FacultyHandBook

FacultyHandBook

Taken from University of Virginia School of Medicine Faculty Handbook 1997

3.13

Research Ethics: Guidelines for the Faculty

3.14

Conflict of Interest Regarding Faculty Endorsement of Industry


Research Ethics: Guidelines for the Faculty


Introduction

The discovery of new knowledge through research is, like teaching and patient care, a fundamental part of the life of an academic faculty member. The formulation of testable hypotheses, the organization of research design, the mobilization of financial support, equipment, technological assistance, and space and time to perform the required experiments all require a strong effort and helpful cooperation from many people. The collection of vital research observations, their analysis and interpretation, and successful scientific publication are important steps in the dissemination of new knowledge. The growth and productivity of a faculty member during his/her academic career may be reflected in terms of publications.

All these are worthy goals, and they should be pursued in ways that express the highest traditions of science, of the University, and of the intellectual integrity of the individual. A fundamental principle of success lies in the acceptance of the interdependence of individual investigators within the structure of the University. Each faculty member is responsible for colleagues, collaborators, or other senior faculty, as well as trainees and students. A faculty member joins a certain division or department of the School of Medicine and his/her research activities, like the other activities mentioned above, should be carried out in the spirit of open cooperation, sharing, and free discussion at every step of the way.

As the decade of the 1990's begins, academic research is under the microscope. Several allegations of research misconduct have stimulated widespread public and Congressional scrutiny of the traditional concepts of scientific honesty and integrity, peer review, and refereed publication, among others. Each institution has been asked to review and disseminate detailed descriptions of its own policy and procedures dealing with the prevention and investigation of research misconduct. The following recommendations from the Research Ethics Committee have been reviewed and approved by the dean, the Executive Committee, and the Medical Advisory Committee and, therefore, constitute the approved policy of the School of Medicine.

The problem is both protean and ubiquitous. In modern science, meaningful discoveries usually require the coordinated activities of a team, yet our evaluation of scientific excellence focuses on the achievements of the individual. The only way to resolve this dilemma is the continual, open, mutual acknowledgment of each member's contribution to the team effort, documented as necessary. Nor does the team responsibility end there: it also includes stimulating the lazy colleague, supporting the inspired guess which takes research in a new direction, restraining unrealistic enthusiasm, and firmly enforcing ethical standards of research behavior whose transgressions would jeopardize the reputation of all members of the team, and, eventually, the entire community of scholarly investigators.

In this context, the following recommendations are directed primarily to the new faculty member, or other junior investigator, beginning his/her academic career at the University of Virginia.

 

Prevention of Research Misconduct


The best way to avoid starting off on the wrong foot is to start off on the right foot. The following specific suggestions should prove helpful.

The Investigator and the University

At the time of appointment to the faculty, an investigator ordinarily receives a formal letter from the department chair and the dean, offering employment and setting forth the major responsibilities and expectations incumbent on the appointee. This communication usually includes policies regarding promotions and tenure, assignment of laboratory space and facilities, etc. This letter is supplemented by the information on research ethics policies and procedures provided in the University of Virginia Faculty Handbook.

These guidelines further supplement the handbook information with specific material concerning research in the School of Medicine. The following points may be helpful:

1. Research Ethics (GSAS 710). This course is offered each fall and is open to all faculty and trainees. It is required by the National Institutes of Health for all National Service Award recipients.

2. Instructions for preparing a grant application will be provided by the dean's Office of Grants and Contracts.

3. If the research involves human subjects in any way, the investigator must obtain prior review and approval from the Human Investigation Committee of the School of Medicine (see section 3.16 of this chapter).

4. If the research involves animals, a detailed protocol must be completed and approved by the Animal Research Committee (see section 3.17).

5. If the research proposes to use the facilities of the General Clinical Research Center (GCRC), a detailed protocol must be prepared according to the GCRC format (see section 2.10.1).

6. If the research involves irradiation or the use of radioisotopes, the research protocol must be approved by the Radiation Safety Committee (see section 3.18).

