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Ethics in Research
Academics and Research – Research
EWU Policy 302-05 Authority: EWU Board of Trustees
Effective January 20, 2011 Proponent: Office of Academic Affairs
Purpose: This policy prescribes ethical standards for conducting research by employees and students of Eastern Washington University. The purpose of this policy is to comply with and support federal and state laws related to research.
History: This policy supersedes UGS Policy 435-020 et seq. It was adopted by the EWU Board of Trustees (BOT) on January 20, 2011.
Applicability: This policy applies to all faculty, staff, and students of Eastern Washington University and to any persons engaged in research activities conducted under the auspices of the University.
CHAPTER 1 – GENERAL
The creation and dissemination of knowledge are primary missions of the university. Accordingly, the university encourages participation in research, scholarship and service activities which contribute to the university’s educational, research, and community service mission. In all of these activities, the University endeavors to maintain the highest standards of integrity and ethics.
Faculty, students and staff who direct or participate in research and scholarship must do so with integrity and strict adherence to the ethical standards of this policy and related laws and regulations.
- Chapter 42.52 RCW, Ethics in Public Service
- EWU Policy 901-01, Ethical Standards
- UGS Policy 590-060-040, Compensation Policy forAdditional or Outside Employment
- 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding Is Sought
- 42 CFR Part 93, Public Health Service Policies on Research Misconduct
- 45 CFR Part 94, Responsible Prospective Contractors
- UGS Policy 590-020-140, Appropriate Use of University Facilities, Equipment and Information
- UGS Policy 435-040-130, Use of University Facilities to Produce Salable Materials
- UGS Policy 435-060 et seq., Animal Research
- UGS Policy 435-080 et seq., Human Research
1-4. Reporting Violations
Any suspected violations of this policy or of any related federal or state law or regulation should be reported to the Provost, the college Dean, the Office or Grant and Research Development (OGRD), the University President, or to other university leaders.
1-5. Reprisal or Retaliation
It is a violation of this policy for any person to engage in reprisal or retaliation against an individual because that individual has, in good faith, filed a complaint, testified, assisted, or participated in any process under this policy, or has attempted to do so.
To protect the privacy of those involved, all information will be maintained in a confidential manner. During any process within this policy, information will be disseminated on a need-to-know basis. Files subject to public disclosure will be released only to the extent required by law.
Any person who violates this policy shall be subject to disciplinary action and/or be subject to sanctions imposed by the Executive Ethics Board of the State of Washington. In addition, any substantiated violation of this policy may result in a suspension of the affected project or activity.
1-8. Priority to Teaching & Instruction
Scholarly activity that contributes, directly or indirectly, to the quality of teaching will receive the highest priority in allocating resources. Consequently, research, scholarship and service should neither exclude teaching (excepting during professional leaves and for faculty whose primary responsibilities are in research or scholarship) nor diminish the effectiveness of the instructional program.
1-9. Use of University Resources
Research, scholarship and/or service activities arranged through the OGRD are official activities of the university. As such, university resources may be used by investigators to support those projects.
Faculty members may use word processors, office supplies, secretarial services and other departmental resources, without charge, to assist in the preparation of professional articles, papers, reviews, etc., if such work is primarily for non-compensated, scholarly purposes.
In the case of textbooks, laboratory manuals or other publications produced primarily for compensation, see UGS Policy 435-040-130.
The use of university resources, including facilities, computers, telephones, and other equipment, for the purpose of conducting outside work is strictly prohibited. See UGS Policy 590-020-140, Appropriate Use of University Facilities, Equipment and Information.
CHAPTER 2 – FINANCIAL CONFLICTS OF INTEREST
The intent of this chapter is to promote objectivity in research and other sponsored project activities by prescribing standards to protect the design, conduct, and reporting of externally funded projects from potential bias posed by conflicts of interest. It includes standards for identifying and managing conflicts of interest in compliance with federal regulations and state laws.
2-2. Office of Grant & Research Development (OGRD)
The Office of Grant and Research Development is the primary point of contact for all matters related to this chapter. OGRD will:
- inform each investigator of this policy, the investigator’s reporting responsibilities, and of the provisions of Part 94, Title 45 CFR;
- report any conflicting interest to the sponsor prior to expending any funds;
- report any interest identified as conflicting subsequent to the initial report within 60 days of identification; and,
- promptly notify the sponsor if an Investigator has biased the research and of the corrective action taken or to be taken.
