INVESTIGATING POSSIBLE SCIENTIFIC MISCONDUCT

10/26/99

The Cook County Bureau of Health Services recognizes the importance of medical Research and recognizes that Research presents an opportunity to improve the quality of patient care and to reduce the incidence of morbidity and mortality among the patients and patient populations it serves. The Bureau supports the performance of Research in an environment which discourages Misconduct in all Research and deals forthrightly with possible Scientific Misconduct. The Cook County Bureau of Health Services desires to comply with all applicable law in the conduct of Research within its facilities. 

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The purpose of this Policy is to delineate the responsibilities of the Bureau, its constituent Affiliates, County-employed personnel working at Bureau facilities and other persons authorized to engage in Research at Bureau facilities with respect to the investigation and reporting of possible instances of Scientific Misconduct in the performance of Research in a manner that is consistent with the requirements of applicable law. 

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This Policy shall apply to all individuals engaged in Research, Service, or Administration at Cook County Bureau of Health Services Facilities. Individuals engaged in/observant of Research activities in Bureau Facilities who are subject to this Policy shall include but not be limited to: scientists, trainees, technicians, students, fellows, volunteers, guest Researchers and collaborators on Research projects in which County-employed personnel are designated key personnel, subcontractors, principal investigators or co-investigators. 

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"Adverse Action" means any action taken by the Bureau, its Affiliates or its employees or representatives which negatively affects the terms or conditions of the Complainant's status at the institution, including but not limited to his or her employment, academic matriculation, awarding of degree, or institutional relationship established by grant, contract or cooperative agreement. 

"Affiliate's Medical Director" shall mean the physician who is responsible for administering the Affiliate's medical activities, and shall include his/her designee. 

"Allegation" shall mean any written or oral statement(s) or other indication of possible Scientific Misconduct made to a Bureau official. 

"Associate Research Integrity Officer (ARIO)" shall mean the official at each of the Affiliate facilities who is responsible for receiving initial Allegations about possible misconduct at that Affiliate site, and who, in collaboration with the Bureau RIO, shall assess such Allegations, and participate in inquiries and investigations into such Allegations 

"Bureau" shall refer to the Cook County Bureau of Health Services. 

"Bureau Affiliate" shall refer to the constituent Affiliates of the Bureau, including Cook County Hospital, Provident Hospital, Oak forest Hospital, the Ambulatory & Community Health Network, Cermak Health Services, and the Cook County Department of Public Health. 

"Bureau Chief" shall mean the Chief of the Bureau of Health Services and shall include his/her designee. 

"Bureau Facilities" shall refer to all institutional or ambulatory care facilities operated by the Bureau and its constituent Affiliates, and all buildings associated therewith at which Research Activities are conducted which are subject to the review of the Bureau's Scientific Committees (IRBs) or Institutional Animal Care and Use Committee. 

"Bureau Research Integrity Officer (RIO)" shall mean the Bureau official who is responsible for assessing Allegations of Scientific Misconduct and conducting or overseeing inquiries and investigations into such Allegations. 

"Chief Operating Officer" shall mean the Chief Operating Officer of a Bureau Affiliate and shall include his/her designee. 

"Complainant" shall refer to an individual who makes an Allegation of Scientific Misconduct as required under this Policy. 

"Conflicts of Interest" shall mean the real or apparent interference of one person's interest with another person's interest, where potential bias may occur due to prior or existing personal or professional relationships. 

"Ex-Officio" shall mean a member of a body by virtue of an office or position held. Unless otherwise expressly provided, "ex-officio" means without voting rights. 

"Formal Investigation" shall refer to any investigation and hearing conducted by the Bureau's Research investigation Hearing Committee after the Research Hearing Integrity Inquiry Committee has recommended further investigation of a report of possible Scientific Misconduct. 

"Good Faith Allegation" or "Allegation in Good Faith" shall mean an Allegation(s) of Scientific Misconduct made by a Complainant who honestly believes that Scientific Misconduct may have occurred. A Good Faith Allegation need not be objectively made nor be subsequently verified to be made in Good Faith. However, a Complainant who recklessly disregards evidence that disproves an Allegation has not made the Allegation in Good Faith. 

