Fr a n k U r s oE x e c u t i v e D i r e c t o r o f R e s e a r c h A d m i n i s t r a t i o n

H a r v a r d Sc h o o l o f P u b l i c H e a l t h

February 14 , 2014

Responsible Conduct of Research Grant Writing, Budgeting and Management

Research Partnership

Peer Review

Project Management

Program Administration

Principle Investigator

DepartmentCentral Administration

Sponsor Applicant

2

Proposal Development

HU Review & Submission

Through Award Set-Up

Award Management

Award Closeout

Award Lifecycle3

Grant Managers and other Dept staff can help you navigate the system

A Principal Investigator (PI) Is…

An individual designated by the grantee to direct the project or activity being supported by the grant. He or she is responsible and accountable to the grantee and NIH for the proper conduct of the project or activity.

NIH Grants Policy Statement 10/11 http://grants.nih.gov/grants/policy/multi_pi/faq.htm#2952

On research projects, the PI is usually a faculty member.

4

Ethical Considerations

GOOD SCIENCE

The scientific research enterprise is built on a foundation of trust

Scientists trust reported results are valid

Society trusts that scientists act honestly and without bias

STEWARDSHIP-Responsible Resource Management

Conducting research is a privilege

Regulatory oversight: human and animal subjects, environmental concerns

Public and or charitable funds

5

Responsibilities

Principal Investigators are in charge of technical and financial aspects of projects

PIs should work with administrators to help: Prepare and submit proposals with achievable scope

and accurate budgets Submit technical reports on time Follow federal cost principles

6

Grant Proposals7

Responsible conduct of research begins at the proposal stage and the Principal Investigator is ultimately responsible for all aspects of the proposal as submitted to the granting agency or organization.

Accuracy of the proposal is paramount to a successful and compliant research award. Scope of Work Budget Collaborators:

Subcontractors, Consultants and Service Agreements

Grant Proposals8

Proposals are reviewed for overall impact and influence over the research fields involved.

Research Misconduct can occur if there is fabrication or falsification in grant proposals.

Do not provide embellished or misleading information in the scope of work, CV or other agency-required documentation.

There is a line between touting your expertise and experience, and exaggerating them – don’t cross it

For help with grant development consider using ORSD editorial or peer review services

Basics of Effective Proposals

DOCUMENTATION and TIMELINESS

Clear language

List full names/titles prior to abbreviating

Presentation is important

Follow instructions and guidance

Cultivate relationships and communication - with all stakeholders

Spend appropriately and to whatever extent possible according to plan

Transparency

9

Recent Notice to SPH Investigators10

PROPOSAL APPLICATION ALERT!

Due to sequestration and budget cuts federal agencies are becoming increasingly stringent about adherence to proposal preparation guidelines as outline in agency FOAs, RFAs, and BAAs. We recently experienced this first hand when an NIH application was returned for “administrative” reasons and was not allowed to proceed to the referral and review process.

Please be aware that NIH has been enforcing with new vigilance the rules regarding font size. In the past this may not have been a reason for not processing an application but now applications are being subject to a different level of scrutiny. Also, take note of what can be included in tables (data in what NIH defines as a “table” can be numerical only the only words included should be labels for numerical data).

Most importantly, read and follow carefully the proposal preparation guidelines for each and every proposal that is being submitted.

Extra Prep Time Needed For…

Collaborations with other departments or institutions

Large, complicated projectsNewsworthy projectsComplex compliance issues (PAs, FCOI,

Provost review)

11

Proposal Submission

Work with your grant administrator to create the best proposal possible

Send proposal for SPA review 10 days prior to sponsor due date (submission deadlines vary by school)

Proposals are ultimately submitted via one of the university Sponsored Program Offices HSPH SPA HMS SPA University OSP

12

12

Choosing your Collaborators

When a Harvard collaborator is not available there are several options for establishing relationships with collaborators.

During proposal development, discuss the collaboration you have in mind with your departmental administrator to determine whether the relationship is a subaward or a vendor procurement/purchased services transaction.

The terms and conditions governing the relationship will differ whether it is with a subrecipient or with a vendor furnishing goods and/or services.

