Award Negotiation and Acceptance

An IPA is a funding mechanism for the VA to provide reimbursement for a portion or all of the salary and fringe benefits of a SBU faculty or non-faculty person working on sponsored research awards funded by the VA. The goal of this type of agreement is to strengthen the relationship between SBU and the VA by the temporary assignment of SBU skilled personnel to work with the VA.

IPAs are generally made for a period of up to one (1) year and may be extended or renewed for additional time as needed. 

Please allow at least four (4) weeks from the date an IPA new proposal and pre-signed agreement is submitted to the VA for processing and execution of the agreement by the VA, and at least three (3) weeks for continuation proposals/agreements.

For NSF IPAs, click here to see related guidelines and documents needed. 

For Northport VA Medical Center agreements, there is mandated training,  and it is the PIs responsibility to notify the VA whenever a new person gets added to their study. All new employees assigned to an IPA need to be brought up to VA's HR committee agenda for review. Training will commence at that time. Early notification is critical to avoid delays in IPA and PO release.

All IPAs will be established as new awards.  

Point of contact at the VA is Joanne Toner at Joanne.Toner@va.gov

Point of contact at SBU is Kristen Ford. 

Sample IPA template

While we encourage that the Chair act as the Principal Investigator (PI) at SBU, if the student works at SBU, as well as under the guidance of a Joint Appointment (JA), the JA can be the PI at SBU, but BNL needs to be made aware so that a different PI/Dept Chair can be assigned at BNL. 

SPIR industrial internships are coordinated through the SPIR Program Director and designated faculty coordinators. Their contact information and sample proposal forms/SPIR Internship Agreements can be accessed here. 

For BNL graduate student research training proposals, and all other off-campus undergraduate or graduate internships/research training opportunities, the PI will be the student’s home department Chair or a full-time faculty within the department designated by the Chair, preferably a Graduate or Undergraduate Program Director.  The SBU PI will have to be knowledgeable of the project where the intern will work, and coordinate the scope of work and budget with the designated mentor at the internship/research site, keeping in mind the student’s academic interests and responsibilities at SBU. The PI is also responsible for the administrative management of the resulting awards. 

NOTE: Students are working on BNL projects not SBU projects.  They only require appointments to payroll, and there is no budget management.   The SBU PI is appointed because a student cannot be the PI of a grant  (same as any other fellowship or training grant to a student or postdoc).    In general, the SBU PI should be able to address any concerns that a student may have (advocate for the student) if there are issues with their BNL work or BNL mentor.    The SBU PI shouldn't be contributing to the BNL project by advising the student - it is a ceremonial PI position rather than an applied PI position.  If it is their project at BNL, then they can be the BNL PI or they can participate in the BNL project from their BNL role (whatever that appointment may be). 

Sample BNL student support proposal package can be accessed here. We strongly encourage you to submit new and continuation proposals through myResearch at least 8 weeks prior to the desired student employment start date.

Budget must include: graduate student salary (please be sure to include an increase of 4% for the out years to cover any graduate student salary increases), fringe benefits, tuition and the appropriate F&A. 

NOTE: If you are asking for funding for only one year, but there are out years, please submit a proposal including all years in the budget.  By doing so, it will alleviate the necessity of submittting subsequent proposals for additional funding and extensions.

For any questions, please contact the Office of Sponsored Programs at osp_contracts@stonybrook.edu

Clinical Trials Process Flowchart  

The resolution of many contractual issues requires coordination between the external funding source, Investigator, Clinical Trials Office, Compliance Office, Intellectual Property Partners (IPP), Office of Grants Management (OGM) and Office of Sponsored Programs (OSP); the involvement of each party is essential to a successful contractual arrangement with mutually acceptable terms.

Who are the parties to a Clinical Trial Agreement?

All Clinical Trial Agreements should be only between The Research Foundation for The State University of New York and the Sponsor. The Investigator is an employee of Stony Brook University and is never a named party to any Clinical Trial Agreements.

What documents are needed in order to negotiate and execute a Clinical Trial Agreement?

Investigators should provide OSP with a copy of the proposed agreement, if they receive it directly from the sponsor, myResearch application, copy of the Protocol, approved Budget and a company contact person as early in the process as possible. IRB approval is required in order for OSP to execute a Clinical Trial Agreement. To expedite the process even before submitting a COP or protocol, please have the company contact send the agreement electronically to osp_contracts@notes.cc.sunysb.edu.

What involves the negotiation of a Clinical Trial Agreement (CTA)?

SBU faculty and staff participate in numerous clinical trial projects to study investigational drugs or devices. These studies are usually funded by pharmaceutical companies and are an important part of the process to assure the safety and efficacy of the drug or device, obtain Food and Drug Administration (FDA) approval and bring a product to market.

Although each document is reviewed on a case-by-case basis, there are a number of key issues that are common to most clinical trial agreements. These following key items will be negotiated by the OSP with the Sponsor:

-  INDEMNIFICATION

The sponsoring company, and the actual owner of the study drug or device if an intermediary is involved, must agree to indemnify and hold harmless the Foundation, Investigator, officers, agents and employees from any and all liabilities, claims, actions or suits for personal injury or death arising from the administration of the study drug or procedures done according to the protocol, including but not limited to the use of the study results by the sponsoring company. The Foundation will only indemnify the sponsor for negligent activities.

- CONFIDENTIALITY

It is often necessary for the sponsoring company to provide information of a proprietary nature to the Investigator or his/her staff and it is important to the company's business interests that the confidentiality of this information be protected. It is encouraged that a Non-Disclosure Agreement gets in place prior to executing a CTA. Written confidential information should be stamped as such and oral communication should be reduced to writing and stamped "confidential". Access to confidential information (including the protocol) must be strictly controlled and each Investigator should have a plan for assuring control. All agreements must have a time limit for information to be kept confidential by the Foundation. Our standard language is only to allow information received from the sponsor to be kept confidential for a period of three (3) years after the termination of an Agreement.

