This Section provides additional information regarding intellectual property rights and obligations with a focus on what happens when these rights are created in the course of sponsored research activities. For specific guidance on these rights and obligations, please contact the appropriate University organization as described in this Section and refer to the University’s Policies on Patents and Scholarly Work, http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf, and Copyright Policy, http://my.gwu.edu/files/policies/CopyrightPolicyFINAL.pdf. These policies define how the University pursues traditional principles of education and research and encourages the creation and publication of scholarly, technical, literary and artistic work.
20.1. PATENTS AND SCHOLARLY WORK
20.1.1. GW Policy on Patents and Scholarly Work
The University’s Policy on Patents and Scholarly Work http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf applies to all faculty, staff, and students of the University. While it imposes certain obligations on those who conduct research, its purpose is to adopt an inventor-friendly process in dealing with patents and scholarly work. In this regard, in order to protect the rights of the inventor and the University, as well as to comply with sponsor requirements, it is essential that appropriate disclosures as described below are made of any potentially patentable subject matter, especially any arising during the course of a sponsored program. A general introduction to this Policy follows.
The University’s purpose in pursuing and disseminating knowledge is sometimes served by seeking protection for Inventions, Discoveries, Technologies, and Innovations made in the course of work by University faculty, staff and students. Inventions, Discoveries, Technologies and Innovations are terms that are meant to cover tangible or intangible inventions, including a process, machine, manufacture, composition of matter, or improvement thereof, which is or may be patentable, whether or not reduced to practice. Patents confer certain rights to inventions and discoveries while simultaneously making those inventions and discoveries known to the public. Subject to any requirements of sponsored research agreements and consistent with the public interest, the University will take steps to promote the development and use of such inventions and discoveries. When the University receives royalties from patents, it uses those royalties in support of its mission of education and research and to provide appropriate incentives for inventorship.
20.1.1.1. University Organization and Patent Responsibilities: The University’s Associate Vice President for Health Research, Compliance and Technology Transfer and the Chief Research Officer are responsible for patent matters, including negotiation of agreements with sponsors of research and with licensees of University owned patents. These officials collaborate in administering the University’s Policy on Patents and Scholarly Work, and working on activities for joint endeavors that involve both non-medical and medical components.
The Office of Health Research, Compliance, and Technology Transfer is available to advise faculty, staff, and students on patent questions, particularly as they relate to specific disclosures. Please refer to the Policy at http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf, or contact the Office of Health Research, Compliance, and Technology Transfer, at http://www.gwumc.edu/research/techtrans.htm.
The Office of the Chief Research Officer oversees the negotiation of agreements with third parties to sponsor research conducted by the University which may contain provisions governing intellectual property including patents. The University will not enter into such agreements if the provisions differ in any way from University policy unless the deviating provisions are deemed acceptable in writing by the faculty member or staff member who will be the principal investigator for the program with agreement of the Chief Research Officer. For questions regarding the terms of a particular Award, or to submit a Patent Disclosure Form, contact the appropriate Research Services Coordinator, http://www.gwu.edu/~research/orsstaffing.htm
20.1.1.2 Patents: A patent is a grant issued by the U.S. Government giving an inventor the right to exclude all others from making, using, or selling the invention within the United States and its territories and possessions for a period of 17 years. When a Patent application is filed, the U.S. Patent and Trademark Office reviews it to ascertain if the invention is new, useful, and non-obvious; it then grants a patent, if appropriate.
20.1.1.3. The three criteria for Patentability: To be patentable, an invention must meet the following criteria:
20.1.2. Sponsor Requirements
As a condition of receiving awards, sponsors impose various requirements and duties on GW, including patent-related obligations. The University, through the Office of the CRO, also seeks to verify that certain protections for the inventor and the University related to such rights are negotiated and included in such awards.
