The Dean for Research and the Office of Sponsored Research (firstname.lastname@example.org) are available to provide guidance to GUMC faculty and staff on internal and external processes, policies and resources related to sponsored research. Some useful links are provided below:
- Institutional Information
- Quick Links
- Policies and Oversight
- External Resources
- Frequently Asked Questions (FAQs)
Georgetown University is a member of the Federal Demonstration Partnership (FDP) and a participant in the FDP Clearinghouse, a public website of organization profiles for entity-based information needed by pass-through entities when they are issuing subawards or monitoring their subrecipient entities. Georgetown University's institutional information is available on the FDP Clearinghouse Georgetown University profile page.
- Office of Regulatory Affairs (ORA)
- Clinical Research Operations Office (CROO)
- Clinical Research Management Office (LCCC/CRMO)
- Sponsored Projects Financial Operations (SPFO)
- Tax Department
- Office of Technology Commercialization (OTC)
- Office of Risk Management (ORM)
- Office of Environmental Health and Safety (EHS)
The Georgetown University Faculty Handbook provides documentation of the rights and responsibilities of Georgetown University faculty members, as well as policies that form part of the contractual obligations of University and faculty. Stated policies include those pertaining to copyrights, conflicts of interest, misconduct in research, and drug-free workplace.
The Georgetown University Office of Regulatory Affairs has developed a program of instruction in the responsible conduct of research (RCR) to promote integrity and accountability in the scientific process and to meet institutional obligations as a federal grantee institution. Instruction is provided on the following core concepts:
- Conflict of interest (personal, professional and financial)
- Research on human subjects
- Research involving animal subjects
- Safe laboratory practices
- Mentor/mentee responsibilities and relationships
- Collaborative research including collaborations with industry
- Peer review
- Data acquisition and management, data sharing and ownership
- Research misconduct and policies for handling misconduct
- Responsible authorship and publication
- The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research.
Institutional Review Board (IRB)
The Georgetown University IRB is charged with safeguarding the rights and welfare of all human subjects who participate in research projects conducted by Georgetown University. All research projects involving human subjects or human material must be reviewed and approved by the IRB to comply with Federal law and institutional policies. All faculty, staff and students engaged in such research should submit requests for IRB approval prior to beginning their work. The IRB also oversees the conduct of the study and requires progress reports from the investigators at least annually.
ORA recently introduced a new electronic IRB submission system to provide a more efficient process of submitting, approving, tracking, and management of IRB study submissions. Details and important dates can be found on the ORA website.
The GUACUC is charged with ensuring proper care and humane treatment of animals. The Committee's develops, reviews, and monitors all animal facilities and care practices within the institution for compliance with federal legislation, agency regulations, and local laws and is responsible for the dissemination of information related to approved methods of animal care to individuals who use animals in research, teaching, or demonstration programs at Georgetown University.
The Office of Environmental Health and Safety is the Medical Center resource for information and training on chemical, biological and radioactive materials, as well as other environmental safety issues. Questions can be addressed to email@example.com, (202) 687-4712.
Federal contractors and subcontractors were required to begin using the U.S. Citizenship and Immigration Services’ E-Verify system starting September 8, 2009, to verify certain employees’ eligibility to legally work in the United States. Under amendments to the Federal Acquisition Regulations ("FAR"), universities who receive federal contracts over $100,000 subject to the FAR must use the E-Verify system to confirm the employment eligibility of all new and existing employees who are assigned to the contract.
Georgetown University's E-Verify Compliance Procedure.
Georgetown University Human Resources E-Verify Checklist for Principal Investigators and Department Administrators.
U.S. Citizenship and Immigration Services' (USCIS) E-Verify Information.
FAR 52.222-54 Electronic Employment Eligibility Verification System (E-Verify).
The Export Administration Regulations, issued by the U.S. Department of Commerce and located in 15 CFR §§ 730-774, govern “dual use” technologies and products that have both military and civilian uses. Goods and services controlled under the EAR are listed on the Commerce Control List (“CCL”) and are divided into ten categories: (0) nuclear materials, facilities, and equipment; (1) materials, chemicals, microorganisms, and toxins; (2) materials processing; (3) electronics; (4) computers; (5) telecommunications and information security; (6) sensors and lasers; (7) navigation and avionics; (8) marine; and (9) propulsion systems, space vehicles and related equipment.
