Resources for Investigators

The mission of the Office of Grants and Contracts (OGC) is to promote the development of scholarly and programmatic initiatives for the research community of The Feinstein Institute for Medical Research of the North Shore-LIJ Health System.

Goals:

To promote access to extramural funding for research projects and programs;
To provide assistance to investigators in procuring research funding;
To provide administrative oversight for those efforts.

Services:

Disseminate funding opportunity announcements
Disseminate information regarding changes or updates from sponsoring agencies
Review all research-related proposal and contract applications; provide advice on proposal organization and the interpretation of regulations as required by granting agencies and The Feinstein Institute for Medical Research
Assist with grant and contract budget development
Negotiate contracts for investigator-initiated research studies
Review, negotiate and accept grant and contract awards on behalf of The Feinstein Institute for Medical Research
Provide training in the form of workshops, seminars and individual instruction on grantsmanship, budget development, and research-related institutional policies and procedures.

DEFINITIONS

Principal Investigator (PI) Program Director (PD)
NIH: 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.
This title identifies the individual responsible for the conduct of the project. This responsibility includes the intellectual conduct of the project, fiscal accountability, administrative aspects, and the project's adherence to relevant policies and regulations.

Co-Principal Investigator
Although the Co-Principal Investigator definition is not used by the NIH, this designation refers to individuals who share the responsibility for the project with the Principal Investigator and therefore requires the same qualifications.

Co-Investigator
NIH: An individual involved with the PI in the scientific development or execution of a project. The co-investigator (collaborator) may be employed by, or be affiliated with, the applicant/grantee organization or another organization participating in the project under aconsortium agreement. A co-investigator typically devotes a specified percentage of time to the project and is considered 'key personnel'. The designation of a co-investigator, if applicable, does not affect the PI's roles and responsibilities.
This title designates key personnel for aproject, but without the oversight responsibility of a Principal Investigator. Individuals do not need to meet the qualifications of PI under this policy, but should be considered key to the performance of the project.

Other Significant Contributor
Other Significant Contributors are participants in a grant application who contribute substantively to the research project but without applying a measurable level of effort.

Multiple Principal Investigator
Recently implemented by the NIH, the Multiple Principal Investigator model permits investigators to seek support for projects or activities that clearly require a 'team science' approach. The multiple-PI option is targeted specifically to those projects that do not fit the single-PI model, and therefore is intended to supplement, and not to replace, the traditional single PI model.

GUIDANCE ON PRINCIPAL INVESTIGATOR ELIGIBILITY

It is the general guidance of The Feinstein Institute for Medical Research of the North Shore-LIJ Health System that employees with full-time or permanent status may serve as Principal Investigators or Project Directors on sponsored research projects and programs.

Individuals who are employed by the Health System but not on a permanent full-time basis (e.g., per diem employees, voluntary attending, adjunct faculty, post-doctoral fellows) may be eligible to serve as Principal Investigator if one (or both) of the following conditions is (are) met:

1. A permanent faculty or staff member is named asco-principal investigator, identified as the responsible person for the project grant account, and accepts responsibility for ensuring that grant/contract reporting requirements and deliverables are met; and

2. The chair or unit head through which the work will be conducted accepts responsibility for ensuring that grant/contract reporting requirements and deliverables are met, and as indication of such, submits an internal memorandum to this effect at the time the proposal is routed through the Health System.

Any deviations from the above may only occur with the express written permission of the Vice President for Research after a presentation and review of extenuating circumstances.

PART 1 FUNDING MECHANISMS FOR SPONSORED RESEARCH PROJECTS AND PROGRAMS

A. DEFINITIONS

Support for sponsored research projects and programs are provided through three funding mechanisms: grants, contracts (including subcontracts and consortium agreements) and cooperative agreements.This section will describe the characteristics of each.

1.0 Grants provide financial support for specific projects or programs with a defined scope of work. Grant applications are generally developed by the investigator; grant applications may also be developed collaboratively with research investigators at other institutions. Such applications may be in response to funding opportunity announcements from a government agency or from other funding sources. With most grants, a peer review process is convened and awards are conferred based on merit. Grants are also awarded for larger projects, typically called program or center grants. They are, often, multidisciplinary in nature and are comprised of core components and project-specific research studies.

2.0 Research contracts are legal documents that describe the terms and conditions that impact the development and delivery of products or services required. Contracts aregenerally awarded to bidders who are able to produce the best product (or service) at a competitive (low-cost) rate. Any modification in the scope or direction of the research project or adjustment in the budget will require prior written approval from the funding agency. There are two types of contracts: fixed price and cost-reimbursement. With a fixed-priced contract, the contractor (Institution) is obligated to complete the required work within a specified period of time at a pre-determined cost rate. A cost-reimbursement contract, which is generally used for research projects, is issued on the basis of an estimate of the cost of performing the work. The contract provides for payment to the contractor (Institution) for costs actually incurred up to a ceiling amount that is equal to the total estimated cost of the contract.

3.0 Cooperative agreements are used for research projects when substantial federal programmatic involvementis anticipated during the performance of the project. While the rules governing cooperative agreements are similar to those governing grants, federal program officials will monitor the progress of cooperative agreements more closely, participate in decisions concerning the direction of the research, and adjust funding levels to assure progress in the conduct of the project and to meet programmatic needs.

B. GRANT SUBMISSION PROCEDURES

1.0 APPLICATIONS FOR SPONSORED RESEARCH PROJECTS

Statement
All applications for research support are submitted in the name of the Institution and designate an employee (full or permanent status) as the Principal Investigator or Program Director. This includes applications that are being submitted to the federal government, to state, municipal or health-related agencies, to private foundations, and to industry. When a grant application is funded, the award is made to the Institution. Since the Institution has responsibility for its administrative and fiscal management it is, therefore, required that each application undergo the appropriate levels of review to ensure that the proposal is complete, accurate and consistent with Institutional policies. To permit appropriate review, the Office of Grants and Contracts (OGC) must receive grant and contract applications at least five (5) days before the agency's deadline for submission.

