Patty Yuhas Kieleszewski
Associate Director
M-F, 9 a.m.- 5 p.m.
313-577-9227

Shaterra Childs
Grant & Contract Officer - Clinical Trials: Post-Award, All Confidentiality and Non-Disclosure Agreements for Sponsored Programs
M-F, 7 a.m. - 3 p.m.
313-577-3275

Asa Mulligan
Grant & Contract Officer - Clinical Trials, Investor-Initiated Agreements
M-F, 8 a.m. - 4 p.m.
313-577-7945

Patrick Piszker
Grant & Contract Officer - Subcontracts
M-F, 8:30 a.m. - 4:30 p.m.
313-577-9490

Karen Tomlinson
Grant & Contract Officer - Non-Clinical Trials Agreements, Federal and Pass- Through Contracts, Data Use Agreements, Confidentiality Disclosure Agreements (All Others)
M-F, 9 a.m. - 5 p.m.
313-577-0192

Procedures for Processing Research Contracts

Processing Research Contracts, Non-Disclosure/Confidentiality Agreements, Data Use Agreements, and other Related Agreements Through Sponsored Program Administration (SPA) 

Definitions

  University Policies that may apply: https://policies.wayne.edu/university-policies  

04-6    Contract Signatures 

04-5    Gifts, Grants and Contracts – Approval, Stewardship and Reporting 

08-2    Investigator Disclosure 

Wayne State University Code Annotated-Board of Governors (WSUCA):   

2.41.01 – University Research Policy  https://bog.wayne.edu/code/2-41-01 

2.81.01 – Contract Awards  https://bog.wayne.edu/code/2-81-01 

SPA’s Procedure for Processing Contracts: 

Generally, the sponsor will provide a legal document for the University to execute. However, occasionally, the sponsor will not have a contract and ask for a standard agreement; this often happens with investigator-initiated projects and smaller sponsors. Contract Administration utilizes several pre-approved templates for research projects, non-disclosure agreements, subcontracts, clinical trials, etc.  

The Principal Investigator, his/her administrative representative, or a sponsor on behalf of the Principal Investigator may submit agreements. They may be mailed, hand-delivered, or electronically transferred to the SPA Contracts Team, who is responsible for the administrative review and obtaining legal review from the Office of General Counsel (OGC). Within SPA, agreements may be received by a Grant and Contract Officer, the Associate Director, and/or an administrative person designated by the Associate Director. 

Monetary Agreements: 

1. Before the Contract Officer* can begin a review, the Administrator and/or PI must enter a complete proposal into Cayuse and route for approval. A complete proposal consists of a PI-certified Cayuse record as well as the following attachments:  

• The contract/agreement 

• An affirmation memo signed by the PI: https://research.wayne.edu/spa/pdf/affirmation_memo_2022.pdf (pdf) 

• The negotiated and sponsor-approved budget (if not attached to the Contract) 

• The completed contract checklist:  https://research.wayne.edu/spa/pdf/contract-checklist.pdf (pdf) 

• A research scope of work 

• Any misc. information needed to process the Contract (e.g. sponsor contact information).  

*Note: The “Contract Officer” is the Grant/Contract Officer on the Contracts Team; it is referred to as “Contract Officer” here for clarity purposes. 

The SPA Contracts Team reviews all proposals entered into Cayuse to determine if there is an associated contract. If there is no contract, 'Timothy Foley' is selected as the Contract Specialist (placeholder) in Cayuse, and the appropriate Grant and Contract Officer should proceed with their normal course of review. If there is an associated contract, proceed to Step 2. 

2. Once received via Cayuse, the Contract Officer will be selected as the Contract Specialist in Cayuse, who will review the complete proposal and begin the negotiation process. The Contract Officer will establish a negotiation record in the COEUS Contracts module to enable the Administrator and/or PI to track the contract negotiation via Researcher’s Dashboard. The contract and affirmation memo will be sent to OGC within 3 business days (if necessary). NOTE: Contracts MUST be received via Cayuse.

If a proposal is submitted without a contract but a contract is received at the time of award receipt, the Grant and Contract Officer must notify the Contracts Team Associate Director or the appropriate Contract Officer (if known), allowing the Contract Officer to proceed with contract negotiations. 

