Novemer 21, 2014

ANNOUNCEMENTS

1. New Mandatory Human Research QI Audit Program for IND or IDE holders

A message to the MGH Research Community from Harry W. Orf, PhD, Senior Vice President for Research and Maurizio Fava, Director of the Division of Clinical Research

The Partners Human Research Quality Improvement Program (QI Program), in collaboration with the Institutional Officials at MGH is initiating a new not-for-cause, onsite audit program for Investigators that hold an investigational drug or device application (IND or IDE) from the FDA for their research studies. The goal of this program is to ensure that Investigators holding IND or IDE applications (called Sponsor-Investigators) are fulfilling the responsibilities set forth in the FDA regulations for drug/device research. This service will complement the education that QI currently provides to new Sponsor-Investigators prior to the start of their study.

How studies will be selected:
This program covers studies that have been reviewed by the Partners IRB and have an IND/IDE Sponsor-Investigator. Studies will be selected for audit based on several factors such as number of years the IND/IDE has been active, investigator experience with IND/IDE studies in the past and number of active protocols under the IND/IDE.

How the Audit Program will work:

• When a protocol has been selected for review, the appropriate Institutional Official will personally notify the Principle Investigator.
• A member of the QI Program will then communicate with the Investigator or study staff to select a time and place for the audit.
• The onsite audit activities will include a brief meeting at the beginning of the audit, review of study files, and an exit meeting.
• QI will provide education and feedback regarding Sponsor-Investigator FDA responsibilities as needed.
• The QI Program will provide a report of observations and corrective actions at the conclusion of the audit. If serious findings are identified, the QI program will work with the investigator and their study team to properly report them to the IRB per Partners policy.

Since 1999, the QI Program has provided education and practical feedback to hundreds of investigators and staff across Partners. We look forward to working with your study team to achieve the highest standards of research at MGH.

Sincerely,
Sarah White, MPH
Director, QI Program

2. Internet Explorer 11 coming to MGH in 2015

Internet Explorer 11 (IE11) will begin rolling out to all PHS standard workstations and laptops in January 2015, replacing Internet Explorer 8. All web-based applications and websites used in departmental workflows need to be certified in IE11 by the end of December 2014.

MGH MGPO IS has been reaching out to web-based application and website owners to provide information concerning the IE11 certification process and testing has started for many of these applications.

If your department manages web-based applications and/or websites, and you have not been contacted by MGH MGPO IS, please refer to the following SharePoint site for information about the IE11 program:

http://sharepoint.partners.org/mgh/mgpoismap/MGHMGPOIE11TESTING/default.aspx

If you have any questions, please contact the IE11 site contacts, Dana Conroy and Mark Osinski.

3. Core of the Week: MGH Research Informatics Core

MGH Research Informatics Core
Director: Misha Pivovarov
Location: Simches Research Center, 5th floor, 185 Cambridge St., Boston

Our objective is to provide software application development and hosting services. We would like to utilize our expertise and the software modules we have created to help others organize, store, analyze and share scientific data.

To learn more about the MGH Research Informatics Core, please click here.

4. The Latest from PCORI - Webinars on Engagement Awards and Dissemination; Health Data Workshop

Please click here to read the latest news from the Patient-Centered Outcomes Research Institute.

5. No Research News on 11/28

Next Week, due to the holiday, the MGH Research News will not be sent out. We hope you have a very safe and Happy Thanksgiving with your friends and family!

EVENTS

1. The 2014 Warren Triennial Prize & Symposium

Monday, November 24, 2:00 - 5:00 PM, Simches Auditorium 3.110
with broadcast to Isselbacher Auditorium, CNY 149, 7th Floor

First awarded in 1871, the Warren Triennial Prize recognizes scientists who are seekers of and contributors to new knowledge in the service of medicine. This year's symposium will focus on "The Genetics of Cancer" and honor the 2014 recipient, Bert Vogelstein, PhD, of Johns Hopkins University School of Medicine, featuring guest speakers such as:

• Gad Getz, PhD (Broad/MGH)
• Tyler Jacks, PhD (MIT/HHMI)
• Kornelia Polyak, MD, PhD (DFCI)
• Alice Shaw, MD, PhD (MGH)

For more information on the event agenda, please click here. For more information about past winners and the history of the Warren Triennial Prize, click here.

