Echo360 for anyone who isn’t able to join us on the following dates.

InfoEd booster sessions:

  • Tuesday, July 14, 10 a.m. to 12 p.m., OHSU Hospital, 8th floor auditorium
  • Thursday, July 16, 2 to 4 p.m., OHSU Hospital, 8th floor auditorium
  • Wednesday, July 22, 12 to 2 p.m., OHSU Hospital, 8th floor auditorium
  • Thursday, July 23, 10 a.m. to 12 p.m., Montagna Auditorium at West Campus

Danny Stockdale will be leading these sessions and is available at infoedfaq@ohsu.edu to answer any questions or concerns about the upgrade.

Enroll in an InfoEd Booster Session in Compass or simply come on by.

Research administration: Introduction to subawards, July 14

Does your department subcontract with third parties for research projects or programs? Are you curious to learn about subawards and subrecipients?

Consider joining Office of Proposal and Award Management’s in-house experts as they provide a general overview on OHSU’s recently updated processes in handling outgoing subaward agreements.

Overview of the subaward process
Tuesday, July 14
12 to 1 p.m.
Mackenzie Hall, room 2201

This will be an informal introduction with OPAM’s subaward team walking you through the basics, introducing you to forms and then answering any questions regarding the how, what, why, who, and when of subawards.

Enroll via Compass or just come on by.

The subaward team hopes to continue this as a series and address related topics based on your interest. This might include subaward budgets and payment schedules, developing a subaward scope of work, subawardee risk assessment, and other topics. For feedback and questions, contact Jen Michaud, subaward grants and contracts administrator.

IRB Brown Bag Special Series: eIRB Upgrade demo, July 23

IRB Brown BageIRB Upgrade demo

Presented by Kelly Kidner, IRB Analyst

Thursday, July 23
11:30 a.m. to 12:30 p.m.
OHSU Hospital, 8th floor auditorium

Are you involved with human subjects research? Come to the eIRB Upgrade demo! During this brown bag we will be giving an overall demonstration of the new eIRB system. You can see a presentation of the new initial submissions process, the modifications and CRQs and the new Reportable New Information (RNI) system. This brown bag session will be open for questions and answers.

New online platform for submitting limited submission applications and more

OHSU has a new online Competitive Application Portal (CAP) for managing applications and review. Sponsored by the Office of the Senior Vice President for Research, in collaboration with the Knight Cancer Institute and OCTRI, this platform streamlines the process of applying for the following types of funding:

  • Limited Submissions
  • AwardsCapture
  • Bridge Support
  • Pilot Grants
  • Other OHSU-sponsored funding

Who will be using it? You will, if you apply for limited submissions, OHSU bridge funding, and several other OHSU-sponsored awards (e.g. pilot funds from OHSU institutes or centers, fellowships). You will also use it if you’re reviewing for these opportunities. Finally, if you yourself are an OHSU sponsor–let’s say you have a T32 program and you want to make it available to OHSU applicants and even those outside the institution–you may want to use this tool.

CAP allows applicants to see upcoming funding competitions, track deadlines, access application materials, and receive automatic notifications on application status. It also provides automatic routing to reviewers, streamlined communications, and tracking of award information (e.g. success rates, number of  applicants per competition) through its reporting function.

Please note: CAP is not in any way connected to, or a replacement for, InfoEd. (It’s licensed by InfoReady, which is a different company.) All grant applications will continue to be submitted through existing channels.

Please contact funding@ohsu.edu with questions or if you would like to set up a competition.

Who’s new at OHSU? Meet Larisa Tereshchenko, M.D., Ph.D.

Members of the lab, from left to right: Muammar Kabir, Ph.D., postdoctoral fellow; Elyar Ghafoori, M.S., research assistant; Larisa Tereshchenko, M.D., Ph.D.; Lauren Hawkins, B.S., research assistant; Charles Henrikson, M.D., M.P.H., director of  Clinical Electrophysiology program, KCVI

Members of the lab, from left to right: Muammar Kabir, Ph.D., postdoctoral fellow; Elyar Ghafoori, M.S., research assistant; Larisa Tereshchenko, M.D., Ph.D.; Lauren Hawkins, B.S., research assistant; Charles Henrikson, M.D., M.P.H., director of the clinical electrophysiology program, Knight Cardiovascular Institute

Meet Larisa Tereshchenko, M.D., Ph.D., assistant professor, cardiac Electrophysiology, Knight Cardiovascular Institute. She’s a new faculty member at OHSU, heading up a lab focused on prediction, prevention, and treatment of sudden cardiac death.