20.1.2.1. The U.S. Government: The ownership of Inventions, Discoveries, Technologies or Innovations made by University faculty, staff, or students on Government sponsored programs is determined by federal law as applied through the Award, whether a prime award directly with the Government or a federal pass-through (subcontract). One major responsibility is to promptly disclose to the Government all Inventions, Discoveries, Technologies, or Innovations made in the performance of such an Award. Such disclosures should be promptly made to the CRO through the appropriate RSC and the Office of Health Research, Compliance and Technology Transfer whenever such Inventions, Discoveries, Technologies, or Innovations are conceived or actually reduced to practice in the course of the program. Making such disclosures enables the University to meets its obligations under the Award and is necessary to enable the inventor to potentially benefit in any royalties that may result in the event that the University elects to retain title and pursue a practical application of the Invention, Discovery, Technology, or Innovation. For a copy of the appropriate disclosure form, please go to the Office of Health Research, Compliance and Technology Transfer at http://www.gwumc.edu/research/techtrans.htm.
20.1.2.2. Sponsors Other Than the U.S. Government: The University will normally not enter into agreements with non-government sponsors unless such agreements explicitly state what the rights of the sponsors and of the University will be in Inventions, Discoveries, Technologies and Innovations that result from the sponsored work. It is expected that the University will retain title to such Inventions, Discoveries, Technologies, or Innovations, and to any resulting patents. The Principal Investigator plays an important role in reviewing and approving these negotiated arrangements.
Normally, the University would grant the sponsor certain exclusive or non-exclusive license rights in exchange for appropriate consideration which may include the payment of patent expense and royalties provided that the University is entitled to practice the patent and to permit other non profit organizations to practice the patent for research purposes. GW also requests that the sponsor agree that its rights in any Inventions, Discoveries, Technologies, or Innovations are subject to any rights the U.S. Government may have by virtue of its sponsorship or related research.
20.1.3. Evaluation of Inventions
Once a proper disclosure is made, a preliminary evaluation is made to determine that the subject matter is an Invention, Discovery, Technology, or Innovation. The University then must initiate one of the following actions within 30 days:
20.1.4. Rights in Inventions, Discoveries, Technologies, or Innovations
For information regarding the patenting review process, inventor’s economic rights in Inventions, Discoveries, Technologies, or Innovations, and related material, please refer to the University’s Policy on Patents and Scholarly Works, http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf, or contact the Office of Health Research, Compliance and Technology Transfer, http://www.gwumc.edu/research/techtrans.htm.
The University encourages the creation and publication of scholarly, technical, literary and artistic works as part of its educational mission. GW’s Copyright Policy, which may be found at http://my.gwu.edu/files/policies/CopyrightPolicyFINAL.pdf, applies to all Faculty, Librarians, Staff and Students of the University. Generally, when Faculty, Librarians, or Students, in pursuit of their normal scholarly, professional, or academic responsibilities, including normal use of the University’s physical facilities, by their own initiative, create copyrightable works, the copyright and any resulting royalties may be claimed by the Faculty, Librarian, or Student as author of the copyrighted work (Note: With appropriate prior approvals as provided in the Copyright Policy, Faculty and Librarians may make Substantial Use of University resources in creating copyrightable works within the scope of their job duties).
Copyright protection covers the manner of expression, rather than the ideas or concepts embodied in the work. This protection is for an extended period of years and enables the author to exercise certain exclusive rights over the work including the rights to reproduce the work, to make derivative works, to distribute the work to perform the work publicly or to display the work publicly.
20.2.1. Exceptions for “Work Made for Hire” and “Substantial Use.”
When a work qualifies as a “Work Made for Hire” or when “Substantial Use” of University resources is involved, the copyright of the work shall be owned or transferred to the University.
20.2.1.1. “Work Made For Hire”: A “Work Made for Hire” is:
20.2.1.2. “Substantial Use”: “Substantial Use” is defined in detail in the Copyright Policy, but, in general, it involves the use of University resources which: (i) falls outside the scope of normal job responsibilities or the Student’s academic program, or (ii) entails a use of such resources that is not ordinarily available to all or virtually all with comparable status in the School or Department. Again, please refer to this Policy for obtaining prior approvals for how to obtain permission for Substantial Use of resources. Additionally, please note that the term “Substantial Use” does not include the use of personal office space, local telephone, library resources and personal computer equipment incidental to outside activities that are permitted under the University’s Conflict of Interest Policy. http://my.gwu.edu/files/policies/ConflictofInterestandcommitment.pdf.
