I. INTRODUCTION

The scientific community and the community at large rightly expect adherence to exemplary standards of intellectual honesty in the formulation, conduct, and reporting of scientific research. Allegations of scientific misconduct are taken seriously by the NIH. The process of investigating allegations must be balanced by equal concern for protecting the integrity of research as well as the careers and reputations of researchers.

The procedures that follow are intended to permit allegations of scientific misconduct to be processed promptly, confidentially, and fairly. A prompt response to an allegation helps to minimize any harm to the public that could result if misconduct is found and allows those who are incorrectly accused to clear their names without going through a long process. Allegations of misconduct that prove to be untrue, even if they were made in good faith, can damage careers and have a chilling effect on research. Confidentiality helps protect innocent people who are incorrectly or unjustly accused and those who bring the allegations. Fairness allows all of those who become involved in scientific misconduct cases to have the opportunity to participate appropriately in addressing the issue and seeks to protect innocent participants from adverse consequences.

II. APPLICABILITY

These policies and procedures apply to research conducted, or proposed to be conducted, in NIH facilities by any person; or research funded by the NIH Intramural Research Program; or research conducted, or proposed to be conducted, by an NIH employee or trainee as part of his or her official NIH duties or NIH training activity in any facility.

III. DEFINITIONS

  A. AIRIO - NIH Agency Intramural Research Integrity Officer - the primary official in the NIH Intramural Research Program designated by the NIH Director to be responsible for all matters related to the NIH's intramural research integrity program.

B. ARILO - NIH Agency Research Integrity Liaison Officer - the primary official designated by the NIH Director to be responsible for all matters related to the NIH's research integrity programs, both intramural and extramural.

C. Allegation - generally, any written and signed statement describing possible scientific misconduct and given to the NIH AIRIO.

Good Faith Allegation - an allegation made with the honest belief that scientific misconduct may have occurred.

Bad Faith Allegation - an allegation by a complainant who knows, or through reasonable inquiry could have known, that the allegation is untrue or frivolous.

D. Complainant - a person (informant) who makes an allegation of scientific misconduct.

E. CSCE - NIH Committee on Scientific Conduct and Ethics.

F. Deciding Official - the NIH ARILO is the deciding official who makes a final determination on findings of scientific misconduct by an Investigation Committee and determines any responsive NIH actions for all Institutes and Centers. The Deciding Official will not be the same individual as the AIRIO and should have no direct prior involvement in the allegation assessment, inquiry, or investigation. The DDIR is the deciding official for Inquiries.

G. Inquiry - the process of gathering information and initial fact-finding to determine whether an allegation or apparent instance of scientific misconduct warrants an Investigation.

H. Investigation - the formal examination and evaluation of all relevant facts to determine if scientific misconduct has occurred, and, if so, to determine the person(s) who committed it and the seriousness of the misconduct.

I. NIH Counsel - counsel from the office of the NIH legal advisor who represents the NIH during the scientific misconduct Inquiry and Investigation and who is responsible for advising the AIRIO, the Inquiry and Investigation Committees, and the Deciding Official on relevant legal issues. NIH counsel does not represent the respondent, the complainant, or any other person participating during the inquiry, investigation, or any follow-up action, except NIH staff responsible for managing or conducting the institutional scientific misconduct process as part of their official duties.

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

K. Research Record - any data or results that embody the facts resulting from scientific inquiry; it includes, for example, laboratory records, both physical and electronic, research proposals, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.

Evidence - includes, but is not limited to, research records, transcripts or recordings of interviews, committee correspondence, administrative records, grant applications and awards, manuscripts, publications, and expert analyses.

E-mail - NIH e-mail messages (including attachments that are created on NIH computer systems or transmitted over NIH networks) that are evidence of the activities at NIH or have informational value are considered Federal records/Government property (NIH Manual Chapter 1743).

L. Respondent - the person (subject) 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.

M. Retaliation - any action taken by the NIH or NIH staff that adversely affects the employment status or reputation of an individual 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 inquiry or investigation of such allegation.

N. Scientific misconduct or misconduct in research -

(from Federal Policy on Research Misconduct http://www.ori.dhhs.gov/documents/42_cfr_parts_50_and_93_2005.pdf)

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

Fabrication is making up data or results and recording or reporting them.

