Research News - December 2, 2016

If you are currently receiving NIH funding for clinical trials research or will be applying for NIH funding to support a clinical trial, you must now comply with a new NIH policy that requires training in Good Clinical Practice (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148.) Like the human subjects research training requirement, GCP training must be renewed every three years.  The NIH has set a compliance date of 12/31/16. 

Investigators and study staff subject to the NIH policy are expected to have completed training by the end of the year or, at a minimum, to have registered for training and maintain documentation of registration. Please click here for more information!

On Tuesday, September 20, 2016, Apple released Operating System (OS) macOS Sierra 10.12 for Mac laptops & desktops. Currently, there are two enterprise applications used for connectivity that do not work automatically after upgrade…click for more.

As immigration was a primary theme of President-elect Donald Trump's campaign, many foreign nationals, family members, and employers are concerned about possible changes after Inauguration Day, January 20, 2017. PIPS will issue email notifications on immigration topics as more information becomes available; please also check the PIPS website.

It is of utmost importance to remember that considerable time is required to make changes to immigration laws, and new laws cannot be enacted quickly. These changes require certain steps, and sometimes lengthy protocols, mandated by our constitutional system and rule of law. The rate at which change may happen depends on multiple factors - certainly political forces, but also timing and legal constraints.
Of more immediate concern are policies and programs that were initiated and are operating based on executive orders issued by President Obama, as these were cited by President-elect Trump as subject to elimination. One such program is the Deferred Action for Childhood Arrivals (DACA), which provides deferral from enforcement for individuals brought to the U.S. as children, and also provides work authorization and travel authorization.

Discussion during the presidential campaign about the protection of U.S. workers may lead to proposals to reform certain visa categories including the H-1B. Employer compliance with the rules governing employment eligibility verification (Form I-9 and E-Verify) will be essential, as will compliance with H-1B and labor condition application requirements. Enhanced enforcement of immigration laws is also anticipated by many commentators.

Finally, the United States Citizenship and Immigration Services (USCIS) recently published the following: 
Many USCIS customers have been contacting us with questions regarding current immigration programs and possible future immigration policies. We continue to process all applications, petitions, and requests consistent with current statutory laws, regulations, and policies. USCIS cannot comment on what sort of policies the incoming Administration may choose to prioritize or pursue.  We remain focused on our mission to administer U.S. immigration laws and to provide a high level of service to our customers. 
 We encourage the public to be extra vigilant about immigration scams. Scammers take advantage of times of uncertainty. For information on protecting yourself and your loved ones, visit uscis.gov/avoidscams. Remember, the wrong help can hurt!

Below, please find helpful links to understanding United States government processes and lawmaking:
https://www.uscis.gov/laws
https://www.uscis.gov/laws/immigration-and-nationality-act
https://www.uscis.gov/laws/8-cfr/title-8-code-federal-regulations

Monday, December 5, 2016, 12:00 - 1:00 PM, Simches Auditorium (3.110)
Broadcast to Isselbacher Auditorium (CNY-149, 7th Floor)

• Isuggest: How you can help Improve Research Operations at MGH & Partners
• ECOR Elections Results

 All MGH Researchers welcome!

Monday, December 5, 2016, 4:00 – 5:00 PM, CNY149, 7th Floor, Isselbacher Auditorium

“T cell migration and function during the anti-tumor response”
Thorsten R. Mempel, PhD
Associate Professor Medicine, Harvard Medical School
Principal Investigator, Center for Immunology and Inflammatory Diseases, Massachusetts General Hospital

Thursday, December 15, 2016, 2:30 – 4:00 pm, Simches 3.120

Speakers: Karen K. Miller, MD and Andrew Nierenberg, MD

NIH mentored K awards are Career Development Awards that support mentored research and research training for up to 5 years. If you are thinking about applying for a K award, please join us for this general information session on the awards and application process.

Karen K. Miller, MD and Andrew Nierenberg, MD, will discuss topics such as:

• Which K is right for you?
• How important is mentoring? How do you choose a good mentor?
• What are the components of the grant application?
• When should you apply?
• What resources are available to help your write the proposal?

