GCO New Staff Additions and a Promotion

The Grants and Contracts Office (GCO) is pleased to announce new staff additions and a promotion as well.

David Dalton joined the GCO team as a Grants Coordinator.  David previously worked for the Program for the Protection of Human Subjects (PPHS) office for approximately 6 years where his primary responsibility was intake of electronic submissions.   David’s GCO responsibilities include processing the intake of InfoEd applications and Sinai Central forms.

Photo from Left to Right: David Dalton, Sarah Sanders, Edwin Berrios, Jennifer Oluoch-Kore

Sarah Sanders is a new Grants Specialist II for the GCO. Sarah previously was employed as  a Subawards Manager at Columbia University.  Notably, Sarah was a recipient of the Oprah Winfrey Fellowship for African Women in Public Service at the Wagner School of Public Service.

Edwin Berrios has been promoted to Grants Specialist I after 10 months of employment in the GCO as a Grants Coordinator.   Grants Specialist responsibilities include reviewing projects for accurate administrative and budgetary information and compliance with extramural and institutional regulations.

Jennifer Oluoch-Kore has joined the group a Senior Contracts Specialist.  Jennifer has over 5 years of experience as a subaward manager working at Engender Health Inc. and Columbia University.  Contracts Specialist responsibilities include the review and negotiation of sponsored project agreements.

Please join us in welcoming our new staff and congratulating Edwin Berrios on his promotion.

Introduction to Machine Learning for Genetics & Genomics Short Course Offered March 30th

In this introductory course offered by the Center for Biostatistics at the Icahn School of Medicine at Mount Sinai (ISMMS), participants will learn important basic concepts in machine learning with a series of hands-on training exercises using R and RStudio. Different machine learning training strategies will be explored and participants will learn all the most important algorithms used in the field, such as Random Forests and Support Vector Machines. The capabilities of R caret package will be utilized extensively and applications in genetics and genomics will be performed. At the end of the course, participants will implement a machine learning strategy and critically evaluate an algorithm’s performance in classification and regression problems.

Introduction to Machine Learning for Genetics & Genomics will be taught by Dr. Joel Correa da Rosa who holds a M.Sc. degree in Probability and Statistical Inference from State University of Campinas (Sao Paulo / Brazil) and a PhD in Decision Support Methods from the Pontifical Catholic University (PUC-Rio- Rio de Janeiro/Brasil). Dr. Correa da Rosa joined the faculty of the Population Health Science & Policy Department at the Icahn School of Medicine in 2017. His expertise includes data analysis, statistical programming, multivariate analysis, and machine learning methods for classification, regression and clustering.

PREREQUISITES: Introductory to intermediate programming proficiency in R and RStudio; Basic foundation in statistical modelling (e.g. linear regression).

WHEN: Friday, March 30, 2018 from 9:00 am to 5:00 pm

Mount Sinai Annenberg Building
12th floor
Room 12-01
1468 Madison Avenue
New York, NY

REGISTRATION: To register for the course and pay the $375 tuition fee, go to: http://bit.ly/2BOje7i

WEBPAGE: http://bit.ly/2BOje7i

QUESTIONS: mary.sandre@mountsinai.org

Spring II Biostatistics Course Offerings

The Master of Science in Biostatistics Program is pleased to announce the following courses that will take place in the Spring II term, beginning Monday April 2nd and ending Friday June 22nd.

BIO9001 – Applied Analysis of Healthcare Databases (3 credits) – Lecture: Thursdays 4:00 to 6:00 pm; Lab: Thursdays 6:00 to 7:00 pm; Course Director: Natalia Egorova
This course will prepare students to identify and use national and local healthcare databases in their own research. Students will evaluate published database studies, complete programming exercises with SAS statistical software and hands-on access to a large database, and prepare a proposal for analyzing a specific research question using a large healthcare database.

BIO9100 – Survival Analysis (3 credits) – Lecture: Wednesdays 3:00 to 5:00 pm; Lab: Tuesdays 3:00 – 4:00 pm; Course Director: Umut Ozbek
This course describes the analysis of time-to-event data. Several concepts of censoring are introduced, as are functions used to describe survival distributions. Both parametric and nonparametric methods to describe and compare survival distributions are given. Cox regression is studied including the assumptions required, examining the validity of these assumptions, and dealing with time dependent covariates. Interval censored data are explored, as well as the analysis of multiple failures. Analyzing data sets will be required.

BIO9200 – Analysis of Longitudinal Data (3 credits) – Lecture: Mondays 4:00 – 6:00 pm; Lab: Tuesdays 4:00 – 5:00 pm; Course Director: Mayte Suarez-Farinas
The aim of this course is to provide systematic training in both the theoretical foundations and the model building strategies of linear regression models for students who have already had some data analysis experience. Modern approaches to the analysis of longitudinal data are presented. The course is organized as a two-hour lecture in which the statistical methodology for longitudinal data is discussed and a one-hour lab in which R will be used to perform analysis of actual data.