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit

Research misconduct does not include honest error or honest difference of opinion.

IV. RESPONSIBILITIES

A. Deciding Official

With respect to the Inquiry Committee Report, the Deputy Director for Intramural Research (DDIR) will evaluate the Inquiry Report and determine whether the evidence is sufficient to support possible findings of scientific misconduct and thereby justify conducting an Investigation. If the DDIR is involved in the case, the Director or his/her designee will assume this role.

With respect to the Investigation Report, the ARILO will be the Deciding Official.

B. NIH Agency Research Integrity Liaison Officer (ARILO)

This Official:

1) oversees and coordinates the NIH's overall activities and policies related to research integrity in both intramural and extramural research supported by the NIH;

2) represents the NIH on matters of research integrity policy through membership on the PHS Agency Research Integrity Liaison Group; and

3) serves as the Deciding Official for all Investigations.

C. NIH Agency Intramural Research Integrity Officer (AIRIO)

This Official:

1) oversees and coordinates the activities of the NIH related to scientific misconduct in the intramural programs;

2) initiates and carries out, or supervises the carrying out of, assessments, inquiries, and investigations of suspected scientific misconduct, whether based on allegations or other evidence;

3) ensures prompt reporting of possible scientific misconduct to the ARILO;

4) is authorized to carry out the above activities throughout the NIH Intramural Research Program, including specifically the authority to secure research records and materials related to suspected or alleged misconduct; and

5) provides Inquiry Report to the DDIR and and Investigation Report to the ARILO (Deciding Officials for Inquiry and Investigation respectively).

D. Institute/Center Director

The NIH Institute and Center (IC) Directors will cooperate with any Inquiry or Investigation conducted and implement appropriate administrative actions based upon the final case decision by the Deciding Official.

E. Institute/Center Scientific Director

1) IC Scientific Directors are responsible for the integrity of the Intramural Research Program in their IC. They are consulted, as appropriate, in the initial handling of allegations of possible scientific misconduct and will cooperate with the inquiries and investigations.

2) For ICs that do not have a Scientific Director, the IC Director will designate an individual to carry out the responsibilities specified for this official with respect to inquiries or investigations of scientific misconduct.

V. ASSESSMENT OF ALLEGATIONS, AND OTHER INFORMATION, PURPORTING SCIENTIFIC MISCONDUCT

A. Allegation of Misconduct

Individuals who believe that they have evidence of or have observed research misconduct are encouraged to discuss their concerns with or seek advice from individuals they trust, including the NIH Ombudsman, before bringing a formal complaint.

1. Bringing Allegations of Research Misconduct

a) Allegations of research misconduct must be made in writing (except as described in part B, below), be signed by the person(s) who alleges misconduct, and include particulars in sufficient detail to make clear the nature of the activity which is regarded as the alleged research misconduct, together with a description of facts, events, and circumstances which led to the allegations. The written, signed report of alleged research misconduct should be provided to the Agency Intramural Research Integrity Officer (AIRIO), Office of Intramural Research, Office of the Director, NIH.

b) The person(s) who reports the alleged research misconduct may request that his/her name(s) be withheld; however, if an Inquiry is conducted, that person(s) will be identified under most circumstances.

B. Other Information Suggestive of Scientific Misconduct

The AIRIO will consider and act upon any information, such as an anonymous allegation, that reasonably suggests that scientific misconduct may have occurred, if sufficient details are included to allow an assessment as described in Part A.1.a above. Such information may independently provide the basis for an assessment under this policy; or that information may complement an allegation of scientific misconduct.

  C. Assessment of Allegations and/or Information

1) An assessment of the allegations and/or other information about suspected research misconduct will be made by the AIRIO solely to determine whether the allegations, if true, would constitute research misconduct as defined and whether the information is sufficiently specific to warrant and enable an Inquiry. No evaluation of the facts themselves will occur at this stage.

2) Normally, the assessment will be completed within seven (7) calendar days of receipt of the report of alleged research misconduct.

3) The assessment may lead to the conclusion that an Inquiry is warranted, which will lead to initiation of the procedures outlined in Section VI.

4) If no Inquiry is initiated, the complainant, if known, and anyone else who became aware of the allegations, will be notified in writing.

5) If the decision is not to proceed, the matter shall be closed and the records will be retained for five (5) years.

