So, Now You Have the Grant

June 2008 — Presentation delivered at NCCAM Grantsmanship Workshop

Catherine M. Stoney, Ph.D.
Program Officer, NCCAM

Laura Lee Johnson, Ph.D.
Statistician, NCCAM

Outline

• 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

Role of Your Institution's Office of Sponsored Research

Office of Sponsored Research

• "Sponsored Programs" — typically handles grant application submission (i.e., pre-award)
• "Grants Management" — typically handles post-award processes
• Remember — the grant was made to the institution on your behalf
• Institution has contractual fiduciary and ethical oversight of the conduct of the study
• Establishment of a grant account from which you can
• Pay salaries
• Purchase equipment
• Purchase supplies
• Pay subcontractors

Grants Management

• Submit required periodic (i.e., annual) Progress Reports
• Typically due 2 months before renewal date
• Are in fact a "non-competing" application (Type 5) for the next year of funding
• Reports are read by assigned Program Officer who decides whether sufficient progress has been made to warrant continued funding
• Monitor expenses and provides reports (including submitting the Financial Status Report to NIH)
• Understanding financial reports
• Retrieving balance information
• Verify cost-sharing
• Cash and travel advances

What To Do If You Don't Have an Office of Sponsored Research?

NESA's Experience

• "A significant practical, yet perhaps under-appreciated, barrier to a more active role of complementary and alternative medicine (CAM) institutions in research is the organizational infrastructure required for submitting and managing research grants."
• New England School of Acupuncture (NESA)
• collaboration with the Harvard Medical School Osher Institute
• support by a NCCAM grant (Developmental Center for Research on CAM)
• developed its grants management infrastructure and increased its research capacity
• "A significant practical, yet perhaps under-appreciated, barrier to a more active role of CAM institutions in research is the organizational infrastructure required for submitting and managing research grants."
• "One key barrier that significantly limited NESA's ability to establish a more autonomous program capable of initiating and managing government-funded research studies was its lack of staffing for and experience with overseeing administrative and financial matters related to research grants."
• NESA had virtually no experience in grants administration and a very limited grants management staff.
• Because NESA's financial and human resource technology requirements were very simple, its accounting systems were based on software and systems typically used for small businesses. These systems were not designed to manage and account for multiple, multi-year grant budgets, each with numerous consortium agreements.
• Furthermore, NESA had no experience developing consortium agreements with collaborating institutions, had yet to negotiate a facilities and administration (F&A) cost rate proposal, and had not yet learned how to comply with NIH procedures such as drawing down and transferring awarded funds and completing annual financial status reports.

NESA Checklist for Grants Management

Getting Started and Staffing Up

• It is common for it to take ~6 months to get going on a study
• IRB approval (for human or animal studies)
• DSMB approval (for human studies)
• Hiring new research staff
• Study coordinator, research assistants
• Graduate students, post-docs
• For clinical trials
• Recruitment of subjects

Budget Management

Daily/Weekly

• Bill payment with assignment of payments to correct accounts
• Assign payroll charges when cost incurred
• Make sure that all costs are allowable and reasonable
• Identify whether subcontractors are billing on a timely basis and follow up as necessary

Monthly

• Review charges to accounts and make any journal entries necessary (note: journals need to be made within 90 days of date of cost incurrence)
• Compare budget to actual and identify critical differences; make necessary corrections
• Generate reports by account—current period and cumulative actual vs budget
• Produce and verify effort reports; have primary investigator sign off; maintain fi le for audit purposes

Yearly Progress Reports and Final Reports

Progress Reports

• are due 2 months prior to renewal date
• Method by which you get the next year of funding
• Read by Program Officer
• Submitted for you by Office of Grants Management (Sponsored Research)
• Content varies depending on type of funding mechanisms (e.g., R01, F32, T32, K23, etc.)
• Read the funding opportunity announcement to determine what content is required

Final Reports

• submitted within 90 days after the expiration of the award
• summary of progress toward the achievement of the originally stated aims
• list of results (positive or negative) considered significant
• list of publications resulting from the project as well as plans for further publications
• copies of manuscripts that have been accepted for publication, but not yet published

Population Tracking and Accrual Reports

Purpose

• electronic database that enables grantor agency staff to monitor compliance with policies on inclusion of women and minorities in clinical research.
• It also provides a centralized and consistent capture of the required data which is then used to generate agency-wide statistical reports.

Enrollment Report

Requirements for NIH-Defined Phase III Clinical Trial Applications

• Progress Reports need to include

Both:

• Enrollment Table
• Statement in text about progress in data analyses for sex/gender and ethnicity/racial effects.

Public Law PL 103-43

• Women and Minorities must be included in all clinical research studies
• Women and Minorities must be included in Phase III clinical trials & the trial must be designed to permit valid analysis
• Cost is NOT allowed as an acceptable reason for exclusion
• NIH to support outreach efforts to recruit and retain women, minorities, and their subpopulations in clinical studies

Instructions in PHS 398

• Inclusion of Women and Minorities Sections must include:
• Subject Selection Criteria & Rationale
• Rationale for Any Exclusions
• Enrollment dates (start and end)
• Outreach Plans for Recruitment
• Proposed Composition Using New Tables

Requirements for NIH-Defined Phase III Clinical Trials

• Research plan must include one of the following:
• Prior studies support significant differences between subgroups:
• Need plans to conduct valid analyses to detect significant differences between sex/gender and/or racial/ethnic subgroups
• Prior studies support no significant differences between subgroups:
• Representation as subject selection criterion is not required; however, inclusion and analyses are encouraged

• For the purpose of this policy, Significant Difference is defined as a difference that is of clinical or public health importance based on substantial scientific data. This is not the same as "statistically significant difference."

Supplements

It is possible to supplement your grant with additional funds

• Research Supplements to Promote Diversity (PA-04-126)
• Individuals reentering a career in science
• Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds
• CAM Practitioner Administrative Supplements (NOT-AT-07-005)
• Eligible grant types (NCCAM R01, P01, U19, U01 or P50 grant)
• 1 year w/ possible renewal for 2nd year
• Administrative Supplements
• Designed for when something happens that was "unanticipated" and "unanticipatable" (e.g., trusty freezer dies)
• No change in scope or aims of grant
• Competitive Supplements
• Offshoot or new direction for existing grant
• Goes through regular peer-review process
• Two years left on parent grant prior to supplement

Dissemination

• Data Sharing — achieves many important goals for the scientific community, such as
• reinforcing open scientific inquiry
• encouraging diversity of analysis and opinion,
• promoting new research, testing of new or alternative hypotheses and methods of analysis
• supporting studies on data collection methods and measurement
• facilitating education of new researchers
• enabling the exploration of topics not envisioned by the initial investigators
• permitting the creation of new datasets by combining data from multiple sources

Sharing "Final Research Data"

Recorded factual material

• commonly accepted in the scientific community
• necessary to validate research findings
• For small studies, it is common that a peer-reviewed publication is sufficient
• For large studies, raw data (stripped of personal identifiers) may need to be made available

Final research data do not include:

• laboratory notebooks
• partial datasets
• preliminary analyses
• drafts of scientific papers
• plans for future research
• peer review reports
• communications with colleagues
• physical objects — such as gels or laboratory specimens

How soon?

• "NIH expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset."

Resource Links

NIH Data Sharing Policy