There are a number of compliance requirements at Georgetown University that must be met in order to conduct research.Major areas of compliance responsibilities include: Human Subjects Animal Subjects Institutional Biosafety, Research Ethics, Research Safety and Security and Export Controls.
OBTAINING REGULATORY APPROVALS
1. Institutional Review Board (IRB-a, IRB-b) for the Biomedical Sciences
The role of the IRB is to safeguard the rights and welfare of all human subjects who participate in research projects conducted by Georgetown. In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB. Complete information regarding the Biomedical IRB can be found on the Office of Regulatory Affairs web site.
2. Institutional Review Board (IRB-c) for the Social and Behavioral Sciences
This IRB evaluates the protection of human subject data as it relates to interviews, questionnaires, surveys, etc. Faculty in the social and behavioral sciences are strongly encouraged to first review the following IRB 101 fundamentals before submitting an application to the ORA.
Complete information regarding the Social and Behavioral Sciences Review Board (IRB-c) at Georgetown can be found on the Office of Regulatory Affairs web site.
3. Students Engaged in Human Subject Research
Students wishing to conduct human subject research are required to familiarize themselves with the IRB process for their discipline (e.g. biomedical, social or behavioral sciences) and to obtain approval and appropriate human subject protection training (next section) before engaging in research. A full review of the process is available at the following Student Conducted Research page on the ORA web site.
4. Human Subject Protection Training
All Georgetown University faculty, investigators, study coordinators and other individuals directly involved in human subject research are required to complete training in human subject protection in research. Certification is required before commencing a research project involving human subjects and subsequently renewed every three years. Complete information regarding the above can be found on the Human Subject Protection Training web page on the Office of Regulatory Affairs web site.
5. Protection of Minors Policy and Human Subjects Research
Principal Investigators who currently have or are planning to propose studies involving minors (under age 18) as human subjects must review and follow the University’s Protection of Minors Policy. It is the responsibility of all PIs and their study team members to become familiar with the Policy’s requirements and responsibilities as outlined in the following: Protection of Minors Policy.
These requirements pertain, and must be met, for both new study proposals as well renewals. Studies involving minors that are currently underway will need to be in compliance with the Policy’s requirements when such studies are due to be renewed.
The eRIC system has recently been modified to serve a gate-keeping function and to track compliance with the Policy. Essentially, when a PI submits a protocol to the IRB for a new study involving minors or is seeking a previous approval to be renewed for an ongoing study, eRIC will identify the study as such and remind the PI of the requirements that must be met before the study protocol or renewal will be considered by the IRB. Questions or comments regarding the Policy should be directed to Anne Koester, Office of Compliance and Ethics.
6. Institutional Animal Care and Use Committee (IACUC)
The IACUC’s mission is to ensure the proper care and humane treatment of animals. The Committee’s responsibility is to develop, review, and monitor all animal facilities and care practices within the institution for compliance with federal legislation, agency regulations, and local laws. The GUACUC 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. For more information regarding obtaining IACUC protocol approval for research involving animals, please visit the Office of Regulatory Affairs web site.
CONFLICT OF INTEREST
1. Financial Conflict of Interest Disclosure Form
Georgetown University’s Financial Conflicts of Interest Policy underscores the University’s fundamental expectation that research and scholarly activities will be conducted with objectivity and integrity. The policy seeks to identify potential, actual, or apparent financial conflicts of interest and provides processes for disclosure of such conflicts and for eliminating or, when appropriate, managing them. It also acknowledges the special obligation that members of our community whose work is supported by public funds have to protect and maintain the public’s trust. Please note that financial conflicts of interest are not inherently problematic, and many employees will have conflicts. What is important is not necessarily the financial conflict itself but rather its disclosure and the development of a management plan, where necessary.
The Financial Conflict of Interest Policy webpage outlines the policies and procedures available to researchers. Faculty and staff can submit their initial and updated General Disclosure form through GU-Pass. The General Disclosure form must be updated no less frequently than annually and sooner if there is a change that requires disclosure.
2. Study Specific Disclosure Form
Each “investigator,” whether faculty, staff, or student, involved in externally sponsored research at Georgetown University must file a Study Specific Disclosure Form as part of each proposal. “Investigator” includes the principal investigator and any other project personnel who are responsible for the design, conduct, or reporting of research. Electronic copies of the Study Specific Disclosure Form are available through GU-Pass. Completed disclosure forms are due to the Office of Research Services in advance of the proposal submission.