6) If the allegation describes events or conduct that might be a threat to human or animal research subjects, a violation of safety regulations, financial irregularities, discrimination, sexual harassment, or criminal activity, then the appropriate official at the NIH will be informed promptly by the AIRIO.

VI. CONDUCTING AN INQUIRY

A. Purpose of the Inquiry

The purpose of the Inquiry is to make a preliminary evaluation of the available evidence and testimony of key witnesses, including the person making the allegation of misconduct and the respondent, in order to determine whether there is sufficient credible evidence of possible scientific misconduct to warrant a formal Investigation, but not to reach a final conclusion about whether misconduct has or has not occurred. The findings of the Inquiry are set forth in an Inquiry Report.

B. Appointment of an Inquiry Committee

The AIRIO, in consultation with the Committee on Scientific Conduct and Ethics (CSCE) and appropriate Institute or Center official(s) (such as the IC Director or Scientific Director), will appoint an Inquiry Committee prior to notification of the respondent. The Committee will consist of at least 3 members, one of whom serves as the Committee chair. A member of the CSCE, preferably with appropriate scientific expertise, will serve as Executive Secretary (non-voting) for the Committee, advising the Committee on procedural issues. In general, it is desirable to include among the members of the Inquiry Committee a person of similar professional designation as the respondent (e.g., another postdoctoral fellow if the respondent is a postdoctoral fellow).

The Inquiry Committee should consist of individuals who do not have real or apparent conflicts of interest in the case, can function impartially, and have appropriate expertise to evaluate the evidence and issues related to the allegations. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the NIH. All committee members must sign a statement indicating that no personal or professional conflicts of interest exist with respect to the respondent, complainant, or the case in question. Members of the CSCE with appropriate scientific expertise may serve as members of the Inquiry Committee.

The Committee's members should be made known to the respondent at the time the respondent is notified of the suspected misconduct and the initiation of the Inquiry (in accordance with Section VI.C.). If the respondent objects to the Committee's membership, a written objection may be submitted to the AIRIO within seven (7) calendar days of the announcement of the Committee's membership. The AIRIO will then evaluate whether that person should be replaced. The Inquiry process will begin as soon as the Committee membership has been finalized.

Under special circumstances, an Inquiry Committee may not be necessary prior to initiation of an Investigation, e.g. if the respondent admits to the allegations.

C. Notification and Sequestration of Research Records

In order to ensure that all materials relevant to the allegations are available for the Inquiry and to protect all parties from concerns about subsequent modification of records, the AIRIO, NIH counsel, and one or more representatives from the Institute or Center will secure all original research records and materials simultaneously with the notification of the respondent.

The AIRIO will lead the notification process, and shall arrange that this process be performed in a private place in the least disruptive manner possible in order to minimize disturbance to the laboratory and embarrassment to the respondent. The respondent's immediate supervisor (as long as he/she is not the complainant) will be present. If needed, a language interpreter should be present.

The AIRIO will explain the mechanism of the Inquiry into research misconduct. A notification memo signed by the AIRIO will be provided and explained to the respondent at this time. The nature of the allegations will be described in the memo, which will also provide information concerning the protections for the respondent. The respondent will receive copies of NIH policies concerning misconduct allegations. The AIRIO will emphasize that the respondent will be considered innocent of scientific misconduct until proven otherwise by the preponderance of the evidence. All necessary steps will be taken to protect the confidentiality of the process and the scientific reputation of the respondent.

Directly after the notification, the AIRIO, NIH counsel, and an Institute or Center representative as appropriate, will accompany the respondent to the laboratory, and to any other location as appropriate, for sequestration of the relevant research records. If the respondent is not available, sequestration from any NIH facility may begin in his/her absence. Materials to be sequestered may include laboratory notebooks, data records, documents, manuscripts, computer files, and other relevant materials. An inventory list will be prepared, and a copy, signed by both the AIRIO and the respondent, will be provided to the respondent at the time of sequestration or at the time of notification of the Inquiry. Starting at the time of sequestration, a chain of custody will be maintained, including locked storage, for all sequestered materials to ensure that the originals are kept intact and unmodified. This policy protects all parties from concerns about subsequent modification of records.