3. If OGC returns the Contract with required edits:

• The Contract Officer will handle all contract negotiations. The Contract Officer will email the sponsor with the requested changes. The PI and/or Administrator will be copied on the correspondence with the sponsor as appropriate. Because of the legal complexities involved and the various levels of review required, sponsors should not be given blanket assurances that Wayne State will automatically accept all of their terms and conditions. Generally, some level of negotiation is required for all contracts. Some examples of general terms that cannot be accepted are: 

  • The laws of states and countries other than Michigan 

  • Professional liability insurance requirements 

  • Warranty for a research project 

  • No publishing clauses or other publication restrictions 

  • Projects classified as secret or top secret 

  • Weaken or undermine PI’s intellectual property rights 

Once the Contract Officer receives a response to the requested changes from the sponsor, the Contract Officer will review the Contract, obtain input from the PI/Administrator, Export Control, Information Technology as needed, and return the updated Contract to OGC for review. If the Contract has further requested changes, the Contract Officer will continue the negotiation process until a mutually agreed upon contract is confirmed. The result is a fully executed approved contract. 

Negotiations can be viewed and are updated in real time on Researcher’s Dashboard: https://dashboard.research.wayne.edu/ 

4. If the Contract comes back APPROVED by OGC or is previously approved by OGC: 

• The Contract Officer will begin the routing and signature process 

• Often, more documents, such as insurance certificates and corporate authority resolutions, must be sent with a fully executed contract. The Contract Officer will gather these other forms as needed. A pdf copy of the documents given to the sponsor will be emailed to the department for their records. 

5. Once the fully executed Contract is received, the Contract will then ensure IRB or IACUC is obtained, if needed, and then turn over all necessary documentation to the assigned GCO for index establishment 

6. The index number and fully executed Contract will be available on Researcher’s Dashboard.   

Non-Monetary Agreements: 

Non-monetary agreements (i.e. non-disclosure or data use agreements) should be sent to the correct Contract Officer via email with the Contract and other documents as attachments: 

1. Confidentiality Agreements (CDA) /Non-Disclosure Agreements (NDA) should be sent to @Shaterra Childs along with the signed CDA/NDA affirmation memo:  https://research.wayne.edu/spa/pdf/affirmation_memo_cda.pdf (pdf) 

2. Data Use Agreements (DUA) connected with an active sponsored project should be sent to @Karen Tomlinson along with the signed DUA affirmation memo:  https://research.wayne.edu/spa/pdf/affirmation-memo-mta.pdf (pdf) 

3. Other miscellaneous non-monetary agreements (e.g., Memorandum of Understanding, Work Orders, Allocation of Rights, etc.) will be handled case-by-case. If received, contact the Associate Director of Contracts for further processing instructions.   

4. The negotiation process follows the same steps as above for the Monetary Agreements. 

5. Non-monetary agreements are kept on file and cannot be viewed on Researcher’s Dashboard. 

The Contract Administration portion of the Sponsored Programs website can be found on the following link, and contains further information and resources:  https://research.wayne.edu/spa/contracts 

• Clinical Trials - SPA Procedures 
• Confidential Disclosure Agreements (CDA)
• SPA Guide to Clinical Trials
• How to Negotiate a Clinical Trial Budget with a Sponsor
• Clinical Trial FAQs
• Helpful Links for Clinical Trials
• Clinical Trial Closure Checklist
• Clinical Trial Fees

What is a Subaward?

A subaward is when a portion of Wayne State's sponsored project is passed through to another entity in order to complete a portion of the sponsored project's scope of work. It does not include payments to a contractor or payments to an individual that is a beneficiary of a program.

A subaward agreement is formal written contract made between Wayne State University and another institution or organization to perform an intellectually significant portion of Wayne State's SOW (Statement of Work) under a Wayne State University sponsored project.

Key Terms

• Pass-Through Entity: Non-federal entity that provides a portion of an award it has received to a subrecipient to carry out a specific program
• Subrecipient: Non-federal entity that expends federal awards received from a pass-through entity to carry out a federal program, but does not include an individual that is a beneficiary of such a program. A subrecipient may also be a recipient of other federal awards directly from a federal awarding agency.
• Tier One: of a series of rows placed one above another, it defines the relationship when awards have subawards in their respective budgets.
• Privity of Contract: a doctrine of contract law that prevents any person from seeking the enforcement of a contract, or suing on its terms, unless they are a party to that contract.

Subaward Characteristics

The Subrecipient:

• Makes programmatic decisions
• Must adhere to compliance requirements
• Uses sponsored funds to carry out portion of entire work scope

Uniform Guidance: 2 CFR section 200.331

• Federal award: Characteristics indicative of a federal award received by a subrecipient are when the organization:
  • Determines who is eligible to receive what federal financial assistance;
  • Has its performance measured against whether the objectives of the federal program are met;
  • Has responsibility for programmatic decision-making;
  • Has responsibility for adherence to applicable federal program compliance requirements; and
  • Uses the federal funds to carry out a program of the organization as compared to providing goods or services for a program of the pass-through entity.