2-3. Contract Disclosures – Externally Funded Projects
Within each proposal submitted for funding from external sources, OGRD will certify that:
- EWU has a written and enforced process to identify and manage, reduce or eliminate conflicting interests;
- prior to expending any funds under the award, EWU will report to the awarding agency, if required, the existence of any conflicting interest and assure that the interest has been managed, reduced or eliminated; and, for any interest that the Institution identifies as conflicting subsequent to the initial report, a report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days;
- EWU agrees to make information available, upon request, to the awarding agency regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated to protect the research from bias; and,
- EWU will otherwise comply with 42 CFR 90.
2-4. Disclosure Requirements
Before a proposal related to this policy is submitted to a funding agency, each investigator must report to the OGRD all known significant financial interests (and those of his/her immediate family):
- that would reasonably appear to be affected by the research, educational, or service activities funded or proposed for funding; and,
- in entities whose financial interests would reasonably appear to be affected by such activities.
Similarly, an investigator must immediately report any new or increased financial interest (and those of his/her immediate family) that have been acquired during the course of a project.
If research is carried out through the use of subcontractors or collaborators, EWU will take reasonable steps to ensure that investigators working for such entities comply with this section, either by requiring those investigators to comply with this chapter or by requiring the entities to provide assurances that will enable EWU to comply with 42 CFR 90.
2-5. Determining Conflicts of Interest
The Provost has ultimate responsibility for reviewing significant financial interest disclosures, determining whether actual or potential conflict of interest exists, and for determining what actions should be taken by the University to manage any conflict of interest.
2-6. Managing Conflicts of Interest
When the Provost determines that the financial interests of an investigator might reasonably appear to be directly and significantly affected by the project, the Provost will take steps to either manage or to eliminate the conflict of interest in accordance with a conflict of interest resolution plan as described at Appendix C.
The University may impose conditions or restrictions to reduce or eliminate actual or potential conflicts of interest. Conditions or restrictions may include, but are not limited to, items identified in Appendix C relating to the Conflict of Interest Resolution Plan. Investigators will be held accountable for compliance with any conditions and restrictions imposed by the University.
If the University finds that it is unable to satisfactorily manage an actual or potential conflict of interest, the University’s Director of Grant and Research Development shall inform the sponsor.
For National Science Foundation (NSF) funded projects only: If a determination is made 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 or welfare, the Provost may allow the NSF- supported research, educational, or service activities to go forward without imposing such conditions or restrictions when permitted by applicable regulations.
2-7. Withdrawal for Noncompliance
The University shall withdraw applications for funding in cases where the investigator, after the process of appeal, chooses to not comply with the resolution plan adopted in accordance with the policy and procedures if the project cannot otherwise be completed without the services of that investigator.
The Office of Grant and Research Development shall maintain all records related to this policy. To protect the privacy of those involved, all information gathered under this policy will be maintained in a confidential manner and disseminated only as required by law or as is necessary for internal operations. In the event a proposal is not funded, any related confidential information shall, at the direction of the investigator, either be destroyed or returned to the investigator unopened. Records for funded projects will be maintained for six years after the project concludes.
CHAPTER 3 – RESPONSIBLE CONDUCT OF RESEARCH TRAINING FOR NSF FUNDED PROJECTS
3-1. Institutional Responsibilities
The National Science Foundation requires that institutions applying for NSF funding maintain a plan for training researchers in the Responsible Conduct of Research. In response to those requirements, EWU will:
- maintain a plan (Appendix B) to provide appropriate training and oversight in the responsible and ethical conduct of research to principal investigators and undergraduates, graduate students, and post doctoral researchers who will be supported by NSF to conduct research;
- include, with each grant proposal submitted to the NSF, an institutional certification that a plan is in place;
- identify the persons responsible for overseeing compliance with the RCR training requirement and verify that the appropriate training was provided; and,
- verify that undergraduates, graduate students, and post doctoral researchers supported by NSF to conduct research have received training in the responsible and ethical conduct of research.
CHAPTER 4 – MISCONDUCT IN RESEARCH
The university assumes responsibility for resolving allegations and investigating misconduct in research and scholarship by its faculty, staff and students. The dean of a college or the Provost and Vice President for Academic Affairs (hereinafter referred to as the Provost) may receive allegations of misconduct in research and scholarship. College deans shall inform the Provost of all allegations of misconduct they receive. The Provost is responsible for directing inquiries and investigations of alleged misconduct in research and scholarship, and in meeting all reporting requirements established by federal and non-federal agencies.