In order to provide the respondent full opportunity to respond to the allegations and to minimize effects of the Inquiry on ongoing research, copies of sequestered materials will be made available to the respondent as soon as is practical upon request. In addition, the respondent will be permitted to view the original sequestered materials under the supervision of the AIRIO. The mere filing of an allegation of research misconduct should not bring research to a halt or be a basis for other disciplinary or adverse action absent other compelling reasons.

D. Confidentiality

A statement of confidentiality must be signed by everyone who receives information about the allegations, including members of the Inquiry Committee, witnesses, the complainant, the respondent, laboratory members, and those involved in notification and sequestration. Members of the Committee and experts will agree in writing to observe the confidentiality of the proceedings and any information or documents reviewed as part of the Inquiry. Outside of the official proceedings of the Committee, they may not discuss the proceedings with the respondent, complainant, witnesses, or anyone not authorized by the AIRIO to have knowledge of the Inquiry.

E. The Charge to, and Functions of, the Inquiry Committee

The Inquiry Committee is charged with interviewing, or otherwise obtaining information from, key witnesses, evaluating preliminary evidence, determining whether the evidence is sufficient to warrant a full-scale Investigation, and writing an Inquiry Report. NIH counsel will be present at all Committee meetings and interviews to advise the Committee as needed.

At the first Committee meeting, the AIRIO will describe the allegations to the Committee and work with them to identify a set of issues to be addressed during the Inquiry process. The Inquiry Committee normally will interview the person making the allegation of misconduct (if any), the respondent, and other individuals likely to have knowledge relevant to the accusations. All interviews will be conducted in a professional and objective manner. Both the complainant and respondent may suggest others to be interviewed or brought in as witnesses, but it is ultimately the responsibility of the Inquiry Committee to decide who will be interviewed. Any witness may bring an interpreter to the interview if necessary.

All interviews will be recorded, for later transcription as necessary, and summarized. A transcript or summary of their interview will be provided to each witness for review and correction of errors. Changes to the transcript or summary will only be made to correct errors in transcription. Witnesses may add comments or additional information as an addendum.

The respondent has the right to bring counsel or an advisor to interviews by the Inquiry Committee. However, that person may participate only by advising the respondent, not by asking or answering questions of the Committee. If necessary, an interpreter will also be present.

The Committee will also examine relevant research records and materials. Throughout the Inquiry process, the respondent will be provided relevant information and will be kept informed as new evidence is obtained. These periodic updates about relevant evidence and other information will be provided by the Committee in the form of summaries of the information the Inquiry Committee has obtained and the issues that the Committee is considering, so that the respondent can prepare a sufficiently complete response. The Committee may request to re-interview the respondent, or the respondent may request another session if issues arise for which additional responses and clarifications are necessary.

After evaluating the evidence collected through the Inquiry, the Committee will determine whether there is sufficient evidence to warrant a formal Investigation. The findings and recommendations of the Inquiry Committee are described in the draft Inquiry Report, which should be completed within sixty (60) calendar days of the first meeting of the Inquiry Committee.

F. The Role of the AIRIO

The AIRIO works closely with the Inquiry Committee to identify relevant issues to be addressed in the Inquiry. Throughout the Inquiry, the AIRIO is available to assist the Committee with organizing the Inquiry, and to answer any questions raised by Committee members.

  G. The Inquiry Report

1. Elements of the Inquiry Report

A written Inquiry Report must be prepared that includes the names, titles, and affiliations of the Committee members and expert consultants, if any; the nature of the alleged misconduct; a summary of the Inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an Investigation is warranted or not; and the Committee's decision as to whether an Investigation is recommended and whether any other actions should be taken if an Investigation is not recommended. All relevant dates should be included in the Report. NIH counsel will review the Report.

2. Comments on the Draft Report by the Respondent and the Complainant

The AIRIO will provide the respondent with a copy of the draft Inquiry Report for comment and rebuttal and will provide the complainant, if any, with those portions of the draft Inquiry Report that address the complainant's role and statements in the Inquiry.

Confidentiality: The AIRIO will establish appropriate conditions for review to protect the confidentiality of the draft Report.

Receipt of Comments: The complainant and respondent will provide their comments, if any, to the Inquiry Committee within fourteen (14) calendar days of their receipt of the draft Report. Any comments that the complainant or respondent submits on the draft Report will become part of the final Inquiry Report and record. Based on the comments, the Inquiry Committee may revise the Report as appropriate.