Procedures

1. Investigators are urged to consult with the OGC staff before or at the beginning of the grant preparation process to clarify administrative issues, budgetary requirements, and granting agency guidelines.

2. Members of the OGC staff (or the Office of Grant Accounting and Special Purpose Funds) shall assist with the preparation and/or review of grant and contract budgets to ensure that salary support levels and other budgeted items are accurate and appropriate for the project. (See Section 1.1, Budget Preparation Guidelines.)

3. All grant and contract applications must be submitted to OGC with a Grant Application Routing Form (OGC Form 1). The Grant Application Routing Form must be signed by the appropriate Department Head (or Department Heads if employees from other departments are represented on the budget). The Department Head's signature indicates the work is scientifically meritorious, that he/she is willing to have the research performed in his/her department, and that space requirements and capital needshave been taken into consideration. The second half of the Grant Application Routing Form serves two purposes: 1) to elicit information about the scope of the proposed project and 2) advise investigators how they may seek out and obtain appropriate compliance approvals that will be necessary for their research project. It is important to note that research projects may not commence before all appropriate approvals have beenreceived.(For guidance, please refer to Section 1.2 Compliance Requirements and Special Approvals)

4. Each grant or contract application must be submitted with Conflict of Interest Questionnaires (OGC Form 2) for all key personnel who will be participating in the research project. (Key personnel is defined as any person who is responsible for the design, conduct or reporting of research.)

5. Following review, a member of the grants management staff will advise the investigator of any errors or omissions in the proposal application. A final version will be requested. The grants management staff will route the proposal application for signature by an Institutional Official (if required) and will notify the investigator when the application is ready to be picked up. It is the responsibility of the Investigator to make the appropriate number of copies and forward the application to the sponsor to meet the deadline.

6. One complete copy of the final version of thegrant application must be submitted to the Office of Grants and Contracts for the Institution's official record.

7. Once the application is submitted for funding consideration, investigators shall keep the Office of Grants and Contracts apprised of any new developments with their application, including the funding status if known. Copies of any relevant correspondence shall be forwarded to the Office of Grants and Contracts.

1.1 BUDGET PREPARATION GUIDELINES

The principal investigator shall identify costs associated with the research prior to meeting with a representative from Office of Grants and Contracts (OGC) (or the Office of Grant Accounting and Special Purpose Funds (OGA)).If specific budget forms and/or instructions are available from the agency acopy should be given to OGC or OGA to use as guidelines in reviewing the budget. Among the items to be consideredare:

Personnel
Equipment
Supplies
Consultant costs
Animals and animal care
Laboratory costs
Computer and/or biostatistical service costs
Travel
Telephone
Xerox
Postage
Space
Publication costs
Patient care
Other

If new personnel are to be hired or new positions created, a job description should be prepared in consultation with Department of Human Resources to determine the appropriate salary range.

Upon assessment of the needs of the project, a budget will be prepared. The following considerations and constraints will be included:

a) Salaries at the current prevailing rate paid by the Institution shall be included in each grant budget.

b) Fringe benefits at the current established rate shall be included for each salary in a grant budget.

c) Salary figures included in the grant budget for future years of grant support shall be estimated to reflect potential annual increases in salary, the percentage to be determined in accordance with Institutional policy for all personnel.

d) Appropriate Purchasing or Material Support Service Departments should be consulted for price estimates for equipment and supplies to be listed. The budgeted price should reflect shipping and installation costs. Major or unusualitems will require justification.

e) Established overhead rates (indirect costs) are largely dependent on the type of grant and source of support; however, the maximum allowable rate must be taken. The following guidelines are to be used:

i. Government Agencies

The DHHS negotiated Indirect Cost Rate shall be used. The appropriate current rate is available here.

ii. Foundations, Agencies, and Private Industry

The policy of the organization will be honored, however, the acceptance of the grant providing less than full cost reimbursement will be at the discretion of Administration.

1.2 COMPLIANCE REQUIREMENTS AND SPECIAL APPROVALS

The Institution has established specific compliance programs to oversee and ensure the ethical and safe conduct of research at its facilities. Toward this end, research investigators are advised to seek out and obtain appropriate compliance approvals for their research projects. It is important to note that research projects may not commence before all appropriate approvals have been received.

a. Use of Human Subjects: The Institutional Review Board (IRB) is the official oversight committee for the protection of human subjects in research, and is responsible for approving all research activity that will involve the participation of human subjects or identifiable private information. For further details on the procedure for submitting protocols, please refer to the Office of the IRB website

NOTE: The following pertains to all NIH grant and contract applications that will involve the participation of human subjects.

When a proposed study includes human subjects, the OGC form letter should be prepared to accompany the grant application. The letter, printed on the department's letterhead, states that all proposed personnel have participated in the Institution's formal education program for the protection of human subjects in research. The letter should be signed by the principal investigator, with a space included for the signature of the Assistant Director of the Institutional Review Board. Please refer to Appendix H to view a sample of the letter.

b. Use of Animals: The Institutional Animal Care and Use Committee (IACUC) is the oversight committee for the protection of laboratory animals in research. The IACUC is responsible for approving research activity that will involve the use of live vertebrate animals. For further information, please contact the IACUC Administrator's office at 526-562-1266 or at IACUC@nshs.edu.

c. Use of Radioactive Materials:Research involving the use of radioactive materials, radiation generating equipment, and/or lasers in research radio isotopes comes under the purview of the Office of Radiation Safety. For information and guidance, please contact William Robeson or Miyuki Yoshida-Hay at 516-562-2543, or 3895.

d. Use of Biohazardous Materials: The Institutional Biosafety Committee oversees research involving use of recombinant DNA, infectious agents, and biological agents in any experiments, and the use of exogenous substances or chemicals administered to animals in order to ensure protection of humans and the environment. For additional information, contact Virginia Duryea at 516-562-FIMR.

