Chapter 3339-15 Human Subjects for Research
It is the policy of the university to foster faculty research and creative activity, and to strongly support faculty members in their effort to establish and maintain programs of research and creative activity.
The university provides many forms of internal support for research and creative activities. Information about internal support for research and creative activities is provided by the office for the advancement of research and scholarship.
(A) Categories of external support
(1) The university encourages faculty, staff, and students to pursue external support in the form of contracts, grants, cooperative agreements and gifts. Contracts and grants are formal agreements requiring the university to carry out a set of specific tasks. A grant is somewhat less specific than a contract in that the specific project schedule is less detailed and final result less certain. A cooperative agreement requires that the university interact on a continuing basis throughout a project with an external agent. A gift is an allocation of funds from an external source that does not require the university to carry out a specific task. Gifts, which may be unrestricted or restricted, may carry a general designation for use, such as scholarships.
(2) Proposals seeking support in the form of a contract, grant or cooperative agreement, whether from a public or private funding source, must be cleared through the approval process which is managed by the office for the advancement of research and scholarship (oars). These proposals must be submitted to the office for the advancement of research and scholarship in sufficient time to permit appropriate internal review and also meet the submission deadlines of external funding agencies.
(3) All proposals submitted by Miami university must be signed by an oars staff member who is designated as an authorized university official. Plans to submit such proposals to a private funding source, such as a foundation or corporation, need to be discussed with the office for the advancement of research and scholarship well in advance of proposal deadlines so that the solicitation efforts may be coordinated with the office of development. Proposals or other plans for seeking support in the form of a gift must be cleared through the office of development.
(B) Conditions for university approval
(1) Miami university must approve a proposal before it is submitted to an external source if any of the following conditions exist:
(a) The project will involve Miami university students, either as research subjects or as project participants.
(b) Any facilities of the university are to be used.
(c) The university is expected to manage project funds.
(d) The university is expected to share some costs for the project by providing faculty and staff time or facilities.
(e) The name of the university will be associated publicly with the project in some way.
(f) The signature of the authorizing official of the university is required.
(2) Specifically included are the following:
(a) Research projects submitted by faculty, students, and staff for activities associated with the university.
(b) Instructional proposals, including those for equipment, academically based student support, workshops, computer and library acquisitions, or the development of curricular materials or other instructional devices.
(c) Public service projects including seminars, short courses, conferences, and special projects involving the university and its faculty, staff, and students with private businesses or nonprofit organizations.
(d) The acquisition of books, manuscripts, or objects of art, or the sponsorship of a musical, cultural, or artistic event.
(e) Applications for individual fellowship or study, unless the university is clearly not involved.
(f) Preliminary proposals where such proposals are required as part of the external source's procedures, where university approval is required, or where the preliminary proposal is likely to evolve into a final proposal with little change.
(3) Agreements that faculty and staff enter into on a private basis such as authorships for textbooks, journal publications, and research monographs for which the author may receive royalties or stipends are not considered to be sponsored programs of the university and do not require approval by the university in the manner described in this rule
(4) The university does require that consultantship agreements entered into on an individual basis be reported to and approved by the office of the provost annually as specified in "outside employment." rule 3339-3-11 of the Administrative Code.
(C) Activities to secure external support in the form of gifts
Plans to undertake fund raising for gifts should be submitted to the office of development for review, coordination and counsel.
Miami university requires investigators on proposals to all external agencies, public and private, to disclose to the university, via the associate provost for research, prior to submittal of the proposal, any significant financial interest (including those of spouse and dependent children) that would reasonably appear to be affected by the activities proposed for funding. Such a disclosure is facilitated by a question on the university's proposal approval form and, in the event of a possible conflict of interest, use of the university's financial disclosure form.
(B) Required disclosure
Investigators must disclose to Miami university all significant financial interests:
(1) That would reasonably appear to be affected by the research or educational activities funded or proposed for funding;
(2) In entities whose financial interest would reasonably appear to be affected by such activities.
A significant financial interest means anything of monetary value, including but not limited to salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interest); and intellectual property rights (e.g., patents, copyrights, and royalties). "Investigator" means the principal investigator, co principal investigator, and any other person at Miami university who is responsible for the design, conduct, or reporting of the research or educational activities funded or proposed for funding.
