Chicago Association for Research and Education in Science
MISCONDUCT IN SCIENCE POLICY

All of the research administered by the Chicago Association for Research and Education in Science is “VA Research” in the sense that it is accomplished by VA employees, either paid or WOC (without compensation) and the research must be approved by the Hines/North Chicago Research and Development Committee and appropriate subcommittees (Institutional Review Board, Institutional Animal Care and Use Committee, Research Safety Subcommittee, etc.). CARES is committed to compliance with the applicable policies and procedures of VA Research including the “Misconduct in Science” policy of the Department of Veterans Affairs which derives from VA Manual M-3, Part 1, Chapter 15 (soon to be replaced by VHA Handbook 1200.14) and which is summarized as follows.

Purpose: The purpose of this document is to define "misconduct in scientific research" and to establish policies and procedures for the reporting, investigating and resolving of complaints alleging scientific misconduct by Department of Veterans Affairs investigators. The procedures are designed to protect public confidence in the integrity of research conducted in the VA and to protect the rights and reputations of the individual(s) accused of misconduct.

Policy: It is the policy of VA's Research and Development Program to require high ethical standards for all research activities and, if necessary, to inquire, investigate and resolve promptly and fairly, all alleged or apparent misconduct in science. Appropriate action will be taken against individuals if it is determined that misconduct has occurred.

Definitions:

Allegation means any written or oral statement or other indication of possible scientific misconduct made to an institutional official.

Conflict of interest means the real or apparent interference of one person's interest with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.

Director means the Director of the Edward Hines Jr. Department of Veterans Affairs Hospital who also functions as the Research Integrity Officer.

Good faith allegation means an allegation made with the honest belief that scientific misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation.

Inquiry means gathering information and initial fact-finding to determine whether an allegation or apparent instance of scientific misconduct warrants an investigation.

Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred and, if so, to determine the responsible person and the seriousness of the misconduct.

ORI means Office of Research Integrity, the office within the U.S. Department of Health and Human Services (DHHS) that is responsible for the scientific misconduct and research integrity activities of the U.S. Public Health Service.

PHS means the U.S. Public Health Service, a component of the DHHS.

PHS regulation means the Public Health Service regulation established standards for institutional inquiries and investigations into allegations of scientific misconduct, which is set forth at 42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science".

PHS support means PHS grants, contracts, or cooperative agreements or applications therefor.

Research Integrity Officer means the institutional official responsible for assessing allegations of scientific misconduct and determining when such allegations warrant further inquiry and for overseeing inquiries and investigations.

Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted or reported research that constitutes the subject of an allegation of scientific misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; x-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; medical charts; and patient research files.

Respondent means the person(s) against whom an allegation of scientific misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.

Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or employee because the individual has in good faith, made an allegation of scientific misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation.

Scientific misconduct or misconduct in science mean the fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest errors honest differences in interpretations or judgements of data.

Whistleblower means a person who makes an allegation of scientific misconduct.

Distinguishing Regulatory Non-Compliance from Scientific Misconduct

Process:

Allegations of regulatory non-compliance or scientific misconduct are to be reported, preferably in writing, to the Associate Chief of Staff for Research (ACOS/R&D).

The ACOS/R&D will immediately perform an administrative audit the purpose of which is to make a prompt determination whether a possible occurrence of regulatory non-compliance or scientific misconduct warrants further attention. The ACOS/R&D will provide a written report of the findings of the administrative audit to the Director and COS within three days after receiving the allegation. The written report will include a recommendation regarding whether or not further evaluation of the allegation is warranted.

Within five days after receiving the written report of the administrative audit from the ACOS/R&D, the Director, with consultation from the COS, will make a determination as to whether further examination of the allegation is warranted.

If the Director makes the decision that further inquiry is not warranted, the reasons for the decision will be documented in writing with a copy provided to the ACOS/R&D. The matter is concluded at this point.

If the Director determines that further examination of the allegation is warranted, the Director will activate a Panel of Inquiry (POI). The purpose of the POI is to make a preliminary evaluation of the available evidence including the testimony of the respondent, to determine if there is sufficient evidence of possible scientific misconduct to warrant an investigation. The inquiry process must be thorough and expeditious. A written report of the inquiry will provided to the Director within 10 days following activation of the POI.

Within five days after receipt of the written report of the POI, the Director will determine whether sufficient evidence of unethical scientific practice exists to warrant an investigation. (If the respondent is a member of the affiliated medical school, the Director will make this determination in concert with the Dean of the affiliated medical school.) The Director may seek additional advice from Regional Counsel, the Director of the applicable VA Research Service (Medical, Rehabilitation, Health Services or Cooperative Studies), the Office of Research Integrity of the Public Health Service or the Office for Protection of Research Risks of the Public Health Service.

In some instances, the allegations may be resolved through the POI process. If the POI Report substantiates that the allegations are clearly frivolous, self-serving, vindictive, or without supporting documentation, no further action is required. However, in such cases, it is the Director's responsibility to create and maintain a record of such inquiries in the event that subsequent allegations are rose which involve issues that were previously reviewed.

If the Director determines that sufficient evidence exists to warrant further investigation, the following steps will be implemented.

The Director will insure that all original research records and materials relevant to the allegation are immediately secured.

If the available evidence suggests a violation of criminal law, the Director will refer the matter to the Office of the Inspector General.