This will be an informal session with time for questions. Light refreshments will be served.

Please note: A formal, multi-session course on preparing a proposal for an NIH Career Development “K” Award will be offered in February 2017. The application process will begin in December 2016. The formal course is specifically for those who have started to work on a K award application and are planning to submit a proposal within the next year.

Registration is required. Please contact Jillian Tonelli with any questions.

Thursdays, January 5, 12, 19, 26, February 2, 1:30 – 3:00 pm, Simches, Room 3.110

Sponsored by the MGH Division of Clinical Research and the MGH Biostatistics Center

Brian Healy, PhD, MGH Biostatistics Center
This course will provide clinical researchers with a solid foundation in biostatistical concepts. Intended for those with minimal statistical experience, these five lectures will serve as an introduction to biostatistical issues in clinical investigation and will prepare students for more advanced courses on clinical trial design and biostatistics offered through the DCR’s Education Unit. 

January 5: Types of Data, P-Value, Steps for Hypothesis Testing, and T-Test
January 12:  ANOVA and Regression
January 19: Analysis of Dichotomous Outcomes and Time to Event Outcomes
January 26: Power and Sample Size
February 2: Grant Writing: Statistical Considerations Section with Pilot Data

Registration is required. Please contact Jillian Tonelli with any questions.

Weekly starting February 1 - March 21, Simches Building, 2nd Floor, Garrod/Mendel Conference Room

This course is sponsored by the MGH Division of Clinical Research

Are you planning on submitting for an NIH Career Development Award? Then plan on attending Conquering the K!

Conquering the K is a comprehensive, eight session course, which focuses on the preparation of a NIH career development proposal. MGH faculty will discuss research design and career development plan focusing on how all the sections of the application must fit together to demonstrate the applicant’s commitment to becoming a clinical investigator. Hands-on workshops are included to help participants prepare each section.

Application deadline is Friday, January 20, 2017. Due to the interactive design of this course, we will accept a maximum of 25 applicants. ** Incomplete applications will not be considered **

Who should attend? Fellows and instructors interested in submitting for an NIH K-Award (i.e. K08, K23) in June/October 2017 or February 2018.

Course Requirements: All attendees will be required to submit their draft of specific aims, name of mentor, and confirm whether they have preliminary data.

Please apply here. Contact Jillian Tonelli with any questions.

Internal Deadline: December 16, 2016

The W. M KECK FOUNDATION’S MEDICAL RESEARCH PROGRAM strives to fund endeavors that are distinctive and novel in their approach.  It encourages projects that are high-risk with the potential for transformative impact.  "High-risk" comprises a number of factors, including questions that push the edge of the field, present unconventional approaches to intractable problems, or challenge the prevailing paradigm.  In all of its programs, "transformative" may mean creation of a new field of research, development of new instrumentation, technologies or methodologies enabling observations not previously possible, or discovery of knowledge that challenges prevailing perspectives. Funded projects cannot focus on clinical or translational research, treatment trials or research for the sole purpose of drug development.

This is a restricted opportunity with concept papers limited to FOUR and proposals limited to ONE PER INSTITUTION. Both Senior and Early Career investigators are encouraged to apply.

Award Amount: Research grants range from $500,000 to $5 million, and are typically $2 million or less.
Indirect Cost Rate: Indirect costs are not allowed.
Please note that any grant that brings in less than 15% in indirect costs (IDC) will need to be supplemented up to the 15% equivalent by existing investigator or departmental sundry funds. Resolution of this issue must occur prior to submission of the award.

