Session Descriptors

2-DAY SEMINAR SESSIONS:  DESCRIPTORS & OBJECTIVES


ACADEMIC RESEARCH ENHANCEMENT AWARD (AREA) PROGRAM

Presenter:  Michelle Timmerman (NIH/OER)

Level:  Beginner

The NIH Academic Research Enhancement Award (AREA) program (R15) supports faculty research at campuses that have not received much NIH funding in the past. It is designed to strengthen the research environment of the institution and to expose students to research. This session will focus on NIH’s goals for the program and provide perspective on how to write a competitive AREA application.

Upon completion of this session, participants will be able to:

  • describe the eligibility requirements of institutions and PIs for the R15;
  • identify the aspects of an application and review criteria that are unique to R15 and provide a brief description of each; and
  • describe strategies that an individual or institution may implement to increase their competitiveness for an R15.

ADVANCED ADMINISTRATIVE TOPICS: POST-AWARD

Presenters:  Jennifer Cho (NIH/NHLBI), Emily Linde (NIH/NIAID), Gabriel Hidalgo (NIH/NIDCR)

Level:  Advanced

Together, let’s explore some of the issues you traditionally encounter (and find frustrating) during the noncompetitive renewal (Type 5).  In this interactive session, we’ll explore scenarios and questions that arise from large unobligated balances, transfers and closeout.

Upon completion of this session, participants will be able to:

  • identify and assess various post-award situations; and
  • determine specific questions for consideration in order to provide resolution towards effective grant oversight.

ADVANCED ADMINISTRATIVE TOPICS:  PRE-AWARD

Presenters:  Brian Albertini (NINR), Jennifer Cho (NIH/NHLBI), Gabriel Hidalgo (NIH/NIDCR)

Level:  Advanced

Is your PI proposing a complex project that includes human subjects, clinical trials research, multiple PI, or change of grantee institution? Oh my! What should be included in the application and what happens (from an administrative perspective), when things don’t go as planned? Join us for this interactive session to discuss some case studies.

Upon completion of this session, participants will be able to:

  • identify and assess various pre-award situations; and
  • determine specific questions for consideration in order to provide resolution towards effective grant oversight.

AFTER THE AWARD IS MADE…THEN WHAT?

Presenter:  Marianne Galczynski (NIH/NCI)

Level:  Beginner

What happens at your institution and at the NIH between grant award and closeout? This session provides a better understanding of NIH post-award activities from the perspective of a senior NIH grants management expert. The emphasis will be on business issues.

Upon completion of this session, participants will be able to:

  • describe the key elements of a Notice of Award;
  • detail NIH reporting requirements;
  • describe grant changes that require prior approval; and
  • explain what is required to closeout a grant.

AFTER YOUR FIRST AWARD:  NEXT STEPS IN YOUR JOURNEY WITH NIH

Presenters:  Anita Bechtholt (NIH/NIAAA), Sherry Mills (NIH/OER)

Level:  Beginner

Congratulations! You just received your first independent NIH award. Nothing but success from here on, right? Maybe… Maybe not. The difference can lie in what you do (or don’t do) after getting this first award. This session will illuminate possible paths to pursue – and common pitfalls to avoid – to enhance the likelihood of the long term success of your funded Research Program.

Upon completion of this session, participants will be able to:

  • appreciate the value of “big picture” strategies designed to enhance the likelihood of their long-term success;
  • realize there is more to a thriving research program than the linear progression of going from grant-to-grant; and
  • explain the value of the mentor’s role, including your NIH Program Director.

ALL ABOUT COSTS:  A POST-AWARD PRIMER

Presenters:  Diane Dean (NIH/OER), Kathy Hancock (NIH/OER), Sahar Rais (NIH/OER), Samantha Tempchin (NIH/OER)

Level:  Beginner

Looking for an introduction to post-award costing issues? If so, this is the presentation for you. This session will emphasize accounting, monitoring and reporting requirements, and other important topics, while encouraging audience participation. It will be a great post-award primer for administrators and investigators.

Upon completion of this session, participants will be able to:

  • identify the various Federal requirements and NIH Policies governing considerations;
  • make more informed determinations regarding the allowability of costs on NIH awards; and
  • gain an understanding of other cost-related requirements, such as the deadlines for submitting required financial reports and closeout documentation.

BONJOUR! HOLA!  INTERNATIONAL ORGANIZATIONS & THE NIH GRANTS PROCESS

Presenter:  Emily Linde (NIH/NIAID), Donna Sullivan (NIH/NIAID)

Level: Intermediate

As research becomes more global, international collaborations become more necessary. Researchers are being faced with issues and concerns in which they have little experience. This session will answer such administrative questions as… What are possible issues when a collaborator is foreign? Are there issues that may be unique to resource poor countries?

