Chapter 3361:10-30 Research

3361:10-30-01 Research: export controls in sponsored research.

(A) Definitions as used herein.

(1) Export Control Regulations" means regulations promulgated under the authority of the International Trade in Arms Regulations, 22 C.F.R. 120-125, and the Export Administration Regulations, 15 C.F.R. 730-774.

(2) "Fundamental Research Exemption" means the exception to "Export Control Regulations" which is recognized for basic and applied research in science and engineering where the resulting information is ordinarily published and shared broadly within the scientific community, as distinguished from research the results of which are restricted for proprietary reasons or specific U.S. government access and dissemination controls. Research will not be considered "Fundamental Research" if:

(a) The university or its researchers accept other restrictions on publication or scientific and technical information resulting from the project or activity, or

(b) The research is funded by the U.S. government and specific access and dissemination controls protecting information resulting from the research are applicable.

(3) "Educational Exemption" means the exception to "Export Control Regulations" which applies to general scientific, mathematical or engineering principles commonly taught in for [credit courses at the university of Cincinnati or at other schools, colleges and universities.

(4) "Employment Exemption" means the exception to "Export Control Regulations" which applies to disclosures of unclassified technical data in the U.S. by the university of Cincinnati to foreign persons who are its bona fide and full time regular employees. This exception is available only if:

(a) The employee's permanent abode throughout the period of employment is in the United States

(b) The employee is not a national of a country to which exports are prohibited by law; and

(c) The university of Cincinnati has informed the individual in writing that the technical data may not be transferred to other foreign person without the prior written approval of appropriate governmental bodies.

(B) Policy.

(1) It is the policy of the university of Cincinnati that, absent extraordinary circumstances, teaching, research, and public service will be accomplished openly and without prohibitions or limitations on the publication and dissemination of scholarly work, including the results of sponsored research. "Export Control Regulations," however, may require the university to obtain permission from the specific government agencies before allowing foreign nationals access to certain controlled technologies. "Export control Regulations" have the potential to limit the research opportunities of foreign students or employees, and to prevent international collaboration in certain research areas. In addition, violations of "Export Control Regulations": can result in the loss of sponsored activity, monetary fines, or imprisonment.

(2) The office of sponsored programs shall perform an initial review of contracts for sponsored research and reach a determination as to whether a sponsored research project qualifies for the "Fundamental Research Exemption."

(3) In any case in which a contract does not qualify for the "Fundamental Research Exemption" due to publication restrictions, the office of sponsored programs shall refer the contract to the office of general counsel. The office of general counsel will attempt to negotiate such changes in the contract as may be required to cause the project to so qualify.

(4) If such efforts are unsuccessful, the office of general counsel will determine whether the activity qualifies for exemption under the "Educational Exemption," the "Employment Exemption," or other applicable exemption as may be provided for in applicable law.

(5) If it is determined by the office of general counsel that the sponsored activity does not qualify for any such exemption, the contract for such activity shall be approved only upon written request of the principal investigator approved by the vice president for research and upon certification by the office of general counsel that all required licenses have been obtained and that the activity otherwise may be conducted in compliance with "Export Control Regulations."

Replaces: 3361:10-30-01

Effective: 8/5/2005
Promulgated Under: 111.15
Statutory Authority: 3361
Rule Amplifies: 3361
Prior Effective Dates: 8/5/2005

3361:10-30-02 Research: publication restrictions in sponsored research.

(A) The university of Cincinnati is committed to maintaining a teaching and research environment that is open to the free exchange of ideas. The university will not approve agreements for the conduct of externally sponsored research which impose unreasonable limitations on the freedom to publish or to disseminate the results of sponsored research. As used herein, "Sponsored Research" includes any research activity which is designed to produce findings of the type which are commonly published in the scientific literature. "Sponsored Research" shall not include testing agreements, fee-for-service agreements, and similar projects which have been determined by the university as being unlikely to produce any publishable or patentable results.

(B) The university will not permit terms in agreements for the conduct of "Sponsored Research" which allow for sponsor editorial control over the publication of research results or conclusions; call for unreasonable delays in dissemination of research results; or which interfere with the evaluation of a student or fulfillment of degree requirements.

(C) Subject to the foregoing limitations, the university will accept reasonable limitations on the right to disseminate research findings in the following circumstances:

(1) Sponsor comment period.

Agreements covering "Sponsored Research" projects may provide for delay of publication, not exceeding ninety days, when requested to permit a sponsor to offer comments or suggestions, provided that such terms shall not include a requirement that the author is bound to accept such comments or suggestions.

(2) Reviews for proprietary information.

Agreements covering "Sponsored Research" which require access to and/or use of a sponsor's bona fide proprietary data or materials will be accepted only if terms regarding access, use, and protection of such data or materials do not unreasonably restrict the dissemination of scholarly findings made within the project.

(3) Delays for intellectual property protection.

Delays, not exceeding ninety days, are permitted to enable the university and/or sponsor to screen proposed publications for possibly patentable ideas and to commence necessary steps to assure appropriate legal protection for such patentable ideas.

(4) Multicenter clinical trials.

A delay for up to twelve months following the conclusion of a multi-center clinical trial is acceptable when necessary to permit a first publication from the trial to represent the work from all sites. Any term reflecting this delay must affirmatively provide for the ability of the faculty member to publish site-specific results if no multi-site publication has occurred within the twelve-month period, and for the right of the faculty member to petition the sponsor to provide information (e.g. randomization codes) which is reasonably necessary to permit a site-specific analysis and publication to occur.