- PUBLICATION

Agreements must allow the Investigator the freely to publish results of the study. However, the sponsoring company may have the right of prior review to identify proprietary or confidential information. Approval rights on publications are not granted to sponsors.

- INTELLECTUAL PROPERTY

Investigator-Initiated Clinical Trials:  Since the protocol is conceived and designed by the SBU investigator, the investigator is likely to be identified as an inventor.  The Foundation retains ownership rights to inventions that result from the study. The company is offered a time-limited first right to negotiate for an exclusive, worldwide, royalty-bearing license to any invention that results from the study.

Industry-Initiated Clinical Trials: Since the study design (protocol) is conceived and designed, or owned by the company, the company retains rights to all inventions developed in the direct performance of the protocol. The Foundation retains the right to use the invention for internal research and educational purposes. The drug or device being tested in the clinical trial is normally owned by the sponsoring company and already covered by patent protection.

- DATA OWNERSHIP

Investigator-Initiated Clinical Trials: The University retains ownership rights to data developed under a Clinical Trial conducted using University resources.  The company funding the Clinical Trial may receive copies of de-identified data, case report forms (if applicable), and a report of the results of the study.

Industry-Initiated Clinical Trials: The University retains ownership rights to source data developed under a Clinical Trial conducted using University resources. The company may have access to data and information developed under the study, and receive copies of de-identified data. The company owns the compilation of data in the case report forms.

- INSURANCE

To support the indemnification the sponsoring company must maintain a sufficient level of insurance. The Foundation has and will maintain in force during the term of its agreements with third parties adequate insurance to cover its indemnification obligations.

- GOVERNING LAW

Agreements must either be governed by the laws of the State of New York or this provision must be absent from the agreement.

- SUBJECT INJURY

Investigator-Initiated Clinical Trials: The University is responsible for providing medical treatment to patients who are injured as a direct result of participation in an Investigator-Initiated Clinical Trial.

Industry-Initiated Clinical Trials: The company is responsible for covering the costs of medical treatment for patients who are injured as a direct result of participation in an Industry-Initiated Clinical Trial.

What are Clinical Trial Master Agreements and does the Foundation have any such agreements in place?

Master Agreements are agreements that embody agreed-upon terms and conditions of a basic relationship between RFSUNY and a sponsor. Once a Master Agreement is in place, an "addendum" , “task order” or "study letter" is generated for each new study to be conducted under the Master Agreement. The Addendum sets forth the items particular to a certain study such as dollar amount, protocol name, and principal investigator. These Addenda are "attached" to each Master Agreement. This alleviates the need to "reinvent" in an agreement for each study with that sponsor; the major terms are agreed upon and only the particulars need to be negotiated.

When dealing with the following sponsors, please inform them to use our Master Agreement

Budgets and Funding Helpful Info

Company sponsored clinical studies are usually funded on a per-patient basis with provisions for pro-rated payment for patients who do not complete the study. All costs necessary to conduct the study, including salaries, supplies and indirect costs, should be considered when determining the fixed per-patient amount. Sponsors usually use one of two options when presenting a budget. They may offer a certain amount per patient and ask that you work within that amount or they may ask you to formulate a budget for them. Regardless, it is the principal investigators responsibility to ensure that the amount agreed upon will adequately cover all costs associated with conducting a clinical trial. Negotiation of budget terms for Industry-Initiated Clinical Trials is necessary and is being conducted by the Office of Clinical Trials (OCT). OSP will not review budgets for Industry-Initiated Clinical Trials when negotiating the agreement with the sponsor but will closely coordinate the negotiation and finalization of such budgets with OCT. If requested, OSP will evaluate your budget for Investigator-Initiated Clinical Trials for compliance with indirect cost calculation and advice to ensure your budget meets your needs.

The Office of Clinical Trials can also help you with all budgets; see their web-site at

https://osa.stonybrookmedicine.edu/octs/mission

Indirect Cost

Indirect cost for human clinical studies generally applicable to both Industry-Initiated and Investigator Initiated Clinical Trials as defined above is 25%. To estimate indirect cost when the direct costs are known, add 25% of the direct costs. The sum of these two figures is the per-patient amount.

Example: If $1,000 is needed to cover direct costs, 25% or $250 should be added for indirect, bringing the total to $1,250 per patient.

All clinical trials funded directly of indirectly by the federal government will be charged the Research and Development Rate in effect.

Office of Clinical Trials (OCT) Fee

An additional fee of $1,000 is charged by OCT for all industry initiated and sponsored clinical trial agreements.  The OCT fee should always be added in your budget as a direct cost line item and not as indirect cost.

IRB Fee

SBU investigators wishing to conduct industry-funded, industry-initiated biomedical research studies may choose between the IRB services provided locally by SBU's IRB  or those provided by our associate, Advarra.

For industry funded, industry initiated studies, Sponsors must pay:

a.                  if the IRB services of Advarra are used, an institutional fee, in the amount of $1,000.00, This fee is in support of SBU’s continuing responsibility for all administrative and regulatory compliance. This fee is separate from any IRB fee directly charged to the sponsor by Advarra.

b.                  if local IRB of SBU are used, a combined IRB/Institutional fee of $3,000.00 for full committee review, OR $950.00 for expedited review, This is a one-time fee which covers service for a time period consisting of initial approval and four (4) continuing review periods. Should the protocol last longer than five (5) years, a 5 year application will be completed for renewal. The then current IRB/Institutional fee will be charged unless a) the human subject aspects of the study are limited to data analysis OR b) enrollment has ended, subjects have completed all research-related intervention, AND the study is now limited to long-term follow-up of subjects.