The Investigator and the Chain of Responsibility

A faculty member, upon appointment, becomes part of a chain of support and responsibility with regard to research. The chain begins at the level of the laboratory group of colleagues he/she joins, and extends upward through the head of the division (if any), the chair of the department, and the dean of the School of Medicine. At each level, the faculty member has specific responsibilities and opportunities.

The investigator must be thoroughly familiar and comfortable with his/her role in the chain of responsibility, continually reaffirming not only dependence on and responsibility for the research of others, but also on the clear and unchallenged demonstration of his/her own investigational achievements. This is not easy, but it can and must be done.

1. Responsibility to the Laboratory Group. Each investigator is expected to work openly and collaboratively with colleagues, sharing ideas and preliminary results in order to obtain useful criticism and suggestions. To forestall any questions which may arise as to the priority of a hypothesis or an experimental finding, its origin should be documented in dated entries in the ordinary laboratory notebooks of the individual investigator who should regularly sign and review all data entries. Work produced through group collaboration is not "owned" by any individual member of the group, and no individual should appropriate or claim work produced by the group as his/her own. Appropriate acknowledgment of the contributions of others should be provided.

2. Responsibility to the Laboratory Director or Division Head. Each investigator is expected to keep his/her laboratory or division head fully and currently informed as to the status of grant applications, research methodology, results, and interpretation, scientific papers in preparation or awaiting publication, etc. In return he/she should be provided with thoughtful guidance and advice, assistance with financing, and protection of professional time in order to pursue attractive research opportunities. He/she should be briefed thoroughly with respect to department/divisional guidelines regarding the listing of authors on research manuscripts, as well as promotion policies.

As a trainee or junior faculty member develops competence in a given field, it is important that adequate opportunity be afforded for him/her to work toward achieving independence. During this transitional period, there is a potential for conflict to develop between mentor and trainee, since it is inevitable that both will be exploring similar hypotheses, using the same facilities and resources, and including similar proposals in applications for future grant support. To minimize such conflict and, more importantly, to assure appropriate growth, periodically scheduled career planning sessions must take place. Such sessions need to be more than the daily discussions of experimental design and results (which should also occur); issues such as hypothesis ownership, plans for collaborative versus independent studies, and appropriate timing of eventual independent authorship should be discussed prospectively. Retrospective accurate assignment of "intellectual property" in such situations is almost always impossible. When disagreements arise, the mentor's supervisor (i.e., division chief or department chair) should be consulted early.

It must never be forgotten that, although senior faculty have the authority to improve and correct unsatisfactory research activity, they, in turn, are themselves subject to correction by juniors on points of fact and ethical propriety. Thus, each contributor to the research is not only responsible for, but responsive to, the other members of the team.

3. Responsibility to the Department Chair. The investigator, with or without assistance of the laboratory director or division head, is expected to submit all grant applications, Human Investigation Committee protocols, and animal research protocols to the appropriate department chair for final approval prior to official action. This provides an opportunity for the chair to review the overall research career of the investigator and direct him/her in advantageous pursuits. The chair should also make clear to the investigator the departmental policies regarding promotion and tenure, and the time constraints on these expectations. In large departments, this responsibility may be delegated by the department chair to the division head. It should be emphasized that the University administration and review committees, as well as most granting agencies, consider signature by the chair (or his/her designee) to signify department review and approval of the ethics of the proposed research.

4. Responsibility to the Institution. All charts, reports, computer discs, x-rays, and other data sets should be carefully and systematically preserved for at least five years, or longer if required, to document every stage of current ongoing research. While such records constitute the best proof for establishing "ownership" of the research, it must be remembered that the ultimate owner of the research is the University of Virginia, which also has responsibility for disposal of such data. The following is the University policy on the recording and storage of University data:

Data and notebooks resulting from sponsored research are the property of the University of Virginia. It is the responsibility of the principal investigator to retain all raw data (in laboratory notebooks or other appropriate format) for at least five years after completion of the research project (i.e., publication of a paper describing the work, or termination of the supporting research grant, whichever comes first) unless required to be retained longer by contract, law, regulation or by some reasonable continuing need to refer to them. If the principal investigator leaves the University of Virginia, he or she may transfer such data to another institution, provided the vice provost for research approves and provided that the University is given written assurance that the data will be retained for the required five-year minimum retention period.