(C) Exempted from disclosure
Investigators need not disclose:
(1) Salary, royalties, or other remuneration from Miami university;
(2) Ownership interest in a business enterprise which is an applicant under phase one of the small business innovation research or small business technology transfer programs;
(3) Income from lectures or teaching engagements sponsored by public or nonprofit entities;
(4) Income from service on advisory committees or review panels for public or nonprofit entities;
(5) Financial interests in business enterprises or entities if the value of such interests does not exceed ten thousand dollars, and represent more than a five per cent ownership interest, for any one enterprise or entity when aggregated for the investigator and the investigator's spouse and dependent children.
Investigators are required to update these financial disclosures during the time in which the proposal is pending and during the period of an award, on an annual basis and as new reportable significant financial interests are obtained.
(D) Identification of actual or potential conflicts of interest
The associate provost for research will review each financial disclosure form that is submitted in the proposal approval process. In consultation with the office of the general counsel, the associate provost for research will make a determination of whether a conflict of interest exists that could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. Principal investigators may request review of this determination by the office of general counsel.
(E) Plan for addressing conflicts of interest
When an actual or potential conflict of interest has been determined to exist, the principal investigator(s) and the department chair will propose a plan for addressing and managing any conflict of interest, detailing what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate the conflict of interest. Examples of conditions or restrictions that may be imposed to manage, reduce, or eliminate conflicts of interest include, but are not limited to:
(1) Public disclosure of significant financial interests;
(2) Monitoring of project by independent reviewers;
(3) Modification of the project plan;
(4) Disqualification from participation in the portion of the funded project that would be affected by the significant financial interests;
(5) Divestiture of significant financial interests; or
(6) Severance of relationships that create actual or potential conflicts.
Such plans must be agreed to by the principal investigator, department chair, dean, associate provost for research, and provost prior to the beginning of the funded project, using the Miami university financial disclosure form.
If the associate provost for research, in consultation with the office of general counsel, determines that imposing conditions or restrictions would be either ineffective or inequitable, and that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the university may allow the project to go forward without imposing such conditions or restrictions.
(F) Enforcement policy
Violations of this financial disclosure policy will be handled by the university in accord with rule 3339-8-03 of the Administrative Code ("Procedures for Disciplinary Action") which provides for sanctions where appropriate.
(G) Notification of funding agency
Miami university will promptly notify the funding agency if it finds that it is unable to satisfactorily manage an actual or potential conflict of interest situation within a funded project.
In accord with federal regulations, Miami university will maintain records of all financial disclosures and of all actions taken to resolve actual or potential conflicts of interest until at least three years after the later of the termination or completion of the grant to which they relate, or the resolution of any civil, government, or university action involving those records.
(1) In the course of research, teaching, and service activities at Miami university, faculty, staff, and students sometimes create intellectual property which may be protectable by copyright, patent, or other means. Miami university seeks to establish an environment in which the creation of intellectual property is suitably recognized as an academic achievement and in which the benefits of intellectual property to the creators, the university, and the general public are optimized.
(2) It is important that the university and the creators of intellectual property assist each other in identifying, evaluating, and protecting this property. The following policy outlines the procedures for handling of intellectual property in ways which will be beneficial to the creators, the university and the public, and also describes the rights and responsibilities of the university and the creators of the intellectual property.
(1) The right of ownership by a faculty member, staff member, or student to his or her own writings, productions, art, videotapes, computer programs, or other works is recognized by the university. Thus, the individual generally is vested with the copyright privilege and receives all royalties which result.
(2) There are exceptions to this general rule, however, and the university will claim ownership:
(a) If called for in an external grant or contract, or specified in the terms of a gift, under which the copyrightable material was produced.
(b) If the faculty member, staff member, or student creates a copyrightable work in the course of performing an explicit university assignment or commission to create such a work.
(3) Situations also may arise in which faculty, staff, or students wish to include in copyrighted commercial products materials generated by Miami university support services. In such cases, in return for unrestricted outside use of the material, the university is entitled to seek reimbursement for development and production costs. The amount of possible reimbursement shall be reasonable and come from, and not exceed a portion of, royalties available to the faculty member, staff member or student.
(4) Miami university wishes to facilitate the use of computer-assisted teaching and on line classes in order to encourage creative and cutting-edge technology usage in the university's educational activities. To that end, the university acknowledges that faculty members that create computing tools and on-line classes shall be sole owner of the copyright to such classroom materials. The university shall not be able to use any such classroom materials without the consent of the faculty member. However, it shall be deemed a violation of rule 3339-3-11 of the Administrative Code for the faculty member to sell the classroom materials to any other institution of higher education while the faculty member is employed by Miami university unless the faculty member obtains the consent required by rule 3339-3-11 of the Administrative Code. In the event that the faculty member is no longer employed by the university, then the faculty member shall remove the classroom materials from Miami university's computer resources.