BIO9002 – Race and Causal Inference Seminar (1 Credit) – Thursdays 1:00 – 3:00 pm; Course Director: Dr. Emma Benn
In this course, we will question the operationalization of race as a “cause” when examining racial disparities in health from a statistical framework grounded in the underlying theories of causal inference. By the end of this course, students will have gained a unique set of knowledge that they can use to: 1) more critically scrutinize the traditional approaches to investigating disparities in health (not just specific to race), and 2) apply a more nuanced inferential, rather than descriptive, approach to future work in the disparities arena that will move us closer to finding efficacious interventions.

QUESTIONS: mary.sandre@mountsinai.org

GCO Helpful Hints- To Be or Not Be (An NIH Clinical Trial) That is the Question

To Be or Not To Be…. The single most powerful soliloquy ever written by man..

Encapsulating the frailty of  the human condition in one stark sentence.
One man overwrought by feelings of despair, indecision, and confusion.
Is there any wonder this quote can be applied to NIH’s new definition of a clinical trial (eff w/ competitive apps. w/ due dates 1/25/18 and later)?

Have you asked yourself these other 4 questions… the ones that will provide the answer you need… the ones that will pull you out of any existential NIH clinical trial conundrum, and put you on the path leading to a successful application?

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If you’ve answered Yes to all of these questions, you’ve got yourself an NIH Clinical Trial.  Note that no other entity but the NIH (although there are no guarantees in this fast paced world, folks.. we will do our best to keep you informed) uses this definition.  So be sure you remember to whom you are speaking or to which funding agency you are applying before stating unequivocally, “To Be or Not to Be!” I mean “Yes, I have a clinical trial!”  If you’re still not sure or need additional resources to help navigate you through, please see the list towards the bottom of this email.

Besides this NIH definition, all should be aware of NIH’s new Human Subjects and Clinical Trial (HS/CT) form in which the top portion must be completed even if you are doing research on potato spuds.*  This form has a sub-form called the “Study Record” form and embedded in that is the sub-sub form entitled the “Inclusion Enrollment Report,” which should sound familiar to veteran applicants.  Recently, Research IT released its instructions for completing this form, which includes what’s required in each section. Click here to view Research IT’s instructions on the form.

If there was ever a time to submit to the Grants and Contracts Office (GCO) EARLY or at least 5 business days prior to your NIH deadline, now is the time.

But before you submit, make that way before you submit, choose the correct funding opportunity announcement (FOA). (Parenthically speaking, the updated FOAs include some pretty important information within the parentheses in the FOA title, namely “(Clinical Trial Not Allowed),” or “(Clinical Trial Required)” or “(Clinical Trial Optional.)”)

And no worries..if you are holding a specimen like this Shakespeare playing Hamlet, you can safely say No to Clinical Trials.  If your protocol does contain a resuscitation intervention, answer Yes.

NIH Clinical Trial Resources

Videos and Podcasts

Video (approx. 15 minutes) – Overview of New NIH Policies on Human Subjects Research and Clinical Trials

* Did you know that according to Wikipedia,  “The word (spud) has an unknown origin and was originally (c. 1440) used as a term for a short knife or dagger, probably related to the Latin “spad-” a word root meaning “sword”; cf. Spanish “espada”, English “spade” and “spadroon”?”  This was approximately 160 years before Shakespeare wrote Hamlet.


GCO Helpful Hints- Believe It or Not, YOU are Doing an NIH Clinical Trial

It is not business as usual at the NIH for competitive applications due Jan 25, 2018 and after. The NIH has a new definition of a clinical trial and with that comes a new Human Subjects and Clinical Trials Info (HS/CT) form and new requirements even for basic science researchers.

Step 1 –  BEFORE You Apply, Answer These 4 Questions.

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?

If you say No – ask yourself when I read question 3 above did I read “efficacy” rather than “effect?” NIH is asking about ANY “effect.” This is much broader.  Please reconsider.

4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If you say No – ask yourself when I read question 4 above did I read “improve or cure any disease or symptom of a medical or psychological condition or syndrome?”  NIH is asking about ANY  “health-related biomedical or behavioral outcome.”   This is much broader.  Please reconsider.

If the answer is Yes to all 4 questions, your study is an NIH clinical trial.

Step 2 – Choose the CORRECT Funding Opportunity Announcement (FOA)

Many of NIH’s updated FOAs include the following information in the title:
– Clinical Trial Not Allowed
– Clinical Trial Required
– Clinical Trial Optional

If you apply to the wrong FOA, your application will be rejected.

Step 3 – Complete the Human Subjects and Clinical Trials Information (HS/CT) Form

Your application will be rejected if completed incorrectly. Please see list below of possible reasons.

  • You did not answer the Clinical Trials Questions correctly at the top of this form.  See Step 1 for more information.
  • You completed sections of the form that are not required for your study.
  • And the opposite – you didn’t complete the sections of the form that are required for your study.
  • You did not follow the character limitation rule.

Click here to view Research IT’s instructions on the form.  These instructions highlight requirements to help you avoid the pitfalls written above.

Other Resources
Contact the Program Officer on the FOA if you have questions. Get in writing whether your study is a clinical trial.

NIH Clinical Trial Resources

Videos and Podcasts

Below are some questions GCO Staff has received regarding NIH’s new HS/CT form and the NIH’s new Clinical Trial Policy in general.  We are passing the answers along to you.