Misconduct in research and scholarship is defined as:
- The fabrication or falsification of data, plagiarism or other serious deviations from ethical principles in proposing, implementing or reporting research or scholarship; or
- Failure to comply with federal, state or university requirements for
- protecting researchers, human subjects and the public during research and/or
- ensuring the welfare of animals used in research; or
- Failure to fully credit student research assistants or other scholars who have made significant contributions to a faculty member’s published or unpublished work; or
- Falsely crediting authors who have made no contribution to the idea, execution, analysis or reporting of the results or interpretations of scholarship or research; or
- Use of research funds, facilities or staff for unauthorized or illegal activities; or
- Adverse distortion of normal academic programs or the direction of students to expressly benefit scholarship or research, particularly those activities involving contracts or collaborations.
In this subtopic, the word activity, used as a generic term, refers to research, scholarship, service and education activities of many kinds that are conducted as enterprises separately from contracted teaching responsibilities.
4-3. Other Methods for Review of Misconduct
The procedures of this policy do not exclude other mechanisms for the review of alleged misconduct.
When allegations involve the misuse of funds, the university’s internal auditor or outside auditors may investigate allegations and report the findings to the proper authorities.
When alleged illegal activities occur, the university president retains the power to direct investigations, take interim measures to preserve property or resources, and request reports on alleged misconduct.
Where university resources are insufficient to resolve the issue of alleged misconduct, the Provost may ascribe the conduct of the investigation to the agency that provided funding for the research or scholarship.
Where an investigation of misconduct under this policy may duplicate other official inquiries, the Provost may elect not to conduct an investigation under this policy when no federal funds are involved.
Where federal funds are involved, if a termination of an inquiry or investigation is planned for any reason without completing all relevant requirements under this policy, a report of such planned termination, including a description of the reasons for such termination, shall be made to the Office of Research Integrity, US Department of Health and Human Services, which will then decide whether further investigation should be undertaken.
4-4. Reporting Allegations to Federal Agencies
When federal funds are involved, the Provost will notify the federal agency immediately of any allegation of scientific misconduct, provided there is an immediate health hazard, an immediate need to protect individuals, funds, or equipment, the likelihood of criminal violation, or the imminent public disclosure of allegations.
4-5. University Inquiries into Allegations of Misconduct in Research and Scholarship
The Provost or his/her designee(s) shall carry out a formal inquiry to determine whether the evidence warrants an official investigation into the allegations of misconduct in research and scholarship. When federal funds are involved, the Provost will inform the Director of Grant and Research Development of the inquiry, who will take appropriate interim action to protect the federal funds and insure that the purposes of the federal financial assistance are carried out. The following guidelines shall be followed in making an inquiry:
The affected individual(s) will be informed about the nature and proposed extent of the inquiry and afforded confidential treatment to the maximum extent possible and an opportunity to comment on the allegations and findings of the inquiry;
The Provost or his/her designee(s) will chair and convene a review committee composed of three or more faculty members. When possible, at least two faculty members will be familiar with the questioned research or scholarship and have the necessary and appropriate expertise to carry out a thorough and authoritative evaluation of the relevant evidence. At least one faculty member will have an academic appointment outside the college of the affected individual(s). Members of the review committee will be carefully selected and must ensure that they have no real or apparent conflicts of interest with those persons involved in the inquiry;
An inquiry will entail information gathering and initial fact finding to determine whether an allegation or apparent instance of misconduct warrants an investigation. Inquiries will be initiated immediately upon the receipt of allegations of misconduct and completed within 60 calendar days of their initiation. This time frame may be extended if the Provost deems that circumstances of the allegations or inquiry warrant a longer period of review;
A written report will be prepared by the review committee that states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions of the inquiry. Affected individuals are entitled to rebut allegations and to provide supporting evidence to be included in the report. If the inquiry takes longer than 60 days to complete, the inquiry report shall include documentation of the reasons for exceeding the 60-day period;
The individual(s) against whom the allegation was made shall be given a copy of the report of inquiry and may comment on the allegations and findings. If written comments are received within 15 days of the individual(s)’ receipt of the report, they will be made part of the record of inquiry;
If it is determined that an investigation is not warranted, records will be maintained in sufficient detail to permit subsequent assessment of that determination. Such records will be kept in a secure manner for a period of six years after the termination of the inquiry and shall, where appropriate, be provided to authorized personnel;
If the formal inquiry concludes that the allegations of misconduct cannot be substantiated, the university, under the direction of the Provost, will undertake diligent efforts to restore the reputations of the persons alleged to have engaged in misconduct;
If the formal inquiry concludes that the allegations of misconduct are substantiated, the Provost will initiate an official investigation. He/she will notify the relevant federal agency prior to an investigation and within 30 days following the completion of an inquiry if federal funds are involved. If there is indication of criminal violations, the Provost will notify the relevant federal agency within 24 hours of obtaining appropriate evidence.