(5) However, ownership of computing tools and on-line classes is subject to the two exceptions to the general copyright rule set forth above. In addition, if the faculty member utilizes significant university resources in the creation of the classroom materials, then the copyright shall be jointly owned by the faculty member and Miami university and the following rules shall apply:
(a) Miami university cannot utilize the classroom materials in any class at Miami university while the faculty member is employed by Miami university without the faculty member's permission;
(b) in the event that the faculty member is no longer employed by Miami university, the faculty member and Miami university, without the other's permission, shall both be permitted a perpetual, royalty-free license to use the classroom materials for teaching and research purposes only;
(c) Miami university has exclusive authority to market and sell the classroom materials and their content to third parties, but Miami university shall provide fifty percent of all net proceeds (i.e., gross revenue minus costs of sale) received from the sale of the classroom materials to the faculty member. In the event that there is more than one faculty member then it shall be up to the faculty members to determine their individual portion of the fifty-percent share.
(6) For purposes of this rule, "significant university resources" shall be defined to mean that the classroom materials were developed with the use of any substantial Miami university-purchased hardware/software (excluding standard personal computing software/hardware), or if the classroom materials were developed during leave time granted by Miami university specifically for the development of the classroom materials, or if the classroom materials were developed with substantial assistance from Miami university's information technology personnel.
(7) This rule is not intended to apply to minor usage of computing technology in traditional classroom teaching (e.g., posting of a syllabus electronically would not transfer ownership to the university.)
(8) Application of this policy, including whether "significant university resources" have been utilized, shall be determined by the provost following discussions with the affected faculty member(s) and a sincere effort to find a mutually agreeable determination. The provost may, at his or her discretion, appoint a committee to review the matter and provide advice to him or her. Faculty members who dispute a determination of the provost shall have the right of appeal to the committee on faculty rights and responsibilities and the president.
(a) In accord with the section 3345.14 of the Revised Code, the university claims all rights to discoveries or inventions, including associated patents, resulting from research or investigation conducted in any facility of the university. The university also has the rights to patentable discoveries or inventions resulting from re-search or investigation financed in whole or in part by the university, or by an agent outside the university under a contract with or grant to the university.
(b) The Revised Code of the state of Ohio permits the board of trustees to retain, assign, license, transfer, sell, or otherwise dispose of rights to, interests in, and income from any such discoveries, inventions, or patents to any individual, firm, association, corporation, or governmental agency, or to any faculty member, employee, or student of the university.
(c) It is the intent of the university not to claim rights in an invention resulting from work not supported by the university or its sponsors or to which the university's contribution is negligible. Therefore, except as provided above, faculty, staff, and students of the university are entitled to apply for, hold, and dispose of patents to their own discoveries, inventions and developments free from any claim or interest of the university.
(2) Patent -application procedure - general
(a) When an inventor associated with the university believes an invention or discovery might be patentable, a written disclosure of the invention or discovery should be submitted to the associate provost for research. A standard invention disclosure form is available from the office for the advancement of research and scholarship. The written disclosure should bear the endorsement and comments of the department chair or unit supervisor, and divisional dean or vice president. It should include a statement of the circumstances under which the invention was made, and a statement as to its commercial possibilities.
(b) The associate provost for research shall have the responsibility to recommend to the provost and vice president for finance and business services whether the securing of a patent is in the interest of Miami university and in the public interest. In this evaluation, the associate provost for research generally will consult with the university attorney and individuals outside the university who are knowledgeable in the field of the invention. If the invention or discovery has arisen under the sponsorship of industry, the university's agreement with industry generally will include a granting of some rights regarding licensing of resulting patents, as well as a commitment by the sponsoring company to its funding of a patent application. Thus, the associate provost for research necessarily will consult with the sponsoring company in evaluating prospects for a patent in such instances.
(c) The university also may use the services of a patent evaluation and management firm, such as the research corporation, to assist in the evaluation of invention disclosures, in filing patent applications, and in marketing and managing subsequent patents, unless the terms of an agreement with a sponsor of the research dictate otherwise.
(3) Patent application procedures for projects funded by external agencies
(a) If the research results from a project sponsored by an outside agency through a grant or contract to the university, the provisions of the grant or contract will prevail. Where such provisions provide for retention of some or all patent rights with the university, the same procedures will be followed with respect to the retained patent rights as those provided for nonsponsored research. Disclosure of all such inventions within the university should follow the same procedures described above as the first step in complying with such patent terms in grants and contracts.
