Agreements

The Office of Sponsored Research (OSR) is the Georgetown University Medical Center (GUMC) Office charged with negotiation and execution of research and clinical agreements with outside institutions, including sub-agreements, Independent Contractor Agreements (ICAs), Professional Services Agreements (PSAs: MedStar Georgetown University Hospital) and clinical trial agreements.

*Note: Sponsored Research Sub-Agreements or Independent Contractor Agreements (ICAs) are Initiated by OSR at PI request after receipt of primary award

Sub-agreements to Collaborating Institutions

OSR is responsible for establishing, modifying and closing out sub-agreements from GUMC to other institutions, such as subcontracts and independent consulting agreements (ICAs).  The Sub-award Tracking and Review System (STARS) is used to track initiation and modification of subawards.  Upon receipt of a prime award, departmental personnel submit a request to initiate or modify a sub-contract to another institution using funds from the incoming sponsored research award.  

Collaborative relationships are generally established during proposal development and documented as subrecipients in the Transmittal Review and Compliance System (TRACS) as part of the proposal review and approval process.  If a project requirement for a subcontractor develops after receipt of award, the principal investigator may need to submit a sole source justification to OSR describing why the contractor is needed and why the proposed subcontractor is the only organization that can do the work.

Payments to subcontractors are processed by the Sponsored Accounting Office (SAO). Once OSR receives a fully executed sub-agreement (signed by the sub-institution and counter-signed by Georgetown University), a copy of the agreement is forwarded to the principal investigator and to SAO to file in departmental records.

Note: Incoming sub-agreements from collaborating institutions are considered awards.  Proposals to other institutions to participate in sponsored research should be entered into TRACS for OSR review and approval prior to submission to the prime institution.  Industry-sponsored clinical trial agreement negotiations are managed using the Pre-Award Clinicals Tracking System (PACTS).

Requirements for a Subcontract Request

  • Letter of Intent
  • Statement of Work
  • Annual budget & budget justification
  • Subcontractor’s Indirect Cost (IDC) Rate Agreement (obtained from subcontractor)
  • Completed online W-9 Form (to be filled out by subcontractor.)  Click here for additional information.

Independent Contractor Agreements (ICAs)

The mechanism to pay a consultant participating in an externally funded research project is an Independent Contractor Agreement ("ICA"). The principal investigator (PI) leading the research project must submit the consultant’s Curriculum Vitae, a Statement of Work and the following completed forms to OSP for Tax Department review.

Requirements for an ICA Request

  • Letter of Intent
  • Statement of Work
  • Annual budget & budget justification
  • Consultant CV/Biosketch
  • Tax Questionnaire Form
  • Completed online W-9 Form (to be filled out by independent contractor.)  Click here for additional information.

Tax forms that contractors are required to complete and submit.

  • U.S. citizens must complete IRS Form W-9 (see online registration information above).
  • U.S. citizens, including those living abroad, must include their U.S. home address on the W-9 form. If they do not have a U.S. address while living abroad, they may use their foreign residential address. Non U.S. citizens living abroad are permitted to use a business address provided it is not a Georgetown University business address.
  • Non U.S. citizens that are performing work within the United States must submit the relevant tax forms on the list.
  • Non U.S. citizens performing work outside of the United States must submit only the W-8BEN
  • Independent Contract General Information Sheet to be completed by the PI or the consultant.

The ICA request is reviewed by OSR and forwarded to the Tax Accounting Department for approval. The Tax Accounting Department must ensure that:

  • The contractor is not currently on the University’s payroll and has not been during the current calendar year
  • Services to be provided by the consultant are not those typically performed by University employees.

Once the Tax Accounting Department's approval is received, the consultant is checked against a database of individuals who are debarred or suspended from participating in U.S. government funded projects. If the consultant clears these requirements, an "Independent Contractor Agreement" (ICA), along with relevant tax forms, is sent to the consultant for signature. A copy of the fully executed contract (countersigned by Georgetown University) is retained in OSR and a copy is sent to the principal investigator for departmental records.

The principal investigator (PI) is responsible for paying consultants/independent contractors once an ICA has been executed. Consultants submit invoices to the PI, who submits an expense authorization, a copy of the fully executed ICA, an authorized and dated invoice (signed by the PI), and relevant tax forms to the Accounts Payable Office.