20.2.1.3. Allocation of Royalties and Copyright Administration: For details on the Author’s share of net income associated with royalties for copyrights transferred to the University, as well as information on how copyrights are administered, please refer to the Copyright Policy at http://my.gwu.edu/files/policies/CopyrightPolicyFINAL.pdf, or contact the Office of the Chief Research Officer, http://www.gwu.edu/~research/orsstaffing.htm.
The George Washington University encourages its researchers, as part of their efforts to generate new knowledge and enable its use for the betterment of society, to enter into collaborative partnerships with business and industry. Such relationships can provide additional funding for their research and can help them develop their inventions and other research discoveries to allow them to be converted into commercial products that benefit society.
As a university, GW’s first responsibility is to enable the results of research to be freely disseminated so that they can advance knowledge in a field and ultimately benefit society. Academic freedom is the basis for scientific progress; investigators must be free to select the programs in which they wish to participate, select the collaborators with whom they work, and freely communicate their findings to the scientific community at meetings, in publications, and by other means. At the same time, when GW enters into collaborative agreements with industry, it understands the concern of industrial sponsors and partners that proprietary information that has been provided in confidence needs to be kept in confidence and that publications should not jeopardize the potential for commercializing new inventions.
21.1. TYPES OF RESEARCH AGREEMENTS WITH PRIVATE INDUSTRY
The University encourages researchers to share their expertise and work collaboratively with both public and private entities outside the university. University-industry relationships can take a variety of forms, and the specifics of contracts and agreements will vary accordingly. Consider first private consulting by an individual faculty member and then four forms of university-industry collaboration, each with somewhat different implications for intellectual property rights ownership.
21.1.1. Private Consulting
One option for faculty whose contracts allow one day a week of outside consulting is to use that day to share their expertise with companies through private consulting agreements. A private consulting agreement can allow a good deal of flexibility, but it has limitations as well. The faculty member acting as a private consultant generally should not hire students to carry out the work because of the inherent conflict of interest involved. For example, the mentor who has a private financial interest in what a student does may not be fair-minded in evaluating the student whose work falls short. Faculty acting as consultants also cannot, without the prior approval of the Vice President for Academic Affairs, make substantial use of University resources, including space, equipment, staff, and students, for private financial gain (see the Policy on Conflicts of Interest and Commitment for a full discussion, http://my.gwu.edu/files/policies/ConflictofInterestandcommitment.pdf).
In addition, consulting agreements generally treat any discovery made in the process of consulting as a Work Made for Hire and grant intellectual property rights and any resulting income associated with the discovery to the company that hired the consultant rather than to the University researcher. As a result, the researcher may lose the ability to develop the discovery further on his or her own or to publish information regarding the discovery.
Because private consulting agreements can sometimes work against the interests of the faculty member and the University, the University encourages faculty to bring consulting work through the University whenever possible. Then University resources can be used to support the work, and graduate and undergraduate students can benefit from involvement in the work. Moreover, the University's expertise in contract negotiation can be brought to bear to help researchers negotiate agreements with more favorable terms and avoid putting themselves or the University at legal or financial risk or losing ownership of intellectual property that is rightfully theirs.
21.1.2. Independent Contractors
A PI may determine to enter into a contractual agreement with an Independent Contractor to help carry out the work proposed under his/her sponsored project award. Independent Contractors (“ICs”) have unique expertise, provide professional advice and guidance, provide a distinct service or product, typically a report, translation, analysis, or the like that is commercially available to the general public. The work is usually performed off University premises and offered to many different buyers within normal business operations. The work performed by an Independent Contractor is ancillary to GW’s sponsored project but necessary to carry out the overall objectives of GW’s sponsored award. ICs are not employees of the University and may not use GW resources to perform their services. Formerly, these agreements were called Consulting/Services Agreements. Effective July 1, 2007, GW will enter into Independent Contractor Agreements.