4-6 University Investigations into Allegations of Misconduct in Research and Scholarship
The Provost or his/her designee(s) shall carry out an official investigation into the allegations of misconduct in research and scholarship when warranted by the evidence and process of investigation. When federal funds are involved, the Provost will inform the Director of Grants and Research Development of the inquiry, who will take appropriate action to protect the federal funds and insure that the purposes of the federal financial assistance are carried out. Investigations will begin within 30 days of the completion of the inquiry. The following guidelines shall be followed in making an official investigation.
The affected individual(s) will be informed about the nature and proposed extent of the investigation and afforded confidential treatment to the maximum extent possible, a prompt and thorough investigation, and an opportunity to comment on the allegations and findings of the investigation.
The Provost or his/her designee(s) will chair and convene a review committee composed of three or more faculty members. These individuals may or may not be the same persons who conducted the formal inquiry. When possible, at least two faculty members will be familiar with the questioned research or scholarship and have the necessary and appropriate expertise to carry out a thorough and authoritative evaluation of the relevant evidence. At least one faculty member will have an academic appointment outside the college of the affected individual(s). Members of the review committee will be carefully selected and must ensure that they have no real or apparent conflicts of interest with those persons involved in the investigation.
The investigation will entail a formal examination and evaluation of all relevant facts to determine if misconduct has occurred. Investigations shall be completed within 120 calendar days of their initiation. If the Provost determines that a longer time frame is needed in which to complete the investigation, and federal funds are involved, he/she will submit a written request to the Office of Research Integrity, US Department of Health and Human Services, for an extension and provide an explanation for the delay that includes an interim report on the progress to date and an estimate for the date of completion of the report and other necessary steps. If evidence of criminal violations results from an investigation, the appropriate state or federal agency will be notified immediately.
A written report will be prepared by the review committee that states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions of the investigation.
The individual(s) against whom the allegation was made shall be given a copy of the report of investigation and may comment on the findings. If written comments are received within 15 days of the individual(s)’ receipt of the report, they will be made part of the record of investigation.
Records of the investigation will be maintained in sufficient detail to permit subsequent assessment of that determination. Such records will be kept in a secure manner for a period of six years after the termination of the investigation and shall, where appropriate, be provided to authorized personnel.
If the official investigation concludes that the allegations of misconduct are false or cannot be substantiated, the university, under the direction of the Provost, will undertake diligent efforts to restore the reputations of the persons alleged to have engaged in misconduct.
When allegations of misconduct have been proven, appropriate remediations and sanctions shall be devised. These shall be subject to thorough review through the faculty grievance procedure (Subtopic 420-020), the rules and regulations governing classified employees in the state of Washington, and the Washington State Administrative Procedure Act (Chapter 34.05 RCW) and related rules derived therefrom. Descriptions of the remediation proposed and the sanctions invoked shall be forwarded to the appropriate state, federal, and outside funding agencies
APPENDIX A – DEFINITIONS
Throughout this policy, the definitions provided in RCW
42.52.010 and the definitions provided below shall apply.
Investigator includes the principal investigator, program director, co-investigator, and any other persons, including outside contractors and consultants, who are responsible for the design, conduct, or reporting of research, educational, or service activities that are funded, or proposed for funding, through grants or contracts.
University Research Employee means a state officer or state employee employed by a university, but only to the extent that they are engaged in research, technology transfer, approved consulting activities related to research and technology transfer, or other incidental activities. For the purposes of this policy, a university research employee is also an investigator as defined above.
Immediate Family refers to the researcher’s parents, siblings, spouse, registered domestic partner, children and any equivalent relatives by marriage. It also refers to any individual who resides on a regular basis in the researcher’s domicile.