The sponsor understands that payment of the above applicable fee is not contingent on whether the protocol is approved or whether the protocol is funded. No F&A (indirect) cost will be assessed against this fee.

ALL investigator-initiated studies MUST be reviewed by SBU's IRB and are NOT ELIGIBLE for review by Advarra.

If you wish to use Advarra's IRB Service, you first need to confirm with your sponsor that the sponsor will accept direct invoicing from Advarra and allow direct payments to Advarra.  Once you have confirmed (preferably in writing) that this billing method is acceptable to your sponsor, see the Guides for submission at: https://www.stonybrook.edu/commcms/research-compliance/External-IRBs/index.php

 W-9, IRS Identification and Payment Information FAQ’s

What is our Tax ID#?

The Tax ID # for our Institution is 14-1368361.

Who prepares W-9 forms?

OSP prepares all W-9 forms requested by sponsors. This form requires official institutional signature. A copy can be found under Codes and Numbers page. 

To whose attention should check be made and mailed?

Checks from the sponsoring company should be made payable to The Research Foundation of SUNY and mailed to The Research Foundation of State University of New York

P.O. Box 9

35 State Street

Albany, New York, 12201-0009

For electronic payments:

Key Bank of New York

        66 South Pearl Street

        Albany, New York 12207-1501

        ABA # 0213-00077

        Account # 10970107

 

Non-profitTax Status - http://www.rfsuny.org/about-us/founding-documents/

 

What documentation is needed for a Clinical Trial Project/Award Set-Up?

To obtain a Foundation project/task/award number for a clinical study the following documentation is required: a completed myResearch application, a copy of the study protocol, approved budget, a signed written agreement between the sponsoring company and the Research Foundation for The SUNY, Institutional Review Board (IRB) approval.

 

What happens at Clinical Trial Project/Award Close-Out?

At the conclusion of any clinical trial study there may be a cash balance remaining. If expenditures incurred to conduct the study are reasonable in relation to the projected cost and when all costs (direct and indirect) have been properly charged and documented, the cash balance will be made available to the Investigator but will be under the ownership of the department by a transfer to the departmental fixed price balance award.

 

What is needed in the case of a Clinical Trial Amendment?

An amendment changes the terms of a previously executed agreement. If the amendment increases the dollar amount of the contract, you will need to complete a new myResearch Grants proposal. If the amendment deals with other non-monetary issues such as extending the timeline of the study, a myResearch Grants application is not required. Simply fax, email, or send a hard copy of the amendment to osp_contracts@stonybrook.edu for OSP review and processing. Terms of amendments may need to be modified or otherwise negotiated with sponsors to assure they are correct and acceptable to the Foundation.

 

Helpful Links

Office of Clinical Trials  

https://osa.stonybrookmedicine.edu/octs/mission

Office of Research Compliance

https://www.stonybrook.edu/commcms/research-compliance/

Clinical Trials.gov

Clinical Trials.gov

ClinicalTrials.gov provides regularly updated information about federally and privately supported clinical research in human volunteers. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details.

Intellectual Property Partners

Faculty interested in exchanging confidential information with outside institutions or industry

https://www.stonybrook.edu/commcms/ipp/

FAQs

Does the Foundation have a Clinical Study Agreement template?

See Standard Agreements Templates for information or access the templates through myResearch Agreements/Help Center.

Our institution follows agreement templates under the Accelerated Research Agreements Initiative (ACTA) that that acceptable to participating institutions and organizations. When used, it has been proven to expedite the study initiation process. https://www.ara4us.org/

What is the definition of a Clinical Trial?

 A controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes.  Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol.  

1.      The objective of the study is either:

        a. testing of a drug, device, diagnostic, treatment, intervention, or preventive measures  including testing for an unapproved indication or

b. data collection, or review of data generated or acquired in a clinical setting, to increase knowledge that would lead to enhanced safety and efficacy of a drug or device.

  2.   The study must involve contact with human subjects or the review of patient care clinical data

  3.   The study must be performed primarily in patient care or clinical space Financial support for a clinical trial must be provided by a private entity, including pharmaceutical companies, interest groups, or charities.   In all cases, the study must include the prospective enrollment of human subjects and the controlled testing of a drug, device, or diagnostic under an approved protocol.   However, retrospective chart reviews, analysis of existing medical data and records, laboratory research, animal studies, and federally funded projects are not categorized as clinical trials for purposes of applying the approved clinical trial indirect cost rate.

 

        1.1 Clinical Trial Phases I - IV Definitions

An Investigational New Drug (IND) may be submitted for one or more phases of an investigation.   The clinical investigation of a previously untested drug, antibiotic drug or biological drug that is used in a clinical investigation is divided into phases that are generally conducted sequentially, but may also overlap (31CFR Part 312, FDA Regulations, Investigational Drugs 312.22, Definitions):

 ·         Phase I - Are typically closely monitored studies of 20 to 80 subjects that are designed to determine the metabolism and pharmacologic actions of the drug in humans, including side effects associated with dose increases,   and if possible, obtain early evidence of effectiveness. During Phase I, sufficient information should be obtained to permit the design of well-controlled, scientifically valid, Phase II studies.   

·         Phase II - Are typically well controlled, closely monitored clinical studies of not more than several hundred subjects that are conducted to evaluate the effectiveness of the drug for a particular indication or indications, and to determine the common short-term side effects and risks associated with the drug.

·         Phase III - Are expanded controlled and uncontrolled trials of several hundred to several thousand subjects conducted to gather additional efficacy and safety information needed to evaluate the overall benefit-risk relationship and to provide adequate basis for physician labeling of the drug.

·         Phase IV - Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.      

How does the Foundation determine if a Clinical Trial is Industry-Initiated or Investigator-Initiated?