Grant Submission Procedures Specific to National Institutes of Health Applications

In December 2005, the National Institutes of Health transitioned the first round of grant applications from hardcopy PHS 398 forms to the electronic submission of the SF424 Research and Related packet of forms. The Small Business Innovative Technology (SBIR) and Small Business Technology Transfer(STTR) grant programs were the first to be submitted for funding consideration via Grants.gov, the Federal government's on-line, agency-wide portal.

Today, several other NIH funding mechanisms are submitted electronically through Grants.gov, including the traditional Research Project Grant mechanism, known as the RO1. In the near future, all NIH applications will be submitted electronically.

To ensure the successful submission of NIH grant applications, applications must be submitted to the Office of Grants and Contracts for review at least five business days before the deadline, with the final version of the SF424 application (including the research plan) returned to the OGC ready for submission two business days before the deadline.

Once the application passes Grants.gov validation, it will go through a more comprehensive validation process by the NIH. If errors are detected, the application will be rejected, the investigator will be required to make the specific corrections and return the changed/corrected application to OGC for re-submission through the Grants.gov portal, www.grants.gov.. For this reason, investigators are urged to remain available for at least 48 hours after the submission of their application.

The Office of Grants and Contracts offer straining sessions to help investigators navigate the SF424 grant preparation and submission process. Please contact our office for further information and scheduling.

C. GRANT SUBMISSION PROCEDURES SPECIFIC TO NIH APPLICATIONS AND PROGRESS REPORTS

1.0 MODULAR GRANT APPLICATIONS Statement

The Modular grant format is designed to streamline the review and award process for all applications requesting up to $250,000 in direct costs per year. This format is used for research project grants.

Direct costs for Modular budgets are estimated using modules of $25,000. This means the total direct cost must be divisible by $25,000 in each of the years for which funding is being requested. The total budget, including cost of living increases for personnel, should be averaged across all years, so that the same amount may be requested in each of the proposed grant years. The only exception shall apply to grants which request funds to purchase equipment in one of the funding years, usually the first year.

All Modular grant applications are now prepared using the SF424 packet of forms and are electronically submitted to the NIH for funding consideration by the Office of Grants and Contracts via Grants.gov, the Federal government's on-line grant submission portal.

2.0 RESEARCH GRANT APPLICATIONS REQUESTING MORE THAN $250,000

Statement

Detailed Budgets are required for grant applications requesting more than $250,000 in direct costs per year. Each line item expense (personnel, consultant costs, equipment, supplies, travel, patient care costs, other expenses, and consortium/contractual costs) must be listed and must be justified in narrative form.

Investigators are required to consult with and seek agreement from NIH program officers if he/she plans to submit a grant application with a proposed direct cost budget of greater than $500,000 or more for any one year. Contact with the NIH program officer should occur at least six (6) weeks before the grant submission deadline. If the requested dollars are significantly greater than $500,000, then approval should be sought even earlier. All applications that meet these criteria must be submitted to the NIH with a cover letter describing the contact with the NIH program officer or the application will be returned without the benefit of review.

This does not apply to applications that are being submitted in response to specific RFAs or in response to other Announcements that include specific budgetary limits.

Procedures

2. All Grant Applications must be submitted to OGC with a signed Grant Application Routing Form (OGC Form 1) and completed Conflict of Interest Questionnaires (OGC Form 2) for all key personnel.

3. For Modular applications, investigators are required to submit a detailed budget OGC to ensure that salary support levels and other budgeted items are accurate and appropriate for the project.

4. Members of the OGC staff (or the Office of Grant Accounting and Special Purpose Funds) shall assist with the preparation and/or review of detailed grant budgets to assure that salary support levels and other budgeted items are accurate and appropriate for the project. (See Section 1.1, Budget Preparation Guidelines.)

5. For projects that will require collaboration with research investigators at other institutions, the investigator must also provide a detailed budget that outlines the scope of work to be done by the collaborating institution. Additionally, the research investigator must obtain a letter of collaboration. The letter must be signed by an Institutional Official and should indicate:

1) their willingness to participate in the research project or program if an award is granted, and

2) their intent to comply with all federal requirements. See Appendix G for a sample Letter of Collaboration.

6. All NIH clinical research grant applications must be accompanied by a cover letter indicating that all key personnel have participated in a formal education program for the protection of human subjects in research. For guidance, see section 1.2 Compliance Requirements and Special Approvals.

7. Following review, a member of the grants management staff will advise the investigator of any errors or omissions in the SF424 proposal application. A final version will be requested and submitted to the NIH by OGC via www.grants.gov.

8. Investigators are urged to remain available after the electronic submission of their SF424 applications to correct identified errors and/or view the electronic version of the assembled application on eRA Commons within the time frame allowed by the NIH.

9. For hard copy submissions, a member of the grants management staff will notify the investigator when the Institutional Official has signed the application. It is the responsibility of the investigator to make the appropriate number of copies and forward the application to the sponsor to meet the deadline.

10. One complete copy of the final version of the grant application must be submitted to the Office of Grants and Contracts for the Institution's official record.

3.0 PROGRESS REPORTS
(Streamlined Non-competing Award Process (SNAP))

Statement

The NIH requires an annual Progress Report to continue the support of NIH awards. There are two methods of submission for Progress Reports: Electronic, (known as e-SNAP)and hard copy submissions. With eSNAP, Progress Reports are submitted electronically through eRA Commons, the NIH's repository for all of its grant information. The e-SNAP process applies to most research grant funding mechanisms and all Career Development Award 'K' series mechanisms.

eSNAPs must be submitted at least 45 days before the start of the project's next budget period. Paper Progress Report submissions are used for selected research project grants mechanisms, including program and center grants, and are dueat the NIH at least 60 days before the start of the project's next budget period.