5. Responsibility to the Funding Agency. The investigator must examine carefully the possibility of a real or perceived conflict of interest among the investigator, the proposed research, and the funding agency (see UVA Faculty Handbook, Conflict of Interest Policy). This issue is becoming increasingly sensitive as private industry provides more support for research performed in academic institutions. As a general rule, funds should not be accepted for research which cannot be fully disclosed in scientific reporting. (Exceptions for U.S. Government classified research are addressed in the Policy for Classified Research for the University of Virginia, available from the University Office of the Vice Provost for Research). Also, investigators should avoid participation in research for which they will receive direct or indirect funds for prescribing a product or producing specific results and are strongly advised not to own stock in companies for whom they are conducting research. Investigators are encouraged to discuss such possible conflicts with the chair of the Human Investigation Committee or the associate dean for research before submitting their proposals.

The Investigator and Publications

Traditionally, academicians must either publish or perish. But over and above the career success of any one individual, the fruition of all productive research stems from timely and appropriate publication. Here ethical considerations and concerns for professional status often create painful dilemmas and dangerous pitfalls for the young investigator. It is beyond the scope of these guidelines to describe them all. However, wise counsel by a disinterested senior scientist and close adherence to the chain of responsibility will almost always prevent serious error.

In preparing a report of original scientific research for publication, investigators need to be familiar with the University of Virginia medical school guidelines for authorship, as listed below.

1. To be listed as first author of an original scientific article, the investigator must (a) have adapted a general hypothesis (his/her own or the senior author's) in a detailed systematic fashion, down to the actual details of methods and materials; (b) have participated in a major way in the analysis and interpretation of data; and (c) have written the paper. It is desirable, but not obligatory, that the first author have also participated substantially in the performance of the research and the data collection.

2. To be listed as a co-author, an investigator must be recognized as an individual who made significant contributions to the planning and execution of the research, the methods and procedures, and the collection and analysis of data.

3. To be listed as a senior author, a scientist must (a) have either formulated the original general hypothesis or have provided significant intellectual resources for the work, (b) have provided constructive criticism of the paper during and/or after its composition, and (c) accept over-all responsibility for all the findings of the final version of the paper and for the order of authorship.

These guidelines will be assumed to govern the publication of original scientific papers from the faculty of the School of Medicine effective January 1, 1991. Any department or laboratory has the option of amending or adapting these guidelines for its own personnel, provided such specific exceptions will be consistently observed and are submitted in writing to and approved by the Research Ethics Committee.

The writing and revising of a scientific paper should actively involve all the authors. Each author should be prepared to defend his/her specific contribution to the research and to the publication, and should be generally familiar with the contributions of all other co-authors as well. The over-all head of the laboratory should have the opportunity to review each manuscript prior to initial submission and may wish to examine the data base upon which conclusions are based, regardless of who is to be listed as senior author.

All authors should be careful to provide adequate documentation of attribution for all information supplied by others, including generous use of personal communications from colleagues not listed as co-authors.

When research involves human subjects, the principal investigator should maintain a comprehensive list of names, addresses, phone numbers and University Hospital (UVH) and/or Social Security numbers of all subjects who have signed a consent form to participate, including subsequent dropouts, for at least five years. Reference to research participation of hospital patients should also be entered in the individual hospital chart.

The Investigator and Promotions and Tenure

Beginning on the date of appointment, the young faculty member should begin to plan ahead toward the next promotion step. He/she should welcome periodic review of progress by the immediate supervisor and department chair. With such ongoing review, the chair will at appropriate times recommend action to the Promotions and Tenure Committee of the School of Medicine. Documentation of progress will be requested by that committee, including a current curriculum vitae, summary of research support, letters of recommendation, representative reprints, and a current bibliography of publications.

The committee is interested primarily in the quality, and not merely with the quantity, of publication. Publications in non-archival or non-peer reviewed publications are not helpful and may even be counter-productive.