"Inquiry" or "Initial Inquiry" shall mean the initial gathering of information and the review thereof by the Bureau's Research integrity Inquiry Committee in order to determine whether an Allegation of possible Scientific Misconduct warrants a Formal Investigation. The purpose of the Inquiry is not to reach a final conclusion as to whether Misconduct occurred or who was responsible for the Misconduct. 

"Misconduct" or "Scientific Misconduct" shall include fabrication, falsification, plagiarism, or other practices that significantly deviate from the commonly accepted practices of the scientific community with respect to the proposal, performance or reporting of Research. "Misconduct" shall not include errors or differences in the interpretation of data or results made in Good Faith; nor shall it include disputes regarding the appropriate acknowledgment of collaborators. 

"ORI" shall refer to the Office of Research Integrity, an independent entity within the U.S. Department of Health and human Services reporting to the United States Secretary of Health and Human Services. 

"PHS" shall mean the Public Health Service, part of the Department of Health and Human Services (DHHS) of the United States government. 

"Research" or "Research Activities" For purposes of this Policy, "Research" and "Research Activities" shall mean all activities designed to acquire new generalizable knowledge in medicine, disease prevention and patient care with the purpose of reducing, directly or indirectly, morbidity and mortality and improving patient care with respect to the patient populations served by the Bureau. Research activities governed by this Policy are those which are subject to the approval of both a Bureau Affiliate and a Bureau Scientific Committee (IRB) or the Cook County Hospital Institutional Animal Care and Use Committee (IACUC) in order to be conducted within Bureau Facilities or by Bureau employees acting as employees or agents of the Bureau. 

"Research Integrity Inquiry Committee (Inquiry Committee)" shall refer to the Committee which is responsible for conducting the Initial Inquiry to determine whether there is sufficient evidence of possible Scientific Misconduct to warrant a Formal Investigation. 

"Research Investigation Hearing Committee (Investigation Committee)" shall refer to the Committee which is responsible for the formal examination and evaluation of all relevant facts to determine if Scientific Misconduct has occurred and, if so the responsible person for the Scientific Misconduct. 

"Respondent" shall mean an individual against whom an Allegation of Scientific Misconduct is directed, or the person who is the subject of the Inquiry or Formal Investigation. There can be more than one Respondent in any Inquiry or Formal Investigation. 

"Responsible Official" means the official designated by and reporting to the Bureau Chief to establish and implement the institution's policies on protecting Complainants against Retaliation in cases of alleged Scientific Misconduct. 

"Retaliation" means any Adverse Action or credible threat of an Adverse Action taken by the institution, or its employees or representatives, in response to a Complainant's Good Faith Allegation of Scientific Misconduct. It does not include an institution's decision to investigate a Good Faith Allegation of Scientific Misconduct. 
 

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A.    Internal Reporting Requirements

The Bureau shall incorporate this Policy in its "Guidebook for Grants and Research" to give notice of the procedures for reporting possible Scientific Misconduct. 

Whenever any individual observes, suspects or reasonably believes that Scientific Misconduct may have occurred, he or she shall promptly report this information to the Affiliate's Associate Research Integrity Officer (ARIO), or the Bureau Research Integrity Officer (RIO), who shall serve as the Chairman of the Bureau's Research Integrity Inquiry Committee (Inquiry Committee) . The Bureau RIO shall be appointed, for a term of five years, by the Chief of the Bureau who shall consult with the Affiliate's Medical Directors and Chief Operating Officers prior to making this appointment. 

Associate RIO's shall be appointed, for a term of five years, by the Chief Operating Officer of the Affiliate who shall consult with the Affiliate's Medical Director in making the appointment. 

If an individual is unsure whether a suspected incident falls within the definition of Scientific Misconduct, the individual may call the appropriate ARIO or the RIO to informally discuss whether the incident falls within the definition. If an RIO or ARIO is involved in suspected Scientific Misconduct, then individuals should report to the Medical Director or Chief Operating Officer of his/her Affiliate. 