The International Traffic in Arms Regulations, issued by the U.S. Department of State, Directorate of Defense Trade Controls and found at 22 CFR §§ 120-130, control munitions, defense articles, and defense services that are listed on the United States Munitions List (“USML”). Most of the items and services on the USML are specifically designed or produced for defense applications and do not have predominantly civil applications. The USML covers items such as firearms; ammunition; launch vehicles, missiles, rockets, torpedoes, bombs and mines; explosives, energetic materials, propellants, and incendiary agents; vessels of war; tanks and military vehicles; aircraft; military training equipment; protective personnel equipment; military and space electronics; fire control, range finder, optical and guidance control equipment; toxicological agents; spacecraft systems; nuclear weapons design and test equipment; directed energy weapons; submersible vessels; and classified articles, technical data and defense services not otherwise enumerated. Unless an exemption applies, a license must be obtained before any item on the USML is exported to a foreign country or to a foreign national or before the University can undertake any work that would be considered to be the furnishing of a defense service.
The U.S. Treasury Department’s Office of Foreign Asset Controls administers and enforces sanctions that have been imposed against specific countries based on reasons of foreign policy, national security, or international agreements. Although the list of sanctioned countries changes on occasion, sanctions are currently in effect for the following countries: the Balkans, Belarus, Burma, Cote d’Ivorie (Ivory Coast), the Democratic Republic of the Congo, Cuba, Iran, Iraq, Liberia, North Korea, Sudan, Syria, and Zimbabwe. The scope of the sanctions varies depending upon the country, but they generally prohibit anyone in the United States from importing or exporting goods, services, or technology to or from a sanctioned country (including all people and entities located in that country) without first obtaining a license. In addition, travel to certain sanctioned countries (particularly Cuba and Iran) may require a license from OFAC.
OSR verifies that individuals and contractors are not listed on certain U.S. Government watch lists prior to issuing any consulting, purchased service or subaward agreements, pursuant to the OFAC regulations.
Georgetown University's Export Control Handbook for Researchers contains additional information regarding Export Controls.
The Sponsored Accounting Policy on Cost Sharing and Matching on Sponsored Projects provides guidance to University staff on the use of University funds toward the conduct of externally funded research projects to ensure they comply with federal regulations and agency guidelines, especially Office of Management and Budget (OMB) Circular A-21and A-110, which require entities to properly account for cost share and matching.
The Sponsored Accounting Cost Transfer Policy for Sponsored Awards establishes the requirements for recording cost transfers of expenditures among externally funded projects or between University cost centers and the externally funded project on the financial accounting records of the University in accordance with a proper system of internal financial accounting controls and federal regulations.
The Sponsored Accounting Policy on Effort Reporting (Payroll Distribution and Certification of Effort on Sponsored Projects) is intended to ensure that the University complies with the Office of Management and Budget Regulations, specifically OMB Circular A-21, with regard to payroll distribution and certification of effort. The policy provides information on proper procedures for payroll distribution on sponsored projects, including required authorizations on HR/Payroll paperwork and certifications for faculty and staff working any part of their time on federally sponsored projects.
The Sponsored Accounting Policy on Participant Costs provides guidance on when indirect cost allocations for non-employee related expenditures such as transportation, stipends, per diem, and other participant (i.e., trainee) costs are applicable to sponsored projects.
Consult the Georgetown University Sponsored Accounting Office (SPFO) for additional information on accounting policies and practices relevant to the conduct of externally funded research.
The Georgetown University Policy for Postdoctoral NIH National Research Service Award (NRSA) Trainees applies to postdoctoral recipients of an individual or institutional NRSA grant from the National Institutes of Health (NIH). The policy provides information concerning the employment status of NRSA trainees at the University and benefits made available to NRSA recipients. Pre-doctoral NRSA recipients are not covered by this policy.