Research means a systematic investigation, including research development, testing and evaluation that may be designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Significant financial interest refers to anything of monetary value including, but not limited to, salary and other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options or other ownership interests), and intellectual property rights (e.g., patents, copyrights and royalties from such rights) of the investigator and the investigator’s immediate family. A “significant financial interest” does not include:
- salary, royalties, or other remuneration from Eastern Washington University;
- income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
- income from service on advisory committees or review panels for public or non-profit entities;
- an equity interest that, when aggregated for the investigator, the investigator’s spouse, and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and constitute more than a 5% ownership interest in any single entity; or
- salary, royalties or other payments that when aggregated for the investigator, the investigator’s spouse and dependent children over the next twelve months are not expected to exceed $10,000.
IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Potential conflict of interest occurs when there is a divergence between an individual’s private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise.
Actual conflict of interest depends on the situation and not on the character or actions of the individual. For purposes of this policy, a conflict of interest exists when the University, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct or reporting of the educational, research, and/or service activities that are funded or proposed for funding.
PHS means the Public Health Service, an operating division of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated.
PHS Awarding Component means an organizational unit of the PHS that funds research that is subject to this part.
Sponsor means the agency or organization providing funding to the University to carry out a program of research, and/or educational or services activities.
APPENDIX B – INSTITUTIONAL RCR TRAINING PLAN
B-1. Training Requirements
All research personnel participating in an NSF supported program shall receive and participate in RCR training. Research personnel may be students or nonstudents, be paid or unpaid, and participate short term or long term on the project. Research personnel shall begin their RCR training as soon as they are employed on a grant and shall complete the training within thirty (30) days. Personnel who do not complete the required training within such time will be suspended from the project until required training is completed.
EWU Researchers participating in NSF programs must access on-line training modules to fulfill their requirements for RCR education. A link to the training website is available through the OGRD website. All research personnel must complete one training module in each of the following areas:
- Collaborative Science
- Conflicts of Interest and Commitment c. Data Management and Integrity
- Mentor-Trainee Responsibilities e. Peer Review
- Publication Practices/Responsible Authorship g. Research Misconduct
Depending on the focus of the research, research personnel may also be required to complete training on Research Involving Human Subjects and/or Animal Care and Use.
B-2. Institutional Certification
The Executive Director of the Office of Grant and Research Development is the Authorized Organizational Representative (AOR) for certifying that the Institutional Training Plan is in place at the time of proposal submission.
B-3. Compliance Oversight and Verification
The Office of Grant and Research Development is the designated unit responsible for overseeing institutional compliance with the NSF RCR educational requirements. Once RCR training is completed, each researcher is required to complete the Responsible Conduct of Research Training Program Log and the Certificate of Completion. Both documents shall be submitted in hardcopy to the employing faculty member (the principal investigator [PI] or project director [PD] on the grant) for review and signature. The supervisor shall then submit the log and certificate to the Office of Grant and Research Development for final approval.
When all training requirements have been satisfied and the required documentation submitted, a signed copy of the certificate will be returned to the researchers along with a copy of the training log for their records. PIs/PDs are responsible for ongoing RCR mentoring in the research setting, for ensuring that all research personnel receive training within 30 days employment o the project and for keeping records of RCR training in their project files. The Office of Grant and Research Development will maintain institutional copies of the certificates and training logs.
B-4. Ongoing Considerations
A primary goal of this plan is to foster and integrate RCR education to ensure a high level of ethical and professional conduct at Eastern Washington University as research and other sponsored projects are undertaken. To this end, the Office of Grant and Research Development will seek collaborative opportunities to promote RCR education with colleges, departments and the Office of Graduate Studies and continue to identify RCR resources and best practices that might be useful in fulfilling and improving RCR education at EWU.
APPENDIX C – FINANCIAL CONFLICT OF INTEREST
C-1. Preliminary Discussions
Prior to writing a proposal, the investigator must consider whether a financial conflict of interest may exist. Review by the department chair, program director, and/or college dean of relevant financial information at an early stage of proposal development may help identify actual or potential conflicts of interest and determine potential conditions to manage or eliminate the conflict of interest.
If the chair, director, and/or dean believe that it will be possible to develop and execute, prior to an award, a conflict of interest resolution plan that will adequately manage or eliminate the conflict of interest, they may endorse the proposal by completing Section B of the Significant Financial Interest Disclosure Form.
Although involving the chair, director, and/or dean in this preliminary manner is recommended to help expedite proposal processing, an investigator is not required to do so. Alternatively, an investigator may consult informally with the staff of the Office of Grant and Research Development or the chair of the Conflict of Interest Review Committee before filing a disclosure, or may simply proceed with the official disclosure process directly.