Procedures for eSNAP

1. TheOGC will download from the eRA Commons website an electronic listing of pending Progress Reports and disseminate this information to each Principal Investigator (PI) 4 - 6 weeks before the progress report is due. The PI will also receive eSNAP preparation guidelines and instructions prepared by OGC. The eRA Commons website address is: https://commons.era.nih.gov/commons/index.jsp.

2. The eSNAP report module is divided into seven sections: Upload Science; Organization Information; Performance Sites; Key Personnel; Research Subject; SNAP Questions; Inclusion Enrollment. All will require completion.

3. The following three Streamlined Noncompeting Award Process (SNAP) questions will require 'yes' or 'no' answers. If you answer 'yes' to a SNAP question, you will have to provide a written explanation.

Has there been a change in the other support of key personnel since the last reporting period?

If there has been a change, then your responses should include details about Other Active Support for key personnel. You will need to provide updated Other Support pages and Other Support pages for new personnel who meet the definition of key personnel.

Will there be, in the next budget period, a significant change in the level of effort for key personnel from what was approved for this project?

If a change is anticipated then your response should be guided by the following federal definition. A significant change in level of effort is defined as a 25% reduction in time (e.g., reducing effort from 40% to 30% would constitute a 25% reduction). Also, if you are adding someone new, you must include a copy of their biographical sketch in the 'Upload Science' section of the eSNAP report.

Is it anticipated that an estimated unobligated balance (including prior year carry-over) will be greater than 25% of the current year's total budget?

Provide the reason for the unobligated balance (including prior year carry-over) and indicate how the funds will be spent during the next budget period. Please note the all balances will be confirmed by the Department of Finance.

Two new questions have been added to the eSNAP progress report, to which 'yes' or 'no' answers are required. They include:

Changes in Select Agent Research.(Select agents include therapeutic sera, toxins, antitoxins, or analogous products for preventing, treating, or curing disease or injury. Investigators who possess or use a select agent must register with and get approval from either the CDC Select Agent Program or USDA APHIS Agricultural Select Agent Program, depending on the agent.)

Changes in Multiple PI Leadership Plan.(Multiple PI Leadership plans describe how the PIs will manage the project, including making decisions on scientific direction, allocating resources, and resolving conflicts.)

4. After you have completed the eSNAP progress report, you will be able to forward your report to the OGC representative for review. This is accomplished by selecting their name from the drop down list. eRA Commons will send notification to the OGC representative that your Progress Report is available for review.

5. Following completion of the review process, the final version will be submitted through the eRA Commons portal tothe NIH by an Office of Grants and Contracts representative.

6. The OGC Routing form and Conflicts of Interest questionnaires must be submitted to OGC by inter-office mail.

Procedures for Paper Progress Report Submissions using PHS 2590 forms

1. Similar documentation is provided for paper Progress Reports.

2. Paper Progress Reports must be submitted to OGC with a signed Grant Application Routing Form (OGC Form 1) and completed Conflict of Interest Questionnaires (OGC Form 2) for all key personnel.

3. A complete application (PHS 2590) will include:

Face Page (Form page 1)
Detailed Budget Pages (Form pages 2 and 3)
The Progress Report Summary (Form page 5)
The Personnel Report (Form Page 7)
Inclusion Enrollment Report Table, if you are conducting a clinical research project

4. If your project includes human subjects, as defined by the NIH, then the Human Subjects section of your progress report should indicate that you and other personnel have participated in the Institution's program for the protection of human subjects in research. (NOTE: This should be part of the body of the progress report and not a separate cover letter.) Refer to Appendix H for sample language.

5. Following review, a member of the grants management staff will contact the investigator to let him/her know when the Institutional Official has signed the Progress Report.It is the responsibility of the investigator to make the appropriate number of copies and forward the application to the sponsor to meet the deadline.

6. One complete copy of the Progress Report must be submitted to the Office of Grants and Contracts for the Institution's official record.

4.0 RENEWAL APPLICATIONS

Statement

Renewal applications are submitted to obtain funds to continue a project or program beyond the currently funded project period. Renewal proposals are so identified because they will become subject to the same levels of review (initial and National Advisory Council/Board review) that are accorded to new and other renewal applications.

Procedures

1. For guidance, please refer to the list of procedures for Modular Grant Applications or Research Grant Applications Requesting Greater than $250,000.

5.0 NO-COST EXTENSIONS ON NIH GRANTS

Statement

Research investigators are permitted to extend (without additional funds) the final budget period of their project for up to 12 months beyond the original expiration date (as shown on the Notice of Grant Award) to assure adequate completion of the original scope of work. Extensions beyond the one-year interval will require prior approval from the NIH.

The research investigator must also update all required certifications, including human subjects and animal welfare, in accordance with applicable regulations and policies.

Procedures

1. Research investigators must notify the Director of the Office of Grants and Contracts, in writing preferably by e-mail, of his or her intent to request a no-cost extension on their research grant. The written request must include: the name of the grants management officer and his/her e-mail address, the grant number, title, as well as current and proposed end dates. To assure that requests are processed in a timely manner, they must be received at least 3 weeks before the end of the final project period.

2. The Director of the Office of Grants and Contracts will notify the NIH awarding office, via e-mail, of the extension at least 10 days prior to the expiration date of the project period.

3. The Office of Grants and Contracts will notify the Department of Grant Accounting and Special Purpose Funds of the approved extension and generate a Fund Memo to extend access to the fund account for the same period.