Upon completion of this session, participants will be able to:

  • explain basic processes for establishing international collaborations; and
  • describe recent updates and changes to related NIH policies for foreign grants.

BUDGET BASICS FOR ADMINISTRATORS

Presenter:  Brian Albertini (NIH/NINR)

Level:  Beginner

Guidance is often requested from NIH staff on how to calculate, develop, and defend a budget request. There is a lot to consider when developing a budget for a grant application. What are the cost principles? What are the limitations set forth in the Funding Opportunity Announcement? What are allowable direct and indirect costs? This session will provide you with the basics you need and the people who can help.

Upon completion of this session, participants will be able to:

  • explain the major differences between modular vs categorical budgets;
  • list the most common budget submission errors; and
  • list pre-award costs and post award actions.

BUDGET BUILDING BLOCKS FOR INVESTIGATORS

Presenters:  Beth-Anne Sieber (NIH/NIAAA), Roger Sorensen (NIH/NIDA)

Level:  Beginner

There is much for an investigator to consider when developing a budget for a grant application, such as what can be requested, how is the budget calculated, and is the request appropriate. An NIH Program Official will guide you on finding the answers to these questions by providing valuable information for preparing a proper grant budget.

Upon completion of this session, participants will be able to:

  • describe the differences in preparing modular and detailed (itemized) budgets; and
  • develop and justify budget requests for grant applications.

CLINICAL TRIALS: WHAT YOU NEED TO KNOW

Presenters:  Sherry Mills (NIH/OER), Rebecca Williams (NIH/NLM)

Level:  All Levels

NIH recently announced enhanced efforts to help ensure information about clinical trials is widely available to the public. These efforts include HHS regulations that clarify and expand the legal requirements (as described in the Food and Drug Administration Amendments Act of 2007 or FDAAA) for registration and results submission of clinical trials of FDA-regulated products.  NIH also issued a complementary policy requiring all NIH-funded clinical trials (including those not covered by the final rule) to be registered and have results submitted to ClinicalTrials.gov.  Attendees of this session will gain a better understanding of both the NIH policy and the final rule and how it applies to extramural grants and key considerations for ensuring your institution is meeting the requirements of the policy and the law.

Upon completion of the session, participants will be able to:

  • explain the necessity for clinical trial reporting to PIs and other investigators they work with;
  • identify clinical trial reporting requirements that apply to NIH grants;
  • apply the registration and reporting requirements to grants and their institution; and
  • identify where to find additional resources and support about the ClinicalTrials.gov reporting process.

COMMON COMPLIANCE PITFALLS AND STRATEGIES FOR SUCCESS: CASE STUDIES

Presenters:  Diane Dean (NIH/OER), Kathy Hancock (NIH/OER), Sahar Rais (NIH/OER), Samantha Tempchin (NIH/OER)

Level: All Levels

Join NIH experts for an introduction to compliance activities, including an interactive discussion of specific case studies that illustrate common compliance issues. A primer for administrators and interested investigators.

Upon completion of this session, participants will be able to:

  • accurately identify and understand key compliance requirements governing NIH awards; and
  • make more informed decisions in accordance with policy and regulatory requirements.

CURRENT ISSUES AT NIH

Presenter:  Shellie Wilburn (NIH/OER)

Level:  All Levels

Don’t miss this opportunity to hear about what is new and being developed within the National Institute of Health’s (NIH) programs, policies, and budgets.  In this comprehensive review participants will learn about the newest policy updates and how their respective institutions may be impacted. Upon completion of the presentation, participants will have the opportunity to ask questions about new and existing policies.  Topics include recent and upcoming changes to NIH policy, compliance requirements, and so much more!

Upon completion of this session, participants will be able to:

  • demonstrate an understanding of the NIH grants policy requirements;
  • identify the source of policy requirements; and
  • provide examples of current issues at NIH.

DIVERSITY IN THE BIOMEDICAL RESEARCH WORKFORCE

Presenter:  Kay Lund (NIH/OER) 

Level:  All Levels

Learn more about diversity in the national scientific workforce, and NIH efforts to expand outreach and recruitment of underrepresented groups applying for support through its policies, processes and programs.  Come with your questions, and join the discussion about this important issue.  You will leave this session with a better understanding of scientific workforce diversity, and where to find funding opportunities and resources designed to support diversity in biomedical research.

Upon completion of this session participants will be able to:

  • explain how scientific workforce diversity contributes to the goals of the NIH mission;
  • identify sources of information about groups that are nationally underrepresented in science;
  • find NIH funding opportunities, and identify funding opportunities that support recruitment and retention of underrepresented groups; and
  • locate resources regarding recruitment and retention strategies to support diversity in science, research and leadership.

