27.1 PRINCIPLES FOR DETERMINING THE SUITABILITY OF RESEARCH DONE IN THE UNIVERSITY.
(President 7/20/84; amended 11/06; 3/10)
(2) "Proprietary" means something exclusively owned by an individual or organization (e.g., patent, trade secret, or copyrighted information) which cannot be used by or shared with other parties without approval by the owner.
b. Appropriateness of sponsored research. All research conducted in the University is expected to be consistent with one or more of the objectives of the University: the education of undergraduate, graduate, and postdoctoral students; the advancement of knowledge through research and scholarship; the preservation and dissemination of knowledge; and public service. The mere availability of funds for research is not a sufficient justification for a research project to be conducted in the University.
The terms of any grant or contract for research shall permit flexible operation under regular University policies and procedures, provide for reimbursement of the direct as well as facilities and administrative (indirect) costs, conform to the provisions of the University's Patent Policy (V-30) and Principles Governing Access to Research Information (II-27.2 below), and, in general, permit the University to exercise administrative control and responsibility for the work.
The Division of Sponsored Programs, a unit within the Office of the Vice President for Research, has the responsibility to approve all applications, budgets, budget revisions, and final research agreements. This process applies to all externally funded research, irrespective of funding source.
c. Dissemination of research results. To ensure that the University and the investigator are not subject to external control, results of the research must be able to be freely discussed in an appropriate forum (scholarly meeting or journal). However, exceptions may be granted for legitimate scholarly reasons. "Legitimate scholarly reasons" do not include efforts to suppress results simply because they are contrary to the business interests of the sponsor, but may include, for example:
(2) Long-term and collaborative projects in which premature release of preliminary results may be prejudicial to the outcome of the research may justify the delay of publication for a reasonable but not unlimited time. An example is a multi-site study for which a publication committee receives data from participating sites and makes decisions about joint publications. Such delays are not considered excessive if based on appropriate collaboration and consultation with members of the research team from other institutions.
(3) Publication review and approval may be performed by a multi-institutional academic research consortium for purposes of assuring proper scientific rigor and professional standards such as statistical analysis of data, inclusion of appropriate co-authors, and protection of individual research subject identifiers.
(2) a description of who will have authority over publication decisions and the justification for this authority,
(3) a statement of the provisions that will allow the investigator to publish within a defined period of time,
(4) measures to provide timely information to the medical community if suppressed information could affect the health and safety of research subjects or patients, and
(5) a listing of overlapping research activities (e.g., funded by other grants and/or contracts) that may be impacted by the proposed restrictions and how these restrictions might affect these other projects.
d. Industry-sponsored grant and contract agreements.
(2) Research agreements with industry for clinical research involving investigational drugs or medical devices should incorporate administrative provisions (indemnification) to ensure that there are safeguards to protect the University from medical costs, claims, and suits from the adverse effects of the study. Waiver of indemnification requires concurrence by the DEO, dean, and Vice President for Research.
When faculty and professional staff request that the University enter into fee-for-service contracts for the purpose of providing professional services to an outside sponsor, the contract shall be routed for approval by the department, college, and a designated institutional official (Office of the Vice President for Research or Business Manager). In reviewing such agreements, a determination will be made as to whether the work contributes to one or more of the University's nonprofit missions. Fee-for-service work may be subject to unrelated business income tax if it does not meet the nonprofit mission of the University.
The statement of work and final product of fee-for-service agreements may contain proprietary restrictions. However, information on the existence and nature of such agreements, including the name of the principal investigator, the project title, the amount and source of funding, and the project time period will be available through the Division of Sponsored Programs (DSP) database in accordance with II-27.3 below. Also, non-proprietary findings associated with the work performed must be freely communicable consistent with II-27.2 below.
f. Enforcement of these provisions.
(2) If the responsible parties referred to above, or any other member of the University community, should disagree about the appropriateness of a particular research proposal and/or its terms and conditions, they will detail in writing to the Vice President for Research their points of disagreement and explain the basis for their position in reference to the specific clauses of this policy.
(3) If disagreement about the appropriateness of a research proposal persists, the Vice President for Research will consult with the University Research Council and may also consult with other senior University administrators as he or she deems appropriate in reaching a decision.
Unless specifically excepted by the Vice President for Research in consultation with the University Research Council, the contents of a funded proposal and related research outcomes will be available for inspection in accordance with II-27.3 below.
b. Policy on secret research. "Secret research" is defined in this policy as research for which the nature, purpose, and non-proprietary results are not freely communicable. No faculty, staff, administrative officer, or student of The University of Iowa may utilize University facilities for the purpose of engaging in secret research. As used in this policy, "secret research" includes activities designated as "classified" by the federal government. Maintaining the confidentiality of proprietary information does not constitute secret research.
c. Restrictions on research participation, access, and dissemination. Research conducted by faculty, staff, and students of The University of Iowa is public domain "fundamental research" as that term is defined in National Security Decision Directive (NSDD) 189. When proposed University research involves information, technology, or other materials that are subject to applicable export control laws and regulations, thereby restricting dissemination of results and access to and participation in research activities by foreign nationals, acceptable language pertaining to the application of export control requirements must be negotiated with the sponsor prior to the University's acceptance of the award and conduct of the research.
(2) Compliance with federal select agent laws or regulations shall not be deemed to be in conflict with the University's prohibition on conducting secret research.
(3) The acceptance of confidentiality restrictions on proprietary information if non-proprietary research results may be freely published shall not affect the status of any University research project as public domain fundamental research.
e. Protection of faculty and staff rights. This policy statement should not be construed to restrict the activities of University personnel who provide private consulting or other professional services outside of their University responsibilities and, in doing so, do not use University resources or facilities.
b. Access to grant-related materials. The University has a commitment to create and disseminate knowledge. The University also has the responsibility to assist its research investigators and sponsors in the protection of their intellectual property. It is, therefore, the policy of the University to permit access by the public to the scholarly materials relating to funded grants and contracts in accordance with the Iowa Open Records Law while also recognizing the need to protect intellectual property rights. Should the requestor of the information conclude that any deletions are without foundation, this issue should be addressed to the Office of the General Counsel. In such instances the General Counsel may consult specialists in the specific field of inquiry, within or outside of the University, with the understanding that the specialists will keep confidential whatever is learned from examining the materials.