(b) In the development of agreements for research with corporations and other private groups, accommodations should be made to recognize both the proprietary rights of the corporation, and the obligation of the university to publish and disseminate research in oral and written form. Where appropriate, such publications may be delayed, but such delay should not be excessive. If a sponsor requires exclusive rights to or interest in a discovery made under a grant or contract, this request will need to be reported to and approved by the board of trustees.
(c) The Miami university proposal approval form will be used to secure university approval for patent agreements with outside funding agencies at the time of acceptance of a proposal. The office for the advancement of research and scholarship has the responsibility of coordinating the proposal approval process for the university, and facilitating discussions involving the investigator, the department or division, the associate provost for research, and representatives of the finance and business services division.
(d) Faculty, staff, and students may not independently enter into agreements concerning Miami university patent rights on inventions. Such agreements are appropriate only when the individual is acting as an independent consultant to a public or private agency or sponsor.
(4) University decision as to patenting
(a) If, after consultation, the associate provost for research determines that it is in the best interests of the university to file a patent application, he or she will recommend to the provost and the vice president for finance and business services that a patent application be filed. Depending upon the circumstances, the associate provost for research may recommend that the application be filed by the university itself, by the sponsoring company on behalf of the university, or by a patent management firm such as research corporation on behalf of the university.
(b) If, after consultation, the associate provost for research determines that it is not in the best interests of the university to file a patent application, he or she will make that recommendation to the provost and the vice president for finance and business services and also will inform the inventor of that recommendation. The inventor may then request the university to waive all or part of its rights in the invention to the inventor. The university shall respond to such a request within a reasonable time period, and, at its discretion, may waive all or part of its rights in the invention, i.e., assign title or grant an exclusive or partially exclusive license to the inventor. Grant of such a waiver by the university shall not be unreasonably denied. Any such assignment shall be subject to the sponsor's rights or approval. The university will retain rights and benefits which are in the best interests of the university; as a minimum, these retained rights will include an irrevocable, nonexclusive, paid-up license to practice the invention for the university's purposes.
(c) The associate provost for research through the provost and vice president for finance and business services will recommend that the board of trustees take appropriate action.
(5) Sharing of royalties
(a) Miami university's policy is to share royalties generated by patents with the faculty, staff, and student creators of inventions according to the following model. Royalty provisions of this policy apply to "net royalties" received by Miami university from the patent. Net royalties are defined as gross royalties, minus the cost incurred in obtaining the patent, the cost of utilizing a patent management firm, and any litigation expenses.
(b) The net royalties totaling up to one hundred thousand dollars first received will be divided equally between the university and the inventors; for the second one hundred thousand dollars a sixty per cent university, forty per cent inventor split will be utilized; for the third one hundred thousand dollars a seventy per cent university, thirty per cent inventor split; and for royalties in excess of three hundred thousand dollars, an eighty per cent university, twenty per cent inventor split will be utilized. If more than one inventor is involved, the university must receive in writing a statement signed by all inventors agreeing how the share of the royalties to be received by the inventors should be divided.
(c) Royalties accruing to the university under this patent policy will be used by the university to support faculty research and patent development.
(d) Acknowledgement: This policy is modeled after the intellectual property policy developed by the university of New Mexico, and borrows language from that policy with permission of the university of New Mexico.
All research conducted at Miami university must comply with federal regulations regulating the use of human subjects, laboratory animals, radiation, and recombinant DNA in research. The university has established the following committees to oversee activities and enforce regulations in these areas:
(A) Committee on the use of human subjects in research (see rule 3339-15-08for the Administrative Code)
(B) Institutional animal care and use committee
(C) Radiation safety committee
(D) Chemical safety committee
(E) Institutional biosafety committee
Information on the operation of these committees, and on procedures to be followed in proposing research involving the entities above, is available from the office for the advancement of research and scholarship.
Miami university is guided by ethical principles regarding all research involving humans as subjects. These principles have been set forth in the report of the national commission for the protection of human subjects of biomedical and behavioral research entitled "Ethical Principles and Guidelines for the Protection of Human Subjects in Research (The Belmont Report)." In addition, requirements set forth in the common federal policy for the protection of human subjects will be met for all research funded by the federal government.
To this end, the board of trustees has approved an "Assurance of Compliance" with federal regulations for the protection of human subjects. The institutional review board for human subjects research is designated as the institutional review board for Miami university. The office for the advancement of research and scholarship provides administrative support for their work.