D. INTER-INSTITUTIONAL TRANSFER OF RESEARCH GRANTS

Statement

Principal investigators who accept appointmentsat other institutions will generally want to transfer their grants and contracts to the new institution. The Institution will relinquish a grant for transfer to another institution provided the transfer is consistent with the policies of the granting agency and the approval of the principal investigator's Department Chair or Center of Excellence Director. The same process would apply to Principal Investigators who have been appointed to positions at the Health System and who are planning to transfer their active grants and contracts to The Feinstein Institute for Medical Research.

Special arrangements are required when two or more investigators are involved in a single project and one moves to another institution. If the person listed as the principal investigator moves, the grant will usually be relinquished by the Institution and transferred to the new institution; if the person listed as the principal investigator remains at the Health System, the grant will usually remain at the Health System. If collaborating investigators wish to continue their collaboration after one moves to another institution, a consortium agreement between the institutions can usually be developed. Creating such a consortium agreement may require prior approval from the funding agency. Funding agencies will consider such factors as the budget, the nature of the research project, the feasibility of the collaboration when the investigators are at separate institutions, and whether the location and facilities of the new institution will allow for successful performance of the project.

The Office of Grants and Contracts will coordinate the receipt and/or transfer of inter-institutional research grants and contracts.

Procedures

1. Since policies governing the transfer of projects tend to vary from agency to agency, Administrators are urged to contact the Office of Grants and Contracts for guidance when they anticipate hiring individuals who have active research grants and contracts or when they learn that an investigator is planning to terminate his/her employment and transfer his/her grants and contracts to another institution.

2. For NIH grants and contracts: Prior approval from the NIH is required for the transfer of a grant-supported project or activity. Such transfers may also involve equipment that was purchased with grant funds and which can be included in the former institution's relinquishment of the grant. The relinquishing institution must submit to the NIH Grants Management Office a Relinquishing Statement

Face page;
Budget pages (current and future years); For Modular Grants, include narrative budget information, including total direct costs and F&A costs for the current budget period;
Updated Biographical Sketches for key personnel;
A statement indicating whether the overall research plans/aims have changed from the original submission, and, if so, providing updated information;
Other Support pages;
Resource page;
Checklist page;
Certification of IRB/IACUC approval, if applicable; and
Certification of human subjects protection education, if appropriate;
If the change includes the transfer of equipment purchased with grant funds, the application must include a detailed list. This list, as part of a transfer application, will serve as an acceptance of title by the new organization. The NIH may request additional information necessary to accomplish its review of the request.

PART 2

RESEARCH AGREEMENTS:
CONTRACTS AND SUB-CONTRACTS

Contracts are written promises that are enforceable by law. They explain the terms and conditions between two or more entities that wish to engage in the exchange of products, services, and/or financial considerations. Contracts may be several pages in length and contain highly legalistic terms; they may also be as brief as a one-page Letter of Agreement. From a legal perspective, both are binding. For this reason, contracts should only be signed by individuals who are authorized to obligate the Institution to the terms of the Agreement. It is important to note, however, that research investigators may also be required to sign agreements as an acknowledgment of their understanding of and agreement with the terms and conditions of the contract.

A.DEFINITIONS

1.0 Confidentiality Agreement: A Confidentiality Agreement is designed to ensure that proprietary information will not be disclosed to anyone who does not have a need to know. The Agreement will define the confidential information, the purpose for which it is being released, and the terms, conditions and interval of time under which the obligation of confidentiality shall be maintained. Written confidential information should be stamped as such and oral disclosures should be reduced to writing and stamped 'confidential' as soon as practical.

2.0 Sponsored Research Agreement: A Sponsored Research Agreement is negotiated between a sponsor (usually a for-profit entity) and the Institution when the sponsor is providing funding, materials or other resources for a particular research project. The Agreement will include terms and conditions, a statement of work or protocol, and a budget that includes direct and indirect costs.

3.0 Clinical Research Agreements: Industry-Sponsored and Investigator-Initiated Agreements: Clinical Research Agreements are executed with private industry for the clinical testing of drugs and/or devices. Generally funded by pharmaceutical companies and under the purview of the Food and Drug Administration (FDA), clinical trials are an important part of the process to assure the safety and efficacy of the drug or device. In addition to the protocol and budget, the Agreement will include terms and conditions that will extend legal protections to the Study Subject, Investigator, and the Institution. Some key terms are defined and explained below:

3.1 Clinical Research Agreements must allow the Investigator the freedom to publish study results. However, the Sponsor may have the right of prior review to identify proprietary information.

In the spirit of academic freedom, the investigator has the right to publish the results of the study without the need for Sponsor approval, as long as the content of the manuscript does not contain any of the Sponsor's proprietary information. The Sponsor is given the opportunity to review and comment on manuscripts, abstracts, or other types of presentation materials prior to their submission for the purpose of identifying the Sponsor's proprietary information. If such information is so identified, the Institution will agree to delay publication for an additional specified period of time (usually 90 days) to permit the Sponsor the opportunity to establish and preserve its proprietary rights.

If the research is part of a multicenter study, the Institution will usually agree to delay publication of the research results until the data from all sites have been pooled and analyzed, and until the first multi-center manuscript has been submitted for publication. However, if a multi-center publication is not forthcoming after a specified period of time (usually 24 months), the Institution shall reserve its right to publish the results of the research that was conducted at the Institution.

3.2 Indemnification: Indemnification is a contractual obligation whereby a party agrees to assume responsibility for loss or damage arising from a contemplated act on the part of another party. It is the policy of the Institution to request indemnification coverage from Sponsors for all clinical trials of pharmaceuticals, medical devices and other health-related items. In the case of a Clinical Trial Agreement, the Sponsor will assume responsibility for the legal defense of any lawsuit, and the payment of any judgments or settlements for any action or claim commenced against the Institution, Investigator, and their agents which arise due to the conduct of the Sponsor's protocol (acts which result in actual or alleged damage, or costs of additional medical care to subjects who experience untoward events from their participation in the study). Under such provisions, however, it is important to point out that the Sponsor's adherence to this obligation is fully contingent upon the investigator's responsibility to conduct the study in accordance with the terms of the protocol. The only exception to this is when deviation from the protocol involves the safety of the research subject, and in such cases, the Sponsor must be notified as soon as practical.