It is the general concern of the University that no research done under the jurisdiction of the University expose persons who participate as subjects or respondents to unreasonable risks to their health, general well-being, or privacy.
Specifically, the University is concerned that in all research and related activities involving the use of human subjects: 1) the rights and welfare of the individuals involved are adequately protected; 2) the participation of the subjects is based on freely given, legally effective informed consent; and 3) the risks to the subject are reasonable in relation to the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks.
Therefore, all research and related activities involving the use of human subjects must be submitted for prior review by the appropriate University Institutional Review Board (IRB) to ensure that the above conditions are met.
Primary responsibility for assuring that the rights and welfare of research subjects are protected continues to rest with principal investigators conducting the research. Others engaged in the conduct of the research share this responsibility. Teachers who assign or supervise research conducted by students have an obligation to consider carefully whether those students are qualified to adequately safeguard the rights and welfare of subjects.
The University has provided the federal government with a formal commitment to ethical and appropriate review and conduct of human subjects research in a document entitled "Federalwide Assurance of Protection for Human Subjects." The detailed University policy and procedures are described in a manual entitled "Investigator's Guide to Human Subjects Research." Both documents are available via the World Wide Web at http://research.uiowa.edu/hso or in hard copy from the Human Subjects Office.
27.5 ADMINISTRATIVE SURVEYS AND
(President 11/9/78; amended 8/99; 4/01; 6/01)
b. In addition to the institution's academic and public accountability, the University has an obligation to respect and safeguard the individual rights and freedoms of members of the community and of the larger society. Individual privacy is one such concern. Freedom of thought and expression are also important because they are inseparable from the freedom to teach and conduct research.
c. For these reasons there is a need for regular and consistent review of the written surveys and questionnaires undertaken by University administration. Many research questionnaires in the University will come within the purview of the Human Subjects Institutional Review Boards (IRBs) (see II-27.4). However, the jurisdiction of these committees extends only to the research context and the nature of review centers on the degree of the risk to human subjects and the presence of free and informed consent by the human subjects.
d. When questionnaires and surveys are undertaken by persons acting in an administrative capacity in the University, or under the auspices of the University administration, the approval of responsible administrative officers is to be secured. Within the colleges, administrative responsibility for approval lies with the dean of the college. Within the non-collegiate administration of the University, it lies with an Administrative Review Panel composed of the University-wide officers responsible for the offices of the Executive Vice President and Provost, Vice President for Research, Vice President for Strategic Communication, Senior Vice President for Finance and Operations, University Hospitals and Clinics, and the deans. The panel or the deans will seek policy advice from an advisory group on administrative surveys composed of the chairs of the two University committees on human subjects research and the Human Rights Committee.
For implementation guidelines, see www.uiowa.edu/hr/implement/html.
e. The purpose of this panel or dean's review is to consider the institution's need for information in order to be accountable and the concerns for individual privacy. In addition, this procedure provides a more comprehensive view of the many information gathering activities of the University and provides a means for systematic administrative review of such activities.
Effective August 2014, this policy has been rewritten. For the most current version without redlining, return to II-27.6.
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
When committed, research misconduct shatters individual careers, taints the conduct of objective research, undermines the credibility of scholarship, and destroys the confidence among scholars as well as between the University and the public.
All researchers -- faculty, staff, and students -- must be unfailingly honest in their work, must refrain from deliberate distortion or misrepresentation, and must take regular precautions against the common causes of error. Steps to minimize the possibility of research misconduct include the following:
(2) Consistent with II-27.10 University of Iowa Authorship Policy, only those who have had a genuine role in the research should be included in authorship of papers, and all named authors should accept responsibility for the quality and integrity of the work reported; and
(3) Researchers should retain research data and records for a period of at least five years following publication to provide verification of the validity of the reported results.
b. Scope. This policy and the associated procedures apply to:
(2) Any person engaged in the above who is employed by or has an official affiliation with The University of Iowa, including any faculty member, staff member, student, postdoctoral scholar, trainee, fellow, visiting scholar, adjunct faculty member, and guest or research collaborator working on campus with University resources.
(2) "Complainant" means a person who in good faith makes an allegation of research misconduct.
(3) "Good faith" is defined as a belief in the truth of an allegation such as might be held by a reasonable person in the same circumstances and based on the information known at the time. An allegation is not made in good faith if it is made with knowing or reckless disregard for information that would negate it.
(4) "Inquiry" means a preliminary review of an allegation to determine whether there is a reasonable basis for concluding that the definition of research misconduct is met and whether the allegation has sufficient substance to warrant an investigation.
(5) "Investigation" means the formal development of a factual record and examination of that record leading either to a recommended finding, based on the preponderance of the evidence, that research misconduct occurred or, based on that same standard, a recommended finding to the contrary.
(6) "Preponderance of the evidence" means proof by information that, after comparison with that opposing it, leads to the conclusion that the fact at issue is more likely to be true than not. The University has the burden of proving by a preponderance of the evidence that research misconduct has occurred. The burden then shifts to the respondent to prove, by a preponderance of the evidence, any affirmative defense.
(7) "Reporting Contact" means the branch of the federal funding agency sponsoring the research that is designated by federal regulation to receive information relating to research misconduct. For example, reports involving research funded by the U.S. Public Health Service are required to be sent to the PHS Office of Research Integrity; those involving the National Science Foundation are required to be sent to the NSF Office of Inspector General. "Reporting Contact" may also mean any other external sponsor of University research where reporting on research misconduct is required by contract.
(8) "Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research).