To assure the protection of human subjects and to comply with federal law, Miami university requires that, prior to initiation, all research projects involving human subjects must be reviewed and approved, or certified as exempt, by the university institutional review board for human subjects research or a divisional or departmental committee to which the institutional review board for human subjects research has delegated review authority, if the research:
(A) Is sponsored by Miami university; or
(B) Is conducted by or under the direction of faculty, staff, or students of Miami university in connection with their institutional responsibilities; or
(C) Is conducted by or under the direction of faculty, staff, or students of Miami university using any property or facility of the university; or
(D) Involves the use of Miami university's nonpublic information to identify or contact human research subjects or prospective subjects.
This policy applies to graduate and undergraduate student research projects which are intended for dissemination beyond the classroom. Student projects designed to provide research training to students which are not intended for dissemination beyond the classroom are not covered by this policy.
The university institutional review board for human subjects research has developed "Guidelines for Research Involving Human Subjects." These guidelines are applicable to all research with human subjects. It is the responsibility of the faculty or staff member to be familiar with these rules, to see that they are followed by students and other coworkers, and to forward research projects either to the university institutional review board for human subjects research, or as otherwise provided.
Questions may be directed to the chair of the institutional review board for human subjects research, or to the office for the advancement of research and scholarship.
This policy statement is adapted from, and affirms, a statement on the subject prepared by the association of american universities, August 22, 1988.
Misconduct in university research undermines the research enterprise and is harmful to the university community, the research community generally, and the public. Institutions such as Miami university have the responsibility not only to promote a research environment that opposes such misconduct in research, but also to establish policies and procedures that deal effectively with allegations or evidence of misconduct. This policy statement deals primarily with the second imperative, and outlines Miami university's procedures for handling allegations of misconduct.
Miami university's process for reviewing allegations of misconduct in research involves three stages as specified by federal regulations: inquiry, investigation and resolution. The overall principles which guide the institutional review process are as follows:
(1) Universities have a responsibility to provide vigorous leadership in the pursuit and resolution of all charges of misconduct in research. Universities should take care, however, that the process pursued to resolve allegations of misconduct not damage research itself.
(2) Universities should treat all parties with justice and fairness, and be sensitive to the reputations and vulnerabilities of all parties. The process for resolving questions of research misconduct should focus on the substance of the issues; personal conflicts or affiliations between colleagues should not obscure the facts. The integrity of the process should be maintained by avoiding to the greatest extent possible any real or apparent conflict of interest.
(3) Procedures should be expeditious, well documented and should preserve the highest attainable degree of confidentiality compatible with an effective and efficient response to questions of research misconduct.
(4) Universities should recognize and discharge their responsibilities after resolving allegations of misconduct - internally, to all involved individuals, and externally, to the public, the sponsors of research, the research literature and the research committee.
This policy applies to all research conducted at Miami university, including that supported by or for which an application has been submitted to the public health service. It applies to all individuals at Miami university engaged in research, including faculty, trainees, technicians and other staff members, students, fellows, guest researchers, and collaborators.
The policy will normally be followed when an allegation of possible misconduct is received by an institutional official. Particular circumstances in an individual case may dictate variations from the normal procedure deemed in the best interests of Miami university and the sponsoring agency. Any change from normal procedures also must ensure fair treatment to the respondent in the inquiry or investigation. Any significant variation must be approved in advance by the provost.
(1) Research misconduct. Research misconduct means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
(2) Inquiry. Inquiry is the first stage of the review process. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, complainant, and key witnesses to determine whether there is sufficient evidence of possible misconduct in research to warrant an investigation. An inquiry is not a formal hearing; its purpose is instead to separate allegations deserving of further investigation from frivolous, unjustified, or clearly mistaken allegations. The purpose is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible.
(3) Investigation. Investigation is a stage of review that will be initiated only after an inquiry leads to a finding that further review is called for. The purpose is to explore the allegations more fully and determine whether there has indeed been research misconduct. The investigation may uncover information which justifies broadening the scope of the review beyond the initial allegation.
(4) Complainant. Complainant is the person making an allegation of research misconduct.
(5) Respondent. Respondent is the person accused of research misconduct.
The university will afford the affected individual(s) confidential treatment to the maximum extent possible permitted by law, and it will protect, to the maximum extent possible, the privacy of those who in good faith report apparent misconduct.
To ensure the safety and security of any written documents associated with an allegation of research misconduct, a single case file will be maintained by the dean of the graduate school.
Members of committees involved in any inquiry or investigation shall be informed of the confidential nature of the proceedings.
(E) Reporting allegations.
Allegations of research misconduct shall be reported to the dean of the graduate school. If the dean has a conflict of interest in the case, the allegation shall be pursued by another administrator designated by the provost.