FAQs on NIH’s new Human Subject and Clinical Trials Information Form

1. Q: I am not doing human subjects research. Therefore, I don’t need to complete the new form, correct?
A: Incorrect. There are questions that must be answered in the top portion of the form even if you are not doing human subject research.   All competitive NIH applications include the new form.

  1. Q: I am not doing a safety and efficacy study. In fact I am only using healthy volunteers.  Therefore, NIH’s new policies on Clinical Trials do not apply to me, correct?
    A:  Incorrect.  You might be doing a study the NIH defines as a clinical trial and therefore be subject to the new requirements.  NIH’s definition of clinical trials is very broad and includes research that one intuitively would not think is a clinical trial.  Please review NIH’s new definition, case studies/examples plus the training and resource material available to make the determination.
  2. Q: I am not doing a safety and efficacy study. In fact I am only studying the pharmacokinetics of a drug.  Therefore, NIH’s new policies on Clinical Trials do not apply to me, correct?
    A: Incorrect. Same response at # 2 above.
  3. From the NIH Case Studies website
    Q:  The study involves the recruitment of healthy volunteers who will be randomized to different durations of sleep deprivation (including no sleep deprivation as a control) and who will have stress hormone levels measured. It is designed to determine whether the levels of stress hormones in blood rise in response to different durations of sleep deprivation. Is this a clinical trial?
    A: Yes, this is a NIH Clinical Trial. See Case #9 on the NIH site for more complete information.

Questions about Sponsored Projects? Please click here for a listing of Departmental Grants Specialists at the GCO who can help you.


IACUC Full Board Protocol Submission Deadlines Posted for 2018 Meetings

The Institutional Animal Care and Use Committee (IACUC) meets every two weeks to review protocols requiring Full Board Review (FBR) and have now posted their new schedule of full board protocol submission deadlines (click here to access). For review at a FBR meeting, researchers must submit their applications by the submission deadline. If a submission deadline should occur on a weekend or holiday, applications will be accepted the next business day. The IACUC reserves the right to move a protocol to the next meeting within the same month where required.

For more information about the MSHS IACUC and IACUC applications, researchers can visit the IACUC website. Please contact IACUC@mssm.edu, if you have any questions.


Call for Applications: STTEP-UP Initiative in Science and Medicine

ConduITS, the Institutes for Translational Sciences is once again seeking applications for the 2018-2019 NCATS funded training program entitled the STTEP-UP Initiative in Science and Medicine.

This program is designed to enable highly motivated underrepresented minority (URM) trainees in residency, subspecialty fellowship training or postdoctoral laboratory positions within our health care system, to become innovative leaders and entrepreneurs in clinical and translational research. The program is designed to provide candidates with the critical thinking skills to evaluate the validity and implications of the published literature and plethora of available information through digital and internet resources; formulate testable hypotheses, design informative, effective and efficient studies, analyze data correctly and interpret quantitative and qualitative findings and their potential impact on the health of individuals across the life cycle.

The components of the program include:

  • Academic Skills:
    • Time management & work/life balance
    • Mentorship
    • Communication Styles
    • Leadership
    • Team Science
    • Practical Tips for Negotiating your Career
    • Must Know Financial Concepts
  • INCHOIR Learning Lab, which will entail participation in hands-on training in clinical and translational science, utilizing an established data repository for secondary data analysis, and monthly didactics on fundamentals in interventional studies culminating in a two day virtual clinical trial development workshop.
  • Opportunities for Multidisciplinary Teamwork with other trainees throughout the education process.
  • Individual Career Development with Primary Mentor & Interdisciplinary Mentor Team
  • Career Development Seminars in the following topics:
    • Loan Repayment Program
    • Diversity Supplements
    • Mentored Awards Roadmap
  • T32 Networking Seminar Series
  • “Meet the Expert” Mentored Investigator “K Club Series”
  • Annual Next Steps Symposium, which will highlight nationally-renowned URM Clinical and Translational Investigators

We are currently seeking nominations for the academic year starting July 1, 2018 – June 30, 2019. This competitive program utilizes an NCATS funded NRSA TL1 mechanism and provides salary support and tuition dollars for four postdoctoral trainees per year. Applicants will be asked to complete a full application and submit to Christine Acevedo (christine.acevedo@mssm.edu) by April 15, 2018. Full application includes:

  • Completed application form (NRSA TL1 Application Form 2018) which should include a brief overview concerning prior, current and/or upcoming involvement in a research project as well as the motivation for embracing a career in clinical translational research.*
  • Current curriculum vitae including bibliography.
  • 1 letter of recommendation from your Training Program Director; 1 letter of recommendation from your Division Chief or Department/Institute/Center Chairperson. These respective letters should indicate that the training program director, division chief or department/institute/center chairperson is committed to make time available for the trainee to participate in the required academic programs.

If you have any specific questions, please feel free to email or contact the office at 212-824-7014. We look forward to receiving your application.

* If an applicant has recently developed or submitted a research proposal or protocol, the specific aim page or synopsis respectively can be used instead.