FEDERAL RESEARCH POLICY UPDATE

Presenter:  Michelle Bulls (NIH/OER), Jean Feldman (NSF)

Level:  All Levels

An NIH policy expert will provide an informative update regarding the status of our current, Federal-wide initiatives.  Research Terms and Conditions, which implement the Uniform Regulations and the Final Research Performance Progress Report (F-RPPR), will be reviewed during this session.

Upon completion of this session, participants will be able to:

  • describe the status of current, Federal-wide initiatives;
  • define Research Terms and Conditions and explain their importance in award management; and
  • explain the implementation plan for the Research Terms and Conditions and the Final RPPR.

FINANCIAL CONFLICT OF INTEREST (FCOI):  WHAT YOU NEED TO KNOW

Presenters:  Diane Dean (NIH/OER), Kathy Hancock (NIH/OER)

Level:  All Levels

This session will provide an overview of the Federal Financial Conflict of Interest (FCOI) regulation (42 CFR Part 50, Subpart F) and will include a discussion on the key requirements of the regulation, institutional responsibilities, and common institutional implementation issues.

Upon completion of this session, participants will be able to:

  • identify and understand the requirements of the FCOI regulation; and
  • identify and list common deficiencies with institutional FCOI policies and FCOI reports.

FINDING AND UNDERSTANDING FUNDING OPPORTUNITY ANNOUNCEMENTS (FOAs)

Presenter:  Amy Mistretta (NIH/OER)

Level:  Beginner

Submitting an application to a Funding Opportunity Announcement (FOA) is the only way to receive a grant from the NIH. Attend this session to find out how to find an FOA, quickly navigate through it to find information of interest, and understand all the nuances of the vocabulary and language contained in FOAs.

Upon completion of this session, participants will be able to:

  • locate funding opportunity announcements (FOA) of interest; and
  • efficiently navigate the FOA to identify all the elements required to submit a responsive, compliant, and complete application.

FROM THE INBOX:  PRE-AWARD & POST-AWARD ISSUES

Presenters:  Sam Ashe (NIH/OER), Tony Corio (NIH/OER), Kristin Ta (NIH/OER)

Level:  Beginner

Ready to test your grants administration knowledge in this interactive session designed for beginners (or anyone who is up for a challenge)? Hear some of the top questions pulled directly from the NIH Policy Office Inbox and see how you fare.

Upon completion of this session, participants will be able to:

  • identify and discuss at least two of the most common pre-award issues that NIH receives queries about from the grantee community; and
  • list at least two of the most common post-award issues that NIH receives from the grantee community.

FUNDAMENTALS OF THE NIH GRANTS PROCESS & NEED-TO-KNOW RESOURCES

Presenter:  Megan Columbus (NIH/OER)

Level: Beginner

If you are new to NIH grants, start here. This session will give you the basics and set the stage for what you’ll be learning about over the next two days.  We will walk you through the grants process, and give you an overview of key resources and websites you will need to be successful.

Upon completion of this session, participants will be able to:

  • describe the organizational structure of NIH and ways it can aid in locating funding opportunities and staff contacts;
  • provide a high level explanation of the path NIH grant applications take from submission to award;
  • find answers to your questions after the seminar, whether it be knowing the right website, helpdesk, or staff contact
  • identify which additional seminar sessions will be the most beneficial to attend.

GRANT WRITING FOR SUCCESS

Presenter: Ruben Alvarez (NIH/NICHD), Stuart Moss (NIH/NICHD)

Level:  Beginner

Are you a new or junior investigator? Do you assist in the preparation of the scientific portions of an application? If you answered “yes” to either question, then don’t miss this popular presentation from NIH experts that provides insights and helpful hints on preparing an application for submission. Learn how to avoid the most common mistakes in writing grant applications and correct some typical misconceptions about the grant review process.

Upon completion of this session, participants will be able to:

  • list significant steps involved from application to award;
  • explain the fundamentals of writing a clear and concise research grant application; and
  • describe the differences in writing a career development (K) award compared to other types of opportunities.

HOW WELL DO YOU KNOW OUR A-MAZING eRA SYSTEMS?

Presenters:  Sheri Cummins (NIH/OER), Scarlett Gibb (NIH/OER), Anastasiya Hardison (NIH/OER), Laurie Roman (NIH/OER)

Level:  All Levels

Explore new features, processes, and policies that impact how you interact electronically with NIH in this highly interactive session. Test your knowledge of our a-mazing eRA systems and engage in rich discussions on such topics as electronic prior approval requests; grant application submission and plans for updating application forms; the differences between RPPR, Interim RPPR and Final RPPR; and more. You’ll help set the pace and discussion topics so bring your questions, curiosity, and a willingness to have fun.