The dean of the graduate school shall consult in confidence with any individual who comes forward with an allegation of research misconduct or with a question regarding possible misconduct. If the individual raising the question does not wish to make a formal allegation, but the dean believes there is sufficient cause to warrant an inquiry, the matter may, at the discretion of the dean, still be pursued. In such a case, there is no "complainant" for the purpose of this policy. Whether an allegation can be reviewed effectively without the involvement of the complainant depends upon the nature of the allegation and the evidence available. Cases which depend upon the observations or statements of the complainant may not be able to proceed without the open involvement of that individual. Other cases may be able to rely upon documentary evidence alone, permitting the complainant to remain anonymous.
(F) Inquiry procedures.
(1) The inquiry process may be handled with or without an inquiry committee, at the discretion of the dean of the graduate school. The committee, if one is used, shall be appointed by the dean and shall have three members. It is the responsibility of the dean to ensure to the best of his or her ability that the inquiry is conducted fairly and, if a committee is involved in the inquiry, that the committee members have no real or apparent conflicts of interest, are unbiased and have an appropriate background for assessing the issues being raised.
(2) Upon the initiation of an inquiry, the dean of the graduate school shall notify the respondent in writing within a reasonable period of time. The respondent shall be informed of the charges and the processes that will be followed, and shall be given copies of any written documents which support the allegations. The respondent shall be entitled to advice by legal counsel. If the dean decides to involve a committee in the inquiry, the members shall be appointed and convened. The dean and the committee members shall be empowered to receive and review relevant documents, interview involved faculty, students and staff, seek additional information as necessary, and, when necessary or appropriate, seek advice from experts outside of the institution.
(3) After determining that an allegation falls within the definition of misconduct in research, the dean of the graduate school must ensure that all original research records and materials relevant to the inquiry and investigation are immediately secured. If the case involves research supported by or for which an application has been submitted to the public health service, the dean of the graduate school may consult with the office of research integrity service for advice and assistance in this regard.
(4) Upon initiation of an inquiry, the respondent shall be invited to present a written response to the allegations. The respondent shall be expected to cooperate in providing the necessary materials to conduct an inquiry. Uncooperative behavior may result in immediate implementation of an investigation, as described below, or in disciplinary action.
(5) During the inquiry phase, the university shall respect any privacy guarantees previously given to research subjects.
(6) The inquiry phase shall normally be completed within sixty calendar days of notifying the respondent of the initiation of the inquiry. If the dean of the graduate school or the inquiry committee anticipates that the sixty calendar day deadline cannot be met, the reasons for the delay and the progress to date shall be outlined in a written document that will be part of the case file. The complainant and respondent shall receive copies of the progress report.
(7) The completion of an inquiry shall be marked by a written report which shall state the names and titles of the committee members and experts, if any; the allegations; the agency supporting the research, if any; a summary of inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether the investigation is warranted; and the committee's determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. The complainant and respondent shall be given copies of the draft report, and they shall have fourteen days to provide comments. Any comments that the complainant or respondent submits will become part of the final report and record. Based on the comments, the inquiry committee may revise the report as appropriate. If an investigation is to be pursued and the research is sponsored by an outside agency, the agency shall also be notified on or before the date the investigation begins. If the case involves research supported by or for which an application has been submitted to the public health service, this notice will be given to the office of research integrity.
(8) If, upon inquiry, an allegation is found to be unjustified, the involved parties shall be notified. The fact that an inquiry has taken place and the identity of the respondent shall remain confidential to the extent permitted by law, unless this right is explicitly waived by the respondent, and the case file shall be secured within the office of the dean of the graduate school. Such record will be kept for a period of six years after completion of the inquiry, and it will be provided to authorized personnel of the United States department of health and human services upon request if the case involved research supported by or for which an application has been submitted to the department of public health service. If, upon inquiry, an allegation is found to be unjustified, the university shall undertake diligent efforts, as appropriate, to restore the respondent's reputation.
(9) The university shall undertake diligent efforts to protect the position and reputation of the complainant. However, if an allegation is found to be unjustified and to have been maliciously motivated, disciplinary action against the complainant may be pursued.
(G) Investigation procedures.
(1) If the inquiry stage results in a finding that an investigation is warranted, the investigation shall begin within thirty days of the completion of the inquiry. The dean of the graduate school shall appoint a five-person investigative body. Members may be chosen from within or outside the university. It is the responsibility of the dean to ensure to the best of his or her ability that the investigation is conducted fairly, and that the individuals chosen to serve on the investigative committee have no real or apparent conflicts of interest, are unbiased, and have an appropriate background for assessing the issues being raised. The committee members shall be empowered to receive and review relevant documents, interview involved faculty, staff and students, seek additional information as necessary, and, when necessary or appropriate, seek advice from experts outside of the institution. The respondent shall have the right to test all evidence against him or her. The committee may hold a hearing for this purpose.
