Research News - January 27, 2017

On January 19, 2017, a revised federal regulation regarding the protection of human subjects in research was published in the Federal Register. The prolonged process for this revision included two draft proposals that were open to public comment as well as open meetings designed to get input from multiple stakeholders, including for example: patients, investigators, institutions, regulators, and industry sponsors.

The final rule is long and we are in the process of a detailed review. At this time, we highlight some of the significant changes. Of note, we have one year to be in compliance with most elements of this final rule – the exception is the mandate for the use of single IRB in multi-site research as noted below. For a more detailed description of the process and some of these changes, please click here to read the 1/19/2017 NEJM article.

The two most significant highlights include:

• Biospecimens: The original draft proposals made any biospecimen, regardless of identifiability, a human subject and required informed consent for the use of any biospecimen in research. In response to comments received, this is NOT included in the final rule. The current status quo remains with IRB review required for collecting biospecimens specifically for research as well as the research use of any existing identifiable biospecimens.  The IRB retains the capacity to consider waivers of consent for specific uses of human samples.
• Single IRB review for domestic multi-site research. Regardless of funding source, research with two or more domestic sites must be reviewed by a single IRB. Exceptions can be requested. Of note, given the complexity of this mandate, we are given three years to be in compliance.

There are many other changes in the final rule that will require changes in our current policies and procedures. Among these are:

• Changes to the formatting and required elements in the informed consent document.
• Changes in the scope of research that requires continuing review.
• Additions to ‘exempt’ categories of research – this is research that includes human subjects, for which the IRB can make the determination that the research is exempt from the Common Rule requirements.

The Plaza Café will close permanently on February 3, 2017 so that we may begin construction of the new Marketplace.

We will have additional vending machines for your use during the construction period. They are located around the corner adjacent to the existing vending machines. Anticipated opening date of the Marketplace is early summer.

Questions: Call Jeanne Kotelly at 724-9807.

LabArchives is a web-based application designed for scientists to organize and share laboratory data within their study team, department, or external collaborators. Enhance your labs workflow and control your intellectual property while being able to access your lab notebooks from the bench, office or on the road. Enterprise Research Infrastructure & Services, ERIS, offers LabArchives at no cost to all researchers. Visit https://rc.partners.org/eln to get started.

Monday, February 6, 2017, 12:00 - 1:00 PM, Simches Auditorium (3.110)
Broadcast to Isselbacher Auditorium (CNY-149, 7th Floor)

AGENDA
Increasing Your Visibility with Industry and Beyond
Gabriela Apiou, PhD, Director, Translational Research Training & Development, MGH Research Institute

Clinical Trials.gov: Final Rule and NIH Policy - Striving for Transparency
Sarah A. White, MPH, Director, Human Research Quality Improvement Program
Emily Ouellette, JD, Assistant Director, FDA and Regulatory Support, QI Program

Elected Representatives will be available 30 minutes before and after this meeting in Simches 3.130 if you’d like to speak with them.

(Lunch available at 11:45 AM)
All MGH Researchers welcome!

Tuesday, January 31, 4:00 - 5:00 pm, CNY 149, Rm 2.204

Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions:
The Connect for Health Randomized Controlled Trial
Elsie M. Taveras, MD, MPH
Chief, Division of General Academic Pediatrics
Director, Pediatric Population Health Management
Mass General Hospital for Children

Friday, February 3, 3:00 pm, CNY 149, Isselbacher Auditorium 7.231

Novel roles for reactive oxygen species in cardiovascular signaling
Thomas Michel, MD, PhD
Professor of Medicine and Biochemistry,
Senior Physician in Cardiovascular Medicine, BWH
Co-Director, Leder Human Biology and Translational Medicine Program

Thursday, February 2, 12:00 PM, CNY 149, Isselbacher Auditorium, 7th Floor
Will be broadcasted to MGH Bulfinch 165

“Imaging Immunity: Developing a Spatio-temporal Understanding of Host Defense”
Ron Germain, MD, PhD. National Institutes of Health

Contact Person – Fiona Chen (617/726-1527)
http://www.massgeneral.org/ciid/ourseminars/seminarseries.aspx

Friday, February 10, 2017, 12:00 – 1:00 pm, O'Keefe Auditorium, Blake Building, 1st Floor

Join us for our quarterly speaker series on innovation in healthcare!  Lunch will be provided starting at 11:30 AM. Register here.

Retsef Levi is a Professor of Operations Management at the Sloan School of Management, MIT.  Dr. Levi’s primary current research domains are supply chain and inventory management, healthcare management, revenue management, risk management and logistics. For the last 6 years Levi has lead several collaborative research efforts and initiatives with some of the major academic medical centers in the Boston area, addressing core system design challenges within these centers.