Upon completion of this session, participants will be able to:

  • discuss applicant responsibilities throughout the grant process;
  • avoid common issues encountered with various application submission and eRA Commons features; and
  • describe new application submission and eRA Commons features.

INTERACTING ELECTRONICALLY WITH NIH:  POST-SUBMISSION

Presenters:  Scarlett Gibb (NIH/OER), Anastasiya Hardison (NIH/OER), Joe Schumaker (NIH/OER)

Level:  All Levels

The eRA Commons allows applicants, grantees, and Federal staff to access, share, and transmit information related to applications and awarded grants. Explore the eRA Commons features used throughout the grant life cycle from the time an application is accepted for review consideration through grant closeout.

Upon completion of this session, participants will be able to:

  • provide a high-level description of eRA Commons reporting tools, including Financial Conflict of Interest (FCOI), Research Performance Progress Report (RPPR), and Federal Financial Report (FFR); and
  • provide a high-level description of other eRA Commons features, including: Just-in-Time (JIT), No Cost Extension (NCE), and Admin Supplements.

INTERNATIONAL INVESTIGATORS:  WHERE TO START

Presenter:  Cheryl Kitt (NIH/OER)

Level:  Beginner

Are you an international investigator interested in learning more about international research opportunities supported by the NIH?  If so, make plans to join this session for information on how to determine eligibility for NIH funding opportunities, how to apply for NIH extramural funding, and how to manage international awards and international collaborations. The session will address international applicants generally, and will also include specific information for investigators from low- and middle-income countries (LMICs).

Upon completion of this session, participants will be able to:

  • describe NIH extramural funding opportunities available to international investigators;
  • determine eligibility for NIH funding opportunities;
  • understand policies and procedures unique to foreign awards; and
  • list resources available to international investigators.

INVENTIONS, PATENTS, COPYRIGHTS, AND DATA…DR. WATSON, COME QUICK!

Presenters:  Scott Cooper (NIH/OER), Ann Hammersla (NIH/OER)

Level:  Beginner – Intermediate

“The inventor is a [person] who looks around upon the world and is not contented with things as they are. He wants to improve whatever he sees, he wants to benefit the world; he is haunted by an idea. The spirit of invention possesses him, seeking materialization.” Alexander Graham Bell (1891)

NIH-funded research can result in valuable inventions, patents, copyrights, data, and other resources. NIH experts will educate participants and assist in their understandings of these resources as they relate to NIH research funding and to advance research in your field for benefits to the public and public health throughout the world.

Upon completion of this session, participants will be able to:

  • explain basic concepts and definitions as they relate to inventions, copyrights, patents, data, and the Bayh-Dole Act and its compliance requirements; and
  • describe basic Bayh-Dole reporting requirements including Invention Reports, Confirmatory Licenses, Government Support Clauses, and Utilization Reports.

KEYNOTE WITH DR. MICHAEL LAUER

Presenter:  Michael Lauer (NIH/OER)

Level:  All Levels

Kick-starting the seminar, Dr. Michael Lauer, NIH Deputy Director for Extramural Research, shares his experiences and perspective on the role of NIH in encouraging and supporting biomedical and behavioral research across the globe.

Upon completion of this session, participants will be able to:

  • explain the general role of NIH in support of biomedical and behavioral research;
  • explain the evolving ecology of biomedical research and how it affects NIH’s ability to issue awards; and
  • describe how NIH is thinking about becoming a federal science agency that excels at managing by results.

“LIVE” MOCK STUDY SECTION MEETING

Presenters:  Multiple

Level:  All Levels

Join us for a brief look at what a peer review study section meeting might look and sound like as applications are discussed. During this 45 minute session, you’ll get a better idea of how the meeting is conducted, as well as hear a sampling of common questions asked by reviewers and mistakes by applicants. A short Q&A will follow the presentation.

After participating in this session, participants will be able to:

  • describe the basic process of what happens to an application during a Peer Review Study Section Meeting; and
  • explain the roles of the scientific review officer, program official and reviewers during the meeting.

MANAGING COMPLIANCE WITH THE NH PUBLIC ACCESS POLICY

Presenters:  Kathryn Funk (NIH/NLM), Neil Thakur (NIH/OER), Bart Trawick (NIH/NLM)

Level:  All Levels

The NIH Public Access Policy requires investigators to submit peer-reviewed manuscripts arising from NIH funds to the free digital archive PubMed Central. Attend this session to learn more about this policy and hear about new features in the National Library of Medicine’s My Bibliography that integrate with eRA Commons and help investigators, authors, and authorized delegates manage publications and compliance with the NIH Public Access Policy.

After participating in this session, participants will be able to:

  • write a paper that is compliant with the NIH Public Access Policy;
  • report a paper to NIH using My NCBI and other tools; and
  • describe how institutions and institutional policies can support public access.