When industrial sponsors have not participated in the development of the protocol, they are not inclined to provide indemnification coverage for the study.Under these circumstances, it is the policy of the institution to request indemnification coverage for data use, product use or full administration of the protocol.

It is the preference of the Institution to not provide cross-indemnification coverage to the Sponsor. However, should it become necessary, it is the policy of the Institution to limit such coverage to instances where the alleged damage results from misconduct or negligent acts of the Institution/Investigator.

3.3 Subject Injury Coverage: Subject injury coverage is a contractual obligation that the Institution requires from the Study Sponsor to cover the cost of any medically necessary treatment a study patient may require should they experience an untoward, study-related event.

From the Institution's perspective, Sponsors must pay for adverse event-related medical expenses that result from a study patient's use of the Sponsor's product or from their participation in the Sponsor's protocol. This requirement, however, is nullified when the adverse event is found to be related to non-compliance with protocol procedures or the negligent acts of the Investigator.

3.4 Insurance: The agreement by a party to maintain stipulated types and limits of insurance coverage provides the Institution with additional assurances that the party will be able to satisfy the indemnification obligations agreed to in the contract, should the occasion arise. The Institution also requires evidence of such coverage and stipulates that the coverage survive the expiration and/or termination of the research agreement.

3.5 Inventions: An 'invention' is defined as any discovery, concept, or idea, whether or not patentable, made during the conduct of the study, and arising directly from the performance of the study. Any inventions that originate solely with any employee of the Sponsor shall be considered the property of the Sponsor. Any invention that originates solely from the Investigator shall be considered the property of the Institution. The Sponsor and the Institution shall co-own any invention that originates jointly between investigator and employees of the Sponsor.

4.0 Sub-Contract Agreements are established when an investigator from one Institution receives funding from a sponsor (Prime Sponsored Research Agreement) and requires the participation of investigators from other institutions to realize research goals.The terms and conditions governing the research relationship between institutions are described, as are the time-dependent schedule of deliverables and rates of compensation. Sub-Contract agreements are generally established for one-year intervals, with annual Amendments developed and executed to extend the life of the study and to specify payment arrangement rates for each study interval. The terms of the sub-contract must be consistent with the terms of the Prime Sponsored Research Agreement.

5.0 Consortium Agreements are established between Institutions when the research is supported (in whole or in part) by federal funds. Similar to the sub-contract agreement, the Consortium Agreement defines the terms and conditions governing the research relationship between the prime and participating Institutions. The fundamental difference between the two types of Agreements is that the participating Institution must at test to and certify their compliance with Public Health Service policies. In the case of clinical research, this would include the Institution's compliance with federally mandated programs for the protection of human subjects in research, etc.

6.0 A Material Transfer Agreement (MTA) is used when an exchange of biomedical materials is anticipated between two or more institutions (or industry) for the conduct of research. Among other key provisions, the MTA ensures that there is a common understanding of how the materials are to be used; it will define and detail any restrictions on theuse of the materials; it will also describe the conditions under which licensing rights shall be obtained. Such agreements are contractually binding upon the parties and a breach of an MTA can potentially create a legal and financial risk for the Institutions and Investigators involved.
MTA's are arranged through the Office of Technology Transfer at the Feinstein Institute for Medical Research's. Investigators are urged to contact that office at (516) 562-FIMR (3467) for guidance in this regard.

B. RESEARCH IN COLLABORATION WITH INDUSTRY

1.0 CONFIDENTIALITY AGREEMENTS

Statement

Prior to the release of information, a sponsor will require the investigator (or an Institutional Official) to sign a Confidentiality Agreement. The Confidentiality Agreement seeks to legally bind the investigator (Institution) to protect the unauthorized release of the sponsor's proprietary information. The Agreement will define the confidential information, the purpose for which it is being released, and the terms, conditions and interval of time under which the obligation of confidentiality shall be maintained. Because such agreements can be legally binding, they must also include exception statements that will provide legal protection to either party if confidential information becomes known to a third party. Such exception statements include: 1) information that was previously known to the investigator; 2)information that becomes publicly available through no fault of the investigator; 3) information that is disclosed to the investigator by a third party with a legal right to impart that information; 4) information that is disclosed in response to governmental or judicial order.

It should be noted that in certain situations, the Institution might also disclose confidential information to the Sponsor. In this regard, the Agreement, where appropriate, shall be binding to both parties.

Procedures

1. Once an investigator receives a Confidentiality Agreement, he/she should forward the Agreement to OGC for review, along with the name and telephone number of the sponsor's contact.If necessary, the OGC will use this contact information to negotiate any needed changes.

2. The agreement will be reviewed to ensure the language includes the aforementioned exception statements, and does not include: 1) statements that will limit the ability topublish the results of the study following its completion, or compromise the Investigator/Institution's invention or discovery potential, and/or 2) language regarding vague or far-reaching remedies in case of breach.

3. The Office of Grants and Contracts will seek consultation with the Department of Legal Affairs if the agreement includes unusual language that requires further legal review.

4. Once the terms of the agreement are appropriate, the investigator will be advised that it is acceptable for his/ her signature.

5. Signed copies of all signed Confidential Agreements must be forwarded to the Office of Grants and Contracts for filing purposes.

*NOTE: Generally, Confidentiality Agreements are signed by research investigators. However, there are occasions where Sponsors will require the signature of an authorized institutional official. In such instances, the OGC will review and negotiate modifications to the language so that it will be appropriate for institutional signature. Nevertheless, the research investigator shall also be required to sign to acknowledge his/her understanding of and agreement with the terms and conditions of the agreement.