All are welcome to attend!

2. MGH Research Council

Monday, December 1, 12:00-1:00 PM, Simches 3.110
with Broadcast to Isselbacher Auditorium (CNY-149, 7th floor), Lunch available at 11:45 AM

• Annual Conversation with Peter Slavin, MD, President of MGH

All MGH Researchers welcome!

3. 2015 World Medical Innovation Forum - Neurosciences

April 27-29, 2015, Boston, MA

Partners HealthCare, its world leading hospitals - Brigham and Women's Hospital, Massachusetts General Hospital, McLean Hospital - and its Harvard Medical School appointed faculty invite you to be part of the World Medical Innovation Forum. Join 1,000 international innovation decision-makers as they define the state of the art in neuroscience technology, care and research. Directly interact with the CEOs bringing game-changing CNS products to market, world-class clinicians delivering the highest-quality care and the scientists rapidly propelling this crucial field forward.

From start to finish every speaker an expert, every panel unique - an unrivaled view into CNS discovery, technologies, markets, and healthcare innovation overall

• Directly engage with world leading clinicians, scientists, CEOs, and investors as they chart CNS innovation and explain its unmet needs
• See the neurotechnology breakthroughs that are reshaping health care
• Assess and enhance the prospects for innovation in a transformed health care industry
• Jointly define the state of the art in neuroscience technology, care, and research
• Meet, share perspectives, and strategize with hundreds of top executives, clinicians, deal makers, investors, scientists, government, and international leaders

A reduced registration rate is available until January 1, 2015. Please join the World's Medical Innovation Forum, its unmatched speakers and cutting edge topics. Join your fellow medical innovation leaders from throughout health care.

Register Now! Please contact Chris Coburn, Partners Vice President, with any questions.

4. Boston Single-Cell Network Meeting

Tuesday, December 2, 2:00-3.30PM, Longwood, DFCI, 44 Binney Street, 16th floor, room 1620

Agenda:
 "Harnessing variation between single cells to decipher intra and intercellular circuits in immune cells"
Aviv Regev (Core Member, Broad Institute; Associate Professor, MIT Department of Biology; Early Career Scientist, HHMI)

"Single-cell RNA-seq highlights intratumoral heterogeneity in primary glioblastoma"
Itay Tirosh (Postdoctoral Fellow, Regev and Golub Labs)

Faculty organizers: Peter Kharchenko and Lev Silberstein

Food and beverage will be provided at the meeting.

FUNDING OPPORTUNITIES

1. MGH ECOR Formulaic Bridge Funding Support 

The Executive Committee on Research (ECOR) is accepting applications for Formulaic Bridge Funding Support. 

What are they?
Formulaic Bridge Funding Support is offered to assist MGH Principal Investigators (PIs) during a lapse or delay in their research funding from the NIH. To be eligible for Formulaic Bridge Funding, applicants must have applied as a PI for an R01 or R21 NIH grant to support an independent, long-term research program.

The Formulaic Bridge process is open to:

1. Investigators whose grants received a score < or = 20th percentile and have received written communication from the NIH that the grant will not be funded.
2. Investigators whose grants received a fundable score (< or = 20th percentile), but are three months past the nominal start date of their NIH grant.

When is the deadline?
7th day of each month

How do I learn more and apply?
Click here to read more and apply online.

2. Center for the Human Immunology (CHI) Pilot Feasibility Program

The Center for the Human Immunology (CHI) invites investigators working in areas relevant to viral persistence or initiating a new area of research relevant to viral persistence to apply for support under the CHI's Pilot Feasibility Program. Pilot Feasibility Awards are one year awards for up to $50,000 direct costs.

The Center for the Human Immunology (CHI) is a multidisciplinary program funded by NIAID. CHI promotes the research of both basic and clinical scientists in areas related to the persistence of hepatitis C virus infection. These include, but are not limited to:

• Immune and Inflammatory Responses to Pathogens (including innate immune recognition and antigen presentation)
• Viral Pathogenesis (including virus-host cell interactions, but related to the immune response)

GOALS: Funds have been made available to support Pilot/Feasibility Study grants consistent with the overall goals of the Center. The goals of the CHI Program are to support:

• Young investigators (junior faculty or senior fellows*) working in areas that will improve our understanding of basic processes relevant to viral persistence.
• Established investigators initiating a new area of research in their laboratories relevant to mechanisms underlying viral persistence.