(9) "Research misconduct" means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
(b) "Falsification" is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
(c) "Plagiarism" is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
A finding of research misconduct must meet this definition; must involve a significant departure from accepted practices of the relevant research community; must be committed intentionally, knowingly, or recklessly; and must be proven by a preponderance of the evidence.
(10) "Research record" means the record of data or results that embody the facts resulting from scientific inquiry, including, but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to the University by a respondent in the course of a research misconduct proceeding.
(11) "Respondent" means the person against whom an allegation of research misconduct is directed.
(2) Reporting allegations to the University. All members of the University community should report suspected research misconduct to the VPRED or the RIO as soon as possible after it is believed to have occurred. Reports to the VPRED are immediately reported to the RIO and vice versa. The RIO then notifies the Provost of the allegation, as well as the Associate Dean for Research from the respondent's college.
(3) RIO conflict of interest. At each stage of the process, the RIO will carry out his or her responsibilities without any unresolved personal, professional, or financial conflicts of interest with the complainant, the respondent, or any witness. Within 10 days of receipt of the notice of inquiry, the respondent may object in writing to the RIO's involvement based on a conflict of interest on the part of the RIO. Within 5 days of receipt of the objection, the VPRED will determine whether to replace the RIO with a qualified substitute, who will carry out the RIO's responsibilities set forth in this policy.
(4) Confidentiality and fair treatment. To the extent allowed by law, the confidentiality of the complainant, the respondent, witnesses, and research subjects identifiable from research records or evidence will be protected and disclosure of their identity limited to those who need to know as part of their involvement with the research misconduct proceeding. Inquiries and investigations will be conducted in this manner unless to do so would compromise public health and safety or the effective completion of the inquiry or investigation. Any process prescribed under this policy will be conducted in a manner that ensures fair treatment of the respondent.
(5) Assessment of allegation. Upon receipt of an allegation of research misconduct, the RIO will promptly assess the allegation to determine whether an inquiry is warranted. An inquiry is warranted only when an allegation is sufficiently credible and specific enough to identify conduct that presents an issue of potential research misconduct and thus falls within the scope of this policy.
(6) Inquiry. When the allegation is assessed to warrant initiation of an inquiry, the RIO will perform the inquiry for the purpose described above in paragraph c(4). Upon opening an inquiry, the RIO will provide written notice of the alleged misconduct and initiation of the inquiry to the respondent (and, in the case of sponsored research, the Principal Investigator where he or she is not the respondent). At the same time, the RIO will sequester all relevant records and any other evidence needed to conduct the inquiry. The RIO may elect to interview the complainant, the respondent, and any additional witnesses with possible information related to the allegation at hand. Where the RIO lacks sufficient specialized expertise, the RIO may consult with qualified experts in order to determine whether an investigation of the alleged misconduct is warranted. Any additional respondents identified during the inquiry process must also be promptly notified of their status.
(7) Inquiry report and recommendation. The RIO will produce a written inquiry report including:
(b) a description of the allegations of research misconduct;
(c) the source of research support, including identifying any grant or contract and any publications listing such support;
(d) a summary of the inquiry process used;
(e) a list of the research records reviewed;
(f) the basis for recommending that the alleged actions either warrant or do not warrant an investigation; and
(g) the RIO's recommendation as to whether an investigation is warranted and whether any other actions should be taken in the event an investigation is not recommended.
(9) Inquiry timeline. The RIO will complete the inquiry and submit the written inquiry report and recommendation to the VRPED for final institutional action within 60 calendar days of initiating the inquiry, unless the VPRED determines that circumstances clearly warrant a longer period and approves an extension for good cause. In such cases, the inquiry record must include documentation of the reasons for the extension, and the respondent must be notified of the extension.
(10) VPRED decision and action on the inquiry report. The VPRED will review the inquiry report and either approve or reject the recommendation of the RIO, stating in writing the reasons for that decision. In the course of this review, the VPRED may also request additional information to assist in acting on the recommendation of the RIO.
(11) Notice to Reporting Contact. Where the VPRED approves a recommendation for an investigation in a case involving federal funding, the RIO will notify the Reporting Contact for the relevant federal funding agency on or before the start of the investigation and will provide a copy of the inquiry report and the VPRED's written decision to the Reporting Contact.
(12) Investigation. The investigation of a research misconduct allegation must be initiated within 30 calendar days of the VPRED's decision that an investigation is warranted. The RIO shall notify the respondent in writing of the VPRED decision prior to the start of the investigation. Before or at the time the notice is provided to the respondent, the RIO will also sequester any additional research records or evidence required to conduct the investigation not previously sequestered at the inquiry stage.
(13) Research Misconduct Committee Pool. The VPRED shall maintain a representative pool of scholars, selected from the tenured faculty, the emeritus faculty, or equivalent rank research scientists, research engineers, and research/clinical faculty. Pool membership shall be by nomination by each college's respective Associate Dean for Research; pool members shall serve three-year terms.
(14) Research Misconduct Committee. The VPRED shall appoint a Research Misconduct Committee (RMC) of seven scholars selected from the Research Misconduct Committee Pool, with no more than one member from any one college. Members of the RMC must have no actual or potential personal, professional, or financial conflict of interest with the complainant, the respondent, or any witnesses and should collectively possess an appropriate level of scientific expertise to competently evaluate the evidence of alleged research misconduct. The RIO attends meetings of the committee to assist the committee in its work.
(15) Notice to the respondent of committee composition. The RIO will notify the respondent of the RMC membership within 5 days. If the respondent submits a written objection to any member of the RMC, the RIO will determine whether a conflict or other circumstance exists such that a committee member's continued participation in the investigation would be improper or raise a perception of impropriety sufficient to require replacement of the challenged member with a qualified substitute from the RMC pool.
(16) Committee meetings. The RIO will convene the first meeting of the RMC to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality, for developing a specific investigation plan, and for ensuring a thorough and sufficiently documented investigation. The RMC will make and the University will maintain transcripts or recordings of any witness interviews.