 The study is an Industry-Initiated Clinical Trial if:

• The protocol is conceived and designed:

  1. Solely by an employee of the company funding the study, or

  2. By a researcher from another institution, or

  3. By a SBU researcher under a private consulting agreement without the use of University resources.

• The study must be funded by a for-profit entity.

The study is Investigator-Initiated Clinical Trial if:

• The protocol is conceived and designed by a SBU researcher using University facilities, or

• By a SBU researcher in the scope of their employment jointly with an employee of another entity (e.g. an employee of another non-profit institution or an employee of the for-profit entity funding the clinical trial), and

• The study is funded by a for-profit entity, foundation, charity or other non-profit organization. 

 

What is the typical language for Subject Injury in an sponsor-initiated Informed Consent Form that is acceptable to our institution?

 Who in the Office of Sponsored Programs (OSP) administers CTA’s on behalf of the Foundation?

A list of Contracts and Clinical Trials Administrators can be accessed here.

View the checklist.

Abiomed, Inc. ~ Effective 1/30/2008 until further amended.

Alexion Pharmaceuticals, Inc. - Effective 2/18/2020 - 2/17/2025

Alpha Oncology Inc. - Effective 10/18/11

Beckman Coulter ~ Effective 2/16/2011 - 2/15/2016

Cardiac Pacemakers, Inc. - Effective 11/20/2006

Children's Oncology Group Foundation, Inc. - Effective 10/3/2022

Correlogic Systems, Inc - Effective 5/8/2006

Criterium, Inc. (CRO for Academic Breast Cancer Consortium ("ABRCC")) - Effective 9/23/2021 - 9/22/2026

Genzyme Corp. - Effective 4/25/2011

Ilex Pharmaceuticals Corp.

Incyte Corporation - Effective 4/5/2017 - 4/4/2027

Karyopharm Therapeutics - Effective 11/10/2017 - 11/9/2024

National Marrow Donor Program - Effective 11/27/2018

NRG Oncology Foundation, Inc. - Effective 3/1/2019 - 2/28/2025

Pharmacyclics, LLC. - Effective 4/10/2017 - 4/9/2022

Public Health Institute - Non-Industry Funding Effective 3/1/2024; Industry Funding Effective 5/15/2021

 

*For RF Master Clinical Trial Agreements and Master Confidentiality Agreements, please visit RF SUNY's website linked below.

Visit RFSUNY's website for more information. 

Data Use Agreements (DUAs) are agreements that can restrict use or publication of data and/or impose data security measures in addition to addressing other legal issues.

What are Examples of Data that might be exchanged under a DUA?

• records from governmental agencies or corporations
• human subject research data
• "limited data set" as defined by HIPAA
• student record information
• proprietary and confidential datasets that have commercial value

Two Types of DUAs and When They Are Used

• Incoming DUA

  This is a DUA that you have received from another institution. The other institution requires the receiving institution to accept certain restrictions on the use of the Data before it will permit a transfer of the Data to Stony Brook University. This agreement requires a signature from someone who is authorized to legally bind Stony Brook University.

• Outgoing DUA

  This is a DUA that would allow a transfer of Data from Stony Brook University to another institution. It is recommended that an outgoing DUA be put in place if one of the following circumstances exists:

  • Data constitutes protected health information (PHI), as defined in HIPAA, and is subject to restrictions because (i) Data is not de-identified, (ii) patient consent does not permit Data sharing, (iii) IRB-approved protocol does not permit Data sharing, and/or (iv) Data constitutes a “limited data set” as defined under HIPAA;
  • Data needs to be kept confidential because it has intellectual property implications (e.g., data would be included in a future patent application, dataset has been generated through efforts of Stony Brook University employees and has commercial value);
  • Data is subject to restrictions existing in a third party agreement including, but not limited to, a sponsored research agreement, clinical trial agreement, collaboration agreement, confidential disclosure agreement, or material transfer agreement.

When don’t I need a DUA?

1. When data is available in the public domain.
2. When data is exchanged that is not subject to a legal or other restriction on its use.
3. When PHI is "de-identified" (as defined by HIPAA), its transfer is not barred by the applicable IRB-approved protocol or by associated consent PHI.

Who signs DUAs?

A DUA must be signed by someone who has the authority to sign on behalf of Stony Brook University. With the exception of Stony Brook Medicine, once a researcher receives a DUA from a data provider or plans to send out a DUA, he or she should submit the request, the DUA, along with a description of the proposed research or other activity to one of the following authorized administrative offices identified below.

For Stony Brook Medicine process and authorization, please click here.

Note that individuals are not authorized to negotiate or sign agreements on behalf of the University.  If an individual signs such an agreement on behalf of the University, the individual could be subjected to legal and financial risks. It is important, however, for the individual to read and understand the terms of a DUA to ensure individual’s ability to comply with its terms.

Note: Concurrent with the Office of Sponsored Programs or Procurement Office review and negotiation process, the Information Security Officer will work with the researcher to review the security requirements of the DUA to determine whether any specific protections need to be employed to meet the requirements of the Data-Provider. 

Additional resources regarding Data Resources, Services and Policies can be accessed at http://library.stonybrook.edu/scholarly-communication/data- services/

Beginning May 1, 2017, investigators are required to share key compliance information with the Office of Sponsored Programs whenever a federal flow through subaward is issued. If a subaward activity involves exchange of human subjects data, the Office of Sponsored Programs will work with the investigator to assess whether a Data Use Agreement will be required. Guidance on when a DUA is needed, glossary and templates can be accessed at http://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_180635.pdf

For a visual representation, an incoming process flowchart can be accessed here.