C-2. Executing the Significant Financial Interest Disclosure Form
The investigator shall complete a Significant Financial Interest Disclosure Form, and attach, when appropriate, supporting documentation that identifies the relevant enterprises and the nature and amount of investigator financial interest. The disclosure form and any supporting documentation must be submitted to the Office of Grant and Research Development at the time the proposal is submitted to the funding agency.
If the investigator completes Section B of the form to declare a reportable significant financial interest, the supporting documentation will be placed in an envelope marked confidential and submitted with the disclosure form to the Office of Grant and Research Development with an endorsement by the investigator’s department chair.
C-3. Office of Grant and Research Development
Upon notification of a grant or contract award, the Director of Grant and Research Development shall review the financial interest documentation to determine whether the disclosed interests and relationships of the principal investigator could affect the design, conduct, or reporting of the project. If the initial judgment is made that an actual or potential conflict of interest exists, the Provost will be formally notified.
C-4. Conflict of Interest Review Committee
When the Provost concurs with the judgment that an actual or potential conflict of interest exists, the case will be referred to the Conflict of Interest Review Committee. This three-member Committee, of which one member serves as chair, will be appointed by the President with nominations submitted by the EWU Academic Senate for a two year term. The Director of Grant and Research Development will serve as an additional non-voting member.
Reporting directly to the Provost, the Committee shall review all pertinent documentation including, but not limited to, the grant proposal, the Significant Financial Interest Disclosure Form, the supporting documentation as required by Section B of the Significant Financial Interest Disclosure Form, and the conflict of interest resolution plan developed and presented by the investigator in consultation with the unit chair or program director and dean. At its discretion, the Committee may request additional information from and/or an interview with the investigator whose significant financial interest is under review.
The Committee will develop a resolution plan with the investigator. The resolution plan shall not include any reduction in an employee’s salary unless the plan also includes a leave of absence from the University. Furthermore, in setting the salary of an employee, no account shall be taken of any payments received by any employee from outside sources that are disclosed in connection with the employee’s disclosure of any conflict of interest.
The Committee may endorse the resolution plan without change or propose alternative conditions which may be either more or less stringent or restrictive. The investigator may propose or the Committee may require one or more of the following as part of the resolution plan:
- No action beyond disclosure to the University, sponsor, and/or competitor, as appropriate;
- Disclosure of significant financial interests to (i) the academic and professional communities in presentations and publications, (ii) the sponsor through written notification, and (iii) the participants through informed consent documents when human subjects are involved. In determining an appropriate means of disclosure, consideration should be given to whether it should be written and/or oral and to the level of detail;
- Monitoring of research by independent reviewers — either through an in-house quality assurance program or through an outside referee or coordinating center;
- Modification of the research plan to manage concerns of bias by establishing protocols that include actions such as blinding, modifying the scope of the project, and setting timetables for the delivery of the product. These modifications would require the approval and cooperation of the sponsor and perhaps collaborating investigators at the University and elsewhere;
- Disqualification of the investigator from participation in all or a portion of the research where no other resolution is acceptable to the investigator and the Conflict of Interest Review Committee;
- Designation of a co-investigator (peer or superior) who has no significant financial interest in the project to assume the lead role on the project;
- The sale or other divestiture of the significant financial interest in a sponsor or competitor and restrictions on re-investment after the project is completed for an appropriate period to provide for publication and critique of the project;
- Placing interest in escrow for the term of the project and perhaps a period beyond the end of the project to provide for publication and critique of the project;
- Severance of other relationships with the sponsor or competitor that create actual or potential conflicts of interests.
- Other strategies that may include variations of options presented, combinations of options, and/or new options not identified herein.
C-5. Committee Recommendation
The Committee shall recommend to the Provost what conditions and restrictions, if any, should be imposed by the University to manage the actual or potential conflict of interest. The final decision regarding management of the conflict of interest shall be made by the Provost with due regard for the Committee’s recommendations. The investigator shall indicate in writing acceptance of the resolution plan prior to the time of the University’s expenditure of any funds under the award.
Investigators may appeal decisions of the Conflict of Interest Review Committee and the Provost. In such cases, the appeal may be reviewed through the faculty grievance procedure. The appeal shall be filed within 20 days of the contested decision and the Faculty Grievance Committee shall reply within 20 days after receiving the appeal.