Sub-award Tracking & Review System (STARS

OSR has implemented the Sub-award Tracking & Review System (STARS) to provide efficient and transparent setup and management of subcontracts and ICAs from Georgetown to other institutions or individuals.  GUMC STARS is managed by a process flow that notifies participants involved in the process when they have an activity to complete and allows investigators or administrators to track the progress of a sub-award or ICA from initiation to completion.

For an introduction to GUMC STARS, see our Quick Reference Guide. To set up an account, or for technical assistance, contact starshelp@georgetown.edu or Manuel Corday (cordaym@georgetown.edu) at 202-687-1372.

To access STARS, click here or copy the following URL into Chrome, Firefox or Internet Explorer (https://georgetownsubs.interneer.com/Intellect/login.aspx)  At the login screen, type your Georgetown Univeristy netID and password in the boxes on the welcome page.  We recommend that you bookmark the URL or add it to your “favorites” ribbon, then check the system regularly to monitor the progress of any agreements you have in process.

Upon login, you will be taken to the main “Contracts” screen, which displays sub-award activities from your department that are currently in process. To submit a subcontract or ICA request, click on the sub-award request button on the top left corner of the screen and fill out the required fields.

Attach the relevant documents listed above and your request is ready to be sent to OSR. Click the “next step” button to automatically route the request to an OSR Subcontracts Specialist with a notification to the OSR Grants Officer responsible for your department.

Honoraria

Honoraria are payments for very short duration of service that are typically are used to compensate an individual for service as a panel member or presenter at a conference. Honoraria are processed by the principle investigator, who issues a letter to the individual offering to compensate them in return for their participation in an activity. The individual to receive the honorarium must complete relevant tax forms and sign the letter accepting the offer. The W-9 tax form is used for U.S. citizens. Other tax forms are used for non-U.S. citizens. Payments to non-U.S. citizens must be cleared through the Tax Accounting Department. To process payment, the PI must submit an "Expense Authorization" to the Accounts Payable Office accompanied by relevant tax forms, the letter of offer and the individual's signed acceptance.

Clinical Trial Agreements

The GUMC Office of Sponsored Research (OSR) is the Georgetown University entry point for initiation of clinical trial agreements and the only office authorized to negotiate and execute clinical trial agreements. OSR works collaboratively with the Clinical Trials Office (CTO), the Medical Center Office responsible for reviewing and approving proposed clinical trial budgets.  Click here for an overview of clinical trial agreement setup at GUMC.

GUMC Pre-award Clinicals Tracking (GUMC PACTS

CTO and OSR use an electronic process tracking and review process, the GUMC PACTS (Pre-award Clinicals Tracking), for submission and review of documents needed to initiate or modify a clinical trial. Departmental personnel upload the clinical trial protocol, budget, contract and GUMC electronic Transmittal Form via PACTS to initiate the process.

CTO is responsible for reviewing budgets for conformance with University pricing policies, negotiating budgets with clinical trial sponsors, and preparing internal budgets. Once approved by CTO, budgets are forwarded to OSR for inclusion in the executed agreement.

**Note** A clinical trial agreement cannot be fulexecuted by OSR until an approved clinical trial budget is received from CTO.

IRB Approval

The Office of Regulatory Affairs (ORA) has established eRIC (Electronic Research and Information Compliance) System for submission and approval of clinical trial protocols. Contact irboard@georgetown.edu.for additional details.

**Note** Investigators are encouraged to seek IRB approval as early in the process as possible. OSR will not establish a spending account, which is required to begin enrollment, prior to receiving notification of IRB approval.

All clinical trials either supported by federal funds or subject to FDA regulation must be registered in the National Library of Medicine’s central Protocol Registration System, known as ClinicalTrials.gov. The entity responsible for registering the clinical trial, the “Responsible Party,” is either (1) the sponsor of the clinical trial, or (2) the PI, if so designated by a sponsor, grantee, contractor or awardee. Georgetown University has established a central ClinicalTrials.gov registration and certification process.  Please contact the Georgetown University Protocol Registration System (PRS) Administrator, Patricia Mazar by email to register a trial. Once registration is completed, a signed certificate will be sent to the PI and to the Office of Sponsored Research by the PRS administrator.