2.0 SPONSORED RESEARCH AGREEMENTS

Statement

The Institution encourages the development of research relationships with industry, whereby research proposals are developed by investigators (either singly or collaboratively) and submitted to industrial sponsors for fundingconsideration. However, the goals of industry (to control the release of data to maximize profit) will, very often,contrast with the mission of the Institution (to disseminate new knowledge to benefit the public good).

OGC will work with the Sponsor to assure balance in the terms and conditions of the arrangement.

Procedures

1. If the Sponsor provides an agreement, it shall be considered a draft and must be submitted to OGC for review.

2. In conjunction with the agreement, the investigator must submit a copy of the proposal, a signed Grant Application Checklist Form (OGC Form 1) and completed Conflict of Interest Questionnaires (OGC Form 2) for participating key personnel (see Forms 1 and 2, respectively).

3. If the Sponsor does not provide a sample agreement, OGC shall prepare and negotiate an agreement with the Sponsor.The agreement shall contain:

a) a statement of workin such detail as to allow a clear understanding of the research project and the expected deliverables;

b) a description of the full costs of the research, including recovery of indirect costs;

c) the start and end dates for the research project, with provisions for extensions;

d) language that permits mutual termination, should it become necessary;

e) a provision on the Institution's right to publish the results of the study;

f) a provision regarding ownership of intellectual property which may ensue from the results of the research project, consistent with Institutional policy.

4. The Office of Grants and Contracts will seek consultation with the Institution's Department of Legal Affairs and/or from the Office of Technology Transfer as needed.

5. OGC shall arrange to have the authorized institutional official sign two final Sponsored Research Agreements. Usually, the Investigator will also be required to sign the agreements acknowledging his/her understanding of their responsibility as it relates to the terms and conditions of the agreement.

6. OGC shall return both original agreements to the sponsor for counter-signature. (In some instances, the sponsor will sign the agreements first with the expectation of receiving for their records an original agreement that has been counter signed by an institutional official.) OGC shall retain one original fully executed research agreement for the file.

7. The proposed study may not commence before a signed agreement is fully executed between the Sponsor and the Institution and all relevant compliance approvals are received (e.g., IRB, IACUC, IBC, etc.).

8. When the Sponsored Research Agreement is fully executed the OGC shall establish a grant fund in the name of the Principal Investigator for the study.

3.0 INVESTIGATOR-INITIATED CLINICAL RESEARCH AGREEMENTS

Statement

All agreements with industry, including the clinical testing of drugs or devices, are considered contracts between the Institution and the sponsor.

The Biomedical Research Alliance of New York (BRANY) is responsible for managing the Health System's participation in industry-sponsored clinical trials.

The Office of Grants and Contracts, working with the Department of Legal Affairs, is responsible for reviewing and negotiating investigator-initiated clinical research agreements.The purpose of the review is to ensure the language complies with prevailing Institutional policies that impact the conduct of ethically responsible research. Of concern -- for industry-sponsored clinical trial agreements and for investigator-initiated clinical research studies -- are clauses that relate to publication rights, indemnification and subject injury coverage, issues of confidentiality, patents, conflicts of interest, and the recovery of all costs including institutional overhead expenses. Non-compliance with any of the terms may be considered a breach of the agreement, and thus, potentially subject to legal action. For these reasons, suchagreements must be signed by an institutional official withauthority to legally bind the Institution to the terms and conditions of the agreement.

The investigator may also be required to sign such agreements acknowledging his/her understanding of the irresponsibility with respect to the terms and conditions of the Agreement.

Procedures

1. Contact BRANY regarding participation in industry-sponsored clinical trials. The telephone number is 516-470-6900, or visit their website at www.brany.com.

2. Contact the Office of Grants and Contracts regarding participation in an investigator-initiated clinical research study.

3. Refer to steps 2-8 under Sponsored Research Agreements.

4. A member of the Office of Grants and Contracts staff will work with the Sponsor to initiate the negotiation process. A typical investigator-initiated clinical research agreement will include, but will not be limited to, details on the following:

a. Name and address of Parties

b. Project title

c. Performance period

d. Milestone-based grant award payments

e. Publication Rights

f. Confidentiality

g. Patents and Inventions

h. Indemnification

i. Subject Injury

j. Insurance

k. Termination

l. Governing law

5. In tandem with contract and budget negotiations, the investigator shall initiate the process for seeking IRB review and approval. Refer to the Institutional Review Board Policy and Procedure Manual for guidance in this regard.

6. Following the approval of the research protocol by the Institutional Review Board, a member of the Office of Grants and Contracts staff will submit the final Clinical Research Agreement to the investigator for his/her signature to acknowledge his/her responsibility for complying with the terms and conditions of the Agreement. OGC will also secure the requisite Institutional signatures and forward to the sponsor for counter-signature, which is necessary to execute the contract and commence the study. (In some instances, the sponsor will sign the agreement first with the expectation of receiving for their records an original agreement that has been countersigned by an institutional official.)

7. A grant fund will be established in the name of the Principal Investigator upon receipt of the fully executed agreement.

C. RESEARCH IN COLLABORATION WITH OTHER INSTITUTIONS

1.0 SUB-CONTRACT AGREEMENTS

Statement

Sub-contract agreements are established when an investigator receives funding from a sponsor and requires the participation of other institutions to realize research target goals. Sub-contract agreements describe the terms and conditions governing the research relationship between the prime contractor and secondary entities. In most cases, the termsand conditions that are developed between the Sponsor and the prime institution flow down to the secondary institution via the sub-contract agreement. The prime institution may also impose additional time-dependent or deliverable conditions to permit compliance with Sponsor requirements (i.e., receipt of financial and/or technical reports, status in relation to target enrollments).