At the same time, the Principal Investigator should assess the potential Collaborator’s ability to perform the work successfully based on:

Expertise and past performance Technical/financial resources Proposed scope of work

13

Cost of Doing Research

Direct Costs + Indirect Costs----------------------- = Project Costs

14

Also referred

to as:-IDC

-Overhea

d-F&A

Cost Principles: Direct vs. Indirect Cost

Direct Costs Expenses that are specifically associated with a

particular sponsored award and/or can be directly assigned to that award with a high degree of accuracy

Indirect Costs (Facilities & Administrative (F&A)) Expenses that cannot be specifically identified with a

particular project or activity. “Overhead costs are administration, buildings, utilities, research infrastructure, and other expenses necessary for the operation of the University.”

15

Cost Principles16

Harvard and its Principal Investigators are jointly responsible for managing sponsored funds in accordance with the cost principles set forth in OMB Circular A-21.

For a cost to be allowable under OMB Circular A-21,it must be reasonable, allocable, and consistently treated. A cost is reasonable if it is necessary for the performance of the specific

award and would have been incurred by a “prudent person” for the particular goods or services obtained.

A cost is allocable if its benefit, either in whole or in part, to the specific sponsored award can be demonstrated.

A cost is consistently treated if it is always institutionally treated as either a direct cost of research or an indirect (Facilities and Administrative; F&A) cost of research when incurred for the same purpose in like circumstances.

Costs Normally Considered F&A

administrative & clerical salaries & fringe

books & subscriptions

conference feeshazardous waste

disposal membership dues

office suppliespersonal

computerspostage & shippingproposal

preparationsoftware- generaltelephone & fax

service (basic costs)

17

OMB Circulars A-21 and A-110

Principles for Determining Costs Applicable to Grants, Contracts, and Other Agreements with Educational Institutions (OMB Circular A-21) provides: the principles governing reimbursement of research

costs for grants made to colleges and universities. These principles define those costs that are allowable

and allocable to the federal government, and those that are not

Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (OMB Circular A-110) provides: the administrative rules for managing grants responsibly,

including procuring goods and services, managing equipment, financial and non-financial reporting, record retention, etc.

18

Budget 19

Estimate the project costs accurately. Don't overstate or understate your expenses

The budget should be complete and fully-loaded Include all the costs of personnel, equipment, supplies, and

activities required for the project Use the correct F & A rate – on-campus v. off-campus (see

policy)Expenditures must be allowable, appropriate, and

reasonable in accordance with applicable cost principles.

Actual expenses must then match up to the budget proposed, or permissions must be obtained from your grant officer for budget variances.

Salary Charges to a Grant andTime and Effort Reporting

20

Grant Proposals must contain an accurate representation of the time commitment of the Principal Investigator and all Key Personnel. Later significant deviations (i.e., 25 percent or greater time

and effort reduction) must be approved by funder.Salary and Wages charged to an award must be both

reasonable and for actual work performed on the project.Time and effort reports are required to be completed at

periodic intervals by employee or supervisor, and must be accurate and signed (Monthly for staff, annual for faculty).

For Federal grants, costs of administrative or clerical staff must be treated as a F & A Cost, and not a direct cost In other words, departmental administrators cannot ordinarily

be listed as Key Personnel and directly charged to your grant.

Proposal Budgets

PIs should work with their grant managerFederal sponsors require the use of federal

cost principlesFor non-federal grants, HSPH provides an

non-federal budget template

21

21

Compliance

For Federal Grants: Congress Passes Laws Agencies publish regulations Harvard Establishes Policies Sponsors issue terms and conditions

For Non-Federal Grants Harvard Establishes Policies Sponsors issue terms and conditions

22

Can be financial( eg: Cost allowability, effort,

etc)&

non-financial(eg:Human subjects protection,

COI, Export Control)

University Policies and Practices

Financial Conflict of InterestIP Ownership

OTD PA Agreement

University Review UCIPS Provost Criteria

23

These add time to the review and submission process !

When Things Go Wrong…

In the news… Yale (7.6M)– 2006; Cost accounting and effort reporting Stanford v Roche ($M’s) – 2011; PI signed a confidentiality agreement when

working in a corporate lab assigning rights to IP to the company FCOI – Institutional responsibility is greatly increased, disclosure threshold

lowered to $5,000 UFlorida (192K) – 2011; Prematurely destroyed records, possibly falsified OT

hours and questionable charges

In our own backyard… Reading NGAs Carry Forwards Billing terms Sub recipients

24

Lesson: DO NOT SIGN ANYTHING

WITHOUT INSTITUTIONAL

REVIEW !

Subrecipient Monitoring25

Subrecipient Monitoring is the process of providing oversight on subawards throughout their lifecycle.

