A.6: TRINITY COLLEGE POLICY AND PROCEDURES FOR REVIEW OF ALLEGED UNETHICAL RESEARCH PRACTICES

Trinity College is committed to maintaining the integrity of scholarship and investigative research and to fostering a climate conducive to such intellectual integrity in the College community. Furthermore, unethical research practices may constitute a breach of the employment contract of the College Faculty or staff members involved in such practices. Consequently, formal procedures have been established by the College for the purpose of investigating and making findings regarding alleged unethical practices. These procedures are not intended to supersede or to establish alternatives to established procedures for resolving other kinds of misconduct, such as fiscal improprieties, the ethical treatment of human or animal subjects, or criminal behavior.

DEFINITION OF UNETHICAL RESEARCH PRACTICES

No list of unethical research practices can be all-inclusive. For purposes of this policy and procedure, the College adopts and refers to the current ethical standards of scholarship of the academic discipline of the particular Faculty or staff member.

Activities constituting unethical research practices include, but are not limited to:

Falsification of data: Dishonesty in reporting results, ranging from sheer fabrication of data, improper reporting of data, gross negligence in collecting or analyzing data, to selective reporting or omission of conflicting data.

Plagiarism: Taking credit for someone else's work and ideas, stealing others' results or methods, copying the writing of others without acknowledgment, or otherwise taking credit falsely.

Abuse of confidentiality: Taking or releasing the ideas or data of others which are given in the expectations of confidentiality: e.g., stealing ideas from submitted grant proposals, award applications, or manuscripts for publication when one is a reviewer for granting agencies or journals.

Dishonesty in presentation and publication: Knowingly presenting material or publishing articles that will mislead listeners or readers: e.g., misrepresenting data (particularly its originality), or adding the names of other authors without permission. Publishing the same material more than once without identification of its prior publication.

Co-authors of publications share responsibility for the published work and should participate in a substantive way in the conception, design, performance, or analysis of the study or the drafting of the manuscript. Co-authors must be willing to take responsibility for the content of the published work and therefore must be certain of the integrity of the data.

Deliberate and serious violation of regulations: Failure to adhere to or to receive the approval required for work under research regulations of federal, state, local or College agencies, including, but not limited to, guidelines for the protection of human subjects or animal subjects, and the use of recombinant DNA, radioactive material, or chemical or biological hazards.

Legal violations: Stealing or destroying the property of others (research papers, supplies, equipment, or products).

Failure to report unethical research practices: Covering up or otherwise failing to report major episodes of misconduct or serious breaches of research ethics.

PROCEDURES FOR INITIAL INQUIRY ("Factfinding") WITH REGARD

TO ALLEGATIONS OF UNETHICAL RESEARCH PRACTICES

Administrative Responsibility: The Dean of the Faculty is the "Misconduct Policy Officer" for Trinity College.

Allegations: An allegation of unethical research practices involving any Faculty or staff member may be communicated, preferably in writing, by any person to the Dean. Alternatively, such allegations may be brought first to the attention of the Faculty member responsible for the individual whose actions are being questioned, such as the research supervisor, the Principal Investigator, or the Department Chair. If the alternative course is followed, the Department Chair should always be notified immediately of the allegation(s), and, if the complaint cannot be handled at the departmental level, the Department Chair shall promptly refer the allegation(s) to the Dean without conducting any inquiry or investigation. The Dean will take the necessary interim actions to protect the agency's funds and insure that the purpose of the financial assistance is carried out. In circumstances where the complaint can be handled at the departmental level, the Department Chair should notify the Dean of the final disposition of the complaint.

Responsibilities of the Dean: Upon receiving the allegation(s), the Dean will seek assistance in its resolution through whatever institutional processes may be appropriate to the particular case, such as referral to the departmental chair as outlined above, the Comptroller, or the appropriate Review Boards. If the Dean determines that the concern is properly addressed through policies and procedures designed to deal with misconduct in research, the inquiry and investigation procedures should be discussed with the individual who has questions about the integrity of a research project. If the individual chooses not to make a formal allegation, but the Dean believes there is sufficient cause to warrant an inquiry, the matter should be pursued; in such a case, there is no "Complainant" for the purposes of this document.

Notification Requirements: Upon initiation of the inquiry, the Dean will notify the Respondent within a reasonable time of the charges and the process that will follow. The identity of the Complainant will be kept confidential during the inquiry phase to the extent permissible by law. The Dean is responsible for disseminating the information to the appropriate individuals in a safe and secure manner and the Respondent is obliged to cooperate by providing material necessary to conduct the inquiry. Lack of cooperation may result in an immediate investigation (see Ad Hoc Investigation Committee).

Preliminary Inquiry Committee: If the Dean determines that the allegation requires investigation, the Dean shall refer the complaint to an ad hoc preliminary inquiry committee, members of which may be chosen from within or outside of the College. In choosing a committee, the Dean shall be careful of conflict of interest, and the parties invited to serve on such a committee should be asked to reveal any relationship to the parties or bias to the matter. (Members of the committee who have an unresolvable conflict in a given case should not be permitted to be involved in any aspect of the committee's handling of that case.) It is important that the committee have appropriate expertise to assure a sound knowledge base from which to work.