SBU makes All of Us Research Hub accessible to researchers with a new
institutional Data Use Agreement

The All of Us Research Hub, part of the National Institutes of Health (NIH) All of Us Research Program, stores health data from a diverse group of participants in the All of Us research program. The Research Hub has tiered levels of access to participant data: public data (no login required); registered data (login required); and controlled data (additional approval required), that incorporate strict data use policies. The program’s tiered data access model allows registered researchers to work with different data types, such as electronic health record data and genomic data, while also protecting participant privacy.

SBU has an agreed institutional DUA (Data Use Agreement) with All of Us, which permits SBU researchers to apply directly for access to a vast pool of health data. A list of all other participating institutions can be found here.  A copy of the institutional DUA can be provided by OSP to the investigators approved to get access to the hub.

Researchers can apply for access through the All of Us Research Hub website and register for an account to begin the onboarding process. After the account is created, researchers must log in, complete an SBU developed intake form for data access, complete all required training, and sign a Data User Code of Conduct. As detailed in the Data Use Policies, participant-level data may not be downloaded, copied, or otherwise extracted from the Research Workbench. SBU’s approval is needed to get access.

Who approves access at SBU?

The Office of Research Compliance would be able to approve access to the registered data as well as the controlled data hubs after their review of the intake form and IRB information. For controlled data access, additional review and internal security approvals may be required.

A sample intake form for data access is included below. For any questions, please contact the Office of Research Compliance at orc_ovpr@stonybrook.edu. Dawn Alomar, Assistant Director of Contracts in the Office of Sponsored Programs, can also be contacted for general information and guidance regarding this program and steps required for access.

Sample Intake Form

Requester:
Email:
Department:
Role/Job Title:
Principal Investigator:
Controlled Tier Interest:
Description of Controlled Tier data that will be accessed and how that data will be used:
Do you have an approved IRB protocol number?
What is your approved IRB Protocol number?
If the use of the data is not for research purposes as approved by an IRB, please explain
the activity you wish to use the data for:
Please provide the name of the Workspace you will create in the Controlled Tier:
What SBU computers/technology devices will you be using to access the All of Us data
platform for the purposes of this endeavor? Please provide the device name:
Are students participating in this initiative?
I understand I am subject to subsection 301(d) of the Public Health Service:

A federal contract is a legally binding agreement with federal agencies. The principal purpose is to acquire property or services for the direct benefit of the U.S. Government (31 USC 6303). In contrast, the U.S. Government uses grants to carry out a public purpose of support or stimulation (31 USC 6304). Federal grants are more flexible in their terms and conditions than contracts since the intent with grants is more general in nature. Some important differences between contracts and grants are:

Background

In 1986,  a demonstration project (FDP I) was initiated by 5 federal agencies to reduce unnecessary administrative burdens on sponsored research. As of 2020, FDP consists of 129 member institutions, 26 emerging research institutions, and 10 Federal agencies enrolled in the project. More uniform procedures for the administration of grants, simplification of the continuation grant application, and elimination of equipment screening requirements as some of the mosre significant accomplishments of FDP, currently in Phase VI.

As a result of SBU's participation in this program, certain administrative documentation required of either potential subrecipient institutions included in SBU proposals (Outgoing Subawards) or of SBU when acting as a subrecipient on another institution’s proposal (Incoming Subawards), has been streamlined.

Documentation Requirements

Participating institutions need to provide project specific data via a Letter of Intent or modified Subrecipient Commitment Form. Subrecipient PI name, project period, proposed amount, cost share amount (if applicable),  compliance, research authorized signature are just some examples of information required. Statement of Work, budget, budget justification, biosketches are generally documents that SBU is required to provide to partnering institutions on incoming subawards, or is requesting from partnering institutions for inclusion in SBU proposals for outgoing subawards.

Whom to Contact

- Jackie Dent, for all Incoming Subaward proposal submissions - SBU to another university to Federal agencies

- The team of Grants and Contract Specialists for all Incoming and Outgoing subawards. 

 

More information for Outgoing Subawards processes, visit the Subawards webpage.

Resources

• FDP Web Site
• PHASE V Participants in the Federal Demonstration Partnership
• FDP Expanded Clearinghouse
• FDP Committees
• FDP FCOI Clearinghouse
• Current Initiatives

NEW: The presentations from the September 2020 FDP Meeting can be accessed here. 

Industry Agreements

Agreements with for-profit sponsors cover many activities including basic, applied or developmental research, collaborative research, and various types of testing.

As a public, non-profit educational institution, The Research Foundation for The SUNY is bound by certain policies and regulations regarding what it can and cannot accept in an agreement. These policies are designed to foster the University's basic mission of teaching, research and public service and to ensure the academic freedom of our faculty.  The team of Contracts and Clinical Trials Specialists in OSP are authorized to negotiate this agreements with the sponsor to arrive at a mutually acceptable agreement.

Whenever possible, our institution tries to negotiate an agreement using the appropriate standard contract language for the activity proposed. These standard agreements address key concepts required by the RF and University policies. When working with the sponsor agreement templates,  these concepts may or may not be addressed and can lead to lengthier negotiations.

Contract negotiations address a substantial number of issues in a variety of areas such as scope of work/budget, intellectual property rights, publication rights, indemnification, termination, confidentiality.

OSP carefully reviews and discusses the aspects of all proposed projects with the Principal Investigators. Information need in a negotiation, such as student involvements, use of background intellectual property, resources needed etc., gets captured and needs to be thoroughly addressed by Principal Investigators in the internal myResearch Grants and Agreements modules.

Federal Research Agreements

Contract negotiations with a federal government agency primarily focus on budget and scope of work issues. The terms and conditions of the award are usually fixed by law or regulation. However, differences in the interpretation of law and regulation can result in the negotiation of certain clauses, especially in the areas of export controls, restrictions based on citizenship status, contractual requirements to provide protected private information in the absence of any regulations, options to classify the project as secret, publication approval and other publication restrictions or editorial controls. Therefore, it is important to make sure that the terms and conditions imposed by the agency are appropriate for the work proposed and applicable to the University and The Research Foundation for The SUNY.