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B. Initial Inquiry by the Research Integrity Inquiry Committee:

1. Preliminary Assessment

Upon receiving an Allegation of possible Misconduct, either directly from the person bringing the Allegation or from an Associate RIO, the RIO shall assess the Allegation to determine whether there is sufficient evidence of possible Scientific Misconduct to proceed with an Inquiry. In conducting the assessment, the RIO shall determine the following: 
 

a.. Whether the Allegation falls within the definition of Scientific Misconduct; and 

b. Whether there is reasonably sufficient evidence of information to warrant further Inquiry into the Allegation.

2. Initiation of Inquiries Into Allegations of Misconduct

If, following the preliminary assessment, the RIO determines that the Allegation falls within the definition of Scientific Misconduct and is substantial enough to allow specific follow-up, he/she should promptly convene a Research Integrity Inquiry Committee to initiate an Inquiry. The RIO shall clearly identify the original Allegations and any related issues which should be evaluated by the Inquiry Committee. 

The purpose of an Inquiry is to gather and expeditiously review factual information to determine if a Formal Investigation of an Allegation of Misconduct is warranted. An Inquiry provides a preliminary review to separate Allegations from frivolous, unjustified, or clearly mistaken conclusions which are drawn from observations. The Respondent is not afforded a formal hearing in the Inquiry stage. At the discretion of the Inquiry Committee, the Respondent may be allowed to meet with its members. 

During Inquiries and Investigations, the Bureau will select necessary and appropriate expertise to evaluate the Allegations, and will take appropriate interim administrative actions to protect Federal funds and ensure that the purposes of Federal financial assistance are being carried out. 

3. Referral of Other Issues

If the RIO or an ARIO identifies non-Scientific Misconduct issues, the RIO or ARIO should refer these matters to the appropriate office or committee for action. Issues requiring referral include, but are not limited to, the following: criminal violations, violations of human and animal subject regulations, violation of Food and Drug Administration regulations and fiscal irregularities. 

4. Research Integrity Inquiry Committee

The Research Integrity Inquiry Committee shall be composed of the Bureau's Research Integrity Officer (RIO) who shall chair the Inquiry Committee, the Associate RIO(s) from the Affiliate(s) involved, and two (2) other RIO-appointed members who possess appropriate expertise as determined by the nature of the Allegation. The members of this Committee should not be members of Scientific Committees (IRBs) or the Institutional Animal Care and Use Committee. The Medical Director(s) and Chief Operating Officer(s) of the Affiliate(s) involved shall be ex-officio members of the Research Integrity Inquiry Committee. 

5. Avoidance of Conflicts of Interest

In appointing the members of the Inquiry Committee, the RIO shall make every effort to avoid real or apparent Conflicts of Interest on the part of those involved in all inquiries and investigations. The RIO shall refrain from appointing any person to the Inquiry Committee who is involved, directly or indirectly, in the Research Activities which are the subject of an Allegation of possible Scientific Misconduct. Further, the RIO shall refrain from appointing persons who are closely associated with a Respondent or potential Respondent, or with the Complainant. 

6. Conduct of the Initial Inquiry

The RIO shall convene the Inquiry Committee prior to the commencement of the Initial Inquiry. The Inquiry Committee shall designate one or more of its members to gather relevant Research records and other materials and conduct interviews including, but not limited to, interviews of the Complainant, Respondent and key witnesses for the purpose of reporting this information to the Inquiry Committee for its review. The Inquiry Committee shall meet as a committee to examine the information gathered and shall designate one of its members to prepare a draft of the Initial Inquiry Report of the Inquiry Committee. The Inquiry Committee shall convene to discuss the draft report and may revise the draft report, where necessary, prior to adopting and issuing its Initial Inquiry Report. 

The Inquiry Committee shall complete the Initial Inquiry and shall submit its Initial Inquiry report to the Respondent and Complainant within sixty (60) days of its initiation unless circumstances clearly warrant a longer period. 