NAVIGATING NIH PROGRAMS TO ADVANCE YOUR CAREER

Presenters:  Henry Khachaturian (NIH/OER), Kay Lund (NIH/OER)

Level: Beginner

Career Development Timeline

Find out which NIH funding mechanisms apply to you throughout your career.  This talk covers many of the mechanisms that apply to Ph.D.’s and M.D.’s (or equivalent research and clinical doctoral degrees), from graduate/medical school through your early-stage faculty years.

Predoctoral Students and Postdoctoral Researchers

This session will describe different types of NIH grant that support mentored research training including fellowships, institutional training grants and career development awards.

Early-Stage Investigators (ESIs)

Do you have less than 10 years of research or research training experience following your terminal research degree or medical residency/fellowship? What is NIH doing to encourage ESIs? Come to this session and find out what your next step should be when it comes to NIH funding.

Upon completion of this session, participants will be able to:

  • identify what kinds of NIH grant support (fellowships, career development (K) awards, research grants) are available based on career stage and training experience;
  • explain the benefits of additional mentored research; and
  • describe funding opportunities for transitioning to an independent position.

NIH BIOSKETCH & SciENcv (Science Experts Network Curriculum Vitae)

Presenters:  Neil Thakur (NIH/OER), Bart Trawick (NIH/NLM)

Level:  All Levels

Have questions about using the NIH Biosketch format? Get those questions answered by NIH experts as they help you gain a better understanding of using this format.  In addition, this session will provide an overview of SciENcv, a feature in My NCBI that helps users create a professional profile and generate biosketches faster.

Upon completion of this session, participants will be able to:

  • identify the 3 primary alterations to the NIH Biosketch format; and
  • explain the purpose and function of SciENcv, including how it can be used to generate biosketches.

NIH CAREER DEVELOPMENT “K” AWARDS

Presenters:  Marianne Galczynski (NIH/NCI), Tracy Rankin (NIH/NIDDK)

Level:  Beginner

NIH Career Development (K) awards provide research training opportunities for both research scientists and clinicians at various stages of their careers. NIH Grants Management & Program Officials will describe the various career award mechanisms and cover policies that apply to these awards. Developed for administrators, but may also be of interest to investigators.

Upon completion of this session, participants will be able to:

  • accurately identify at least two types of NIH Career Development (“K”) Awards; and
  • describe three features of this type of award.

NIH LOAN REPAYMENT PROGRAMS (LRP)

Presenter:  Ericka Boone (NIH/OER)

Level:  Beginner

Do you (or does someone you know) have student debt? If so, find out how the NIH Loan Repayment Programs (LRPs) can repay up to $35,000 each year. This session is for students, new researchers, and administrators/mentors, who want to learn how biomedical and behavioral scientists with student debt can benefit from NIH’s five extramural LRPs and start planning an application.

Upon completion of this session, participants will be able to:

  • list the 5 types of extramural Loan Repayment Programs available and their purpose;
  • provide general eligibility requirements; and
  • describe the peer review process for LRP applications.

NIH PEER REVIEW PROCESS

Presenters:  Sally Amero (NIH/OER), Weijia Ni (NIH/CSR)

Level:  Beginner

Understanding the NIH peer review process can improve one’s chance of getting funded. Learn the key features of NIH peer review from NIH experts, and better navigate the process for your next application submission!

Upon completion of this session, participants will be able to:

  • describe the basic review criteria for research grant applications;
  • locate review criteria for other types of applications;
  • prepare grant applications that correspond to the NIH review criteria;
  • explain the NIH scoring system for overall impact scores and criterion scores; and
  • outline the key parts of the NIH summary statement.

“OPEN MIKE” WITH DR. MICHAEL LAUER

Presenter:  Michael Lauer (NIH/OER)

Level:  All Levels

Dr. Michael Lauer is the NIH Deputy Director for Extramural Research and author of the NIH blog, “Open Mike.” If you are interested in a personal and candid conversation about what is on the mind of senior NIH management, then this is an unforgettable opportunity.

Upon completion of this session, participants will be able to:

  • explain challenges that affect the rigor and reproducibility of research findings;
  • describe how NIH and others are evaluating the effectiveness and role of peer review in making funding decisions;
  • describe how NIH plans to expand the dissemination of findings from NIH-funded clinical trials; and
  • describe how NIH is thinking about the value of bibliometric assessments of its funded research.

POLICY & COMPLIANCE:  WORKING TOGETHER LIKE HAND IN GLOVE

Presenters:  Michelle Bulls (NIH/OER), Diane Dean (NIH/OER)

Level:  Intermediate

Want a behind the scenes look at extramural research policy development at NIH?  If so, make plans to join this session for all the details direct from the NIH Office of Policy for Extramural Research Administration (OPERA).  Hear about the development and evolution of policy, as well as how policy and compliance work together internally to support the extramural research enterprise.