(17) Use of consultants or content experts. Consultants or content experts may be used at the discretion of the RMC to provide information or specialized content knowledge, but should not be present during final committee deliberations and are not members of the committee.
(18) Investigation report. The RMC will prepare a written investigation report that:
(b) describes the source(s) of funding, if any;
(c) describes the policies and procedures under which the investigation was conducted;
(d) describes the research record and the evidence reviewed, as well as any evidence sequestered but not reviewed; and
(e) states the committee's recommended findings relative to each allegation and explains the basis for each finding. Where the committee recommends a finding of research misconduct, the report will include recommendations for appropriate institutional actions, including, for example, whether any publications should be corrected or retracted, and will list any current support or known applications for support that the respondent has pending with any federal research sponsor.
(20) Investigation timeline. An investigation by the RMC should be completed within 120 calendar days of initiation, with the initiation being defined as the first meeting of the RMC. This includes conducting the investigation, preparing the report of findings, making the draft report available for comment, submitting the report to the VPRED for final institutional action, and submitting the institution's final report to the Reporting Contact. If the RMC determines that it will not be able to complete the investigation in 120 days, the RIO will notify the VPRED and submit to the Reporting Contact a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the Reporting Contact grants the request the RIO will file periodic progress reports on behalf of the committee as requested by the Reporting Contact.
(21) Institutional decision and action on investigation report. The RMC submits the final written report of its recommended findings to the RIO, who meets with the VPRED to discuss the report. The VPRED makes the final institutional decision whether to accept, modify, or reject the committee report recommendations.
(b) If the VPRED's determination differs from the committee's recommendations, the VPRED will explain in the institution's letter transmitting the RMC report to the Reporting Contact the detailed basis for reaching a conclusion different from the RMC's recommendations. The VPRED's written explanation should be consistent with this policy and its definition of research misconduct and should be based on the evidence reviewed by the RMC to which the respondent has had an opportunity to respond.
If the findings of the investigation warrant personnel or other administrative actions, the VPRED will meet with the appropriate senior administrator who has oversight responsibility for the respondent's department/unit or the respondent's University classification (either the Executive Vice President and Provost or other vice president) and appropriate action will be initiated in accord with University policy as follows:
(d) Professional and scientific staff. Disciplinary actions resulting from investigations of misconduct are taken by the vice president responsible for the unit employing the respondent staff member.
Appeals from administrative actions involving professional and scientific personnel are governed by III-28.4. The procedure contained therein contemplates that a Hearing Officer will be used, with the final decision being made by a Reviewing Officer appointed by the President.
(e) Merit staff. Disciplinary action resulting from investigations of misconduct involving merit staff personnel are taken in accordance with the collective bargaining agreement.
(f) Graduate assistants. Disciplinary procedures, including dismissal of graduate assistants, is covered by III-12.4.
(g) Others. Disciplinary action related to other categories of individuals within the University, not covered in paragraphs (c) through (f) above, including postdoctoral trainees, professional students, and undergraduates, will be undertaken by the Executive Vice President and Provost or the vice president responsible for such individuals, as applicable.
(22) Notice to Reporting Contact of completion of investigation. Once the institution has accepted the investigation report and determined any administrative action(s) to be taken in response to it, the RIO is responsible for complying with any notice requirements of federal agencies funding the research. The University will comply with any actions required by the funding agency, including the obligation to make restitution for the funding, if applicable.
The responsible vice president or Executive Vice President and Provost, as applicable, oversees any audits and corrective action that may be required as a result of the findings of the investigation.
(23) Finding of no research misconduct. If no investigation is warranted following an inquiry, or if the alleged misconduct is not substantiated by the finding of an investigation and the Reporting Contact concurs in that conclusion, the RIO will consult with the respondent and undertake all reasonable, practical, and appropriate efforts to restore the respondent's reputation. Depending on the particular circumstances, the RIO should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the respondent's personnel file. Any institutional actions to restore the respondent's reputation must first be approved by the VPRED.
(24) Retaliation; reputation of complainant and others. Regardless of whether the institution or the Reporting Contact determines that research misconduct occurred, the RIO will undertake all reasonable and practical efforts during the inquiry and/or investigation stages to protect complainants who make allegations of research misconduct in good faith, witnesses, and committee members. Those who make allegations with knowing or reckless disregard for their truth will be subject to discipline under applicable University policies.
Upon completion of an investigation, the VPRED will consult with the complainant and determine what steps, if any, are needed to restore the position and reputation of the complainant. The same process will also be followed to protect or restore the position and reputation of any witness or committee member, if needed. The RIO is responsible for implementing any steps the VPRED approves.
(25) Circumstances requiring immediate reporting. The RIO will notify the Reporting Contact at any stage of the inquiry or investigation if:
(b) there is an immediate need to protect sponsoring agency funds, interests, or equipment;
(c) research activities should be suspended;
(d) there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is/are the subject of the allegations, as well as his or her co-investigators and associates, if any;
(e) it is probable that the alleged incident is going to be reported publicly, so that the agency may take appropriate steps to safeguard evidence and protect the rights of those involved;
(f) the research community or public should be informed (e.g., where the allegation involves a public health-sensitive issue such as a clinical trial); or
(g) there is a reasonable indication of possible violation of civil or criminal law. In this instance, the institution must inform the Reporting Contact within 24 hours of obtaining that information.
If the University of Iowa plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the applicable federal agency regulations (other than closing an inquiry because no investigation is warranted or a finding of no misconduct from a completed investigation), the RIO will submit a report of the planned termination to the Reporting Contact, including a description of the reasons for the proposed termination.
The RIO will report to the Reporting Contact as required by regulation and keep the Reporting Contact apprised of any developments during the course of the inquiry or investigation that may affect current or potential funding for the individual(s) under investigation or that the federal agency needs to know to ensure appropriate use of funds and otherwise protect the public interest.