7. Initial Inquiry Reports

The report of the Inquiry Committee shall be a confidential document that : (1) identifies the evidence that was reviewed; (2) summarizes relevant interviews; and (3) includes the conclusions of the Inquiry Committee that a Formal Investigation be conducted or that the matter be dismissed due to insufficient evidence of possible Scientific Misconduct to warrant further investigation. The Inquiry Committee's report shall be a confidential committee document, but shall be made available to the Respondent. The Inquiry Committee shall also notify the Respondent, in a separate communication, regarding whether or not it has concluded that the Allegation of possible Scientific Misconduct warrants a Formal Investigation. The Respondent may make written comments regarding the findings and recommendation contained in the Initial Inquiry report. The Respondent shall forward any such written comments to the Inquiry Committee within fourteen (14) days of the issuance of the Initial Inquiry Report. The Respondent's comments shall be made part of the Initial Inquiry Report which shall be maintained in the files of the Inquiry Committee for at least three (3) years after the Inquiry. Where the Inquiry Committee has failed to complete the initial Inquiry within 60 days, the reasons for exceeding 60 days shall be made part of the Initial Inquiry Report. 

Where the recommendation of the Inquiry Committee is that a Formal Investigation be conducted, the RIO shall promptly forward a copy of the Initial Inquiry Report to the Bureau Chief and the Chief Operating Officer(s) and Medical Director(s) of the Affiliate(s) involved. 

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C. Formal Investigations Into Allegations of Scientific Misconduct

1. The Research Investigation Hearing Committee

Within thirty (30) days after the issuance of a report by the Research Integrity Inquiry Committee concluding that a Formal Investigation of the Allegations of possible Scientific Misconduct is warranted, a three  (3) member Research Investigation Hearing Committee shall be convened by the Affiliate's Chief Operating Officer, with approval from the Bureau Chief. The Affiliate's Medical Director, in consultation with the President of the Affiliate's Executive Medical Staff, shall appoint the members of the Investigation Hearing Committee. This Committee may be composed of members of the Medical Staff, representatives from the Affiliate or Affiliate's Administration and may include persons from various departments within the Affiliate or Bureau, including scientific officers and nursing personnel. None of the individuals who serve on the Investigation Hearing Committee shall have served as appointed members on the Inquiry Committee concerning the same Allegations under Formal Investigation. The Affiliate's Medical Director or a designated member of the medical staff, the Associate RIO, and the Chief Operating Officer shall be ex-officio members of the Research Investigation Hearing Committee. 

In the case that an Allegation concerns Research activities at more than one Bureau Affiliate, the Medical Directors of the Affiliates involved will act in consultation with each other and with their Chief Operating Officers, Medical Staff Presidents, and the Bureau Chief to appoint members to the Hearing Committee. In such cases, the membership of the Hearing Committee may be expanded to include no more than three (3) appointed members from each Affiliate involved. 
 

2. The Formal Investigation and Hearing

The Investigation Hearing Committee shall provide at least seven (7) days advance written notice to the Respondent (s) of the date or dates on which it shall conduct its hearing. The Formal Investigation normally will include the examination of all documentation including but not limited to relevant data materials, proposals, publications, correspondence, memoranda and notes of telephone calls. The Bureau's Research Integrity Officer shall present the Initial Inquiry report, together with any evidence obtained by the Inquiry Committee, for consideration by the investigation Hearing Committee. The Investigation Hearing Committee shall review the information, findings and conclusions of the Inquiry Committee and shall provide Respondent (s) with an opportunity to present testimony and documentary evidence in defense of the Allegations of possible Scientific Misconduct. 

Where circumstances warrant, either the RIO or the Investigation Hearing Committee may request witnesses to appear and provide information regarding the matters in issue and may request that documents be produced for review. All interviews should be transcribed or tape recorded. Complete summaries of the interviews must be provided to the interviewed party for comment or revision and included as part of the investigation file. Upon completing its Investigation, the Investigation Hearing Committee shall issue a Formal Investigation report which sets forth its factual findings and conclusions regarding whether Scientific Misconduct has occurred. 