Eligibility/Restrictions: 

• Keck is looking for BASIC, FUNDAMENTAL RESEARCH. Keck does not support clinically-oriented or disease-specific research. The ultimate application can be clinical, but the focus should be on basic underlying mechanism(s).
• KECK HAS MOVED AWAY FROM HYPOTHESIS-DRIVEN RESEARCH. An external review committee found that hypothesis-driven research was less impactful than the development of novel basic tools, techniques, and methods.
• Keck will only fund PROJECTS THAT FALL OUTSIDE OF THE MISSION OF PUBLIC FUNDING AGENCIES.  If a proposal is declined by federal agencies (e.g., NIH), include reviewer comments verbatim, especially if it was turned down because the project was considered too high-risk or outside-of-the-box.
• Applications must represent priorities of INSTITUTIONAL LEADERSHIP and receive some INSTITUTIONAL SUPPORT (including coverage of indirect costs).  Although not an explicit selection criterion, past successful proposals have had significant institutional support.
• Keck places value on MULTIDISCIPLINARY and INTER-INSTITUTIONAL COLLABORATION as well as the use of novel technology in the project. 
• For Instrumentation and Methodology proposals, DESCRIBE QUANTITATIVELY THE IMPROVEMENT (BY ORDERS OF MAGNITUE) OVER EXISTING METHODS.  It must represent a quantum leap over the state of the art.  New tools and techniques should have broad applicability across disciplines.

For additional eligibility requirements and descriptions of previously funded projects, please see the program website, http://www.wmkeck.org/grant-programs/research/medical-research-grant-abstracts

Internal Submission Instructions:
Please submit a ONE-PAGE CONCEPT PAPER to ECOR at ecor@partners.org by DECEMBER 16, 2016 that includes the following:

• An overview of the proposed project emphasizing any unique aspects and pilot studies.
• A brief description of the key personnel and methodologies.
• A brief justification of the need for Keck support (with specific statement why not eligible for traditional funding).
• An estimated budget broken down, if possible, by major areas, e.g., personnel (no more than 10% of PI salaries are allowed), equipment, consumable supplies. Please include potential institutional support.

For questions or concerns about this opportunity, please contact Erin Kelly-Clabaugh, Development Office Senior Director, at 617.724.5882 or eclabaugh@partners.org

Key Deadlines:
Internal One-Page Concept Paper:  December 16, 2016
Internal Review and Selection: January 2017
Phase One Application: May 1, 2017
Notification of Invitation to Submit Full Proposal: July 15, 2017
Full Proposal: August 15, 2017

The Office for Faculty Affairs is pleased to announce the 22nd year of the Eleanor and Miles Shore 50th Anniversary Fellowship Program for Scholars in Medicine. The application is now available online.

The Eleanor and Miles Shore 50th Anniversary Fellowship Program for Scholars in Medicine seeks to support the academic success of junior faculty, women and men, at the most vulnerable point in their careers, when young physicians and scientists must teach, do research, compete for grants, publish, and practice (if a clinical faculty member) at the same time they may be assuming increased family or other responsibilities. 

Stipends, typically in the $30,000 amount, may be used to buy protected time from clinical or laboratory responsibilities to pursue academic work, including writing a grant application, preparing a manuscript, completing a research project, or developing a new curriculum. Funds awarded could also be used for additional laboratory assistance at a time when the junior faculty member does not yet have independent funding.

The application deadline is January 4, 2017, 12:00 PM (noon). Letters of support must be submitted online by January 11, 2017, 12:00 PM (noon).
  
For more information (including eligibility criteria) and to apply, please visit http://fa.hms.harvard.edu/shore

Questions? Please contact the faculty development coordinator, Damien Mahiet, at (617) 432-1198 or hmsofa_programs@hms.harvard.edu

Deadline: Tuesday, December 20th, 5pm EST

The Center for Skeletal Research (CSR), based in the Endocrine Unit at MGH, and funded by the National Institute of Arthritis and Musculoskeletal Diseases (NIAMS) is announcing a request for Pilot and Feasibility Research proposals. ONE clinical grant ($30,000/year) will be awarded this year, which may be renewable for an additional year for a maximum of two years funding in total. Awardees will be expected to present progress to CFSR members biannually and provide a written annual report.

