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), conducted a 3-day grantsmanship workshop. This workshop provided researchers, fellows, and graduate students with an in-depth understanding of the NIH grants and review processes, clarified Federal regulations and policies, and highlighted areas of special interest and concern.

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

Workshop Highlights:

Agenda

Day 1—June 3, 2008

9:00 a.m.

Welcome—Josephine Briggs

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Introduction and Overview of Agenda—Richard Nahin
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9:15 a.m.

Part 1: Overview of NIH—Richard Nahin

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  • Mission
  • History & Organization
  • Facts
9:30 a.m.

Part 2: Overview of NCCAM—Richard Nahin

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  • Mission
  • History & Organization
  • Facts
9:45 a.m.

Part 3: Lifecycle of a Grant Application

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  • Grant Process Overview—Martin Goldrosen
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  • Electronic Submissions—Dale Birkle
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    • Registration
    • Submission
    • Validation
    • How to get Help
  • Peer Review—Dale Birkle
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    • Overview
    • Application Assignments
    • Peer Reviewers
    • Preview Criteria
    • Actions and Outcomes
  • NCCAM's Advisory Council—Martin Goldrosen
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  • Budget Review by Grants Management—George Tucker
    • Notice of Grant Award
    • Terms and Conditions of Award
  • Just-in-Time Information
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Video of Question and Answer

11:00 a.m.

Part 4: Roles of NIH Staff—Carol Pontzer

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  • Scientific Review Administrators
  • Program Officer
  • Grants Management Specialist
  • Office of Clinical and Regulatory Affairs

Product Integrity Working Group—Sheila Caldwell
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11:15 a.m.

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

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

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

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  • 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)—
Kate Stoney, Laura Lee Johnson

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  • 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

Video of Question and Answer

2:30 p.m.

Break

3:00 p.m.

Part 8: FDA The IND and IDE Process as Relating to CAM—
Shaw Chen, Chiu Lin, Josh Berman

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3:45 p.m.

Part 9: Issues in Recruitment and Retention of Human Subjects—
April Bower

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  • NIH Inclusion Policies
  • Roles & Responsibilities
  • Issues with Diverse Populations
  • Recruitment and Retention Planning
  • Subject Incentives
  • Data & Safety Monitoring and Verification

Video of Question and Answer

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—
Cherkin, Gardner, Maki, Phillips, Ritenbaugh

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  • Strategies and Tricks of the Trade
  • Successful Stories
  • Writing a Grant
  • Creating Application Teams (vs. research teams)
  • Developing Collaborations

Video of Question and Answer

10:00 a.m.

Part 11a: How To Read a Summary Statement with Examples—
Dale Birkle

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10:30 a.m.

Break

11:00 a.m.

Part 11b: Hints from Seasoned Study Section Members—
Clarke, Dusek, Duffy, Winkelstein, Wayne

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  • 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

Video of Question and Answer

12:30 p.m.

Lunch

2:00 p.m.

Part 12a: CSR Mock Review (taped)—
Dale Birkle

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3:00 p.m.

Part 12b: Commentary/Discussion of CSR Mock Review—
Dale Birkle, moderator

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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 CAM Clinical Research—
Frank Miller

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Video of Question and Answer

9:30 a.m.

Part 14: Institutional Review Boards—
David Peden

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  • IRB Responsibilities
  • IRB Members
  • Investigators' Responsibilities

Video of Question and Answer

10:30 a.m.

Break

11:00 a.m.

Part 15: Data and Safety Monitoring Board—
Josh Berman

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  • Purpose vs. IRB
  • Roles and Responsibilities of DSMB Members
  • Role of PI
  • Role of NIH

Video of Question and Answer

12:00 p.m.

Part 16: So, Now You Have the Grant—
Partap Khalsa, Anita Greene

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  • 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 to existing grants
  • NIH Policy on Public Access

Video of Question and Answer

1:00 p.m.–1:05 p.m.

Closing Comments—Jack Killen

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Lunch

2:00–4:00 p.m.

One-on-One Sessions with NCCAM Staff

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