Within one hundred twenty (120) days of the appointment of the Investigation Hearing Committee, the Committee shall complete its Investigation including the conducting of the Investigation, the preparing of its final report, making the report available for comment by the subject of the Investigation, and submission of the final report to the ORI. Where the Investigation Hearing Committee cannot complete its report within 120 days of its initiation and the report of possible Scientific Misconduct involves a Research project that is funded by the PHS, the Committee must submit a written request to the Office of Research Integrity (ORI) for an extension, which shall include an explanation for the delay, an interim report on the progress of the Formal Investigation and an indication of the additional steps which must be taken and the amount of additional time which will be required to complete the Formal Investigation and issue a report. A copy of any such request shall be provided to the Bureau Chief and the Chief Operating Officer(s) of the Affiliate(s) involved 
 

3. The Formal Investigation Report: Contents and Distribution

The Formal Investigation Report shall be strictly confidential and must include the policies and procedures under which the investigation was conducted, describe how and from whom information was obtained, state the findings, explain the basis for the findings, include either the actual text or an accurate summary of the position of each person whom the Investigation Hearing Committee concludes has engaged in Scientific Misconduct, as well as whether any sanctions have or may be imposed by the Affiliate(s) or Bureau. Records of the proceedings shall be maintained by the Formal Investigation Committee for no less than three (3) years following the termination of the Formal Investigation. 

The Investigation Committee must make available its final report to Complainants and Respondents. Complainants and Respondents shall forward any written comments to the Investigation Committee within fourteen (14) days following the issuance of the final report. Such comments shall be made part of the final report. 

The Formal Investigation report issued by the Investigation Hearing Committee shall be forwarded to the Bureau Chief, the appropriate Chief Operating Officer(s), and the responsible Scientific Committee (IRB) or the IACUC, as appropriate, upon its adoption by the Committee. 

4. Sanctions

As a result of a positive finding of Scientific Misconduct in Bureau Facilities by the Investigation Hearing Committee, the Chief Operating Officer(s) of the Affiliate(s) involved, in consultation with the Bureau Chief, may issue a sanction prohibiting the Respondent from engaging in Research Activities in Bureau Facilities or imposing restrictions on the type of Research which the Respondent may participate in or the circumstances under which the Respondent may participate in Research Activities. Nothing herein shall prohibit the Affiliate's Medical Director or Chief Operating Officer from issuing a temporary order to this effect during the pendency of an Initial Inquiry or a Formal Investigation conducted pursuant to this Policy. 

Nothing in this Section shall be construed to limit an Affiliate's Medical Staff from taking appropriate action with respect to the medical Staff membership and clinical privileges of a Respondent who is a Member of the Affiliate's Medical Staff at any time. Similarly, nothing in this Section shall be construed to limit the Bureau or its Affiliates from taking appropriate action with respect to the employment of a Respondent who is employed by the County of Cook to work at a Bureau Facility. In addition and notwithstanding the decision of any other person or entity regarding the imposition of sanctions pursuant to this Policy, the Bureau Chief shall retain the authority to prohibit or restrict the participation of the Respondent in Research Activities in Bureau Facilities at any time. 

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Mandatory Immediate Reporting to ORI during Initial Inquiry or Formal Investigation Procedures of PHS Funded Research Project

If it is the conclusion of the Inquiry Committee that a Formal Investigation must be initiated, and the incident involves a PHS funded project, the RIO must notify in writing the Office of Research Integrity (ORI), National Institutes of Health (NIH), Bethesda, Maryland of the decision to initiate a Formal Investigation on or before the Formal Investigation begins. Notification should include the name of the Respondent(s), the general nature of the Allegation and the PHS application or grant number involved. 

If it is the conclusion of the Inquiry Committee that a Formal Investigation must be initiated, and no PHS support is involved, reporting to the ORI shall be at the discretion of the RIO. 

If the Bureau plans to terminate an Inquiry or Formal Investigation involving a PHS funded Research project without completing all relevant Federal requirements, the RIO shall submit a report of the planned termination to the ORI including a description of the reasons for the termination. 

Further, any significant variations from the provisions of this Policy should be explained in any reports submitted to the ORI. 