Maintenance of Confidentiality: Strict confidentiality should be maintained diligently throughout the initial inquiry (factfinding) process, and only those persons with a need to be informed shall be told of the allegation(s) and the process underway. No funding agency will be informed until completion of the factfinding phase of the inquiry. The person making the allegation(s), to the extent permitted by law, shall remain anonymous throughout the initial inquiry (factfinding) process to all but the members of the committee and those to whom the allegation was first brought. If the committee determines that further action is required, continued anonymity cannot be guaranteed. If, however, the dean determines that other factors outweigh the need for confidentiality, such as a potential for significant risks to the health and safety of individuals or overriding concerns in dealing with granting agencies, some breaches of strict confidentiality may be necessary. Any breaches of confidentiality should be discussed with all of the parties concerned.

Procedures of the Preliminary Inquiry Committee: The purpose of the committee in conducting the initial inquiry (factfinding) is solely to determine whether reasonable grounds exist for conducting a more detailed investigation of the allegation(s). The committee shall review the allegation(s) and the known facts, and may interview any persons having relevant information, including the person making the allegation(s), the researchers in questions, their supervisors, and those assisting in the research. The Faculty or staff member against whom the allegation is made shall be informed of the allegation and the fact that it has been referred to a committee. The Faculty or staff member against whom the allegations were made shall be permitted counsel.

Findings of the Preliminary Inquiry Committee: The committee shall complete its inquiry within 60 days from the date of its formation and report one of three possible recommendations to the Dean:

(1) The complaint should be dismissed as the allegation is without grounds or insignificant. If the recommendation is for dismissal of the complaint, the committee must provide justification so as to preclude the premature ending of the investigation.

(2) The alleged misconduct is not determined to be sufficiently significant to warrant further investigation by this committee and is properly to be referred to another existing College procedure. If the committee recommends that the matter be dealt with in this manner, the Dean will consult with the appropriate Department Chair to determine what alternate procedures are applicable.

(3) A more detailed investigation is warranted. If the committee concludes that a more thorough investigation is warranted, it shall recommend such an investigation to the Dean.

Regardless of the Committee's conclusions, it shall prepare a report summarizing its findings and conclusions and submit the report and its recommendation to the Dean. The report will state what evidence was reviewed, summarize relevant interviews, and include the conclusions of the inquiry. The individual(s) against whom the allegation was made shall be given a copy of the report of the inquiry. If they comment on that report, their comments may be made part of the record at the individual's discretion. If the inquiry takes more than 60 days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period.

Funding Agency Notification: If the results of the initial inquiry support the need for a more detailed investigation, the Office of Scientific Integrity or other granting agency will be immediately informed. The Dean will report in writing to the Director, Office of Scientific Integrity, Public Health Service or other appropriate granting agency, on or before the date the investigation begins. At a minimum, the notification will include the name of the person(s) against whom the allegations have been made, the general nature of the allegation, and the granting agency's application or grant number(s) involved. Information provided through the notification will be held in confidence to the extent permitted by law, will not be disclosed as part of the peer review and Advisory Committee review processes, but may be used by the agency in making decisions about the award or continuation of funding.

The College will notify the Office of Scientific Integrity or other granting agency if it ascertains at any stage of the inquiry or investigation that any of the following conditions exists:

1. There is an immediate health hazard involved;

2. There is an immediate need to protect Federal funds or equipment;

3. 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/her co-investigators and associates, if any;

4. It is probable that the alleged incident is going to be reported publicly;

5. There is reasonable indication of possible criminal violation. In that instance the College will inform Office of Scientific Integrity or other granting agency within 24 hours of obtaining the information. The Office of Scientific Integrity will notify the Office of Inspector General.

If the situation requires such immediate action for the reasons specified above, the Dean is authorized to notify the Office of Scientific Integrity or granting agency even prior to referring the complaint to the committee. In such extraordinary circumstances, it is expected that the Dean will solicit the advice of the Department Chair involved and the chair of the preliminary inquiry committee prior to taking action.

If the committee finds that the allegation is not substantiated and does not warrant an investigation, the written report of the committee shall be maintained in confidence by the Dean, and the process shall be deemed completed.

PROCEDURES FOR INVESTIGATION OF ALLEGATION OF UNETHICAL

RESEARCH PRACTICES THAT APPEAR SUBSTANTIAL

Administrative Responsibility: An Ad Hoc Investigative Committee will be formed as follows: upon receiving a recommendation for an investigation of alleged unethical research practices, the Dean shall notify the Faculty Conference. The Conference will select nine individuals from whom five tenured Faculty members will be eventually chosen to serve as an ad hoc committee to conduct a prompt and thorough investigation of the allegation(s) of unethical research practices. The Dean and the Respondent are each allowed to veto two names, in that order, from the list presented by the committee. This committee shall elect a chairperson from its membership. The membership of the ad hoc committee shall consist of Faculty members who have sufficient expertise to analyze the specific research and publications (if any) involved. Other members may include department chairs or other Faculty of uninvolved departments. None of the members of the ad hoc committee shall have any personal responsibility for, or involvement in, the research under investigation. The Director of Faculty Grants shall provide staff support.