Eligibility is based on the criteria listed below:

1. Junior faculty proposing highly focused Skeletal Biology research projects with the goal of generating preliminary data sufficient to support an application for independent NIH research support. Applicants in this group must meet the NIH Early Investigator Criteria (New Investigators who have had less than 10 years of research or research training experience after the completion of their terminal research degree or medical residency, see http://grants.nih.gov/grants/new_investigators/index.htm).  Awardees of K grants in their last 2 years of K funding may apply with committed effort but cannot receive salary from the P&F.
2. Established researchers from outside the bone field proposing innovative studies relevant to Skeletal Biology.
3. Established Skeletal Biology investigators proposing studies relevant to Skeletal Biology that represents a clear departure from their established line of investigation. Investigators must invest at least 1 calendar month of effort.  If salary requests do not reflect this effort, cost-sharing plans must be indicated. Applicants who are not U.S. citizens or permanent U.S. residents must have active visas permitting them to remain in the U.S. for the full period of the proposed research Funding is anticipated to start on June 1, 2017.

For submission details, go to https://csr.mgh.harvard.edu/pilot-and-feasibility-studies

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:

• Name of the Principal Investigator with appropriate contact information
• A descriptive title of the potential application
• Brief description of the project
• Brief description of why you specifically should be selected to receive institutional nomination for this award

If there is more than one MGH investigator 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.

• NINDS Institutional Center Core Grants to Support Neuroscience Research (P30)
• St. Baldrick’s Foundation – NEW!
• T Cell Reagent Research for the Study of Allergic Diseases (U19)
• Asthma and Allergic Diseases Cooperative Research Centers (U19)

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.

Please note that any grant that brings in less than 15% in indirect costs (IDC) will need to be supplemented up to the 15% equivalent by existing investigator or departmental sundry funds. Resolution of this issue must occur prior to submission of the award.

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.

• Anesthesia Patient Safety Foundation (APSF) Grant Program, Anesthesia Patient Safety Foundation (APSF)
• Arthritis and the Aging Process Research Grant, Arthritis National Research Foundation (ANRF)
• Psoriatic Arthritis Research Grant, Arthritis National Research Foundation (ANRF)
• Investigator Initiated Studies Program for U.S. Investigators (IIS Program), Boehringer Ingelheim Pharma GmbH & Co. KG/Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI)
• Fellowship Awards, Jane Coffin Childs Memorial Fund for Medical Research (JCC Fund)
• Clinical Research Mentorship, Doris Duke Charitable Foundation (DDCF)
• Clinical Fellowship Training Program, Dystonia Medical Research Foundation (DMRF)
• Enhanced Career Development Award (Enhanced Research and Clinical Training for Physicians in Inherited Orphan Retinal Degenerative Diseases), Foundation Fighting Blindness (FFB)
• Mentored Research Training Grants, Foundation for Anesthesia Education and Research (FAER)
• Research in Education Grant, Foundation for Anesthesia Education and Research (FAER)
• FRAXA Postdoctoral Fellowships, FRAXA Research Foundation
• Young Investigator Grant for Probiotics Research (YIGPRO), Global Probiotics Council (GPC)
• Charles A. King Trust Postdoctoral Research Fellowship Program, Health Resources in Action (HRiA)/The Medical Foundation
• ISHLT/O.H. Frazier Award in MCS Translational Research Sponsored by HeartWare, International Society for Heart and Lung Transplantation (ISHLT)
• Norman E. Shumway Career Development Award, International Society for Heart and Lung Transplantation (ISHLT)
• Hollis Brownstein Research Grants Program, Leukemia Research Foundation, Inc.
• International Call for Nemaline Myopathy 2016, Muscular Dystrophy UK 
• Mentored Clinical Research Award (MCRA) for New Investigators in Patient Oriented Research in Parkinson's Disease and Related Disorders, Parkinson Study Group (PSG)
• Global Healthy Living Foundation and Pfizer Independent Grants for Learning & Change Request for Proposals (RFP) Rheumatoid Arthritis Shared Decision Making, Pfizer, Inc.
• SRF Postdoctoral Fellowship, Scleroderma Research Foundation (SRF)
• SRF Research Awards:  Molecular Pathogenesis and New Interventions in Scleroderma, Scleroderma Research Foundation (SRF)
• Working Longer, Alfred P. Sloan Foundation

Please click here for further details on these funding opportunities.

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

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

Merck KGaA Darmstadt Germany Biopharma Innovation Cup 2017
Application Deadline: January 31, 2017

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

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