If at any stage of the Inquiry or Formal Investigation any of the following conditions exist and PHS funds are involved, there is an obligation to provide written notification to the ORI: 

1) There is an immediate health hazard; 
2) There is an immediate need to protect federal funds or equipment; 
3) There is an immediate need to protect the interests of the Complainant or Respondent as well as any of their 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 which the ORI must be informed within 24 hours of information obtainment)

The ORI shall also be apprised of any developments during the course of the investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest. 

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D. Confidentiality; Medical Studies Act

All information, data, reports, minutes or memoranda relating to the implementation of this Policy are intended for use in the conduct and review of medical Research performed with the purpose of reducing morbidity and mortality and improving patient care with respect to the patients and patient populations served by the Bureau. All such information shall be treated as strictly confidential and its disclosure shall be prohibited in accordance with the requirements of the Illinois Medical Studies Act, 735 ILCS 5/8-2101 et seq. 

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Inquiries and Investigations will be conducted in a manner that will ensure fair treatment to the subjects of the Inquiry or Investigation and confidentiality to the extent that it is consistent with protecting public health and safety and with the carrying out the Inquiry and Investigation. Respondents are entitled to private and confidential treatment to the maximum extent possible during the course of Inquiries and Investigations. 

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The Bureau shall undertake diligent efforts to protect the positions and reputations of those persons who, in Good Faith, make Allegations. For this reason, the Bureau adopts the following principles for the protections of Complainants: 

(1) Complainants are free to disclose lawfully whatever information supports a reasonable belief of Research Misconduct as it is defined by PHS Policy, 

(2) The Bureau has a duty not to tolerate or engage in Retaliation against Good-Faith Complainants, 

(3) The Bureau has a duty to provide fair and objective procedures for examining and resolving complaints, disputes and Allegations of Research Misconduct, 

(4) The Bureau has a duty to follow procedures that are not tainted by partiality arising from personal or institutional conflict of interest or other sources of bias, 

(5) The Bureau has a duty to elicit and evaluate fully and objectively information about concerns raised by Complainants 

(6) The Bureau has a duty to handle cases involving alleged Research Misconduct as expeditiously as possible without compromising responsible resolutions, and 

(7) At the conclusion of proceedings, the Bureau has a responsibility to credit promptly, in public or private as appropriate, those whose Allegations are substantiated. 

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A. Responsible Official 

The Bureau Chief shall designate a "Responsible Official" to implement the institution's Complainant protection policies who shall be free of any real or apparent conflicts of interest in any particular case. If involvement of the Responsible Official in a particular case creates a real or apparent conflict of interest with the Bureau's obligation to protect Good Faith Complainants, the Bureau Chief shall appoint a substitute Responsible Official who has no conflict of interest. The Responsible Official also serves as a liaison between the institution and ORI for transmitting such information as ORI may require. 
 

B. Notice of Bureau Policy

The Bureau shall incorporate this Policy in its "Guidebook for Grants and Research" to give notice of the procedures and time frame for filing Allegations of Retaliation against Complainants in a Scientific Misconduct case. 

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C. Filing Complaints of Retaliation

1. A Complainant who wishes to receive the procedural protections described by these Guidelines shall file his or her Retaliation complaint with the Responsible Official within 180 days from the date the Complainant became aware or should have become aware of the alleged Adverse Action. The Bureau shall review and resolve all Complainant Retaliation complaints and should do so within a reasonable time after receipt of the complaint. 

2. The Retaliation complaint must include a description of the Complainant's Scientific Misconduct Allegation and the asserted Adverse Action, or threat thereof, against the Complainant, by the Bureau or its employees or representatives in response to the Allegation. If the Retaliation complaint is incomplete, the Responsible Official shall describe to the Complainant what additional information is needed in order to meet the minimum requirements of a complaint. 

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D. Responding to Complaints of Retaliation

1. Upon receipt of a Complainant Retaliation complaint, the Responsible Official shall notify the Complainant of receipt within a reasonable time after receipt. The notice shall inform the Complainant of the Investigation process the Bureau will follow in resolving the Retaliation complaint and the necessary actions by the Complainant required under that process. 