Upon completion of this session, participants will be able to:

  • list factors considered and used when creating policy;
  • describe the role of compliance; and
  • explain how well-written policy complements compliance efforts.

POST-REVIEW TO AWARD FOR INVESTIGATORS

Presenters:  Tracy Rankin (NIH/NIDDK), Meredith Temple-O’Connor (NIH/NICHD)

Level:  Beginner

Your application has gone through the NIH Peer Review Process, so now what happens?  Who do you talk to if you have questions at this point in the application process? This session covers the time period after a competing application undergoes peer review until it is awarded by the NIH. If you have limited experience with the NIH application and award process and are hoping to get a better understanding of this point, then this session is for you.

Upon completion of this session, participants will be able to:

  • explain what happens after peer review;
  • identify who to discuss their priority score and summary statement with;
  • assess the appropriate actions if the application is not selected for award; and
  • determine the actions necessary if the application is selected for award, including resolving concerns from peer review and meeting just-in-time requirements.

PREPARING & SUBMITTING MULTI-PROJECT GRANT APPLICATIONS USING ASSIST

Presenter:  Sheri Cummins (NIH/OER)

Level:  All Levels

All complex, multi-project grant applications to NIH must be submitted electronically. Learn how NIH’s ASSIST (Application Submission System & Interface for Submission Tracking) tool can be used to prepare, submit, and track your multi-project application. Participants will gain valuable insight into navigating the system; setting access controls to allow people to work concurrently on an application; running validation checks against NIH and Grants.gov business rules; and viewing an application image before and after submission.

Upon completion of this session, participants will be able to:

  • explain the structure of an electronic, multi-project application and how it is assembled for funding consideration; and
  • describe basic ASSIST actions, including: application initiation, managing access, validating application content against NIH business rules, previewing the application in the NIH format, changing component and application status to prepare for submission, submitting an application, and tracking the status of a submitted application.

REDUCING THE ANXIETY – GETTING TO KNOW OIG’S ROLE IN GRANT FRAUD INVESTIGATIONS

Presenters:  Les Hollie (HHS/OIG)

Level:  All Levels

The Department of Health and Human Services (HHS) is the largest grant-awarding department in the federal government. The Office of the Inspector General (OIG) for HHS is statutorily charged with providing independent oversight of all HHS programs, including those funded through grants operations at the NIH. OIG accomplishes its oversight mission through audits, evaluations, inspections, and investigations. HHS OIG has authority to investigate NIH grantees to ensure the appropriate use of federal funds.

This session will provide an introduction to OIG grant fraud investigations. By using case examples, we will explain the circumstances under which fraud, waste and abuse can occur, and describe what can happen when grantees do not implement proper internal controls. HHS programs are put at greater risk from fraud, waste and abuse if grantees are unaware of the circumstances that lead to enforcement.

By sharing cautionary case examples in this session, our aims are:

  • to increase grantee awareness about the effect of fraud, waste and abuse on NIH grants;
  • to share examples of fraud indicators from known NIH grant cases; and
  • to increase grantee capacity to prevent fraud from negatively affecting grants awarded by NIH.

R & D CONTRACT ADMINISTRATION OR “HOW TO GET PAID FOR YOUR WORK”     

Presenter:  Richard Hartmann (NIH/NIAID)

Level: Beginner – Intermediate

What happens once a contract is awarded?  Join us as we discuss the basic parameters for all contracts and delve into the nuances of the common (and less common) rules pertaining to contracts.  This presentation will also address the “cost ground rules’ that determine a timely reimbursement.  A major objective of this presentation is to provide Principal Investigator and Administrators the knowledge they need to properly bill and be reimbursed for work performed under contract.

Upon completion of this session, participants will be able to:

  • recognize and understand the roles of the parties involved in contracts at the NIH;
  • explain the basic types of contracts;
  • list basic rights and responsibilities provided in a contract;
  • explain how different types of contracts are funded;
  • determine when a contract needs to be changed;
  • recognize how to apply costs to a contract; and
  • know how to be reimbursed for their work.

 

R & D CONTRACTS:  FINDING OPPORTUNITIES & WRITING PROPOSALS

Presenter:  George Kennedy (NIH/NIAID)

Level: Beginner

In this session, we will examine how to search for contracting opportunities, including an interactive demonstration of FedBizOpps.  Be sure to take notes as our NIH contract expert provides pointers on preparing a proposal in response to a solicitation.  In addition, we’ll highlight what to be aware of in preparing a proposal and explain some of the more common pitfalls offerors make in preparing a proposal.  The target audience for this session is Principal Investigators, Administrators, and Administrative Assistants.