(2) The dean of the graduate school shall notify the complainant and respondent promptly in writing that an investigation has been initiated, and shall invite the respondent to submit a written response to the allegations. The respondent shall be entitled to advice by legal counsel. The respondent shall be expected to cooperate in providing the necessary materials to conduct the investigation. Uncooperative behavior may result in immediate disciplinary action.
(3) Upon the initiation of an investigation, the university may, if necessary, act to protect the health and safety of research subjects, patients, and students. The university shall also respect any privacy guarantees previously given to research subjects.
(4) The investigation phase shall normally be completed within one hundred twenty calendar days, with the initiation of the investigation being defined as the first meeting of the investigation committee. This period includes conducting the investigation; preparing the report of findings; making the draft report available to the respondent for comment (fourteen days); revising the report, if appropriate, in light of the comments from the respondent; submitting the report to the provost for approval; and submitting the report to any agency sponsoring the research project in question. If the dean of the graduate school or the investigative committee anticipates that the one hundred twenty calendar day deadline cannot be met, the reasons for the delay and the progress to date shall be outlined by the dean in a written document that will be part of the case file. The complainant, the respondent, and any agency sponsoring the research shall receive copies of the progress report. If the case involves research supported by or for which an application has been submitted to the public health service, the dean of the graduate school shall submit a request for an extension to the office of research integrity. The request shall include the reasons for the delay, an interim report on the progress to date, an outline of what remains to be done, and an estimated date of completion. The complainant and the respondent shall receive copies of the extension request.
(H) Resolution, disciplinary procedures, and appeal
(1) The completion of an investigation shall be marked by a written report from the investigative committee to the dean of the graduate school which indicates whether research misconduct within the meaning of this policy has or has not taken place. The complainant, respondent, and any agency sponsoring the research shall receive copies of the final report. If the respondent comments on the report, the comments may be made part of the final report and the record.
(2) If an allegation is, by means of the investigation phase, found to be unjustified, the involved parties shall be notified. The investigation and the identity of the respondent shall be held in strictest confidence to the extent permitted by law, unless this right is explicitly waived by the respondent, and the case file shall be secured within the office of the dean of the graduate school. Such record will be kept for a period of six years after completion of the investigation, and it will be provided to authorized personnel of the United States department of health and human services upon request if the case involved research supported by or for which an application has been submitted to the Public Health Service. If the allegation is found to be unjustified, the university shall undertake diligent efforts, as appropriate, to restore the respondent's reputation.
(3) The university shall undertake diligent efforts to protect the position and reputation of the complainant. However, if an allegation is found to be unjustified and to have been maliciously motivated, disciplinary action against the complainant may be pursued.
(4) If the investigation leads to a finding of research misconduct, the dean of the graduate school shall refer the matter for possible disciplinary action as described below.
(5) In the case of a finding of research misconduct, disciplinary action will be pursued in accordance with university policy. The following list of possible university sanctions is illustrative: removal from a particular research project; special monitoring of future work; letter of reprimand; suspension; salary reduction; rank reduction; and termination of employment. The university shall also have the discretion to take administrative actions such as informing other affected parties, including co-authors, co-investigators or collaborators in the research; editors of journals in which the research was published; sponsoring agencies and funding sources with which the individual has been affiliated; and professional societies with which the individual has been affiliated.
(6) In the case of a finding of research misconduct, the case file shall be secured within the office of the dean of the graduate school. Such record will be kept for a minimum of six years after completion of the case.
(I) Other considerations
(1) The following provisions apply in cases involving research supported by or for which an application has been submitted to the public health service.
(a) The university will take interim administrative actions, as appropriate, to protect federal funds and ensure that the purposes of the federal financial assistance are carried out.
(b) The university will notify the office of research integrity within twenty-four hours of obtaining evidence of criminal violations. In addition, the university will notify the office of research integrity if it ascertains as a result of an allegation of research misconduct that any of the following conditions exist:
(i) there is an immediate health hazard involved;
(ii) there is an immediate need to protect federal funds or equipment;
(iii) there is an immediate need to protect the interests of the complainant or the respondent as well as the respondent's co-investigators and associates;
(iv) there is a probability that the alleged incident is going to be reported publicly.
(c) If the university plans to terminate an inquiry or investigation for any reason without completing all requirements set forth in this policy, the dean of the graduate school will submit a report of the planned termination to the office of research integrity, including a description of the reasons for the proposed termination.
