Agreements

The Office of Sponsored Research (OSR) is the Georgetown University Medical Center (GUMC) Office charged with negotiation and execution of research-related agreements with outside institutions, including sub-agreements and independent contractor agreements, Professional Services Agreements (PSAs: MedStar Georgetown University Hospital) and clinical trial agreements. Sponsored Research Sub-Agreements or Independent Contractor Agreements (ICAs) are Initiated by OSR at PI request after receipt of a primary award. Upon receipt of award, Research Development Services (RDS) Subcontract Specialists (SS) will work with investigators to initiate a request to the Office of Sponsored Research (OSR) to establish, modify or close out a subagreement from GUMC to other institutions, such as subcontracts and independent consulting agreements (ICAs). The Subaward Tracking and Review System (STARS) is used to track the initiation and modification of subawards and ICAs. RDS staff will help the Principal Investiagtor (PI) to obtain the necessary documents from the sub institution and will route the information in STARS. 

 

Sub-agreements to Collaborating Institutions

OSR is responsible for establishing, modifying and closing out sub-agreements from GUMC to other institutions.  The Sub-award Tracking and Review System (STARS) is used by RDS and OSR to track initiation and modification of subawards.  Upon receipt of a prime award, RDS will reach out to the PI on the award and departmental personnel to determine if a sub-agreement is to be issued and to confirm the details of the sub-award. RDS staff will then submit a request to OSR in STARS 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) by RDS as part of the proposal institutional 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 Sponsored Projects Financial Operations (SPFO). 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 SPFO to file in departmental records.

Note: Incoming sub-agreements from collaborating institutions are manages as sponsored research awards.  Proposals to other institutions to participate in sponsored research should be entered into TRACS by RDS 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

RDS will work with the PI and collaborating institution during proposal development to collect the information below and include it in the TRACS submission for institutional review and approval. When an award is received, RDS will reach out to the PI and departmental personnel to confirm that a sub-award will be issued. If so, RDS will work with the PI to make any needed changes to the sub-institution documents listed below and submit a request to OSR in STARS to negotiate a sub-agreement.

  • 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 in the GMS vendor database.)  Click here for additional information.

Independent Contractor Agreements (ICA)

The mechanism to pay a consultant participating in an externally funded research project is an Independent Contractor Agreement ("ICA"). ICAs are managed by Georgetown University Purchasing and Contracts as outlined in the Financial Affairs Contracts Policy (FA 102). The current process is for RDS to work with the PI and independent contractor to collect required information and initiate a request to OSR in STARS to draft an ICA at the request of the PI after receipt of a primary award. 

The ICA request is reviewed by the Tax Department to 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 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) is drafted by OSR and sent to the consultant for signature and the GUMC department grants manager who works with a department requisitioner to route to Purchasing and Contracts for signature, initiation of appropriate actions in GMS and financial management of the contract. A copy of the fully executed contract (countersigned by Georgetown University's Chief Procurement Officer) is retained in the PI's department and a copy is sent to OSR, uploaded in STARS and retained in OSR 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 in GMS along with appropriate forms to Accounts Payable.

Requirements for an ICA Request

The following documents are required for Tax Department review and Purchasing and Contracts review and approval:

  • Independent contractor curriculum vitae (CV)
  • Statement of work (SOW)
  • Annual budget & budget justification
  • Tax questionnaire form

Other tax forms that independent 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.

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

OSR works collaboratively with the Clinical Research Operations Office (CROO), the Medical Center Office responsible for assisting with start-up and administration of clinical studies.  Click here for an overview of clinical trial agreement setup at GUMC.

GUMC Pre-award Clinicals Tracking (PACTS

CROO, CRMO and OSR  GUMC PACTS (Pre-award Clinicals Tracking) as a platform for submission, review and negotiation of industry-sponsored clinical trial agreements. Departmental personnel complete the GUMC electronic transmittal form in PACTS and upload the clinical trial protocol, budget and contract to initiate the process.

Federal clinical trial proposals and agreements with pass-through academic institutions for GUMC participation in clinical studies are prepared by RDS and routed in TRACS as sponsored research proposals

**Note** A clinical trial agreement cannot be fully executed by OSR until an approved clinical trial budget is negotiated with the sponsor by CROO (BGRO) or CRMO (LCCC). A GMS spending account cannot be created until evidence of IRB approval is received and an internal budget is provided to manage the spending account.

IRB Approval

The Office of Regulatory Affairs (ORA) has established eRIC (Electronic Research and Information Compliance) for submission and approval of clinical trial protocols. Contact the Institutional Review Board (IRB) 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.