These types of agreements are sometimes referred to as "gentlemen agreements" and are most usually entered into between institutions of higher education, with individuals, or with local school districts, and can sometimes be a requirement of a grant proposal submission or grant award. The planned activity may or may not come to fruition as described in the MOU, however there is no penalty for failure.

A Memorandum of Understanding (MOU) is:

• A contract between two or more parties planning to create a research or educational partnership,
• Outlines the type of relationship that will be created, the objective for the relationship and the responsibilities of each party,
• Not a legally binding agreement and therefore should not address formal plans for compensation, confidentiality, or intellectual property and licensing rights. 

The Office of Sponsored Programs is responsible for processing sponsored research agreements with private foundations and other nonprofit organizations, and also supports the research community by reviewing and submitting applications to non-profit and foundation organizations.

Non-Profit/Foundation sponsors may have a published or restricted F&A rate,. Our institution will accept such rate, but proof of the sponsor's published and universally-applied policy confirming their limited rate must be included at proposal stage through a myResearch proposal application. 

• IMPORTANT: Some Non-Profit/Foundation sponsors do not require institutional endorsement. It's important that you always route these proposals to OSP through myResearch, and don't wait until award stage for your initial contact with your OSP Specialist, when either an Agreement or payment is provided by the sponsor.
•  
• Note that some of these agreements, such as Gifts, may be administrated by Stony Brook Foundation. 

A Gift is defined as any item of value given by a donor who expects nothing of significant value in return, other than recognition and disposition of the gift in accordance with the donor's wishes. In general, the following characteristics describe a gift:

• No contractual requirements are imposed and there are no "deliverables" to the donor. However, the gift may be accompanied by an agreement that restricts the use of the funds to a particular purpose.

• A gift is irrevocable . While the gift may be intended for use within a certain timeframe, there is no specified period of performance or start and stop dates.
• There is no formal fiscal accountability to the donor.

IMPORTANT NOTE : Gift awards must be approved and managed by the Stony Brook Foundation (SBF) with the exception of gift awards where the activity involves compliance approvals (such as use of human subjects, laboratory animals, radiological hazards, recombinant DNA). Read SBF's gift  policy   and contact our office you have questions.

 

Gift Agreement Template

Contract negotiations with state agencies primarily focus on budget and scope of work issues, payment terms, reporting requirements, requirements for documenting invoices, audit, ownership of research records, termination and penalty clauses for breach of contract.

SUNY faculty and other members of the campus community ​are highly encouraged​ in participating in SBIR or STTR funded activities. ​However,​ ​participation in these programs can create a conflict of interest in situations where the faculty member holds equity or has other interests in or with the ​small business company. These conflicts must be properly
disclosed and managed. Due to the potential for conflicts of interest and/or conflicts of commitment, and the potential need or desire to use SUNY or RF resources, individuals considering involvement in SBIR and STTR proposals must consider the Guidance for Faculty Participation in SBIR and STTR Programs 

SBIR or STTR? Which One is Right for Me? 

The team of Contracts & Clinical Trials Specialists in the Office of Sponsored Programs negotiate and execute these agreements on behalf of The Research Foundation for The SUNY. 

The applications must be received through myResearch Grants. Once awarded, a myResearch Agreements record will be created and shared with PIs by OSP. For questions, contact us at osp_contracts@stonybrook.edu.

Small Business Technology Transfer (STTR) 

Small Business Technology Transfer (STTR) is a federally funded research program that expands funding opportunities in the federal innovation research and development (R&D) arena. Central to the program is expansion of the public/private sector partnership to include the joint venture opportunities for small businesses and nonprofit research institutions. The unique feature of the STTR program is the requirement for the small business to formally collaborate with a research institution in Phase I and Phase II. The most important role of a STTR is to bridge the gap between performance of basic science and commercialization of resulting innovations.

Small Business Innovation Research (SBIR) 

Small Business Innovation Research (SBIR) is highly competitive federally funded research program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated and the United States gains entrepreneurial spirit as it meets its specific research and development needs.

To find out more about these programs:

http://www.sbir.gov/ 

What federal agencies participate in STTR/SBIR programs? 

Eleven federal agencies participate in the SBIR program and five federal agencies participate in the STTR program. A list of the agencies and links to their website can be located at: http://www.sbir.gov/agencies

What is the Indirect Cost Rate for STTR/SBIR Application? 

For Phase 1 proposals, the rate is 15% of total direct costs.  For Phase 2 and 3, the full federally-approved F&A rate is applied.

A subaward is an agreement with a third-party organization performing a portion of a funded  research project or program. The terms of the relationship (subgrant/subcontract) are influenced by the prime agreement, and all subawards must be monitored to ensure that the subrecipient complies with these terms. A subrecipient works collaboratively with the prime award recipient to carry out the scope of work as proposed. After an award is made, subrecipients are required to comply with flow down terms associated with the prime award, including any federal regulations and compliance requirements for federal funding sources.     

Not all third party work is a subaward, some third party work is considered services and is a vendor agreement. The information below explains in detail the differences between a subaward and a vendor agreement. 

There are two types of subawards: incoming and outgoing. An incoming subaward is funding coming to SBU and an outgoing subaward is funding going out of a SBU proposal.

1. Outgoing Subawards

When SBU receives funding from a sponsor (aka prime sponsor) and subawards a portion of the work to another institution, it’s called an outgoing subaward.

Preparation and Processing of Proposals with Outgoing Subawards

Outgoing subawards involve multiple individuals and offices, therefore it's important to start the process early.  Subrecipient institutions most likely have their own routing and approval policies and procedures.  Remember to communicate our 5/2 proposal deadline policy, to ensure that documents signed by the subrecipient’s institutional official are received in time to route and submit your proposal at SBU.