UNIVERSITY CODE OF ETHICAL CONDUCT
All members of the Georgetown University community are responsible for helping to create and maintain an environment characterized by high standards of ethical behavior and compliance with law and University policies. The University is subject to a wide range of laws, regulations and policies that govern its various activities; honest, informed and responsible conduct by faculty, staff and students can help the University avoid most compliance problems. Our Code of Ethical Conduct can be found on the Office of Compliance and Ethics (COE) web site.
All faculty and staff are responsible for understanding and complying with this policy.
RESPONSIBLE CONDUCT OF RESEARCH
The National Institutes of Health (NIH) and the National Science Foundation (NSF) require training on the Responsible Conduct of Research (RCR) for certain grant-funded personnel. Given the large number of relevant agency funded grants, the Main Campus’ RCR Plan was created to accommodate the NIH’s and NSF’s respective RCRs, and therefore shall serve as the basis for signature authorization on NSF proposals as well as be partially or fully incorporated into NIH proposals. The Main Campus’ RCR also is applicable to Law Center and SFS-Qatar faculty who are recipients of NIH and NSF grants. Links to each of the aforementioned RCRs are available below:
The University also provides RCR training for all researchers through the Office of Regulatory Affairs (ORA). We strongly encourage ALL research personnel (e.g. faculty, students, postdoctoral fellows, etc.) to become familiar with the University’s RCR Training preferably before engaging in new research projects.
Finally, the Health and Human Services (HHS) Office of Research Integrity has posted a Responsible Conduct of Research (RCR) Casebook. The teaching resource features cases organized on the following topics: authorship and publication, research misconduct, collaboration, data acquisition and management, conflicts of interest, peer review, mentor and trainee relationships, and social responsibility. All researchers are strongly encouraged to review and become familiar with these policies and procedures before embarking on research projects.
Although Federal laws restricting exports of goods and technology have been in existence since the 1940’s, the federal government has increased its scrutiny of export control compliance by colleges and universities due to concerns about homeland security, proliferation of weapons of mass destruction, terrorism, and unauthorized releases of technology to U.S. economic competitors. Export control regulations, e.g., the Export Administration Regulations (“EAR”) and the International Trafficking in Arms Regulations (“ITAR”) cover the shipment of controlled physical items out of the country as well as the provision of controlled information, technology, software, or equipment to a foreign national abroad or in the United States (“deemed export”). Export control issues arise when grants and contracts require publications to be approved in advance by the sponsor, when there are restrictions on the participation of foreign nations, and when foreign nationals’ access to controlled equipment, technology or information rises to the level of “use.” “Use” is defined as “operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing.” The University must also comply with the regulations issued by the Office of Foreign Assets Control when faculty and students travel to certain sanctioned or embargoed countries for purposes of teaching or performing research.
The University complies with all applicable United States export control laws, including the Export Administration Regulations (“EAR”) administered by the Department of Commerce, Bureau of Industry and Security (“BIS”); the International Traffic in Arms Regulations (“ITAR”) administered by the Department of State; and the foreign sanctions programs administered by the Department of Treasury through its Office of Foreign Assets Controls (“OFAC”). Please note that the majority of exports associated with academic research and scholarly activities do not require an export control license even if they involve controlled technologies because they are subject to one of the following exemptions: 1) fundamental research exemption which applies to basic and applied research conducted at a university located in the United States where the resulting research is ordinarily published; 2) publicly available/public domain exemption meaning that under the EAR, information that is already published or will be published as generally accessible or available to the public through certain methods; and 3) educational information exemption which, under the EAR, covers information released through instruction in catalog courses and associated teaching laboratories at academic institutions.
Additional information is available on the Export Controls web page on the Main Campus Research website.
The duties of the Office of Technology Commercialization (OTC) include management of Georgetown invention disclosures, patenting and licensing activities, oversight of material transfer agreements and confidentiality agreements, and engagement of Georgetown University in the founding and growth of local businesses.
Investigators are encouraged to visit the OTC website for further information regarding their services.
FUNDED RESEARCH INCENTIVE PROGRAM
The Provost’s Office provides incentives to Main Campus investigators based on the indirect costs generated each month on externally funded grants and contracts. For more information, please view the Funded Research Incentive Policy on the Main Campus Research website.