Notification of Involved Parties: Upon selection of the members of the Ad Hoc Investigation Committee, the following parties shall be notified that an investigation is being undertaken: all parties concerned, including the researcher(s) in question and the person making the allegation(s), all collaborators or supervisors of the researcher(s) under review, the Principal Investigator for the research, the Department Chair, senior College officials, including the College's legal representative, and the granting agency. All those informed will be reminded of the need to continue to maintain confidentiality during the investigation.

Procedures of the Ad Hoc Investigative Committee: The College's legal representative shall be requested to provide legal counsel to the investigation committee. Legal principles that pertain to the investigation shall be stipulated in advance. The Faculty or staff member(s) against whom the allegation has been made shall be granted all due process rights during the proceedings and will be allowed to be present, accompanied by one person of his or her choice. At the conclusion, records relevant to the investigation shall be sealed. The committee may confer in executive sessions to organize its work and do its report.

The ad hoc Investigative Committee shall conduct a thorough investigation of all relevant facts and circumstances, during which consideration should be given to the review of all research in which the individual under review is involved. The investigation committee should seek to determine whether any unethical research practices, as defined above, have taken place. All collaborators or supervisors whose roles in the alleged unethical research practice(s) are questionable should be advised of the progress of the investigation and be afforded the opportunity to respond to any allegations made against them and to provide additional information.

The Ad Hoc Investigation Committee shall complete its investigation within 120 days from the date of its formation. Confidentiality should be observed whenever possible, unless a request for an open hearing is made by the researcher(s) under review.

Recommendations of the Ad Hoc Investigative Committee: Upon completion of its investigation, the committee will prepare a report to the Dean summarizing its findings. The committee report should reach one of three possible general conclusions: No violations of ethical standards have been committed; problems have been identified that require action; or serious infractions have occurred. The committee may also recommend specific actions regarding research programs or publications.

Finding of No Unethical Practices: If the Dean concurs with the committee findings that no unethical research practices have been committed by the researcher(s) involved, all parties shall then be notified of the committee's conclusions with a particular emphasis on fully restoring the reputation of the researcher(s) and others under investigation, particularly with the granting agency involved. This effort might include, at the request of the researcher(s) involved, a public statement about the incident designed to make certain that the researcher's professional standing is not diminished. In addition, appropriate action should be taken against any parties whose involvement in leveling unfounded allegations was demonstrated to have been malicious or intentionally dishonest.

Finding of Inappropriate Practices: The committee may find evidence of inappropriate practices or other problems, but deem that these problems are not sufficiently serious to merit further review. If the Dean concurs with this recommendation, the Dean will confer with the researcher(s) and Department Chair(s) involved to determine the most appropriate administrative actions. These actions may include retractions or corrections of publications or return of grant funds. The Dean and/or Department Chair may take whatever other administrative actions are deemed appropriate and within their delegated authorities. A Faculty member who feels that the actions are unfair or otherwise inappropriate may appeal through existing institutional mechanisms.

Finding of Unethical Research Practices: If the committee finds evidence of unethical research practices or other ethical or legal principles, it shall submit its finds and conclusions in a report to the Dean, along with recommendations for appropriate action. The Dean shall then advise the researcher(s) involved of the findings and take appropriate administrative action.

If the alleged unethical research practice is substantiated by a thorough investigation, the following actions will also take place:

1. The granting agency will be notified of the finds of the investigation, and appropriate restitution of grant funds will be made;

2. All pending abstracts and papers emanating from the research found to be unethical will be withdrawn by the author(s) and the editors of journals in which previous abstracts and papers appear will be notified;

3. Institutions and granting agencies with whom the researcher(s) previously had been affiliated will be notified if there is reason to believe that the validity of previous research might be questionable;

4. Consideration will be given, in consultation with legal counsel, for the release of information about the incident to the public press, particular when public funds were used to support the unethical research;

5. Faculty practices, and College policies and procedures, for promoting the ethical conduct of research and investigation of allegations of misconduct will be scrutinized and modified in light of the experience gained;

6. The matter will be referred to the Dean of the Faculty for determination of whether further disciplinary action is appropriate, which action may include but is not limited to referral to the appropriate Faculty committee.

COLLEGE RESPONSIBILITY IN CASE OF RESIGNATION OR TERMINATION

Even if the Respondent leaves the College before the case is resolved, the College has a responsibility to continue the examination of the allegations and reach a conclusion. Further, the College will cooperate with the processes of other institutions to resolve such questions.

RECORDKEEPING REQUIREMENTS FOR THE PUBLIC HEALTH SERVICE

The College will make a submission to the Office of Scientific Inquiry of an annual assurance that will include aggregate information on allegations, inquiries, and investigations as the Secretary of the Public Health Service may prescribe.

ACKNOWLEDGMENT

We wish to thank the University of California at Los Angeles and the University of Connecticut for providing the model policies on which these guidelines were based.