Considerations Prior to Proposal Submission

• A need for additional expertise is identified by PI
• Subrecipient selection process is decided
• Proposal package from subrecipient is collected
• If the proposal is going to be a PHS agency the Financial Conflict of Interest review must take place
• PI assesses potential recipients PI documents decision based on evaluation criteria. Some important criteria used in the decision process include:
  • Past scientific and financial performance
  • Technical/financial resources
  • Strength of the proposed scope of work
  • Reasonableness of proposed costs
• The proposal package from the subrecipient includes:
  • Statement of work
  • Budget and associated budget justification
  • Signed commitment letter
  • Biosketches, other support, and other associated information as required by the sponsor
  • Other documentation as requested based on sponsor requirements
• The subrecipient selection process entails
  • Subrecipient competitive bidding: A process whereby a potential subrecipient submits a bid to the PI. The PI considers all bids and decides based on the quality of the science, the best price, and the contract terms.
  • Sole source procurement: The PI's documentation of selection criteria is used.

Roles & Responsibilities

• Department/Principal Investigator (PI)
  • Request proposal package from proposed subrecipient and evaluates selection.
  • Verify FCOI policy and/or obtain FCOI Forms 1 & 2 if sponsor uses PHS FCOI regulations
  • Indicate subawards on PRF.
  • Prepare proposal and sends to SPA
  • Provide additional information required for subaward issuance
  • Monitors subrecipient technical progress and performance
  • Monitor subrecipient's adherence to terms and cost sharing requirements
  • Verify compliance approvals are current for subrecipient's portion of statement of work (human subjects, animal subjects, biosafety)
  • Monitor receipt of invoices and reviews that expenses are aligned with technical progress and all required reports are received
  • Review, sign, and dates invoice (PI)
  • Send approved invoice to SPA mailbox subkinvoices@wayne.edu for processing or returns to subrecipient for more detail or documentation
  • Assesses need to modify statement of work or budget (PI)
  • Plan for timely closeout and obtain prime no cost extension if needed (follow up on missing reports, receipt of final invoice)
  • Promptly alerts SPA when problems arise (inability to obtain satisfactory invoice, non-performance).
• Sponsored Program Administration
  • Reviews and submits proposal
  • Verifies FCOI policy and reviews Forms 1 & 2
  • Works with COI office to verify FCOI training and disclosures
  • Negotiates with sponsor and accepts prime award
  • Follows-up with PI / Dept. to obtain any additional required documentation/data required for subaward
  • Reviews risk levels and, if necessary, modifies subaward agreements
  • Prepares, negotiates, issues and distributes subaward agreement
  • Collects, maintains, and reports FFATA data
  • Activates/encumbers subaward funds in financial system
  • Assists PIs and departments with monitoring subawards
  • Requests and reviews annual audit reports
  • Verifies corrective action plans are implemented (if necessary)
  • Notifies department administrators if the invoices are incorrect
  • Tracks and processes invoices with PI approval
  • Prepares, negotiates, issues, and distributes amendments
  • Modifies subaward encumbrances in the financial system
  • Completes closeout
  • Resolves problems that arise during performance

Subrecipient vs. Contractor Guidance

• Vendor vs. Subrecipient: Guidance on Appropriate Classification of Legal Relationships
  • Under the OMB Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards, which went into effect on 12/16/2014, the term "vendor" was replaced with "contractor." The terms vendor and contractor substantially have the same meaning and may be used interchangeably in other guidance. For consistency purposes, when Wayne State provides funds from a federal award to a non-federal entity, the non-federal entity receiving these funds is classified as a subrecipient or a contractor based on the nature of the agreement and the criteria in 2 CFR §200.331.
• 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 Wayne State.
    • The entity regards itself, and/or is regarded by Wayne State, as "engaged in research" involving human subjects under the Common Rule and therefore requires approval for its interactions with human subjects.
• Contractor (Vendor)
  • 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 Wayne State 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 Wayne State, either academic or administrative in nature.

• Research Contracts - Other Key Documentation 
• Statement of Work Guidance
• SPA Procedure for Processing Contracts (non-clinical/pharmaceutical) (pdf)
• Contract Checklist 
• Affirmation Memo Non MTA 
• WSU Research Policy 
• Request for Waiver of WSU Research Policy
• Researcher's Dashboard