The University will provide full and continuing cooperation with any federal funding agency during its oversight review of any alleged research misconduct or any subsequent administrative hearings or appeals resulting from agency oversight review.
(27) Records. All records pertaining to an allegation of research misconduct shall be kept in accordance with the record-keeping requirements of the federal funding agency.
a. Prevention of research fraud. Academic research fraud entails more than mere error; it generally involves falsification or fabrication of data, plagiarism, or grossly negligent data collection or analysis.
(2) It is recognized that a deterrent to research fraud is the possibility that such fraud will be detected soon after presentation. Findings of significance will be questioned and reexamined, and the likelihood that falsified, fabricated, or plagiarized research will go unquestioned is slim. Despite the self-correcting nature of research, however, instances of fraud have occurred. It is necessary, then, that research fraud be detected and reported, and it is, therefore, the obligation of faculty, staff, and students to report instances of fraudulent research to appropriate University officials.
(3) Such abuse of research freedom must receive an appropriate response, as it is hardly possible to exaggerate the damage that can result from such a breach of the academic commitment to truth. Academic fraud not only shatters individual careers, but taints the entire cause of objective research, undermines the credibility of scholarship, and destroys the confidence between scholar and scholar as well as between the University and the public.
(4) Therefore, researchers, whether faculty members, staff members, or students, have the responsibility to be unfailingly honest in research; they must refrain from deliberate distortion or misrepresentation; and they must take regular precautions against the common causes of error. Positive steps to insure an environment that minimizes the possibility of research fraud include the following:
(b) Only those authors who have had a genuine role in the research should be included in authorship of papers, and all named authors must accept responsibility for the quality of the work reported; and
(c) Researchers are encouraged to retain research data and records for a period of at least five years following publication to provide verification of the validity of the reported results.
(2) Definition. Research misconduct or misconduct in research means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
(3) The University community is educated to report research misconduct or possible misconduct as soon as possible after it is identified to the office of the appropriate vice president (or Executive Vice President and Provost) or a central Research Integrity Officer (RIO).
(4) Reporting allegations of misconduct. Reports to either the vice president (or Executive Vice President and Provost) or the RIO are immediately reported to each other. In cases involving externally funded research, the RIO will report allegations and/or the results of subsequent inquiries and investigations to the research sponsor and/or its designee (Reporting Contact) in accordance with sponsoring agency regulations or the terms and conditions of any contract where the funding source is a private entity. For example, cases involving Public Health Service Funding will be reported to the Office of Research Integrity.
(5) The RIO is appointed by the Vice President for Research. A liaison is appointed in the office of each vice president or Executive Vice President and Provost.
(6) The RIO performs an initial inquiry and must notify the accused and the Principal Investigator (PI) immediately upon initiation of the inquiry. The notification will include the nature of the alleged misconduct and the fact that an inquiry has been initiated. The RIO reports findings to the appropriate vice president (or Executive Vice President and Provost). This initial inquiry must be completed within 60 calendar days from receipt of the allegation.
(7) Conflicts. The RIO shall not have real or apparent conflicts of interest in the case, and shall be unbiased, possessing the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. Where the RIO is not in possession of such expertise, he or she will solicit and obtain necessary and appropriate expertise in order to conduct a thorough evaluation of the evidence and witnesses during the course of the inquiry. Within ten days after receiving notification of the initiation of the inquiry, the accused may submit written objection to the RIO presiding over the inquiry based on bias or conflict of interest of the RIO. The Vice President for Research (VPR) shall within five days determine whether to replace the RIO with a qualified substitute.
(8) Confidentiality. The University of Iowa will protect the privacy of those who report misconduct in good faith to the maximum extent possible.
(9) Opportunity for comment:
(b) Within 14 calendar days of their receipt of the draft report, the accused and whistleblower (where applicable) will provide their comments regarding the draft report to the RIO. Any comments that the whistleblower or accused submits on the draft report will become part of the final inquiry report and record. Based on the comments, the RIO may revise the report as appropriate.
(11) The RIO will prepare a written inquiry report and recommendation for review by the VPR, which shall include the name of the RIO and any experts on whom the RIO relied; the allegations; the source of research support; a summary of the 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 an investigation is warranted or not; and the RIO's determination, as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. The VPR shall either approve or reject the recommendation of the RIO, stating in writing the reasons for the VPR's decision. The VPR may also request additional information to assist in acting on the recommendation of the RIO. The General Counsel will review the report for legal sufficiency as necessary.
(12) Where the VPR approves the recommendation of the RIO for an investigation, such investigation must be initiated within 30 calendar days after completing the initial inquiry. The RIO immediately notifies the Reporting Contact (if outside the University) that an investigation is proceeding.
(13) The RIO also convenes the Research Misconduct Committee, composed of representatives from each college and augmented by consultants and content experts as necessary. The Vice President for Research appoints the committee members.
(14) The Research Integrity Officer will notify the accused of the committee membership within 5 days. If the accused submits a written objection to any appointed member of the investigation committee or expert, the RIO will determine whether a conflict, bias, or other circumstance exists such that a committee member's continued participation on the committee in the particular situation would be improper or raise the perception of impropriety sufficient to replace the challenged member or expert with a qualified substitute.
(15) An investigation should ordinarily be completed within 120 calendar days of initiation, with the initiation being defined as the first meeting of the Research Misconduct Committee. This includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Deciding Official (VPR) for approval, and submitting the report to the Reporting Contact. If the committee determines that it will not be able to complete the investigation in 120 days, the RIO will notify the VPR and submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the Reporting Contact or research sponsor grants the request, the RIO will file periodic progress reports on behalf of the Committee and as requested by the Reporting Contact.
(16) Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the accused in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.
(17) The Research Integrity Officer will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan.
(18) The Research Misconduct Committee will provide the accused with a copy of the draft investigation report for comment and rebuttal. The accused will be allowed fourteen (14) days to review and comment on the draft report. The accused's comments will be attached to the final report. The findings of the final report should take into account the accused's comments in addition to all other evidence.