A PI should not confuse an Independent Contractor with a Subrecipient. A subaward is collaborative in nature whereby the subrecipient is performing an actual portion of GW’s statement of work to the prime sponsor. A subrecipient may be a co-author in a publication or may seek protection for his or her invention. Subrecipients have their performance measured against the portion of the scope of work proposed to GW and have the responsibility for programmatic decision making. The scope of work proposed by a subrecipient is generally of a research and development nature performed on a best efforts basis. The costs proposed are generally based on estimates as the outcome may be unpredictable.
To initiate an Independent Contractor Agreement with your Research Services Coordinator, please complete the Request for an Independent Contractor Agreement form found at the OCRO website.
21.1.3. Collaborative Partnership Agreement
Collaborative partnerships are agreements in which the University and a company (or possibly a group of companies) in the same industrial sector agree to conduct research and development activities collaboratively. To illustrate, a team of University and Company researchers might enter into an agreement to invent, develop, and test a particular product with the idea that intellectual property rights will be jointly owned. Alternatively, the agreement might call for a joint program of research in a particular area and specify that ownership of any resulting intellectual property will lie with the inventor(s), whether in a particular instance it is a University researcher, Company researcher, or both. Where one company is involved, the agreement would typically grant a first option to license the invention to the company. Where more than one company joins the University in a consortium, a more complex agreement is necessary. Agreements of this sort, when they pertain to more than a single, delimited research program, must be approved according to the procedures specified in the University's policy for establishing memoranda of understanding and therefore require approval of the Vice President for Academic Affairs and, where commitments of University resources are made, approval of the Vice President and Treasurer.
21.1.4. Research Agreement
In a research agreement, a company agrees to sponsor research by University researcher(s), often with the hope that the work will result in patentable discoveries and commercial products. The University is eager to encourage company sponsorship of University research and is likely to negotiate especially favorable licensing agreements with companies that have invested in the development of an invention.
Research sponsorship may be provided at various points in the research life cycle, from the time when a new line of research is just being undertaken to the point when the company has already entered into a license agreement for a University-owned intellectual property and needs the University's involvement in further research in order to bring the technology to market. Because the scientific work is done exclusively by University researchers, the intellectual property rights to any discoveries belong with the University alone.
The sponsoring company can expect, however, to be granted first option to license the intellectual property and then, if it chooses, a license with provisions appropriate to the particulars of the situation (e.g., the extent of its investment). A research agreement for industry sponsorship of research normally pertains to a particular research program or set of research activities (as opposed to a broader relationship with a company or companies, as in a Collaborative Partnership) and is handled as sponsored programs are normally handled, through the Office of the Chief Research Officer.
Clinical trial research agreements with commercial sponsors involving use of investigational drugs or devices in human subjects require specific terms and conditions distinct from commercially sponsored research agreements that do not involve human subjects. All clinical drug and device research contracts are processed and negotiated in accordance with the University’s Clinical Contracting Manual.
21.1.5. Licensing Agreement
A licensing agreement is the vehicle for granting to a company the right to sell or otherwise use an intellectual property owned by the University. The agreement will be very clear regarding the field of use of the license, its exclusivity (i.e., whether the licensee has exclusive rights to market a product), its duration, and the circumstances under which it can be terminated.
It does not always make sense to patent biological material made at the University. However, even when the University has not patented a material, that material may be of commercial value to others if they would find it cheaper to buy it from the University than to develop it themselves. In such cases, the University can grant an interested company a nonexclusive license to make or use the material.
License agreements are worked out through the collaborative efforts of the Office of the Chief Research Officer and the Office of the General Counsel.
21.2. GUIDELINES FOR AGREEMENTS
GW offers the following guidelines to researchers and to companies wishing to partner with GW.
21.2.1. Authority to Enter into Agreements
Researchers can engage in preliminary discussions with industry but they cannot speak for the University or enter into agreements on their own (with the exception of private consulting agreements). It is in their interest to follow University policy and leave the formal negotiation process and the review of proposed agreements to the appropriate University officials..