Note: PIs that initiate their myResearch proposal, budget and budget justification 14 days in advance can take advantage of OSP support in the preparation of the proposals, where OSP Specialists will contact and collaborate with partner subrecipient institutions to secure all necessary subrecipient documentation (14 days notice mandatory)

The general subrecipient proposal documentation required include:

• Letter of Intent (LOI) or Subrecipient Commitment Form signed by authorizing official
• Subaward Scope of Work (SOW) that includes background info/objectives and a clear description of the work to be performed
• Detailed budget on prime sponsor budget form or spreadsheet
• Budget Justification that ties specifically to the budget line items

These documents must be incorporated into the SBU proposal and routed through myResearch Grants.

Why is a Subrecipient Commitment Form necessary at proposal stage? 

The Subrecipient Commitment Form is created to collect information about each Subrecipient named in a SBU proposal at proposal stage. The information on the Form helps the Specialists in the Office of Sponsored Programs verify the eligibility of the Subrecipient and that the information about the Subrecipient contained in the SBU proposal has been reviewed and endorsed by the Subrecipient’s Authorized Organizational Representative (AOR).

At award stage, the information on the Subrecipient Commitment Form helps OSP Specialists conduct a risk assessment of the Subrecipient prior to entering into a Subaward Agreement. Subawards may not be issued to Subrecipients that pose a great or an unacceptable risk to our institution. A Subrecipient Pre-award Checklist is completed by the OSP Specialists and provided to the Office of Grants Management for further review and input. As of July 1, 2021, OSP Specialists will also be required to conduct and complete a Risk Analysis action in addition to the Checklist prior to processing a Subaward Agreement. 

Note: See below the information on how to determine the type of relationship involved (subaward vs. service/contractor).

Including a subaward in your award (Outgoing Subaward)

If your award involves subrecipients (subawardees or subcontractors), you should submit a RF Purchase Requisition to OSP Contracts. OSP will need a copy of the Subrecipient Commitment Form, subrecipient's statement of work and budget (if they were not previously submitted with your myResearch application) in order to develop a subrecipient agreement (either a subaward or a subcontract).

Principal Investigator Responsibilities on Outgoing Subawards

• At proposal stage, clearly determine the appropriate classification of costsl as either a subaward or service agreement (see below additional guidance).
• Monitor subrecipient to assure that invoices and progress reports are submitted in a timely manner.
• Review invoices received from the subrecipient for allocability, allowability and reasonableness of costs and that charges are within the period of performance of the prime award, and approve them. Ensure that invoices provide enough details to determine how funds are being utilized. Discuss any concerns with your departmental administrator or your designated Analyst in the Office of Grants Management. Note that payment can be withheld if explanations are needed, and until such satisfactory explanation is received from subrecipient.
  • Monitor subrecipient’s progress and determine whether payments are in alignment with progress and terms of the subaward.
  • Approved invoices must be submitted to the Office of Grants Management for processing.
• If the subrecipient is contributing to any mandatory cost sharing commitments, review the invoice for indications that the subrecipient is meeting commitments and has certified that all expenses are appropriate.
• Verify that  scientific progress reports and other material requested from the subrecipients have been collected and reviewed.
• Verify that project closeout requirements required by federal award terms are completed.

Subrecipient Responsibilities include:

• Submit appropriate invoices and reports in accordance with subaward.
• Submit required technical reports.
• A-133 / Audit compliance - completion of required audits and any adverse findings which impact the subaward.
• At closeout, submit accurate final invoice and submit final reports, including technical, inventory, and inventions.

Subaward Modification Requests - what is needed

All actions and documentation  outlined below must be submitted together with a RF Purchase Requisition to your OSP Specialist.

- Increase of funding 

A detailed budget from the subrecipient is required for an increase in funding, unless subject to SNAP. If the budget period is also extended, the Notice of Award must provide new end date.

- Decrease of funding

Substantial decreases (greater than 25% of total cost) require a revised budget and scope of work (SOW).  The new budget and SOW must reflect the revised total cost and the work performed. 

- No Cost Extension

Documentation of sponsor approval is always required, usually through a revised NOA.

- PI Change

Both parties must agree to this change, and documentation is required. In most cases, sponsor approval and a revised notice of award is required.

Annual modifications/renewals will be processed by OSP via amendments to the Subrecipient. At that time, Subrecipients will be required to complete and return an Annual Subrecipient Questionnaire.

2. Incoming Subawards

Incoming subawards, happen when another institution (pass through entity) receives funding from a sponsor (aka prime sponsor) and that institution subawards a portion of the work to SBU.

Preparation and Processing of Proposals

If you are going to be a subawardee on another organization’s proposal, submit a complete myResearch proposal that includes the following information specific to your role on the project:

• Statement of Work
• Budget
• Budget Justification
• Any other documents required by the pass through entity

Follow deadlines provided from the pass through entity NOT the prime sponsor. This allows the pass through entity to incorporate our proposal materials into their proposal to to the prime sponsor.​

Is it a subaward or a service?

Just because another entity is involved in carrying out work on a sponsored project does not mean that a true subrecipient relationship exists. It is sometimes difficult to tell the difference between a subrecipient and a vendor, which could lead to problems managing a sponsored project. Therefore, it is important to ascertain if the work to be carried out meets the definition of a subaward at the proposal stage. 

Questions to ask before including a subaward in a proposal:

• Does the entity commonly provide these goods and/or services as part of their normal business operations?

• Does the entity provide similar goods and/or services to other purchasers?

• Does the entity compete with comparable entities to provide the same goods and/or services?

• Are the goods and services being provided by the entity secondary to the central purpose of the project?