The Director, in consultation with the Dean of the affiliated medical school if appropriate, will appoint a Scientific Misconduct Investigation Committee (SMIC) within ten days of the initiation of the inquiry. Unless special circumstances dictate otherwise, the ACOS/R&D will chair the SMIC. The SMIC should consist of staff of the VA medical facility and the affiliated medical school who have experience in research and who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence as it relates to the allegations, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, administrators, layers, or other qualified persons. Additional individuals with special expertise or scientific expertise similar to that of the respondent from outside the institution may also be appointed to the committee. The Chair of the committee will keep the Director informed of the progress of the inquiry and is responsible for issuing the final, written report of the committee.

At the time the Committee is appointed, the Director will notify the respondent(s) in writing of the allegations and that a committee of investigation has been formed to consider the allegations. In this same document, the respondent(s) must also be informed that they have the right to be represented by legal cousel or other personal representatives. NOTE: The personal representative(s) may act in an advisory capacity only.

At the time the Committee is appointed, the Director and Dean will determine when other interested parties such as collaborators, supervisors, and agencies sponsoring or funding the reseacher(s) in question are to be informed of the pending investigation.

At the time the Committee is appointed, the ACOS/R&D will notify in writing those listed below, as applicable, with a critical summary of the facts to include: Name of respondent; general nature of the allegation as it relates to the definition of scientific misconduct; the name of the sponsor of the research; and the specific grant or award number(s) if a funded research project.

The appropriate VA Central Office Service (Medical, Health Services, Cooperative Studies, Rehabilitation),
The Director, ORI.
The FDA if the research in question is a sponsored clinical trial
Other sponsor of the research

If the alleged unethical practice involves the abuse of humans, animals or biohazards, the SMIC is expected to have an active liaison with the Chairman of the Institutional Review Board (IRB) or the Institutional Animal Care and Use Committee (IACUC), the Biohazard Subcommittee or others as appropriate.

The SMIC has discretion in choosing the manner in which it conducts the investigation including the securing and review of documentary evidence including all original records, protocols and date; interviewing relevant persons either in person or by telephone; group meeting of discussion or inquiry and hearings. Hearings must be closed so that a fair and judicious investigation which protects the rights and reputations of all involved can be maintained. Records of the investigation will be disclosed only in accordance with law. The respondent(s) and the individual(s) making the allegations must be interviewed by the SMIC. Both parties must be given the opportunity to offer comments and other relevant information and to propose witnesses. The SMIC will ensure that the information collected is recorded properly and that confidentiality is maintained.

Files maintained by VA in conjunction with the investigation will not be retrievable by personal identifiers (e.g., name, social security number, etc.) If an Agency employee fails to observe this prohibition and maintains investigation records by personal identifiers, such conduct may constitute a violation of the Privacy Act, i.e., U.S.C. (United States Code) 552a. This violation may lead to a Federal Court imposing sanctions against VA and imposing criminal penalties against the responsible employee, and/or appropriate disciplinary action.

The length of time from reporting an instance of possible misconduct to completion of the investigation should not exceed three months unless circumstances are exceptional. If interval progress reports are made by the SMIC, they must be provided to the Director, COS, Dean, Director of the appropriate Research Service.

Procedures to be taken following completion of the investigation and following receipt of comments of respondent(s).

A written summary of findings, which must include the content of critical summary of the facts of the incident as described above, must be made available to the respondent(s) for comment and rebuttal. If the text of the summary is acceptable in principal, the signatures of the respondent(s) should so indicate.

If the investigation does not confirm the alleged unethical scientific practices:

The Director, COS and (if applicable) Dean of the medical school must take appropriate action to ensure that the reputation of the respondent(s) is cleared of suspicion.

Other interested parties such as collaborators, supervisors and agencies sponsoring or funding the research, must be notified that the respondent(s) was absolved of wrong doing by the investigation.

The respondent must be given the opportunity of having a written notice of clearance sent to the relevant members of the faculty from the Dean of the medical school and by the Director of the VA medical facility to the relevant VA staff members.

If the investigation confirms the alleged unethical scientific practice:

A written report (RCS 10-0758) of the finding must be prepared by the ACOS/R&D and sent to the Director and, as applicable to the Dean and President of the medical school if applicable).

Following review of the RCS 10-0758, the Director (and Dean of the medical school if applicable) must prepare a written summary of the finding to include recommendations for administrative action to prevent future instances of unethical practices. This summary plus a description of corrective action taken against the respondent(s), if any, must be submitted promptly to:

The Director of the appropriate Research Service in VAHQ. If the respondent is a VA funded investigator, the VAHQ Research Service Director will make a decision regarding the VA research funding of the respondent and will communicate the outcome of the entire process to the VHA Under Secretary for Health and, as may be applicable, to the Office of Research Integrity, Office for Protection from Research Risks, the Food and Drug Administration and possibly other as may be required by law or regulation.

The Director, COS and Dean (if applicable), will take action to have all pending abstract and papers associated with the unethical scientific practices of the respondent(s) withdrawn; they must notify editors of journals in which previous abstract, articles and papers relating to the research in question were published.

The Director, Dean of the affiliated medical school (if appropriate) and the Under Secretary for Health, in consultation with legal counsel, should decide if the release of information regarding the scientific misconduct, to the media is warranted.