Consulting agreements and research agreements with industry, like other grants and contracts that support specific research programs, must be negotiated and approved by the Office of the Chief Research Officer. Collaborative Partnership Agreements, because they imply a broader and longer-term relationship with a company than does a specific research contract or grant and often involve the commitment of University resources must follow procedures specified by the University's policy on memoranda of understanding and be reviewed not only by the appropriate research administrator (the Chief Research Officer on the University side, the Associate Vice President for Health Research, Compliance, and Technology Transfer on the Medical Center side) but also by the Office of the General Counsel, and they must be signed by the Vice President for Academic Affairs and, where significant University resources are committed, by the Vice President and Treasurer.
21.2.2. Ownership of Intellectual Property
Although exceptions may be approved in rare circumstances, the University will retain ownership of any intellectual property that results from the efforts of its researchers. However, it can transfer the property to a company through an appropriate licensing agreement and thereby grant a company the right to commercialize it.
GW's policy in this regard is entirely consistent with those of other research universities. As an educational institution, we must maintain control of discoveries made at the University so that they can continue to inform and enrich research and teaching. Often research programs are sponsored by multiple sources of funding so that giving ownership to one company is inappropriate. In addition, the Bayh-Dole Act (http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf) prohibits universities from transferring ownership of intellectual property to a company if federal funding has supported the work; instead it encourages transferring technologies to industry through licenses. More generally, the University has made a large investment in its faculty and research facilities and, as a result, has an interest in remaining involved as a discovery makes its way from the laboratory to the marketplace. By retaining title to patents, the University can enable and protect its interests. It can seek commercialization of an invention with a second company should a first company fail to keep its promises. In addition, its researchers can continue to perfect the inventions they developed. Most importantly, this arrangement, which is standard procedure at universities, creates an optimal university-industry partnership: the University offers its research resources and expertise to help convert idea to product, and the company contributes its financial support and expertise in product development and marketing.
21.2.3. Publication of Findings
Agreements must protect both the researcher's responsibility to freely disseminate research findings and the company's interest in keeping certain information confidential.
The University recognizes that it has a responsibility to a commercial partner not to disseminate proprietary information that might, if released, jeopardize the company's market position. It also appreciates that a company sponsoring research will want an opportunity to review a research discovery stemming from the research it funds in order to determine whether the discovery is patentable. Agreements should specify that the investigator has an obligation to disclose discoveries to the University and the company as soon as possible, ideally before a publication is prepared. In addition, the company should be given up to 60 days in which to review draft publications and presentations in advance of their release where there is a possibility that they might disclose sensitive information or scientific discoveries. The University will agree not to disseminate proprietary information from a company or information that might constitute a public disclosure of an invention without the company's approval. In turn, the company will be expected to support the University's right to publish or otherwise disseminate results that are not proprietary and do not adversely affect the company's financial well-being.
21.2.4. Licensing Agreements
A license to an intellectual property allows a company to sell or otherwise use it. Licensing agreements should strike a proper balance between a company's desire for exclusive control of a research discovery and the University's desire to verify that discoveries are indeed developed and brought to the marketplace as products that can benefit society.
Licenses can take varied forms, and the University is willing to negotiate with individual companies to seek the fairest agreement for all, taking into account the nature of the discovery; the previous investments made by the University, the company, and other sponsors; and the investments required to develop it as a commercial product.
Some licenses will be non-exclusive, either because federal requirements demand it or because the research has had multiple sponsors. Under some circumstances, the University is willing to grant an exclusive license to a company. However, care will normally be taken to verify that:
Normally, licenses will obligate the company to pay or to reimburse the University for expenses associated with obtaining patents and to pay the University licensing fees and/or royalties on the sale of products. If the company and the University cannot reach agreement or the company does not wish to obtain a license, the University will be free to negotiate with other parties.
As spelled out in GW’s Policy on Patents and Scholarly Works and in the Copyright Policy http://my.gwu.edu/files/policies/PatentsandScholarlyWorksFINAL.pdf, GW applies a formula in distributing revenue from intellectual properties to which the University has a claim. In most cases, 50% of the net income after expenses associated with patenting, marketing, licensing, protecting, or administering the intellectual property goes to the inventor(s), 20% to the inventor's department, 10% to the inventor's school, and 20% to the office of the appropriate Associate Vice President for Research.