The committee has adopted the policy of asking each candidate to submit reprints of his/her best and most representative work - not to exceed three such for promotion to associate professor, for awarding tenure, and for promotion to professor. It is the excellence of these major publications, not the multiplicity of all others, that characterizes the faculty member worthy of promotion and tenure.

The Investigator and the Research Ethics Committee

Ideally, the investigator who has carefully and conscientiously adhered to the recommendations of these guidelines will never have any contact with the Research Ethics Committee. But to reiterate the philosophy of the University of Virginia, it is necessary not only to be ethical in one's own research but to preserve the integrity of all scientific research by moving actively to prevent, identify, and correct ethical deficiencies in the research of others. It is therefore incumbent on all faculty to be thoroughly familiar with the current procedures or the Research Ethics Committee for dealing with allegations of research fraud.

 

The Methods of Procedure Regarding Research Misconduct


Introduction

The Research Ethics Committee is appointed by and reports to the dean of the School of Medicine. Its major function is to investigate allegations of fraud committed by a person during a period of employment by the School of Medicine. As regards the purview of this committee, research fraud is defined as the intentional (a) fabrication of nonexistent data, (b) falsification of existing data, (c) presentation as one's own of data originated by another without the latter's permission, or (d) plagiarism of research proposals, protocols, results, or reports. It does not include each and every instance of research impropriety, such as arising unintentionally out of haste and hurry, carelessness, poor planning, sloppy performance, erroneous calculations, failures of communication. These can be minimized by careful supervision and supportive counseling and best corrected by forceful and rigorous discussion at a number of levels.

The committee's procedure as described in this document is an investigation, not a due process hearing procedure. The charge of the committee is to investigate so that it can recommend action to the dean. If the dean decides to take disciplinary action against an investigator employed by the School of Medicine, the individual may use whatever grievance procedure applies to the particular case. Any required due process hearing will be provided in the course of such a grievance procedure, not in the committee's investigational procedure.

Request to Investigate

The committee will only investigate suspected research fraud at the direction of the dean. Any person (the "complainant"), inside or outside the Health System, may request the dean to direct the committee to investigate. This request may be implemented in several ways:

1. Ideally, the complainant will provide the dean with a written and signed description of the alleged misconduct, providing as much specific detail as possible.

2. If desired, the complainant may first seek to meet jointly with the senior associate dean or a department chair, and the chair of the research ethics committee, for a completely confidential discussion of the circumstances leading to the request. Unless parties to this discussion agree that the matter should be dropped, it will then be presented to the dean who will decide, after consulting the University's legal counsel (if necessary), whether to proceed to investigation.

3. Non-specific and informal allegations will be considered by the dean, in consultation with the University's legal counsel, as to appropriate disposition. In most cases there will be obvious ways to clarify such allegations so as to formalize them as a basis for investigation via option 1 or 2.

4. If a finding of scientific misconduct is determined in the ordinary course of business of the Human Investigation Committee, the Animal Research Committee, the Clinical Research Advisory Committee, or the Radiation Safety Committee, these committees may themselves take appropriate disciplinary action. In addition, such finding shall be promptly and completely reported to the dean, who will transmit the report to the Research Ethics Committee. If research fraud is suspected, the dean may request further action by the committee; if not, the transmittal is for information only.

Investigation Procedure

In investigating suspected research misconduct the committee seeks to obtain as much accurate and relevant information as it needs, and to make its recommendation to the dean in as prompt, efficient, and least disruptive manner as possible. The most effective procedures for achieving this goal will vary with the particular circumstances of each case. The following procedures are, therefore, only a preliminary and general guide to the committee, which may alter the procedure as needed to fit the circumstances of any particular case.

1. As a first step, the chair will meet with the dean to review the allegations and information available.

2. The chair will then meet separately with the complainant and the researcher, in order to deliver to each a copy of the Investigation Procedure and to determine whether either believes a conflict of interest exists for any member of the committee. If so, the dean will be informed immediately so that he may excuse certain members (if necessary) and appoint substitutes. (The University's legal counsel may also be consulted.)