Where were you before coming to OHSU?
I was born and raised in Omsk, a small town in southwestern Siberia, where my parents were physicians. For me, there was no question but that I would go to medical school. At Omsk and Novosibirsk Medical School in the industrial city of Novosibirsk, Siberia, I studied math, science and engineering and got an M.D. Ph.D. degree, completed a clinical fellowship in cardiology and cardiac electrophysiology, and then worked as an assistant professor of medicine at Tyumen Medical School. My first mentor in cardiology died suddenly from ventricular fibrillation at age 51, which inspired me to focus on sudden cardiac death prediction and prevention. I look at the electrical side of things.

I came to the U.S. in 2004 as a visiting research associate at Washington University in St. Louis, and then became a postdoc in electrophysiology at Johns Hopkins in 2007. I conducted studies to build on the technology of implantable cardioverter defibrillators—to make these devices smarter and better able to predict and respond to irregular heartbeats. The same year I came to the U.S., in 2004, Hungarian soccer player, Miklos Feher, suffered sudden cardiac death during a game and died instantly. It’s a dramatic example of why we need to do this work. How can we predict how deaths like this happen? How can we tell if someone is at risk when they have none of the traditional markers of cardiac arrest? Much research has been done to trace cardiac arrest from its obvious origins: plaque buildup in the arteries, a history of stroke or heart attack, or genetics. But who’s at risk for sudden cardiac death in the general population? There’s no way to save them unless we know who’s at risk. In 2013, I received an R01 to look at who’s at risk for sudden cardiac death in the general population.

What brought you to OHSU?
I joined the Knight Cardiovascular Institute that same year to grow and expand my program in order to advance prediction, prevention and treatment of the cardiac arrhythmias. At the Knight Cardiovascular Institute, we work closely together with the clinical electrophysiology group under director Charles Henrikson, M.D. Close collaborations with Dr. Henrikson help us to work on clinically important questions and implement the results of our research findings in clinical practice, to improve patient care. I am working to identify the risk factors that lead to sudden cardiac death and underlying cardiac arrhythmias: ventricular arrhythmia, paroxysmal atrioventricular block, and atrial fibrillation.

What specific avenues of research are you exploring?
I am aiming to redesign the electrocardiogram analysis approach, developing a method to reveal and quantify unapparent ventricular conduction, variability in repolarization, and other electrical abnormalities. I am using non-invasive mapping to engineer models that display the body’s electrical activity, measure arrhythmia and ultimately identify predictors of cardiac arrest. We study the risk of arrhythmia in different groups of patients: heart failure patents, kidney failure patients on dialysis, and those who have rare diseases with a high risk of arrhythmias.

So far, our work has yielded two patent-pending inventions designed to measure and map electrical activity. We are looking at these measurements of heart function, overlapping them with other organ functions, to show more detail than an electrocardiogram ever could. We have three-dimensional bodies, so we should be looking for three-dimensional answers.

I am also conducting two ongoing clinical studies at OHSU that are actively enrolling patients. I am the principal investigator of a randomized controlled trial, called “aCRT ELSYNC,” which has the goal of determining the best treatment approach for heart failure patients. Another study is observational: we try to find the best way to record and analyze electrocardiograms to determine if subcutaneous defibrillators would be a suitable treatment option for those patients who might need it.

Also, recently I initiated and organized an electrophysiology patient council, a group of patients with cardiac arrhythmias who advise us how to conduct clinical research, which questions they consider important, and how they would like us to address those questions. This is a completely novel approach that put patients at the center of clinical research. The Patent-Centered Outcome Research Initiative (PCORI) inspired this revolutionary clinical research, and I am glad to be part of this effort.

Tell us something about your career that’s not on your CV?
I want to grow my team! I am looking for M.D.-Ph.D. students, postdocs, residents, cardiology and electrophysiology fellows, and, specifically, anyone with an electrical or biomedical engineering background. The work in my lab is translational research. Our lab-generated information is helping answer some very important clinical questions.

What do you like to do for fun?
I like to travel. This summer, I am going to Iceland to go snorkeling with my son. He’s an M.D.-Ph.D. student at the University Of Iowa Carver College Of Medicine.