2. The Complainant may raise any concerns about the Investigation process with the Responsible Official and the Bureau may modify the process in response to the Complainant's concerns. 

3. When the original misconduct allegation involves federally funded research, the Bureau shall notify ORI of any Retaliation complaint it receives. 

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E.   Interim Protections

1. At any time before the merits of a Retaliation complaint have been fully resolved, the Complainant may submit a written request to the Responsible Official to take interim actions to protect the Complainant against an existing Adverse Action or credible threat of an Adverse Action by the Bureau or its employees or representatives. 

2. Based on the available evidence, the Responsible Official shall make a determination of whether to provide interim protections and shall advise the Complainant of his or her decision in writing. Documentation underlying the decision whether to provide interim protections shall become part of the record of the complaint. When the Retaliation complaint is fully resolved, any temporary measure taken to protect the Complainant shall be discontinued or replaced with permanent remedies. 

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1. For each Retaliation complaint received, the Bureau shall carry out its Investigation in a timely fashion. The process should be completed within 180 days of the date the complaint is filed, unless the Complainant agrees to an extension of time. When the original misconduct allegation involves federally-funded research, the Bureau shall promptly report the final outcome of the Investigation or any settlement to ORI. 

2. If the Complainant declines the Bureau's Investigation process according to this Policy, he or she may pursue any other legal rights available to the Complainant for resolution of the Retaliation complaint. However, ORI will deem the Bureau to have met its obligation under 42 C.F.R. Part 50.103(d)(13) and will not pursue the complaint further. 

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1. An investigation of a Retaliation complaint shall be timely, objective, thorough, and competent. The investigation should be conducted by a panel of at least three (3) individuals appointed by the Responsible Official. The members of the investigation panel, who may be from outside the Bureau, shall have no personal or professional relationship or other conflict of interest with the Complainant or the alleged individual retaliator(s), and shall be qualified to conduct a thorough and competent investigation. 

2. The investigation shall include the collection and examination of all relevant evidence, including interviews with the Complainant, the alleged retaliator(s), and any other individual who can provide relevant and material information regarding the claimed Retaliation. 

3. The Bureau shall fully cooperate with the investigation and use all available administrative means to secure testimony, documents, and other materials relevant to the investigation. 

4. The confidentiality of all participants in the investigation shall be maintained to the maximum extent possible throughout the investigation. 

5. The panel members shall evaluate and respond objectively to any concerns raised by the Complainant about the process, including concerns regarding the selection of the Responsible Official and specific panel members, which are raised prior to resolution of the complaint. 

6. The conclusions of the investigation shall be documented in a written report and made available to the Complainant. The report shall include findings of fact, a list of witnesses interviewed, an analysis of the evidence, and a detailed description of the investigative process. 

7. The Bureau Chief shall make a final determination as to whether Retaliation occurred. This decision shall be based on the report, the record of the investigation, and a preponderance of evidence standard. 

8. If there is a determination that Retaliation has occurred, the Bureau Chief, in consultation with the appropriate Chief Operating Officer(s) shall determine what remedies are appropriate to satisfy the Bureau's regulatory obligation to protect Complainants. The Bureau Chief shall, in consultation with the Complainant, take measures to protect or restore the Complainant's position and reputation, including making any public or private statements, as appropriate. In addition, the Bureau Chief may provide protection against further Retaliation by monitoring or disciplining the retaliator. 

9. When the original misconduct allegation involves federally-funded research, the Bureau shall promptly notify ORI of its conclusions and remedies, if any, and forward the underlying investigation report to ORI. 

10. The ORI will review the report to determine whether the Bureau has substantially followed the process described herein. If the Bureau has substantially conformed to the process, ORI will not review the merits of the Bureau's determination under Paragraphs 7 and 8. 

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At any time ORI may review the Bureau's compliance with 42 C.F.R. Part 50.103(d)(13) and this Policy. The Bureau and its employees or representatives shall cooperate with any such review and provide ORI access to all relevant records. If the Bureau's procedures and implementation thereof substantially conform to those described in this Policy, it shall be deemed to have met its Complainant protection obligation under 42 C.F.R. Part 50.103(d)(13).