21.2.5. Indirect or Overhead
The University must recover full indirect costs (the approved federal rate for on-campus or off campus, whichever applies) for research funded by industry to develop products.
Any research conducted at the University is supported by a myriad of University resources, ranging from faculty and research laboratories and equipment to the administrative offices that process the paperwork required to undertake research. Federal cost accounting regulations require that all research programs, whether federally funded or not, be fully costed out and that the government not be charged more than other sponsors for research expenses. So-called "indirect" costs are a real cost of undertaking research activities. They must be treated as such by the University if its research missions are to be achieved without draining University resources. Viewed in the context of overhead rates in the business world, GW's indirect cost rate is very reasonable.
21.2.6. Conflict of Interest
University-industry agreements must be consistent with the University's Policy on Conflicts of Interest and Commitment. my.gwu.edu/files/policies/ConflictofInterestandcommitment.pdf.
The Policy on Conflicts of Interest makes clear that conflicts of interest can result when a faculty member has involvements outside the University that deprive the University of his or her time and effort (e.g., when consulting activities exceed the "one-day-a-week rule"); makes inappropriate use of University resources for non-University purposes such as making money for himself/herself or for an outside commercial interest; has a financial interest in a company sponsoring his or her own research; enters into agreements that interfere with the free publication of research findings; or deprives the University of revenue to which it is entitled (as when intellectual property that should be owned by the inventor and University is instead kept by the researcher alone or is given by the researcher to an outside individual or entity). Researchers have an obligation to understand and abide by the Conflicts of Interest policy in their relationships with business and industry.
Clinical Research involves awards from federal and commercial pharmaceutical sponsors to solicit patient participation in various research activities. This Section is reserved for guidance on Clinical Research and Medical Billing matters.
For a variety of legal and practical reasons, many additional complexities are involved in conducting sponsored research internationally. This is especially true for those Programs not funded by a federal sponsor, such as the National Institute of Health. U.S. Government sponsors will have their own rules and regulations that must be followed, which take into account the differences in conducting research outside the United States. Non-federal sponsors require additional attention and reviews. There are additional concerns of a practical nature arising from differences in cultures and business practices, difficulties in managing remotely due to geographic separation and challenges due to language barriers, local laws and customs, and payment arrangements due to currency differences and arrangements.
Following are some basic issues to consider in pursuing and performing sponsored research on an international level, whether at the prime or subcontract level.
It is University policy to comply with US Export Control laws . Export Control Laws are federal laws that control the conditions under which certain types of information, technologies, and commodities that can be communicated or transmitted to individuals, including US citizens, abroad (an “Export”) or made available to foreign nationals on US soil (a “Deemed Export”).
23.1. 1. Federal Export Regulations
The Department of State, through its International Traffic in Arms Regulation (ITAR), and the Department of Commerce, through its Export Administrative Regulations (EAR), have defined regulations governing export of certain technologies and information. If research or educational activities involve specified technologies, the ITAR and/or the EAR may require the researcher or educator to obtain prior federal approval (a “License”) before an Export or Deemed Export can occur. Failure to comply with such laws can result in severe consequences to the University and any individuals involved, including loss of research funding, very large fines and even imprisonment.
The researcher or educator must review descriptions of technologies that are controlled by ITAR, 22CFR Section 121.1, http://www.epic.org/crypto/export_controls/itar.html, and the EAR, 15 CFR Section 774, Supp.1 (categories 0-9), http://www.gpo.gov/bis/ in order to determine whether the technology involved in their particular program falls within one or more of these categories.
Export regulations apply regardless of whether the research is done under a sponsored program or whether it is funded by a non-federal or federal grant, contract or agreement.
23.1.1.1. Fundamental Research Exclusion: If either ITAR or EAR apply, an appropriate federal license is required prior to Export or Deemed Export, unless an appropriate exclusion applies. In the University setting, a common exclusion is the Fundamental Research Exclusion from licensing requirements for most research conducted at an accredited institution of higher learning located in the US. The Fundamental Research Exclusion includes basic or applied research in science or engineering where the results of the research are ordinarily shared with the scientific community, published in the public domain and made accessible and available to the public.