(D) In any circumstance in which a publication restriction appears in a written agreement in violation of this rule, the appropriate office of sponsored programs in coordination with the office of general counsel and the principal investigator shall promptly confer with the sponsor in an effort to remove or modify such restriction. If such efforts are unsuccessful, such restriction or delay may be approved only upon written request of the principal investigator subject to approval by the vice president for research, who shall retain records of all such approvals.

Replaces: 3361:10-30-02

Effective: 8/5/2005
Promulgated Under: 111.15
Statutory Authority: 3361
Rule Amplifies: 3361
Prior Effective Dates: 8/5/2005

3361:10-30-03 Research: policy on sensitive but unclassified research.

(A) Applicability.

This policy applies to all sponsored research agreements involving university of Cincinnati employees, or which will be carried out on university of Cincinnati premises, or utilizing university of Cincinnati resources, and which, although not subject to federal security classification, have been identified by the sponsor or the university as involving information or materials which are sensitive or inappropriate for release to the public, or which are subject to DFARS 204.404 -70(a) ("Disclosure of Information") or equivalent contractual controls. The policy excludes the following:

(1) Technical services.

Activities involving technical measurement, analysis, observation, or evaluation in a controlled setting which have been approved by appropriate offices within the university and are not intended or expected to lead to publishable information.

(2) Personal consulting.

Personal consulting activities under the existing rules and regulations of the university which do not involve the use of university facilities or resources.

(B) Background.

The university of Cincinnati values the free dissemination of knowledge through education, publication, and other means. The performance of classified research for which dissemination of research methods or results is restricted to individuals with government security clearances is incompatible with the values and legal status of the university and is not permitted. The performance of governmentally funded research which, although not classified, includes requirements for equivalent publication controls, restrictions on participation based on national origin, or significant restrictions on free communication between and among faculty and students imposed for reasons of national security, law enforcement, or similar reasons is also in conflict with basic values of the university, and may jeopardize the status of the university under federal export control regulations and other regulations. Notwithstanding the foregoing, the university of Cincinnati recognizes that there may be instances in which the expertise of the university and its facilities may be required to meet the needs of the national government in cases of emergency and that such circumstances may justify a determination that the performance of sensitive but unclassified research is in the best interests of the university.

(C) Requirements for approval of sensitive but unclassified research:

(1) Agreements calling for the performance of sensitive but unclassified research projects require the approval of the vice president for research. Such approval should normally be obtained prior to the submission of a formal proposal to the potential sponsor. In all cases, however, approval is required before acceptance of the award by the university.

(2) Petitions for the conduct of sensitive but unclassified research will have a cover sheet containing the following information:

(a) Project title

(b) Names of principal investigator and co-investigators

(c) Address and phone number(s) of principal investigator

(d) The granting agency

(e) Proposed funding level

(f) Time period of the research

(g) The university of Cincinnati location of the research (h) Time deadlines (if any) for proposal submission

(3) In addition, the following factors should be addressed explicitly in the petition in the order shown:

(a) A summary of the proposed research expressed in nontechnical terms and suitable for public dissemination;

(b) A statement of the intellectual content of the proposed research; i.e., the extent to which it may lead to significant new knowledge in science, engineering, or other fields;

(c) The relationships between the proposed research and the openness of the academic environment; i.e., the extent and duration of special security arrangements; the extent to which portions of the campus will have restricted access; the extent to which students and faculty involved in the research will be allowed to discuss their results with students and faculty not involved in the research; and the restrictions that will be applied to publication of results;

(d) The effect of the proposed research on the resources of the university (funds, equipment, personnel, space, etc.), i.e., the extent to which the research project will contribute new resources that can be applied to non-classified work, and the extent to which the research project will require the dedication of resources that would otherwise be available for non-classified work;

(e) The extent to which students will be involved in the proposed research; and;

(f) The proposed time duration of the project.

(4) All petitions shall be reviewed and approved by the appropriate academic unit head prior to submission to the vice president for research.

(5) Projects receiving continuation funds do not require further review and approval unless there is a change in the scope of the required security arrangements.

(D) Additional conditions for the performance of approved classified or sensitive but unclassified research:

(1) Export controls.

Any contract for the performance of sensitive but unclassified research must be conducted in compliance with all federal export control laws.

(2) Patent rights.

The interests of the principal investigator and of the university in patentable discoveries, inventions, and improvements that are made during the performance of approved sensitive but unclassified research shall be subject to the university's patent policy.

(3) Human and animal studies.

Federal law and guidelines mandate that the usual committee reviews for human and animal studies, when included in sensitive but unclassified research, will not be modified in any way from those required for other types of research.

(4) Utilization of sensitive but unclassified research in faculty personnel decisions.

The university will continue to base decisions concerning faculty personnel matters on contributions to teaching, research, and service. Sensitive but unclassified research results which may not be published in the open literature will not be considered in faculty personnel decisions until and unless the research results are released for publication.

(5) Student theses/dissertations.

Students must be free to pursue knowledge in an open environment. Consequently, formal academic work by students (coursework, theses, dissertations, etc.) shall not include sensitive but unclassified research.

(6) Security costs.

All classified and sensitive but unclassified research projects will finance the unique security costs that are required with sponsor funds.

Replaces: 3361:10-30-03

Effective: 8/5/2005
Promulgated Under: 111.15
Statutory Authority: 3361
Rule Amplifies: 3361
Prior Effective Dates: 8/5/2005