(19) To the extent it deems it necessary, the Research Misconduct Committee will provide the whistleblower, if he or she is identifiable, with those portions of the draft investigation report that address the whistleblower's role and opinions in the investigation. The report should be modified, as appropriate, based on the whistleblower's comments.
(20) The final report submitted to the Reporting Contact must describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. The report will include the 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 any sanctions imposed and administrative actions taken by the institution.
(21) The committee submits a written report of its findings to the RIO, who, with the chair of the committee, meets with the appropriate vice president (or Executive Vice President and Provost) to discuss the findings.
(22) If the findings of the investigation warrant further personnel actions, the vice president (or Executive Vice President and Provost) shall initiate such actions when appropriate, in accordance with University policy:
(b) Professional and scientific staff. Disciplinary actions resulting from investigations of misconduct are taken by the vice president or Executive Vice President and Provost responsible for the unit employing the accused staff member.
Appeals from such an administrative action are governed by III-28.4 of the University Operations Manual. The procedure contained therein contemplates that a Hearing Officer will be used, with the final decision being made by a Reviewing Officer appointed by the President.
(c) Merit staff. Disciplinary action resulting from investigations of misconduct are taken in accordance with the collective bargaining agreement.
(d) Graduate assistants. Disciplinary procedures, including dismissal of graduate assistants, is covered by III-12.4.
(e) Others. Disciplinary action related to other categories of individuals within the University, not covered in paragraphs (a) through (d) above, including postdoctoral trainees, professional students and undergraduates, will be undertaken by the Executive Vice President and Provost or the appropriate vice president responsible for such individuals.
(b) All pending abstracts and papers emanating from the fraudulent research shall be withdrawn, and editors of journals in which previous abstracts and papers appeared notified in sufficient detail, in such form, and through such channels as to inform the relevant academic and public communities and establish a correct public record.
(25) If after the inquiry and/or investigation the Research Misconduct Committee finds no misconduct and the Reporting Contact concurs, after consulting with the accused, the Research Integrity Officer will undertake all reasonable efforts to restore the accused's reputation. Depending on the particular circumstances, the Research Integrity Officer should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the accused's personnel file. Any institutional actions to restore the accused's reputation must first be approved by the Deciding Official.
(26) The Research Integrity Officer will take appropriate steps during the inquiry and investigation to prevent any retaliation against the whistleblower. Regardless of whether the institution or the Reporting Contact determines that research misconduct occurred, the Research Integrity Officer will undertake all reasonable efforts to protect whistleblowers who made allegations of research misconduct in good faith and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Deciding Official will determine, after consulting with the whistleblower, what steps, if any, are needed to restore the position or reputation of the whistleblower. The Research Integrity Officer is responsible for implementing any steps the Deciding Official approves. Prompt and appropriate disciplinary action will be taken against any parties involved in leveling ungrounded charges.
(27) The Research Integrity Officer will notify the Reporting Contact at any stage of the inquiry or investigation if:
(b) there is an immediate need to protect sponsoring agency funds or equipment;
(c) there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as his or her coinvestigators and associates, if any;
(d) it is probable that the alleged incident is going to be reported publicly;
(e) the allegation involves a public health sensitive issue, e.g., a clinical trial; or
(f) there is a reasonable indication of a possible criminal violation. In this instance, the institution must inform the Reporting Contact within 24 hours of obtaining that information.
(29) If The University of Iowa plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the sponsor's regulation, the Research Integrity Officer will submit a report of the planned termination to the Reporting Contact, including a description of the reasons for the proposed termination.
(30) The RIO will report to the Reporting Contact as required by regulation and keep the Reporting Contact apprised of any developments during the course of the inquiry or investigation that may affect current or potential funding for the individual(s) under investigation or that the sponsor needs to know to ensure appropriate use of funds and otherwise protect the public interest.
(31) All records pertaining to an allegation of research misconduct shall be kept in accordance with the record-keeping requirements of the sponsoring agency and shall be physically located in the office of the RIO.
27.7 CORPORATE- AND INDUSTRY-SPONSORED PROJECTS.
(10/99; 1/08; 1/09; 3/10; 10/10; 5/12; 3/13; 4/13)
Corporate or industry contracts generally involve a quid pro quo, i.e., something is given and something is received. These agreements must be entered into in the name of The University of Iowa and not in the name of the department or principal investigator. Neither The University of Iowa Foundation nor other external entity is permitted to accept payment for activities related to corporate- and industry-sponsored research projects conducted within the University.
b. Is a corporate-sponsored project subject to unrelated business income tax (UBIT) or is it tax exempt? The conduct of scientific research is an exempt activity and should not generate UBIT. The Internal Revenue Service (IRS) has determined that some activities carried on incident to commercial or industrial operations are not research. The University, therefore, may be required to demonstrate that the project is substantially related to its mission by establishing that:
(2) The project is conducted in the public interest, e.g., seeks a cure or treatment for disease, provides treatment opportunity not otherwise available to patients, tests for public safety, etc. The results will be made available to the public; or,
(3) The project furthers an educational purpose. Students or trainees involved in the project will have specific tasks and duties. Investigators are free to publish findings in a timely manner.
c. Establishing the account. The following documents are required for the assignment of a Master File Key (MFK) to establish an account:
(2) Investigators must exercise diligence to only charge expenses against the project that are reasonable, allowable, and allocable. All revenues and expenses will be accounted for in the University accounting system.
When applicable, UBIT will be assessed on the residual balance. The tax rate is based on the prevailing federal, state, and local corporate income tax rate for taxable income (currently 34percent federal, 8 percent state, and 0 percent local). Grant Accounting will retain in a project account all federal and state income taxes assessed on the project's net balance.