More information
Tereshchenko’s team’s paper –Electrocardiographic Deep Terminal Negativity of the P Wave in V1and Risk of Sudden Cardiac Death: The Atherosclerosis Risk in Communities (ARIC) Study” – was  published in the Journal of the American Heart Association in November 2014.

 

Reminder: register for the NRSA Application Workshop, June 30

If you’re planning to apply for a pre- or post-doctoral NRSA fellowship from the NIH in the near future, we encourage you to attend this workshop to learn about essential, non-research elements of your fellowship application. Topics covered include elements needed for an InfoEd proposal, how to develop a budget, how to manage reference letters, biosketches and PMCID numbers,and elements of a great training plan.

This workshop is led by Johanna Colgrove, M.D., Ph.D., program coordinator; Jerry Robertson, grants and contracts administrator; and Rachel Dresbeck, Ph.D., director of research development.

NRSA Application Workshop
Tuesday, June 30, 2015
11 a.m. to 1 p.m. in the Biomedical Research Building 381

Open to both researchers and administrators. Registration now available on Compass.

Maintaining integrity in peer review: new NIH guidelines

Do you know someone on the study section reviewing your NIH application? Do you want to give them a friendly call to update them on your current results? The NIH says DON’T! Because the research community is inherently small, investigators within the same field often have contact with the very people who may be reviewing their NIH applications. How then should confidentiality be maintained? What are the parameters? Last week, the NIH issued new guidelines for Applicant Responsibilities in Maintaining the Integrity of the NIH Peer Review that provide answers to these questions as well as possible consequences of unethical behavior.

In a recent guest posting on Sally Rockey’s Rock Talk blog, Richard Nakamura, Ph.D., director of the NIH Center for Scientific Review, wrote: “We understand that professional interactions need to continue while your application is undergoing peer review. However, as a PI, you cannot attempt to influence the outcome of the review…You cannot provide new information or data on your application directly to reviewers… You also cannot contact reviewers to get your scores or critiques.”

More specifically, the new guideline state that applicants:

  • Should not contact reviewers on the study section evaluating his or her application to request or provide information about the review or to otherwise attempt to influence the outcome. The only acceptable process for such communication is through the Scientific Review Officer (SRO) who is managing the study section.
  • Should not send information or data directly to a reviewer on the study section evaluating his or her application. The only acceptable processes for submitting post-submission materials are outlined in NOT-OD-10-115, NOT-OD-12-141, and related notices.
  • Should not attempt to access information related to the review of that application in secure NIH computer systems.

Maintaining the integrity of the scientific review process is perhaps more important than ever. Attempts to influence this process can erode public confidence, drain limited federal resources, and diminish the level of trust within the scientific community. As such, the new guidelines clearly outline the repercussions of engaging in this type of behavior:

Consequences:
The NIH may defer or withdraw an application if it determines that a fair review is not feasible because of a breach of these guidelines. Additional steps to ensure the integrity of the peer review process may be taken, including but not limited to:

  • Notifying or requesting information from the applicant institution or the individual’s institution
  • Pursuing a referral for government-wide suspension or debarment
  • Notifying the NIH Office of Management Assessment (OMA) with possible referral to the U.S. Department of Health and Human Services Office of Inspector General (OIG)

Still in doubt about what constitutes a violation? Further details, including information about reviewer violations, can be found on the NIH’s updated website, “Integrity and Confidentiality in NIH Peer Review.”  In addition, the FAQs on Confidentiality in Peer Review provide scenarios to help you evaluate potential breaches.

 

IRB Brown Bag Special Series: eIRB Upgrade demo, June 25

IRB Brown BageIRB Upgrade demo

Presented by David Holmgren, IRB Manager

Thursday, June 25
11:30 a.m. to 12:30 p.m.
OHSU Hospital, 8th floor auditorium

Are you involved with human subjects research? Come to the eIRB Upgrade demo! During this brown bag we will be giving an overall demonstration of the new eIRB system. You can see a presentation of the new initial submissions process, the modifications and CRQs and the new Reportable New Information (RNI) system. This brown bag session will be open for questions and answers.

Welcome to the Research News Blog

Welcome to the Research News Blog

OHSU Research News is your portal to information about all things research at Oregon Health & Science University. Visit often for updates on events, discoveries, and important funding information.

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