3. In meeting with the complainant the chair will also seek to develop a list of pertinent witnesses, documents, and other evidentiary material which might be relevant to the investigation. In meeting with the researcher the chair will present a copy of the allegation(s) of fraud, and will request the researcher to provide, in his/her defense, a list of any witnesses or evidentiary material believed to refute the allegation. The researcher will be asked to provide, within 24 hours, all the requested evidentiary material which will be secured in the office of the senior associate dean.

4. The chair will then arrange for a meeting or meetings of the committee, to (a) review the allegation, (b) examine the evidentiary material, (c) hear any witnesses, and (d) interview the complainant and the researcher, separately. (Confrontation of the accused by the accuser may be permitted at this point under certain conditions, where objective proof or disproof of the allegation cannot be attained.) All such meetings will be recorded and transcribed for possible use in the grievance procedure(s).

5. At the conclusion of the meeting(s), the committee will discuss the issues and vote whether (a) the allegation is unproven, and no further investigation is needed; (b) the allegation is proven, and appropriate action by the dean is recommended (the committee must also decide whether any further investigation is needed to tie up loose ends), or (c) there is insufficient evidence to prove or disprove the allegation, and a more extensive investigation is recommended. The question of whether to consult outside experts can be decided at this point.

In the case of (b) or (c), the dean will then (i) report the finding of the committee to the sponsoring agency(ies) and supply further information in response to any requests required by the policies of the latter; (ii) notify the proper authorities if any academic degree requirements are in question; and (iii) communicate appropriately with the editors of scientific journals to which the research in question has been submitted.

6. In pursuing a more extensive investigation, the committee may (a) seek to establish a more extensive list of witnesses or evidentiary material, (b) conduct further interviews with the complainant, (c) conduct further interviews with the researcher (who may be accompanied by legal counsel), (d) engage the consultative service of outside experts, (e) consult the University's legal counsel, and/or (f) take any other action calculated to discover the truth of the allegations.

7. In all its investigative activities the committee requires that each participant make every effort to preserve the confidentiality of the parties involved, in deference to the rights and reputation of the complainant as well as the researcher. However, both parties are warned at outset that it may not be possible to maintain full confidentiality indefinitely. After the completion of its investigation, the committee will provide the dean with a written report, organized into two sections: (a) the factual findings of the investigation, and (b) the committee's interpretation and recommendations, if any, concerning action to be taken by the dean.

Revised 08/09/94

 

Conflict of Interest Regarding Faculty Endorsement of Industry


As technological advancements have progressed at an unprecedented rate, the traditional financial support from federal, state, and philanthropic sources has failed to keep pace. As a result, faculty from academic institutions have increasingly turned to private industry as a resource for funds for their research and educational programs. Industry has been responsive to such requests, but has increasingly been interested in exploiting such support for marketing purposes. This has created the potential for major conflicts of interest, since academic institutions must at all times remain objective and assure both the fact and the appearance of neutrality if they are to fulfill their mission of revealing and teaching truth in the scientific and educational arenas. Even the appearance of bias can inflict long-term damage to societal trust of the institution and, hence, its future effectiveness. This document is written in an effort to alert the faculty to potential conflicts and to define what collaborative relationships the institution deems acceptable.

 

Existing Guidelines or Policies


Continuing Medical Education

All faculty participating in educational programs developed or implemented by the Office of Continuing Medical Education of the School of Medicine, regardless of the assignment of AMA Category 1 or 2 credit, must comply with the Standards for Commercial Support of the Accreditation Council for Continuing Medical Education and the AAMC Guidelines for Faculty Involvement in Commercially Supported Continuing Medical Education. These standards require faculty independence from commercial organizations in program design, content, and implementation, in addition to full disclosure of potential conflicts of interest as they relate to educational initiatives. A formal letter of agreement between commercial grantors and sponsors of continuing medical education must be signed, so as to ensure complete acknowledgment of the roles of the grantor and the grantee. At each presentation, the audience must be made aware of any potential speaker conflict of interest imparted by relationships with commercial sponsors and/or donors, be it research grants, honoraria, travel/lodging, or other subsidies that might have an impact on speaker objectivity. The reader is encouraged to contact the Office of Continuing Medical Education for written policies related to conflict of interest and educational initiatives sponsored by the School of Medicine.