At the proposal stage, the Principal Investigator is responsible for choosing an appropriate collaborator as well as: Obtaining the appropriate information prior to submitting the proposal (statement of

intent, accurate budget, statement of work) Reviewing appropriateness of subawardee Executing an agreement consistent with federal requirements (Note: Drafted,

Reviewed and signed by SPA) Acquiring all required representations, certifications, and assurances (e.g., human

subject assurance).

Subrecipient Monitoring26

The federal regulations that describe subrecipient monitoring are general, but contain the following core elements of compliance:

Advising subrecipients of all applicable federal laws and regulations, and all appropriate flow-down provisions from the prime agreement

The routine receipt and review of Technical Performance Reports The routine Review of Expenses-to-Budget The periodic performance of On-site Visits, or regular contact, if necessary The option to perform "audits" if necessary Review of A-133 audit reports filed by subrecipients and any audit findings Review of corrective actions cited by subrecipients in response to their

audit findings Consideration of sanctions on subrecipients in cases of continued inability or

unwillingness to have required audits or to correct non-compliant actions

Subrecipient Monitoring27

Principal Investigators are responsible for the overall monitoring of the subrecipients including if: Subrecipient has performed the research in accordance

with the Statement of Work Subrecipient is continuing to meet compliance

requirements Subrecipient is meeting reporting requirements Subrecipient is requesting reasonable expenditures

Monitoring can be through reporting, regular contact and communication and detailed invoice review

Rights to Research Data28

Research Data are critical to protecting intellectual property Obtaining patents Enforcing patents

Government has right to inspect those data and research materials whose collection and analysis government has funded

Disclosure and dissemination of Research Data is critical for University reputation and assures future research support.

Research Data Ownership and Use29

Harvard retains ownership of all research data and materials, but researchers have rights to use the data and materials, publish their findings, and retain copyright

Harvard does not ordinarily perform “classified research” or accept any significant restrictions on publication of research results (such as confidentiality)

Harvard Principles for Access to and Retention of Research Data and

Materials 30

1. Harvard researchers and staff should have systems or practices for maintaining the essential Research Records that they create in order to be able reasonably to support research findings, justify the uses of research funds and resources, and protect any resulting intellectual property. In determining which records are essential, Harvard researchers and staff should use prudence and reasoned judgment and may seek to refer to the prevailing standards in their relevant academic or professional disciplines. In general, researchers and staff should keep those records that will document research findings and justify the uses of research funds and other resources.

2. Research Records should be retained, generally, for a period of no fewer than seven (7) years after the end of a research project or activity.1 For this purpose, a research project or activity should be regarded as having ended after (a) final reporting to the research sponsor, (b) final financial close-out of a sponsored research award, or (c) final publication of research results, whichever is later.

3. As needed, researchers and staff must make Research Records available to the University so that it may respond to federal audits or other official requests, respond to subpoenas or other document demands, and conduct other internal and external oversight activities.

Harvard Principles for Access to and Retention of Research Data and

Materials 31

4. The record keeping systems or practices used by Harvard researchers and staff should allow unmediated access by the University to the Research Records over their entire retention period. Such systems include, but are not necessarily limited to, electronic systems owned by the University or those located on the physical premises of the University. To the extent that use of University computing or other electronic systems for these purposes is not reasonably possible or is not preferred (e.g., research conducted off-site, electronic records that are required to be stored on non-Harvard servers, research conducted in collaboration with researchers whose primary affiliation is not Harvard), Harvard researchers and staff should assure that, if needed by the University for oversight purposes, such Research Records are readily available to the University.

5. The record keeping systems or practices used by Harvard researchers and staff should be designed to include the retention of important written correspondence (including mail and electronic mail, and copies of reports, analyses and progress reports) related to their research. The scope of the correspondence that should be retained should be sufficient to enable an independent party reviewing that correspondence to identify and understand primary findings, major events, and major strategic decisions or judgments made in the course of that research.

6. Harvard researchers and staff should be mindful that for research that has led to major academic findings or major scientific discoveries, a wider and more inclusive set of Research Records should likely be maintained, for historical purposes and for the protection of intellectual property.

HSPH Research Administration Support

Proposal review and submission - SPA Funding opportunities, Research Oversight, ORARC , IACUC, &

Award Administration – ORSD, OER Website: http://hlcra.harvard.edu Frank Urso

Executive Director for Research Administrationfurso@hsph.harvard.edu

32