After full F&A costs (1) and UBIT are assessed, the remaining balance will be transferred to an Organized Activity (fund 240) account. The account will be administered by the department with expenditures directed by the principal investigator who originally obtained the funds. The expenditure of funds will be to support research of the principal investigator who originally obtained the funds as long as the investigator is a regular faculty or staff member of the University. If the investigator leaves the University, the expenditure of the funds will be determined by the departmental executive officer to support departmental programs.
If, after audit, the project is not exempt from UBIT or it is determined that certain expenditures charged to the project were done so in error, the department will be responsible for any errors as well as additional tax, interest, and associated penalties due to the taxing authority (e.g., IRS, State Department of Revenue and Finance).
In cases where the principal investigator transfers to another institution or organization prior to completing the study, contract document permitting, The University of Iowa will appoint another investigator to fulfill the responsibilities of the project(s), or, if the University deems it appropriate, it may retain the former employee as principal investigator. When so directed by sponsor, or at the discretion of the University, the University may transfer the final account balance to the new institution or organization subject to the restrictions placed on the funds by the grantor. No money will be paid to an individual investigator.
In cases where the principal investigator leaves The University of Iowa after the project has been closed out, funds remaining will be transferred to the DEO of the investigator's department for discretionary use in research at The University of Iowa.
f. This policy is effective on all projects with an effective or start date on or after July 1, 1999.
27.8 ANTI-RETALIATION POLICY FOR REPORTING OF MISCONDUCT IN RESEARCH.
These guidelines apply to all instances of possible retaliation against whistleblowers who make allegations of research misconduct covered by the University of Iowa Policy on Ethics in Research (II-27.6).
(2) "Allegation" means any disclosure, whether by written or oral statement, or any other communication, to a University, a governmental or other sponsoring agency official who receives the allegation while acting in their official capacity, that the University or member thereof has engaged in research misconduct.
(3) "Deciding official" means the official designated by the President of the University to make a final University determination as to whether retaliation occurred.
(4) "Good faith allegation" means an allegation of research misconduct made with a belief in the truth of the allegation which a reasonable person in the whistleblower's position could hold based upon the facts. An allegation is not in good faith if made with reckless disregard for or willful ignorance of facts that would disprove the allegation.
(5) "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 or creative innovations that are nonetheless ethical, legal and meet professional standards.
(6) "Responsible official" means the official designated by and reporting to the President of the University to establish and implement the University's anti-retaliation policy for reporting of misconduct in research.
(7) "Retaliation" means any adverse action or credible threat of an adverse action taken by the University, or member thereof, in response to a whistleblower's good faith allegation of research misconduct. It does not include the University's decision to investigate a good faith allegation of research misconduct.
(8) "University" means The University of Iowa.
(9) "University member, or member" means a person who is employed by, affiliated with under a contract or agreement, or under the control of the University. University members include but are not limited to faculty, students, administrators, teaching and support staff, researchers, clinicians, technicians, and fellows.
(10) "Whistleblower" means an individual who makes a good faith allegation of research misconduct or demonstrates an intent to make a good faith allegation (or what is perceived to be an allegation) while a member of the University at which the alleged research misconduct occurred.
(b) The Responsible Official shall be free of any real or apparent conflicts of interest in any particular case.
(c) If involvement of the Responsible Official in a particular case creates a real or apparent conflict of interest with the University's obligation to protect good faith whistleblowers, and the conflict cannot be satisfactorily resolved for that case, the Vice President for Research shall appoint a substitute Responsible Official who has no conflict of interest.
(3) Filing complaints.
(b) The retaliation complaint must include a description of the whistleblower's research misconduct allegation and the asserted adverse action, or threat thereof, against the whistleblower, by the University or its members in response to the allegation. If the retaliation complaint is incomplete, the Responsible Official shall describe to the whistleblower what additional information is needed in order to meet the minimum requirements of a complaint under this II-27.8c(3).
(b) The whistleblower may raise any concerns about the proposed process with the Responsible Official and the University may modify the process in response to the whistleblower's concerns.
(c) The whistleblower has five (5) working days from the date of receipt of the initial notification in II-27.8c(4)(a) to:
(ii) not accept the proposed process. If the whistleblower rejects the proposed process, he or she may pursue other remedies as provided by law.
(b) Based on the available evidence, the Responsible Official shall make a determination of whether to provide interim protections and shall advise the whistleblower of his or her decision in writing. Documentation underlying the decision whether to provide interim protections shall become part of the record of the complaint. When the whistleblower retaliation complaint is fully resolved, any temporary measure taken to protect the whistleblower shall be discontinued or replaced with permanent remedies.
(b) The process should be completed within 180 days of the date the complaint is filed, unless the whistleblower agrees to an extension of time. The University shall promptly report the final outcome of either process or any settlement to the sponsoring agency.
(c) If the whistleblower declines the University's proposed process according to these guidelines, he or she may pursue any other legal rights available to the whistleblower for resolution of the retaliation complaint. However, sponsors, including the federal government, may deem the University to have met its obligation under federal regulations and may not pursue the whistleblower complaint further.
(b) An investigation of whistleblower retaliation shall be timely, objective, thorough, and competent. The investigation should be conducted by a panel of at least three (3) individuals appointed by the Responsible Official. The members of the investigation panel, who may be from outside the University, shall have no personal or professional relationship or other conflict of interest with the whistleblower or the alleged individual retaliator(s), and shall be qualified to conduct a thorough and competent investigation.
(c) The investigation shall include the collection and examination of all relevant evidence, including interviews with the whistleblower, the alleged retaliator(s), and any other individual who can provide relevant and material information regarding the claimed retaliation.
(d) The University shall fully cooperate with the investigation and use all available administrative means to secure testimony, documents, and other materials relevant to the investigation.
(e) The confidentiality of all participants in the investigation shall be maintained to the maximum extent possible throughout the investigation.
(f) To encourage and protect whistleblowers, it is University policy that no reference to good-faith reporting of University-related misconduct shall be made in personnel files, letters of recommendation, performance appraisals, or any other permanent evaluative documents without the concurrence of the whistleblower.