Tuesday, March 14, 8:00 am - 4:30 pm, Simches, 3rd Floor

The 7th Annual Research Administrators Retreat will take place on Tuesday, March 14, 2017, 8am-4:30pm in the Simches 3 conference area.

Please stay tuned for more information about how to register for the retreat. We hope you will all be able to join us!

Applications are now being accepted by the Executive Committee on Research (ECOR) for the Fund for Medical Discovery (FMD) Clinical Fellowship Awards!

What are they?
MD fellows, PhD postdoctoral research fellows and Instructors within 5 years of the start of their fellowship training at Massachusetts General Hospital are encouraged to apply.
The award may be used only for salary and fringe benefits. The awards are not transferable to any other institution and will be effective on or about July 1, 2017. The awards are restricted to clinical research as defined by the NIH Grants Policy Statement

How much is each award?
The awards will include a stipend of $47,500 plus applicable fringe benefits and 15% indirect costs.

When is the deadline?
Wednesday, February 1, 2017 - 5:00 PM

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

For a guide to help make your application more competitive click here. 

Four Year Award for Investigators who are Underrepresented in Academic Medicine*
*Basic, Clinical, Translational, and Health Services investigators are all eligible

Applications for grants are invited by the MGH Center for Diversity and Inclusion (CDI), and the Executive Committee on Research (ECOR). 

What is the Award?
The MGH Physician/Scientist Development Award (PSDA) is designed for MD and/or PhD investigators at MGH who are considered underrepresented in academic medicine (URM). This Award is intended to provide transitional funding for support in the development of physicians and scientists underrepresented in academic medicine, and thereby increase opportunities for URM researchers to advance to senior positions in academic medicine at MGH.  The CDI will evaluate the need for this Award on a regular basis.

Am I URM (Underrepresented in Medicine)?
For the purposes of the PSDA, MGH follows the definition of underrepresented in medicine and biomedical research (URM) of the NIH and the Association of American Medical Colleges (AAMC).  URM groups may include Latino/ Hispanic (including Brazilian), African-American/Black, American Indian, Native Hawaiian and Alaskan Natives, among others. Please note that Asians are not considered URM, UNLESS they are underrepresented relative to the population MGH serves, e.g., Cambodian or Laotian.

How much is the award?
A maximum of $120,000.00 will be awarded to be spent over a three or four-year period, with a maximum of $40,000.00 per year of funding in direct costs, plus 15% for indirect costs.

When is the deadline?
Thursday, March 2, 2017 – 5:00 PM

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.

• Asthma and Allergic Diseases Cooperative Research Centers (U19)
• FY17 Partnerships to Achieve Health Equity

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.

• Biomarkers Development, Alzheimer's Drug Discovery Foundation (ADDF)
• AALAS Grants for Laboratory Animal Science (GLAS) Program, American Association for Laboratory Animal Science (AALAS)
• ATA Research Grants, American Thyroid Association (ATA)
• Research Grant Program, Aplastic Anemia & MDS International Foundation, Inc. (AA&MDSIF)
• Young Investigator Grants, Breast Cancer Alliance (BCA)
• Irvington Postdoctoral Fellowships, Cancer Research Institute (CRI)
• Damon Runyon-Sohn Pediatric Cancer Fellowship Award, Damon Runyon Cancer Research Foundation
• Deborah Munroe Noonan Memorial Fund, Health Resources in Action (HRiA)/The Medical Foundation
• Research Grant Award Program, International OCD Foundation (IOCDF)
• McKnight Memory and Cognitive Disorders Awards, McKnight Endowment Fund for Neuroscience
• Research Fellow Award Program, Multiple Myeloma Research Foundation (MMRF)
• Research-Specific Grants: OREF/Musculoskeletal Tumor Society Clinical Research Grant in Orthopaedic Oncology (MSTS Clinical Research Grant), Orthopaedic Research and Education Foundation (OREF) 
• Pancreatic Cancer Action Network Precision Medicine Targeted Grant, Pancreatic Cancer Action Network (PANCAN)
• ASPIRE Oncology/Hematology Research Awards Program, Pfizer, Inc./Advancing Science through Pfizer - Investigator Research Exchange (ASPIRE Research Awards)
• Faculty Research Award for Early Career Faculty Investigators, Shock Society
• Research Grants, Sjogren's Syndrome Foundation, Inc.

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

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

MGH ECOR Formulaic Bridge Funding Support
Application Deadline: February 7, 2017; 7th day of each month

KL2 Catalyst Medical Research Investigator Training (CMeRIT) Award
Application Deadline: March 30

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

IRB Issues for the Bench and Desk Scientist – February 1

What Does the IRB Really Want? How to Write a Human Studies Protocol – February 9

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