The objective of a Pilot/Feasibility Study grant is to enable an investigator to complete sufficient preliminary studies to enable successful application for more substantial funding from other sources. Pilot/Feasibility Study grants are not intended to supplement ongoing or currently funded projects.

FUNDING: The CHI will be funding grants of up to $50,000 direct costs through this program. Pilot/Feasibility Study awards are made for a one-year period; a second year may be considered on a competing basis.

APPLICATIONS: May be obtained by sending a request to Barbara Steele via telephone at 617-724-7554 or via email at bsteele@mgh.harvard.edu. The deadline for receipt of applications is December 12, 2014.

*Fellow must be in the final year of training and must have a documented commitment to a faculty appointment by the sponsoring unit or department. 

3. Limited Submission Funding Opportunities

We ask that all MGH Investigators interested in applying for any limited submission award submit a Letter of Intent (see detailed instructions below) to the MGH Executive Committee on Research (ECOR) by the deadline indicated for each award to be considered to receive an institutional nomination.

Process
Submit a one- to two-page Letter of Intent (LOI) to the MGH Executive Committee on Research (ECOR) via email to ecor@partners.org. In addition to your LOI, please include an NIH Biosketch.

The letter of intent should include:
1. Name of the Principal Investigator with appropriate contact information
2. A descriptive title of the potential application
3. Brief description of the project
4. Brief description of why you specifically should be selected to receive institutional nomination for this award

In the event that there is more than one MGH investigators interested in applying for each limited submission award, the LOIs will be used to assess candidates and a review and selection process will take place.

Current Limited Submission Funding Opportunities
Please click here for more information and for our internal deadlines.

• NIH Director's Early Independence Awards (DP5)

If there is a limited submission funding opportunity you do not see listed above or you have any additional questions, please contact Erin McGivney at 617-643-6471.

4. Private Funding Opportunities 

Please contact Corporate & Foundation Relations in the Office of Development at devcfr@mgh.harvard.edu if you wish to submit a proposal in response to any of these funding opportunities. Note that proposals are still routed through the standard InfoEd/Research Management process.

• OREF Prevention of Musculoskeletal Youth Sports Injuries Grant, Orthopaedic Research and Education Foundation (OREF)
• Pediatric Scientist Development Program (PSDP), Cincinnati Children's Hospital Medical Center
• Fellowship Awards, Jane Coffin Childs Memorial Fund for Medical Research
• Applied Epidemiology Fellowship Program, Council of State and Territorial Epidemiologists (CSTE)
• Professional Development and Education, Paralyzed Veterans of America (PVA)
• Consumer, Caregiver, and Community Education, Paralyzed Veterans of America (PVA)
• Assistive Technology, Paralyzed Veterans of America (PVA)
• Research Utilization and Dissemination, Paralyzed Veterans of America (PVA)

Please click here for further details on these funding opportunities.

5. NIH Update for Week Ending November 21, 2014

For the latest National Institutes of Health notices, requests for applications, and program announcements, follow this link: http://grants.nih.gov/grants/guide/WeeklyIndex.cfm

IN CASE YOU MISSED IT

Reminders of recently posted funding opportunities, deadlines and events

MGH ECOR Formulaic Bridge Funding
Application Deadline: 7th day of each month

Boston Biomedical Innovation Center (B-BIC) Accepting PILOT & DRIVE Grant Pre-Proposals

The Warren Triennial Prize & Symposium - November 24

CRP Spotlight Series: Delegation of Responsibilities in a Clinical Research Study - December 4

HMS Faculty Seminar - “Meet and Greet” Faculty Networking Lunch with Dr. Susan Slaugenhaupt - December 9

Introduction to Proteomics and Metabolomics - December 18 

Save the Date! SAC 2015 - April 1 & 2, 2015

Executive Committee On Research (ECOR) Massachusetts General Hospital

50 Staniford Street, Suite 1001, Boston, MA 02114

ecor@mgh.harvard.edu