Resources

The Dean for Research and the Office of Sponsored Research at Georgetown University Medical Center 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:

Quick Links: Sponsored Research-Related Offices  

Office of Regulatory Affairs (ORA)
Clinical Trials Office (CTO) 
Sponsored Accounting Office (SAO) 
Tax Department
Office of Technology Commercialization (OTC)
Office of Risk Management (ORM)
Office of Environmental Health and Safety (EHS)

Georgetown Institutional Information

Georgetown University Medical Center institutional identification, assurance and compliance numbers, official address, authorized signatories, cognizant audit agency and disclosure statement filing information can be accessed here.

Georgetown Policies and Oversight

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.

NIH T32 Training Grant Policies

  NIH T32 Training Grants policies.8.8.13 (6).docx

 

 

Responsible Conduct of Research

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 laboratory tools; data management, 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.

The RCR Plan applicable to the Medical Center, other campus plans, and the NIH and NSF RCR regulations are available at the Medical Center Office of Regulatory Affairs.

Human Subjects Protection

Institutional Review Board
The Georgetown University Institutional Review Board (IRB) is charged with safeguarding the rights and welfare of all human subjects who participate in research projects conducted by Georgetown University. In order to comply with Federal law and institutional policies, all research projects involving human subjects or human material must be reviewed and approved by the IRB. The Institutional Review Board for social and behavioral science research involving human subjects (IRB-C) has the responsibility of reviewing proposed research projects, regardless of the source of support, to ensure that the privacy and welfare of the research participants are adequately protected. All faculty, staff and students engaged in such research should submit requests for IRB approval prior to beginning their work. The IRB has the authority to disapprove, modify, or approve protocols based upon consideration of human subject protection. The IRB also oversees the conduct of the study and requires progress reports from the investigators at least annually.

ORA recently introduced eRIC, an Electronic IRB Submission System to provide a more efficient process of submitting, approving, tracking, and management of IRB study submissions. IRB new study applications and post-approval activities, such as amendments, continuing reviews, adverse event reports, and terminations are entered into the system by the principal investigator, regulatory coordinator, study coordinator, co-investigators, or other study team members. eRIC electronically routes all applications, forms, materials and correspondence associated with the Institutional Review Board (IRB) review and approval process.

E-mail: irboard@georgetown.edu

Phone: 202.687.1506

Animal Care and Use

Georgetown University Insitutional Animal Care and Use Committee (IACUC) 
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.

As of January 2012, the GU Office of Regulatory Affairs launched TOPAZ, an online protocol submission and management program. All new and 3-year renewal protocols submitted for GUACUC review must be submitted through Topaz. Click on the link above for additional information.

For more information on GU IACUC and TOPAZ, contact:
IACUC Administrator
guacuc@georgetown.edu

Hazardous Chemicals, Biohazards and Radioactivity

Environmental Health & Safety
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 ehands@georgetown.edu, (202) 687-4712.

Click here to access the Georgetown University Biosafety Manual.

Employment Eligibility 

E-Verify Compliance
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.

More information about E-Verify compliance is available at the Georgetown Office of Sponsored Programs website.

Export Controls 

Export Administration Regulations ("EAR")

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.

International Trafficking in Arms ("ITAR")

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.

Office of Foreign Assets Controls ("OFAC") Sanctions Programs

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.

Prior to issuing any Independent Contractor (consulting), Purchased Service or Subaward Agreements, pursuant to the OFAC regulations, OSP verifies that the individuals and contractors are not listed on certain U.S. Government watch lists.   

Georgetown University's  Export Control Handbook for Researchers contains additional information regarding Export Controls.

Sponsored Accounting Policies

Cost Sharing
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.

Cost Transfers
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.

Effort Reporting
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.

Note: All federal grants and contracts are governed by OMB Circular A-21 entitled “Cost Principles for Educational Institutions.” OMB issued a clarification dated January 5, 2001, which stated that any effort committed in the proposal, compensated or not, must be tracked in the University’s Effort Reporting System.

Participant Costs
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 for additional information on accounting policies and practices relevant to the conduct of externally funded research.

 

External Resources

eRa Commons
Grants.gov

Agency Websites

NIH Office of Extramural Research (OER)
Administration for Children and Families (ACF)
Administration for Community Living (ACL)
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.gov Grants Management Resources

HHS Forms
HHS Code of Federal Regulations, Title 45 CFR
HHS Grants Administration Manual (GAM)
HHS Grants Policy Directives (GPDs)

NIH Grants Policy Statement (GPS)

Grant- and Contract-Related Regulations and Oversight

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 Federal Acquisition Regulations (FAR) governs all federal contracts. The agency specific contract regulations can also be accessed from the FAR.

Research.gov: The Research.gov Policy Library is the U.S. Government's electronic portal for accessing Federal policies, guidelines and procedures.

OMB Circulars

The OMB (Office of Management and Budget) Circulars are the documents that govern all federal grants. The following are the circulars are pertinent to research conducted at educational institutions:
A-21: Cost Principles for Educational Institutions.
A-110: Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations.
A-133: Audits of States, Local Governments, and Non-Profit Organizations.

Federal Demonstration Partnership (FDP)

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. NSF serves as the official host of participating agency documents relating to the FDP.

Effective July 1, 2008, FDP Federal agencies implemented use of Federal-wide Standard Terms and Conditions for Research Grants. These Federal-wide research terms were a direct result of years of cooperative work between Federal agencies and institutions participating in the FDP.

All research agencies now utilize this standard core set of administrative terms and conditions on awards subject to OMB Circular A-110 (2 CFR Part 215), to the extent practicable.

FDP Terms and Conditions, Agency-Specific Requirements (scroll down for NIH requirements)
Source: http://www.nsf.gov/awards/managing/fed_dem_part.jsp

Intergovernmental Personnel Act (IPAs) 

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. Additional details about this program can be found here.