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NCCAM Grantsmanship Workshop

June 3–5, 2008
Rockville, MD

The National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health (NIH), will conduct a 3-day grantsmanship workshop. This workshop will provide researchers, fellows, and graduate students with an in-depth understanding of the NIH grants and review processes, clarify Federal regulations and policies, and highlight areas of special interest and concern.

Emphasis will be placed on complementary and alternative medicine (CAM) research. The workshop will include time to interact and discuss research ideas with NCCAM staff. Due to limited space, attendees will be selected through an application process.

Workshop Highlights:

Application has closed.

DRAFT AGENDA

DAY 1 — June 3, 2008
9:00 a.m. Welcome
Introduction and Overview of Agenda
9:15 a.m.

Part 1: Overview of NIH

  • Organization
  • Mission & Plans
  • Research & Training
  • People & Places
  • Staff
9:30 a.m.

Part 2: Overview of NCCAM

  • Organization
  • Mission & Plans
  • Research & Training
  • People & Places
  • Staff
9:45 a.m.

Part 3: Lifecycle of a Grant Application

  • Grant Process
    • e-Submissions
      • Registration
      • Validation
      • Trouble spots
  • Receipt and Referral
  • Peer Review
    • Study Section
      • Overview
      • Streamlined Procedures
      • Review Criteria
      • Human Subjects/Animal Safety
    • Resubmission
  • Advisory Council

  • Resubmission
  • Budget Review by Grants Management
  • Notice of Grant Award
    • Terms and Conditions of Award
  • Just-in-Time Information
10:45 a.m.

Part 4: Roles of NIH Staff

  • Scientific Review Administrators
  • Program Officer
  • Grants Management Specialist
  • Office of Clinical and Regulatory Affairs
  • Product Integrity Working Group
11:15 a.m.

Part 5: Types of Grants and Fellowships (Funding Mechanisms)

  • R mechanisms
  • U mechanisms
  • K mechanisms
  • F mechanisms
11:30 a.m.

Part 6: Solicited vs. Unsolicited (Investigator-Initiated) Applications

  • Types of Initiatives
    • Program Announcements
    • Request for Applications
    • Request for Proposals
11:45 a.m. LUNCH
1:00 p.m.

Part 7: Grant Writing (How To Get a Grant or Fellowship)

  • General Informaiton
  • Research Plan
    • Specific Aims and Hypotheses
    • Background and Preliminary Data
    • Choice of Outcomes
    • Sample Size
    • Analysis Plan
  • Problems and Common Pitfalls (Examples of Good and Bad)
  • Special Issues When Resubmitting Applications
  • Developing a Budget
2:30 p.m. BREAK
3:00 p.m.

Part 8: Food and Drug Administration

  • Relation to NIH-Funded Research
  • IND and IDE
    • What is it?
    • When is it required?
    • What is the process?
  • Timing of IND/IDE Submission vs. Funding of Grant
  • IND vs. PIWG Review
3:45 p.m.

Part 9: Issues in Recruitment and Retention of Human Subjects

  • NIH Inclusion Policies
  • Roles & Responsibilities of PI and NIH Staff
  • Common Issues with Diverse Populations
  • Successful Recruitment
  • Impediments to NIH Funding
  • Payment of Subjects
4:30–6:00 p.m. One-on-One Sessions with NCCAM Staff

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DAY 2 — June 4, 2008
8:30 a.m. Part 10: Hints from Seasoned Researchers
  • Strategies and Tricks of the Trade
  • Success Stories
  • Writing a Grant
  • Creating Application Teams (vs. Research Teams)
  • Developing Collaborations
  • Product Integrity Working Group
10:00 a.m. Part 11a: How To Read a Summary Statement with Examples
10:30 a.m. BREAK
11:00 a.m.

Part 11b: Hints from Seasoned Study Section Members

  • What really goes on during peer review?
  • What makes a good application
    • How to make a study section member smile
  • What makes a bad application?
    • How to make a study section member cringe
12:30 p.m. LUNCH
2:00 p.m. Part 12a: CSR Mock Review (taped)
3:00 p.m. Part 12b: Commentary/Discussion of CSR Mock Review
4:00–6:00 p.m. One-on-One Sessions with NCCAM Staff

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DAY 3 — June 5, 2008
8:30 a.m. Part 13: Ethical Issues in Research
  • Responsible Science
  • Ethical Responsibilities
  • Ethical Challenges
  • Irresponsible Science
  • Conflicts of Interest
  • Ethical Guidelines
  • Human Subjects Research Codes
  • HIPAA
9:30 a.m. Part 14: Institutional Review Boards
  • IRB Responsibilities
  • IRB Members
  • Investigator Responsibilities
10:30 a.m. BREAK
11:00 a.m. Part 15: Data and Safety Monitoring Board
  • Purpose vs. IRB
  • Roles and Responsibilities of DSMB Members
  • Role of PI
  • Role of NIH
12:00 p.m. Part 16: So, Now You Have the Grant
  • Role of Your Institution's Office of Sponsored Research
  • What To Do If You Don't Have an Office of Sponsored Research
  • Getting Started and Staffing Up
  • Budget Management
  • Yearly Progress Reports and Final Reports
  • Population Tracking and Accrual Reports
  • Supplements
  • Dissemination
  • NIH Policy on Public Access
1:00 p.m. Closing Comments
LUNCH
2:00–4:00 p.m. One-on-One Sessions with NCCAM Staff

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