(g) The panel members shall evaluate and respond objectively to any concerns raised by the whistleblower about the process, including concerns regarding the selection of the Deciding Official, Responsible Official, and specific panel members, which are raised prior to resolution of the complaint.
(h) The conclusions of the investigation shall be documented in a written report and made available to the whistleblower. The report shall include findings of fact, a list of witnesses interviewed, an analysis of the evidence, and a detailed description of the investigative process.
(i) The Vice President for Research shall be the Deciding Official. The Deciding Official shall make a final University determination as to whether retaliation occurred. This decision shall be based on the report, the record of the investigation, and a preponderance of evidence standard. Appeals may be made to the University President and subsequently to the Board of Regents via the usual appeals process.
(j) If there is a determination that retaliation has occurred, the Deciding Official shall determine what remedies are appropriate to satisfy the University's obligation to protect whistleblowers. The Deciding Official shall, in consultation with the whistleblower, take measures to protect or restore the whistleblower's position and reputation, including making any public or private statements, as appropriate. In addition, the Deciding Official may provide protection against further retaliation by monitoring or disciplining the retaliator.
(k) The University shall promptly notify the sponsoring agency of its conclusions and remedies, if any, and forward the underlying investigation report to the sponsor.
(l) The University recognizes that the sponsoring agency may, at its own discretion, review the University report to determine whether the University has substantially followed the process described herein.
(m) University compliance with this process does not bar the whistleblower from seeking redress against the University's decision under state law, University procedure, rules of the Board of Regents, policy, or agreement, or as otherwise provided.
b. All research and instruction performed by University of Iowa faculty, staff, and students involving the use of live vertebrate animals must be submitted for prior review and approval to the Institutional Animal Care and Use Committee (IACUC) to ensure that the above conditions are met. This requirement applies irrespective of the funding source or location on or off campus of the research or instruction. In the absence of an IACUC-approved, valid Animal Care and Use Review Form, an investigator may not perform procedures with live vertebrate animals or acquire animal data under the project in question.
c. The Office of Animal Resources is responsible for the procurement and husbandry of all live vertebrate animals at The University of Iowa.
d. It is the responsibility of the principal investigator to assure that all individuals involved in the use of animals in research and instruction be appropriately trained in the procedures to be used in their approved activities. All individuals named in research protocols involving the use of live vertebrate animals must also have completed the University of Iowa training requirement prior to performing animal procedures.
(2) Adherence to this policy is specifically intended to eliminate authorship assignment rooted in power inequities, inappropriate practices, and perceptions of conflict of interest in the presentation of scholarly findings.
(3) Participants are expected to engage early in the publication development process in open and clear communication about the assignment of authorship roles with their potential publishing colleagues. Written agreements specifying the details of authorship and contributions may be warranted in many cases but are good practice in all cases.
(2) Colleges and departments are encouraged to develop additional "best practices" guidelines regarding authorship for their faculty, staff, and students that address discipline-specific issues.
(3) The term "publication" as used in this policy is meant generically, representing as inclusively as possible any manner of report, paper, manuscript, article, book, chapter, treatise, or other publishable product whether printed or digital in format.
(a) Significant intellectual contribution to a project through conception and design, or data collection and analysis, or interpretation; and
(b) Ability to identify their own contribution, and ideally the contributions of each participating author, and defend the major aspects of the project presented in the publication, although not necessarily all the technical details.
In addition, it is expected that each author has been given the opportunity to participate in the drafting of the manuscript (or substantive revision of its scholarly content) and approves the final version of the manuscript to be published.
(2) Provision of logistical, financial, or administrative support alone does not constitute a valid basis for authorship. Recognition of these types of contribution is appropriate for an acknowledgements section of a publication.
(b) Participating author. Each author of a publication, regardless of relative seniority or level of contribution, is responsible for providing confirmation of authorship in accordance with this policy's criteria and the requirements of the selected publication venue. Confirmation of authorship includes verifying review and approval of the final manuscript to be published. Each author is responsible for the content of those portions of the manuscript ascribed to them, including the integrity of any applicable research. An individual offered authorship of a publication for which they do not satisfy the criteria for authorship as set forth in this policy should decline authorship in accordance with this policy and University policies regarding responsibilities to scholarship (see III-15.3). All reasonable attempts will be made to seek confirmation in accordance with this policy from individuals who meet authorship criteria but have left the institution (e.g., students who have graduated) or are no longer in contact with the lead or other participating authors.
(b) All authors, in their manuscripts submitted for review and publication, must disclose the source(s) of support (financial and/or tangible resources) for the work unless otherwise instructed by the journal or publication. Examples of support include but are not limited to 1) research and educational grants, 2) contracts, 3) corporate sponsorships, 4) gifts, and 5) institutional sources (departmental, collegiate, central administration, or hospital). Authors shall fully disclose all relevant financial interests that could be viewed as a potential conflict of interest in accordance with University policies (see II-18).
(c) Since it is possible that readers may infer endorsement of the data and conclusions from an acknowledgement, those acknowledged should give written permission and a disclaimer shall be included specifically indicating that inclusion in the acknowledgements does not imply endorsement by those named.
(2) Acceptance or ascription of an honorary authorship. Honorary (guest, courtesy, or prestige) authorship is granting authorship out of appreciation or respect for an individual, or in the belief that the expert standing of the honored person will increase the likelihood of publication, credibility, or status of the work.
(3) Acceptance or ascription of a gift authorship. Gift authorship is credit, offered from a sense of obligation, tribute, or dependence, within the context of an anticipated benefit, to an individual who has not appropriately contributed to the work.
(4) Acceptance or ascription of a ghost authorship. Ghost authorship is the failure to identify as an author someone who made substantial contributions to the research or writing of a manuscript thus meriting authorship or allowing significant editorial control of a publication by an unnamed party, which may constitute a real or perceived conflict of interest that should be disclosed.