Conflict of Interest While Functioning as a State Employee

The Commonwealth and the University have clearly defined policies prohibiting any state or University employee from receiving unapproved personal benefit for services performed within the scope of official duties (e.g., for purchasing, award of contracts, employment, promotions.). The reader is referred to the University's Faculty Handbook or the Financial and Administrative Policies Manual, Policy XV.A.1, Conflict of Interest. The Financial and Administrative Policies Manual can be found on the World Wide Web at gopher://Minerva.acc.Virginia.edu: 70/00/admin/polproc/pol/fpol15/15al.

Conflict of Interest of Investigators Who Receive Funding from the Public Health Service

The Association of American Medical Colleges (AAMC) has published a booklet entitled Guidelines for Dealing With Faculty Conflicts of Commitment and Conflicts of Interest in Research. In addition, the Department of Health and Human Services has recently established guidelines which regulate or mandate disclosure of a potential conflict of interest for any investigator who receives federal funds (Federal Register, 59:123,33242-51, June 28, 1994). See also the University's Objectivity in Research Policy [section 3.12].

Conflict of Interest Regarding Personal Opinions, Political Activity, or Governmental Relations

The University's Faculty Handbook describes a policy which prohibits faculty members from expressing personal opinion or political positions in a manner which might imply that the position is necessarily representative of the University. The handbook references the AAUP Statement on Professional Ethics as the primary doctrine which should guide such behavior.

Research Misconduct and Fraud

The Health Sciences Center has clearly defined guidelines regarding an investigator's responsibilities for assuring ethical behavior in the generation, analysis, and reporting of research data. See Research Ethics: Guidelines for the Faculty (section 3.13).

 

Impartiality and a Faculty Member's Commitment to Academic Obligations


A faculty member may encounter a variety of opportunities for conflict of interest which are not covered by the policies cited above. For example, a faculty member may participate in a nonaccredited CME program, which is sponsored by a pharmaceutical company planning to use publicity about the conference in its product marketing. The faculty member may receive immediate financial remuneration for participation and the department may subsequently receive special consideration for research support from the company at a later date. Since the CME program is nonaccredited and was not developed through the Office of Continuing Medical Education, it is not subject to the ACCME rules; since no immediate research funds are involved, the research conflict of interest regulations do not apply; and direct payment to the faculty member is permitted under the honorarium allowance. However, the perception by the public of a University faculty member directly endorsing a product can be quite destructive to the public's image of the University and, thus, to the academic mission. Although the faculty member may truly believe that the product is superior, use of an official title and inferential implication of the University in the endorsement (e.g., perhaps through citation of the faculty member's appointment at the University, or by use of University letterhead in a promotional cover letter), will tend to erode the image of impartiality which has long been fundamental to academia and the discovery of truth. The following policy has been developed to address potential conflicts of a nature similar to that described above.

 

School of Medicine Policy Regarding Faculty Interactions with Industry and Product Endorsement


In general, the faculty member is expected to publish objective scientific data and educational writings in refereed publications. Requests from commercial organizations for the faculty member to provide educational material for the lay public or for health care professionals should be carefully considered and undertaken only when objectivity can be assured and product endorsement is not involved (unless such endorsement is specifically approved, as described below). In an effort to protect the University's image of impartiality, while preserving an individual's academic freedom, the following guidelines have been developed regarding a faculty member's interaction with industry or other outside sponsor:

1. Faculty members are encouraged to solicit financial support from industry for research, educational, and/or service activities. However, such support must be administered through the Office of Sponsored Programs, or must follow the regulations associated with the University's gift policy. In accepting such funds, unless pre-approved as described below, the faculty member must sign a statement that no endorsement of a specific product is either stated or implied and that no endorsement will be a part of the faculty member's professional activities.

2. A faculty member's apparent or real endorsement of a commercial product must not be associated with any indication of real or implied similar endorsement by the University, unless expressly approved in writing by the dean of the School of Medicine. Therefore, such endorsement must not contain reference to the faculty member's official University title(s) or the University's name or logo (e.g., use of University letterhead is prohibited). See appendix I for the Conflict of Interest Agreement form.

Effective 4/4/95