Upon completion of this session, participants will be able to:

  • describe the scope and types of solicitations at the NIH;
  • explain the fundamental differences between contracts and grants;
  • present information on how to look, and respond to, contract opportunities;
  • show how the NIH makes contract award decisions; and
  • provide insight into considerations in deciding to pursue a contract.

READY! SET! SUBMIT! APPLICATION PREPARATION & SUBMISSION

Presenters:  Sheri Cummins (NIH/OER), Laurie Roman (NIH/OER)

Level:  All Levels

How do you get your great research idea to NIH for funding consideration? You must find an appropriate opportunity; prepare your application; submit your error-free application through Grants.gov to NIH on-time; and confirm NIH received it correctly. Learn about the NIH grant application process and the NIH resources available to complete each step, including a high-level overview of NIH’s new online ASSIST system for the preparation and submission of grant applications.

Upon completion of this session, participants will be able to:

  • state the broad steps required to prepare and submit an application to NIH and identify the variables that make a submission successful;
  • discus various documents that provide instructions for completing an application; and
  • describe basic ASSIST actions used to submit a single-project grant application to NIH, including: application initiation, managing access, validating application content against NIH business rules, previewing the application in the NIH format, submitting an application and tracking the status of a submitted application.

RESEARCH INTEGRITY

Presenters:  William Trenkle (HHS/ORI), Patricia Valdez (NIH/OER)

Level:  All Levels

The NIH Extramural Research Integrity Officer and an expert from the HHS Office of Research Integrity provide information on research misconduct regulations, share how to recognize and avoid research misconduct, and describe how allegations are handled at the agencies. Current initiatives to promote research integrity will also be discussed.

Upon completion of this session, participants will be able to:

  • explain the various elements of research misconduct;
  • list the assurance requirements for NIH grant applications; and
  • describe the roles of the HHS Office of Research Integrity (ORI) and the NIH in promoting research integrity.

RESEARCH INVOLVING ANIMALS:  OFFICE OF LABORATORY ANIMAL WELFARE (OLAW)

Presenter:  Neera Gopee (NIH/OER), Paula Knapp (NIH/OER)

Level:  All Levels

Are you considering using live vertebrate animals in your research? Are you aware that the policies and regulations regarding research animals are different than those involving human subjects? This session provides information on the requirements for using animals, appropriate completion of the Vertebrate Animal Section of the grant application, peer review considerations, the functions of an Institutional Animal Care and Use Committee, details on the various Assurance documents, including which type is required for consortium projects, and the consequences of what happens when animal activities become non-compliant.

Upon completion of this session, participants will be able to:

  • describe OLAW’s role in the grant process involving vertebrate animals;
  • explain the applicability of the PHS Policy;
  • identify the differences between the types of Animal Welfare Assurance;
  • explain the importance of institutional accountability and compliance; and
  • identify the areas of a grant application involving the use of vertebrate animals.

RESEARCH INVOLVING HUMAN SUBJECTS:  REVISED HHS REGULATIONS & NEW NIH POLICIES

Presenters:  Misti Ault Anderson (HHS/OHRP), Petrice Brown-Longenecker (NIH/OER)

Level:  All Levels

OHRP and NIH faculty will discuss your responsibilities regarding human subjects protection in your NIH-funded research. This session will cover the fundamentals of the Common Rule including Federal-wide Assurance, IRB reviews, and informed consent. OHRP faculty will discuss the impact of the revised Common Rule. NIH faculty will discuss new NIH human subjects policies such as the Clinical Trial Stewardship Reforms and the Single IRB Policy.

Upon completion of this session, participants will be able to:

  • describe the role of the Office for Human Research Protections (OHRP) and the federal regulations on human research protections;
  • explain some of the changes to the Common Rule and know how to make basic determinations on whether a study needs IRB review, including changes to the conduct of secondary research;
  • recognize how NIH will implement the Common Rule changes; and
  • identify new NIH policies related to human subjects research.

RESEARCH INVOLVING HUMAN SUBJECTS:  BASIC NIH REQUIREMENTS AND Q&A

Presenters:  Petrice Brown-Longenecker (NIH/OER), Dawn Corbett (NIH/NIMH)

Level:  All Levels

NIH faculty will discuss the NIH policies for human subjects research and inclusion from application through award. An overview of recent regulatory and policy changes will be provided. If you have questions related to the human subjects regulations, policies for human subjects protections in the NIH application, and/or inclusion policies, this session will also provide the basic information you can take back to your lab or office.

Upon completion of this session, participants will be able to:

  • recognize the requirements for human subjects in NIH grant applications;
  • know and be able to apply the requirements for addressing inclusion of women, minorities, and children in NIH grant applications; and
  • understand post award requirements for human subjects research including the monitoring of inclusion in clinical research.