23.1.1.2. Limitations on Fundamental Research Exclusion: This exclusion is subject to some important limitations and will not apply if:
23.1.1.3. Educational Activities Exception: There is also a Public Domain/Publicly Available exception under the ITAR and EAR that allows Exports or Deemed Exports without a License and this applies generally to information and non-encrypted software that is already published through a variety of normal sources such as libraries, newspapers, books, etc.
23.1.2. Faculty and Researcher Obligations
If the export control laws apply and the Fundamental Research Exclusion is not available, then the faculty member or researcher must obtain the appropriate License under ITAR or EAR before the Export or Deemed Export can occur. This is a lengthy and complicated process. The University will assist researchers and educators in complying with export control laws, but the primary responsibility rests with the researcher or educator. For further information, please contact the Office of Health Research, Compliance, and Technology Transfer, http://www.gwumc.edu/research/, or consult the University’s Policy Limiting Distribution and Sharing of Information, Technology and Commodities Both Internationally and Domestically (“Export” Control), http://my.gwu.edu/files/policies/ExportControlFINAL.pdf.
23.1.3. Economic Sanctions
The United States also has in place economic sanctions that may affect GW's research activities. The sanctions are administered by the Office of Foreign Assets Control (OFAC) of the U.S. Department of Treasury. Absent a general or specific license from OFAC, the sanctions generally prohibit most imports and exports of goods, technology and technical data to end-users in sanctioned countries as well as the provision of services to entities or individuals in sanctioned countries. Please refer to the U.S. Department of Treasury website http://www.treas.gov/offices/enforcement/ofac/index.shtml for current information concerning these sanctions. Any GW faculty, researchers or other employees contemplating activities with sanctioned countries, or persons in them, must first contact the Office of the Vice President and General Counsel at (202) 994-6503 for a determination on appropriate action.
23.2. INTERNATIONAL CONTRACTS FOR SPONSORED PROGRAMS
23.2.1. International Contract Compliance, Section for Sponsored Research Handbook
In addition to laws on economic sanctions discussed above, various U.S. laws and other requirements apply to “international contracts,” i.e. contracts GW enters into with entities overseas, or with other U.S. entities, to implement activities [grants, research] overseas.
A full description of such laws, and specific contract provisions, is beyond the scope of this Handbook and are matters for discussion with the Office of the Chief Research Officer and/or the Office of the Vice President and General Counsel, which can assist with international contract drafting. Only designated University officials have the authority to sign contracts and agreements for GW.
Research faculty or staff who are contemplating entering into an international contracts should refer to the following GW policies and contact the appropriate RSC within the Office of the Chief Research Officer, before beginning any contract negotiations:
23.3. INTERNATIONAL SUBAWARDS ON SPONSORED PROGRAMS
23.3.1. Qualifying International Subawardees/Subrecipients
The University requires assurances of fiscal strength and integrity on the part of its domestic subawardees and it verifies proper standing to subaward on University programs by performing financial due diligence prior to awarding domestic subawards. This process is relatively straight forward as most domestic subrecipients are subject to OMB Circular A-133 audits or they can at least produce satisfactory financial statements suitable for this verification process. In the international arena, however, there is not necessarily comparability in these kinds of fiscal reports and reviews. Further, because of varying laws and regulations, as well as the difficulties inherent in trying to manage subrecipients at a distance, the problems can compound. A common problem on federally sponsored cost reimbursable programs is that just as the University prefers to receive advance payment from international sponsors, so, too, do international subrecipients. Federal cost reimbursable awards, however, do not permit such advance payments. The larger and more sophisticated subcontractors recognize this constraint. The smaller, less sophisticated sources may not.
The University requires that different types of business records be retained for specific periods of time. The University’s Interim Record Retention Policy is designed to address the University’s commitment to effective records retention to meet legal standards, protect privacy, improve the use of space, minimize the costs of record retention and provide for the proper destruction of outdated records, http://my.gwu.edu/files/policies/RecordRetentionINTERIM.pdf.