- NIH Office of Extramural Research (OER)
- Administration for Children and Families (ACF)
- National Council for Aging Care (NCAC)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- HHS Code of Federal Regulations, Title 45 CFR
- HHS Grants Administration Manual (GAM)
- HHS Grants Policy Directives (GPDs)
- NIH Grants Policy Statement (GPS)
Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
The OMB (Office of Management and Budget) Uniform Guidance Circular (2 CFR 200 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is the document that governs all federal grants.
The Federal Acquisition Regulations (FAR) governs all federal contracts. The agency specific contract regulations can also be accessed from the FAR.
The Federal Demonstration Partnership (FDP) is a cooperative initiative among federal agencies and institutional recipients of federal funds established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds.
An IPA Agreement may be negotiated to enable a Georgetown faculty member to take a one year leave of absence to work at a federal agency. The concept of the program is one of mutual benefit. While the Georgetown faculty member works full time at the government agency, he or she remains a University employee with all customary benefits. When an IPA Agreement is negotiated, the budget should include salary and fringe benefits only. Contact Trudy Bright in OSR (firstname.lastname@example.org, 202-687-1227) for additional information.
Where can I find assistance with opportunity identification and proposal development?
Contact Research Development Services for assistance to identify sponsored research opportutnities and receive proposal development support, including collaborations with other institutions or indviduals.
Where can I find the Georgetown fringe rates?
The University fringe rates are available on the RDS Institutional Information page.
Can I use an Indirect Cost (IDC) Rate on a proposal that is different than the official University rate?
University policy requires the use of our federally negotiated and approved indirect cost rates on all sponsored research proposals submitted to external agencies. Any deviation to this rule must first be reviewed and approved by the Department Chair and then forwarded to the Medical Center Chief Business Officer (CBO) for review and a final decision. OSR approval of a proposal with a reduced rate is contingent on CBO approval.
Do I need budgets for the out years of a modular grant?
A budget is required for each budget year proposed for all sponsored research proposals. The information is needed to properly determine and calculate appropriate IDC, fringe and effort projections.
What happens if I can’t meet the 10 day GU-PASS electronic transmittal package deadline or get my finalized proposal package to OSR at least 5 days prior to the sponsor deadline?
Submission of a GU-PASS electronic transmittal package (abstract, budget, budget justification, SSDF(s) and FOA link) no less than 10 days prior to the sponsor submission deadline is required to allow OSR to review the information and coordinate with the PI, department staff and other administrative offices to ensure that the proposal submission complies with University and sponsor requirements and policies. If additional time is needed, submit a written email request to the OSR Deputy Director, Trudy Bright, at email@example.com. Failure to comply with the deadlines could result in a proposal submission being denied or the University not being to accept the award.
Do I need approval for my IRB or IUACUC protocol when I submit my proposal?
It depends. Many sponsors do not require this information until a funding decision is made. Check the funding opportunity announcement to be sure.
Where can I obtain a Human Subjects Certificate?
The IRB Office will issue a Human Subjects Certificate after the appropriate review course has been completed.
Where can I obtain information for IBC issues?
Contact the Environmental Health and Safety Office for information related to IBC or other research-related safety issues.
I am including a collaborator (sub-institution) on my application. What documentation is required?
Contact Research Development Services (RDS) for assistance with collecting required documentation needed for the GU PASS submission for institutional approval. The GU PASS transmittal package must include a Letter of Intent (LOI) from the sub-institution along with a budget for each year the sub-contractor will be involved in the project, a budget justification and the sub-institution’s IDC Rate Agreement.
My grant has been awarded and it contains a sub-agreement. How do I set this up?
Contact Research Development Services (RDS) to identify a Sub-award Specialist who will submit a request to OSR using the GU-PASS sub-awards module using required documents (e.g., statement of work (SOW), budget and budget justification) provided by department personnel. OSR will negotiate the sub-agreement with the sub-institution. See the “Resources” page of the OSR website for additional information.
What is the procedure for submitting an eSnap to NIH?
eSNAP requires the investigator to first complete their part and then submit the electronic document to the OSR Grants and Contracts Officer responsible for their department (see the OSR “About Us” page to find the Grants Officer for your department.). Once reviewed, it will be up-loaded by OSR staff through the NIH Commons.