RESEARCH TRAINING AWARDS

Presenter:  Tony Corio (NIH/OER)

Level:  Beginner

What are the issues specific to grants awarded under the auspices of Ruth L. Kirschstein National Research Service Awards (NRSA), specifically Individual Fellowships and Institutional Training Grants? This session provides administrative and financial aspects of training grants and fellowships.

Upon completion of this session, participants will be able to:

  • distinguish between NIH’s individual and institutional award mechanisms;
  • differentiate stipends from compensation;
  • discern allowable and unallowable costs along with re-budgeting authorities for NRSA awards;
  • understand NRSA payback requirements and options; and
  • identify post-award reporting requirements and submission procedures.

RIGOR AND REPRODUCIBILITY:  BACK TO BASICS

Presenters:  Michael Lauer (NIH/OER), Patricia Valdez (NIH/OER)

Level:  Beginner

One of NIH’s goals is to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science. The NIH initiative to Enhance Reproducibility through Rigor and Transparency clarifies a commitment to this goal. Attendees of this session will gain a better understanding of the updates to research grant and career development award application instructions and review language that includes increased attention to scientific premise, scientific rigor, consideration of biological variables, such as sex, and authentication of key resources, such as cell lines.

Upon completion of this session, participants will be able to:

  • describe the issue of reproducibility and NIH plans to address it;
  • summarize changes to application instructions and review criteria for NIH grants; and
  • explain how the policies behind rigor and transparency will impact different types of grants along with the implementation timeline.

TAKIN’ CARE OF BUSINESS – SBIR/STTRs

Presenter:  Robert Vinson (NIH/OER)

Level:  Beginner

Overview of the Small Business Innovative Research/Small Business Technology Transfer Programs, including ways small businesses and academia can develop mutually beneficial partnerships to undertake early stage, high tech projects.

Upon completion of this session, participants will be able to:

  • describe the basic goals and structure of the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs;
  • explain recent programmatic changes as a result of the SBIR/STTR Reauthorization of 2011; and
  • exhibit more confidence in submitting a competitive application.

USING RePORT TO YOUR ADVANTAGE

Presenters:  Megan Columbus (NIH/OER)

Level:  All Levels

NIH makes an abundance of grant and funding data – including analyses of who and what we fund – available to the public through a resource called RePORT. Learn how to use this resource to find information to help target your application, find key contacts at NIH and in the grantee community, and more.

Upon completion of this session, participants will be able to:

  • search for information on NIH funding by institution, principal investigator, and more;
  • identify existing projects NIH is funding on their topics of interest and explain how this information can help prospective applicants;
  • demonstrate how to determine which NIH institutes and types of programs are supporting their research topics of interest; and
  • explain how to identify which study sections review applications in their specific field.

WRITING AN EFFECTIVE “K” APPLICATION

Presenters:  Henry Khachaturian (NIH/OER), Kay Lund (NIH/OER)

Level:  Beginner

This session will provide an overview – along with insights and helpful hints – on preparing a mentored career award (K award) application for submission to the NIH.  It is designed for junior investigators and those who assist in the preparation of the scientific portions of an application. Learn how to develop a strategy, plan your application, application requirement, and review criteria.  In addition, hear advice on how to avoid the most common mistakes in writing K applications and correct some typical misconceptions about the review process.

Upon completion of this session, participants will be able to:

  • understand the steps involved from application to award;
  • explain the fundamentals of writing a clear and concise application; and
  • describe the nuances in applying for a career development (K) award.

X-TRAIN & X-TRACT:  YOUR TICKETS TO MANAGING TRAINING & CAREER AWARD DOCUMENTS FOR NIH

Presenter:  Anastasiya Hardison (NIH/OER)

Level:  Beginner

The xTrain and xTRACT modules, accessible through the eRA Commons, support extramural training programs funded by NIH. The xTrain module allows an institution’s users to electronically prepare, route and submit appointments, amendments and termination notices. The xTRACT module allows applicants, grantees and assistants to create research training tables for progress reports and institutional training grant applications. If your role in an institution involves working with the eRA Commons on either of these modules, it’s time to get on board and join NIH eRA experts to learn even more!

Upon completion of this session, participants will be able to:

  • describe the roles and activities supported by xTrain;
  • explain how to submit appointment and termination requests in xTrain;
  • describe how these requests are routed within an organization and to the agency;
  • understand how data entered in xTRACT is used to generate data tables for new/renewal and revision applications and RPPR;
  • preview PDFs, in xTRACT, to see how things look while data entry is in progress; and
  • finalize the PDF, in xTRACT, so it can be attached and submitted with the RPPR or New/Renewal/Revision application.