24.1. RECORDS RETENTION POLICY
The University is subject to numerous record retention requirements by Federal, State and District of Columbia regulations. The University also requires that financial and operational records be maintained and retained in a consistent and logical manner as provided in GW’s Interim Records Retention Policy. my.gwu.edu/files/policies/RecordRetentionINTERIM.pdf.
24.1.1. Changes to Record Retention Policy Requirements
Retention periods may increase by government regulation, judicial or administrative consent order, private or governmental contract, pending litigation or audit requirements. Such notifications or events may change the requirements listed in GW’s Interim Records Retention Policy. Any record that is the subject of litigation, or pertaining to a claim, audit, or agency charge, investigation or enforcement action should be kept until authorized notification of final resolution of the action.
24.1.2. Departmental Responsibilities
As provided in the Interim Records Retention Policy, Departments that maintain University records are responsible for establishing appropriate record retention management practices.
24.1.3. General Categories of Records Retention Requirements
GW’ Interim Records Retention Policy provides a number of general categories of record retention requirements. If there are inconsistencies in required retention periods, the longer period should be followed.
24.1.4. Detailed Records Retention Information
For more specific information on the general categories of record retention requirements, details on how to appropriately dispose of certain records and other general information, please refer to the Interim Records Retention Policy, http://my.gwu.edu/files/policies/RecordRetentionINTERIM.pdf.
Personnel costs represent the single largest category of expense charged to the federally sponsored awards. Accordingly, the government mandates that institutions receiving federal funds for sponsored programs maintain an effort certification process that complies with OMB Circular A-21 requirements. Personnel costs are posted to awards based on estimates of anticipated effort reflected in documents prepared in advance. These forms, Hire or Change in Status (CIS) Forms, are prepared based on anticipated levels of effort. As programs progress, monthly payroll reports are provided to Principal Investigator to assist with fiscal management. Principal Investigators should review these monthly payroll reports to be sure that those individuals who are working on the program (and only those individuals) are being charged to it. OMB Circular A-21 requires that universities maintain semi-annual post facto confirmations that the personnel costs are, in fact, reasonable estimates of the effort devoted.
By regulation, effort reporting is based on reasonable estimates of total percentage of effort, not by hours. Effort on an award is NOT based on a 40-hour work-week, but rather is the percentage of total GW-related effort devoted to a particular award whether a researcher works 30 hours a week or 80 hours. Individuals that spend a portion of their time doing research in addition to teaching and other administrative duties should re-verify that those percentage time estimates in the effort certification process are reasonable.
25.1.1. University Compensated Effort: In determining effort for Effort Certification purposes, only University compensated effort is considered. University compensated effort includes research, teaching, administration, clinical activity and any other activity for which an individual receives compensation of salary, wages, supplementary salaries and overloads (but not bonuses) from the University. Any effort for sources outside the University such as for consulting is excluded from total compensation for effort reporting purposes. D
25.2. EFFORT REPORTING PROCESS
At GW, Effort Reporting is done retroactively for the periods January to June and July to December for all Monthly and Bi-Weekly employees involved in sponsored research. CIS forms are submitted at any point in the research program when there is a substantial change in a person’s time and effort on a sponsored program, such as when a grant begins or ends, or when it is discovered that time is being charged in error. Principal Investigators should review labor reports every month to identify discrepancies between what an award is being charged for a person’s time and actual practice. CIS forms are submitted to correct significant changes. Twice a year, Effort Certifications are distributed for each School. These Certifications reflect the charges in the Banner Payroll system for anyone charging sponsored research programs. These effort certifications are organized by Principal Investigator (Oracle Award Manager) for monthly-pay employees who have had salary allocated to at least one sponsored program during the previous six-month reporting period. The Certifications are distributed to the individuals on sponsored programs. Each form requires two signatures. In cases where the employee is the Principal Investigator of the program, GW asks her or him to review and sign, not only her or his form, but also the signed form of anyone who is working under their direction, such as a research technician or lab assistant. Similarly, the Dean or Chair co-signs the Principal Investigator’s Effort Certification form. If the Principal Investigator is the Chair, then the Dean co-signs.
For more information on GW’s Effort Reporting and Certification process, see http://my.gwu.edu/files/policies/EffortCertificationFINAL.pdf