When this Institution is the prime contractor, the Office of Grants and Contracts (OGC) shall be responsible for preparing, negotiating and issuing Sub-contrac tagreements. When the Institution is the subcontractee, the prime contractor will prepare and submit similar documents to OGC for review and signature by the Institutional Official.

Procedure

Institution as the prime organization:

1. The research investigator shall advise the OGC when he/she anticipates that their research project will require the involvement of investigators from other institutions.

2. The research investigator must provide a detailed budget and a Statement of Work in such detail as to allow a clear understanding of the research project and a schedule for expected deliverables.The OGC will assist with the development of the study budget, as needed.

3. The investigator shall provide to the OGC the names and telephone numbers of individuals to contact at the secondary institutions to begin the process and to develop the sub-contracts.

4. The agreement shall include, but not be limited to:

a) a statement of work in such detail as to allow a clear understanding of the research project and the expected deliverables;

b) a description of the full costs of the research, including recovery of indirect costs (as appropriate);

c) the start and end dates for the research project, with provisions for extensions;

d) language that permits mutual termination, should it become necessary;

e) a process for the development, review and publication of research results;

f) a provision regarding ownership of intellectual property which may ensue from the results of the research project, consistent with Institutional policy.

5. Once the sub-contract has been negotiated and signed by the secondary institution, a final sub-contract agreement will be executed by an institutional official. The Investigator will also be required to sign to acknowledge his/her understanding of the terms and conditions of the research agreement.

Institution as the sub-contract organization:

1. The research investigator shall notify the OGC when he/she has been asked to collaborate on a research project with another institution. Research investigators must provide to OGC a copy of the draft Sub-contract agreement for review, along with contact information, a copy of the proposed budget and the scope of work they anticipate performing for the prime institution.

2. Once the sub-contract has been negotiated, a final sub-contract agreement will be executed by an institutional official. The Investigator will also be required to sign to acknowledge his/her understanding of the terms and conditions of the research agreement.

In all cases, the study may not commence before a signed sub-contract agreement is executed between the Institution and the sub-contract sites.

2.0 CONSORTIUM AGREEMENTS
(Research Sponsored by the Federal Government)

Statement

Consortium agreements are established when an investigator, who is based at one institution, will be responsible for providing substantive, scientific input on a research project or program at another institution. Consortium agreements describe the terms and conditions governing the research relationship between the grantee (prime) institution and a secondary institution. In most cases, the terms and conditions that are developed between the federal agency and the grantee institution will flow down to the secondary institution via the Consortium Agreement. Participating institutions must attest to and certify their compliance with federal wide regulations. In the case of clinical research, this would include the Institution's compliance with and participation in a formal education program for the protection of human subjects in research. The grantee institution may also impose additional time-dependent or deliverable conditions to permit compliance with funding agency requirements (i.e., receipt of financial and/or technical reports, status in relation to research aims and objectives).

When this Institution is the prime institution, the Office of Grants and Contracts (OGC) shall be responsible for preparing, negotiating and issuing consortium agreements. When the Institution is the collaborating institution, the prime institution shall prepare and submit similar documents to OGC for review and signature by the Institutional Official.

Procedure

Institution as the grantee (prime)organization:

1. The research investigator shall advise OGC when he/she anticipates that their research project will require the involvement of an investigator from another institution.

2. During the grant application process, the research investigator must submit a proposal and budget that outlines the scope of work to be done by the collaborating institution. Additionally, the research investigator must obtain a Letter of Collaboration (see Appendix G for sample), executed by an Institutional Official, from the collaborating institution, which indicates their willingness to participate in the research project or program if an award is granted, and their intent to comply with all federal regulations.

3. At the time of the award, the investigator shall provide to the OGC the names and telephone numbers of individuals to contact at the secondary institution to begin the agreement process.

4. If an award is granted to the Institution, the OGC shall prepare and submit to the secondary institution two original sets of a Consortium Agreement for review and counter-signature by their designated institutional official. Along with the federal requirements, the Agreements will include a detailed budget, the Scope of Work (as prepared by the principal investigator or project director), the period of the agreement, and a written a description and schedule for the type and frequency of required reports.

5. The secondary institution will be advised to return both signed original Consortium Agreements to permit full execution of the Consortium Agreements by the appropriate Institutional Official; one will be returned to secondary institution for their records.(In some instances, the Institution will sign the consortium agreements first with the expectation of receiving, in return, a consortium agreement that has been countersigned by the secondary institution's authorized official.)

Institution as the collaborating organization:

1. The research investigator shall notify the OGC when he/she has been asked to collaborate on a research project with another institution.

2. Research investigators must provide to the OGC a copy of the proposal and a budget outlining the scope of work they anticipate performing for the applicant institution. The OGC will arrange to secure a signed Letter of Collaboration. The Letter of Collaboration will convey the willingness of the Institution to participate in the research endeavor if an award is granted. It will also assert the Institution's acknowledgment of and compliance with regulations promulgated by the federal agency regarding the conduct of research.

3. At the time of the award, the grantee institution shall notify the research investigator and/or the OGC to finalize the consortium agreement process.

4. When the Institution is the collaborating institution, the prime institution will prepare and submit similar documents for the Institution's review and signature by an institutional official.

5. OGC will be responsible for reviewing and negotiating the Consortium Agreement and for obtaining appropriate institutional official signatures.

Last Update

July 30, 2009

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Feinstein

Resources for Investigators

OGC - Grants And Contracts Guidance

THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

OFFICE OF GRANTS AND CONTRACTS

A Guide for the Preparation, Submission and Management of Research Grants and Contracts

THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

OFFICE OF GRANTS AND CONTRACTS

THE MISSION

DEFINITIONS

GUIDANCE ON PRINCIPAL INVESTIGATOR ELIGIBILITY

PART 1

FUNDING MECHANISMS FOR SPONSORED RESEARCH PROJECTS AND PROGRAMS

A. DEFINITIONS

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