SMHS Contract Review Guidance

Non-Funded Agreements

Contract Type Office initiating review/negotiation POC Signatory
Collaboration Agreements

Clinical Collaboration Agreements – OCR

Non-clinical Collaboration Agreements – Dean’s Office

For clinical – 
researchcontracts@mfa.gwu.edu

For non-clinical – Erica Grant
smhs_contracts@gwu.edu

For MFA – CEO

For SMHS – Dean or Vice Dean

Confidential Disclosure Agreements (CDA)/Non-Disclosure Agreements (NDA)

Clinical CDAs/NDAs – OCR

Non-clinical CDAs/NDAs – Dean’s Office

For clinical – 
researchcontracts@mfa.gwu.edu

For non-clinical – Erica Grant
smhs_contracts@gwu.edu

For MFA – CEO

For SMHS – Dean or Vice Dean

Data Use Agreements (DUA)/Data Transfer and Use Agreements (DTUA)

Clinical DUAs/DTUA  – OCR

Non-clinical DUAs/DTUAs  – Dean’s Office

For clinical – 
researchcontracts@mfa.gwu.edu

For non-clinical – Erica Grant
smhs_contracts@gwu.edu

For MFA – CEO

For SMHS – Dean or Vice Dean

Material Transfer Agreements (MTA)

Clinical MTAs – OCR

Non-clinical MTAs – Office of Sponsored Projects (OSP)

For clinical – 
researchcontracts@mfa.gwu.edu

For non-clinical – Robert Pitysingh
materials@email.gwu.edu

For MFA – CEO

For SMHS – Office of the Vice Provost for Research (OVPR), Assistant Vice Provost for Sponsored Projects

Memorandums of Understanding SMHS Dean’s Office Erica Grant
smhs_contracts@gwu.edu
SMHS, Dean or Vice Dean
Health Sciences Affiliation Agreements SMHS Dean’s Office Erica Grant
smhs_contracts@gwu.edu
SMHS, Dean or Vice Dean
MD Affiliation Agreements SMHS Dean’s Office Sherry Brody
sherrybrody@gwu.edu
SMHS, Senior Associate Dean for MD Programs
Equipment Loan Agreements SMHS Dean’s Office Erica Grant
smhs_contracts@gwu.edu
SMHS, Dean or Vice Dean
SMHS Facility Use Agreements SMHS Dean’s Office Erica Grant
smhs_contracts@gwu.edu
SMHS, Dean or Vice Dean

Review and Processing of Funded Agreements

Office POC When Review of Contract is Required
Office of Clinical Research researchcontracts@mfa.gwu.edu

OCR is responsible for the review, negotiation, acceptance, and execution of all Clinical Trial Agreements (CTA) between GW and its clinical partners, Medical Faculty Associates, Inc., and The George Washington University Hospital (as applicable).

Signatory for Medical Faculty Associates (MFA) – CEO

Signatory for School of Medicine and Health Sciences (SMHS) – Dean or Vice Dean

Office of Sponsored Projects (OSP) Claire Stamm
c.stamm@gwu.edu
When a contract is with a sponsor that provides funding for a project with financial reporting requirements, OSP reviews via myResearch
Procurement Donna Ginter
dginter@gwu.edu
When purchasing a good or service from an outside party, Procurement will route the contract for review by OGC, Risk, Finance, GWIT and other necessary reviewers via Gatekeeper.

Collateral Review by Office

Office POC When Review of Contract is Required
Technology Commercialization Office (TCO)

Brian Coblitz (transfers of biological materials)
coblitz@gwu.edu

Michael Harpen (transfers of physical materials, i.e. devices, software)
mharpen@gwu.edu

Involves intellectual property and patent language
Office of Research Safety labsafety@email.gwu.edu Involves shipment or use of hazardous materials; MTAs when materials are being transferred to/from Ross Hall
Office of Research,  Integrity & Compliance resinteg@gwu.edu Involves data, export controls, Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC). Note: ORIC does not typically review DUAs for SMHS.
Privacy

MFA Contracts
Janine Fadul
privacyofficer@mfa.gwu.edu

SMHS Contracts
Cristina Grigore
privacy@gwu.edu

Involves personal information protected by various privacy laws and regulations, including personal information, health information, student information and personal financial information
International Programs Huda Ayas
impinfo@email.gwu.edu
Involves academic or other programmatic relationships with an overseas partner
Risk Management Hubert Fisher/Jefferson Smith - 
risk@gwu.edu
Involves activities involving potential liability; indemnification and insurance language
Office of General Counsel (OGC) contracts@gwu.edu Review of contracts not managed by OSP or Procurement

Glossary

Affiliation Agreement: An agreement between the university and another entity for purposes of establishing a relationship to provide an educational opportunity for students or share academic programs, personnel, and/or resources for a particular purpose.

Clinical Trial Agreement: An agreement covering the terms for a clinical trial to study investigational drugs or devices.

Collaboration Agreement: An agreement covering an unfunded collaboration where both GW another entity are contributing to the performance of a research scope of work.

Confidentiality Agreement/Non-Disclosure Agreement: An agreement that requires the parties to the agreement to keep certain information disclosed between them confidential.

Data Use Agreement: An agreement between the entity that owns access to a data source, typically a dataset or database, and a secondary entity that will receive the data, or a subset of it, for reuse.

Equipment Loan Agreement: An agreement that governs the loan of equipment from outside entities to GW for research purposes.

Facility Use Agreement: An agreement to permit non-GW entities to use GW facilities.

Material Transfer Agreement: An agreement that governs the transfer of research materials between the university and another entity.

Memorandum of Understanding: An agreement that is used to set forth the basic and general principles and guidelines under which the parties involved will work together to accomplish a shared goal, but that does not involve the exchange of money or a reliance of one party on the actions of the other that could result in a loss if not performed.

Resources

SMHS Contract Process

Third party sends clinical contract to PI

  

PI sends contract to OCR Contract Officer to review and redline

  

Contract Officer sends contract to other offices for collateral review as needed

  

Contract Officer sends redlined contract to 3rd party for review

  

Once 3rd party approves edits, Contract Officer routes for signature to MFA CEO
 

  

Contract Officer saves fully executed agreement in Box

Third party sends non-clinical contract to PI

  

PI sends contract to SMHS Managing Director to review and redline

  

Managing Director sends contract to other offices for collateral review as needed

  

Managing Director sends redlined contract to 3rd party for review

  

Once 3rd party approves edits, Managing Director routes for signature to SMHS Dean or Vice Dean

  

Managing Director saves fully executed Agreement in Box