(d) The dean of the graduate school will promptly advise the office of research integrity during the course of an investigation of any developments that may affect current or potential funding for the respondent or that the department of health and human services needs to know to ensure appropriate use of federal funds and otherwise protect the public interest.
(e) After completion of the case, the dean of the graduate school will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to him or her or to the committees. The dean of the graduate school will keep the file for a minimum of six years after the completion of the case and furnish it to the director of the office research integrity, if the file is requested.
(f) In the case of a finding of research misconduct, the final report to the office of research integrity will include the policies and procedures under which the investigation was conducted, how and from whom information relevant to the investigation was obtained, the findings, and the basis for the findings. The report will include actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct, as well as a description of the administrative and disciplinary actions taken by the university.
It is the policy of the university to comply with U.S. export control laws. Export control laws restrict certain types of information, technologies, and commodities that can be transmitted overseas to individuals, including U.S. citizens, or made available to foreign nationals on U.S. soil. It is the responsibility of faculty, staff, and administrators to be aware of and comply with these laws and follow the university's written instructions and procedures.
The export of certain items, technologies, software, and services is regulated for reasons of national security, foreign policy, prevention of the spread of weapons of mass destruction, and for competitive trade reasons. Prior written authorization (a license) from one or more U.S. government agencies will be required to carry out certain sponsored research or other educational activities involving specified technologies or certain countries, if an exemption or exclusion is not available.
Export control laws restrict the shipment, transmission, or transfer of certain items, technologies, software, and services from the U.S. to foreign countries, as well as deemed exports, which are releases of controlled technology and software source code to foreign nationals located in the U.S.
Although many of the university's activities are exempt from export control laws, some activities may be restricted. Failure to comply with these laws exposes both the employee and the university to severe criminal and civil penalties (fines and prison sentences) as well as administrative sanctions (loss of research funding and export privileges). Criminal penalties for unlawful export and disclosure of information in violation of U.S. export control laws may include fines up to one million dollars and/or imprisonment up to twenty years. Civil penalties can be assessed up to two hundred fifty thousand dollars or two times the value of the transaction, whichever is greater, for each violation. The university and the individual(s) involved also may lose their ability to export in the future.
The U.S. department of state, through its international traffic in arms regulations (ITAR) of the directorate of defense trade controls (DDTC) and the department of commerce, through its export administration regulations (EAR) of the bureau of industry and security (BIS), regulates the export of certain technologies, information, and software. The U.S. export controls also apply to "re-exports" of items, software, and technology subject to U.S. law from one foreign country to another. In addition, the department of treasury, through its office of foreign assets control (OFAC), maintains targeted economic sanctions programs that restrict or prohibit a wide range" of export and other transactions which may include educational services involving designated countries, entities, and individuals.
Before engaging in activities that may involve an export, all faculty and staff must understand and identify any potential export limitations. A few examples of export control "triggers' include:
(A) where foreign nationals will participate in the research;
(B) where the university will partner with a foreign company;
(C) where the university hosts foreign visiting scholars for the purpose of research that involves certain specified technologies subject to export controls;
(D) where equipment needed for experiments or research abroad will be exported (i.e., shipped or accompanying the researcher/faculty member), including, for example, laptops, gps equipment, other hand-held mobile devices, etc., or any device that contains encrypted software.
While many university activities may be eligible for one of the EAR, ITAR, or OFAC exclusions, the university must document its analysis of export control issues, including the availability of any exclusion or exemption. The export control analysis should be undertaken with the assistance of the office for advancement of research (OARS). It is important to note that if a license will be required, this analysis must be done prior to engaging, or agreeing to engage, in the activity because the process for obtaining U.S. government approval is lengthy. In some cases, the university may decide not to accept funding for research containing export controls or restrictions, including, but not limited to, when there is insufficient time to obtain a license or to take appropriate measures to handle properly export-controlled information.
For detailed information about export control "triggers," activities that may present export-control issues, and these exclusions (e.g., fundamental research, educational information, published information and software, and the exclusion for fiilltime university employees) see the office for advancement of research (OARS) website.
If anyone employed by, acting on behalf of, or associated with the university receives information identified as "export controlled," the information may not be disclosed until the export control analysis has been completed to determine licensing requirements, if any, for such information. In addition, if an anticipated university research or educational activity involves a country subject to U.S. government sanctions, the faculty member or researcher will need also to consult with the director of technology transfer and business partnerships in oars before entering into any negotiations or agreements involving or before traveling to such countries.