• Is the entity's work carried out according to the prime sponsor's specifications using standard operating procedures?

If the answer to any of these questions is "yes," the work fits the profile of a vendor and a subaward will not be the best solution.

Subrecipient

A subrecipient relationship is appropriate when:

• Substantive, programmatic work or an important or significant portion of the research program or project is being undertaken by the other entity. 
• The research program or project is within the research objectives of the entity.
• The entity participates in a creative way in designing and/or conducting the research.
• The entity retains some element of programmatic control and discretion over how the work is carried out.
• The entity commits to a good faith effort to complete the design or conduct of the research.
• The entity makes independent decisions regarding how to implement the requested activities.
• A principal investigator has been identified at the entity and functions as a “Co-Investigator”.
• There is the expectation that the entity will retain ownership rights in potentially patentable or copyrightable technology or products that it produces in the course of fulfilling its scope of work.
• Publications may be created or co-authored at the entity.
• The entity provides cost sharing or matching funds for which it is not reimbursed by SBU.
• The entity regards itself, and/or is regarded by SBU, as “engaged in research” involving human subjects under the Common Rule and therefore requires approval for its interactions with human subjects.

Contractor/Vendor Relationships (Service Agreements) 

If a vendor relationship is required, indirect costs will need to be charged on the entire amount of the transaction and the researcher/vendor should work with Procurement to either develop requests for proposals, obtain bids, or, after the award is made, negotiate the university's purchase order terms as well as any federal flow down requirements if the source of funding is federal.

A contractor (vendor) relationship (including that of an individual acting as a vendor of consulting services) is appropriate when:

• The entity is providing specified services in support of the research program.
• The entity has not significantly participated in the design of the research itself, but is 
• implementing the research plan of the SBU investigator.
• The entity is not directly responsible to the sponsor for the research or for determining research results.
• The entity markets its services to a range of customers, including those in non-academic fields.
• Little or no independent decision-making is involved in the design and conduct of the research work being completed.
• The agreement only specifies the type of goods/services provided and the associated costs.
• The entity commits to deliverable goods or services, which if not satisfactorily completed will result in nonpayment or requirement to redo deliverables.
• The entity does not expect to have its employees or executives credited as co-authors on papers that emerge from the research.
• The expectation is that the work will not result in patentable or copyrightable technology or products that would be owned by the entity.
• In the case of an individual vendor of consulting services, the person has no employment relationship with SBU, either academic or administrative in nature. 

It is the responsibility of the principal investigator to determine whether the price is competitive and reasonable for agreements with both subrecipients and vendors. In either case; however, the agreed-upon cost is not relevant in determining whether the relationship is that of subrecipient or vendor. It is required by federal grant terms and conditions and by good business practices that competitive bids are sought for goods and services from multiple vendors, whenever possible and when the cost exceeds $5,000. Sole source contractor (vendor) relationships may be prohibited by the conditions of the prime award, and if allowed, are typically subject to specific conditions and procedural requirements. Contact Procurement for additional clarification for agreements with vendors.

If you are unsure which type of relationship is most appropriate, please contact your OSP Specialist or osp_contracts@stonybrook.edu.

Testing/Lab Study Agreements involve the Principal Investigator testing a specific compound, device, or process for a sponsor. No data analysis will be performed by the principal investigator. Also no inventions should be anticipated. The team of Contracts & Clinical Trials Specialists in the Office of Sponsored Programs negotiate and execute these agreements on behalf of The Research Foundation for The SUNY.

An evaluative testing/lab study agreement  will qualify for the Other Sponsored Programs F&A Rate when the private sponsor is providing our institution a company-developed protocol that specifies all procedures in detail and leaves no room for the Principal Investigator to experiment on his or her own; where the type of work required is characterized as testing of the private sponsor’s proprietary product (e.g. a new or investigational device, drug, material or compound) and the deliverable must be raw data which cannot include any interpretation. Such testing or studies cannot involve contact with human subjects. The F&A rate for such agreements is currently 42% MTDC.

Testing should not be confused with an evaluative research agreement. An evaluative research agreement for which the Organized Research Rate applies is defined as any agreement with a private sponsor with a protocol developed by either Sponsor, University Principal Investigator, University Principal Investigator with direction from Sponsor or Sponsor with direction from University Principal Investigator; the protocol is moderately specific and leaves room for the University Principal Investigator to experiment or interject his or her own ideas; where the type of work required is characterized as testing of the private sponsor’s proprietary product (e.g. a new or investigational device, drug, material or compound) and the deliverable will be provided to sponsor in the form of expert data analysis and interpretation from University. The F&A rate for such agreements is currently 59.5% MTDC.

 To process a Testing/Lab Study Agreement, OSP much receive the following:

- myResearch Grants and myResearch Agreements applications, including of a copy of the Protocol or Statement of Work.

- name, address, telephone number and email address of your company contact

OSP usually provides standard template agreement. Should sponsor request to use their agreement, please send directly to osp_contracts@stonybrook.edu.

A fully executed agreement from sponsor and, depending on the sponsor type, the initial/start-up funds are needed for an internal award set-up. At the conclusion of these studies, residual balance may be transferred to departmental fixed price balance account.  

 

Evaluative Testing Agreement Template

Lab Study Agreement Template

A Visiting Scientist Agreement is a legally binding agreement between Stony Brook University and organizations wherein the employee of the organization is granted permission by a SBU faculty member to access the facilities and intellectual resources of the University for a specific period of time in order to perform a research project. Such permission should not generate costs and liabilities to SBU (i.e., the costs associated with the visit, such as equipment, materials, animal costs, reagents, together with F&A, must be covered by the home organization, absent unique circumstances). 

The Office of Sponsored Programs may have to work with other offices on campus before such agreements are finalized.