3. Inquiry Decision and Notification

The AIRIO will transmit the final Report and any comments to the Deputy Director for Intramural Research, who will make the determination, within fourteen (14) calendar days of receipt of the final Inquiry Committee Report, of whether the evidence is sufficient to support findings of scientific misconduct that justify conducting an Investigation. The DDIR will make the final determination whether to accept the Inquiry Report, its findings, and the recommended NIH actions. If this determination differs from that of the Inquiry Committee, the DDIR will explain in detail the basis for rendering a decision different from that of the Inquiry Committee. The DDIR's explanation should be consistent with the PHS definition of scientific misconduct, the NIH's policies and procedures, and the evidence reviewed and analyzed by the Inquiry Committee. The DDIR may also return the report to the Inquiry Committee with a request for further fact-finding or analysis. The Inquiry is completed when the DDIR determines that an Investigation will be conducted or that the Inquiry is complete and does not justify an Investigation.

The AIRIO will notify both the respondent and the complainant, if any, in writing of the Deputy Director for Intramural Research's decision as to whether to proceed to an Investigation and will remind them of their obligation to cooperate in the event that an Investigation is opened. The AIRIO will also notify all appropriate NIH officials, including IC officials, the ARILO, and ORI, if the Deputy Director for Intramural Research 's decision is to go forward with an Investigation.

4. Time Limit for Completing the Inquiry Report

The Inquiry Committee will normally complete the Inquiry and submit its Report in writing to the AIRIO no more than sixty (60) calendar days following its first meeting, unless the AIRIO approves an extension for good cause. If the AIRIO approves an extension, the reason for the extension will be entered into the records of the case and the Report. The complainant and respondent will also be notified of the extension. All records of the Inquiry process will be retained for five (5) years by the NIH.

5. Protection of Reputation

If the Inquiry concludes that there is no basis to proceed to an Investigation, reasonable steps will be taken to protect/restore the reputation of the respondent. The respondent should receive a written statement summarizing the conclusions of the Inquiry, and if the respondent so wishes, these final conclusions of the Inquiry Committee can be made public.

6. Protection from Liability

All NIH representatives and Committee members involved in any phase of the Inquiry process will be represented by the Office of General Counsel for all official actions associated with the Inquiry.

7. Protection against Retaliation

No NIH staff member shall subject another staff member to harassment nor take any action against that staff member as a reprisal for making a complaint or providing any information pursuant to this policy (NIH Manual Chapter 1754). However, if the complaint was made in bad faith, any administrative action against the staff member based on that complaint would not constitute a reprisal action.

Individuals working in the Intramural Research Program, including fellows and students, who believe that they have been subject to retaliation prohibited by this policy may wish to discuss their concerns informally with the NIH Ombudsman, and may formally present their concerns to the Scientific Director of their IC, following NIH Intramural Research Program procedures for conflict resolution. Federal employees who believe that they have been subject to retaliation also have the option of filing an administrative grievance within the NIH personnel system, or filing a complaint with the Merit Systems Protection Board under the Whistleblower Protection Act, 5 U.S.C. 2302.

VII. INVESTIGATION PROCESS

A. Purpose of the Investigation

The purpose of the Investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The Investigation will also determine whether there are circumstances that would justify adding additional charges of misconduct and identify these circumstances. The findings of the Investigation will be set forth in an Investigation Report.

B. Sequestration of the Research Records

The AIRIO will immediately sequester any additional pertinent research records that were not previously sequestered during the Inquiry. This sequestration should occur before or at the time the respondent is notified that an Investigation has begun. The reasons for additional sequestration of records may include, for example, the institution's decision to investigate additional allegations not considered during the Inquiry stage or the identification of records during the Inquiry process that had not been previously secured. The procedures to be followed for sequestration during the Investigation are the same procedures that apply during the Inquiry (See section VI. C.).

C. Notification of the Respondent

The AIRIO will notify the respondent within 24 hours, if possible, after the determination is made to open an Investigation. The notification includes: a copy of the Inquiry Report; the specific charges of scientific misconduct; the definition of scientific misconduct; the procedures to be followed in the Investigation, including the appointment of the Investigation Committee and experts; the opportunity for the respondent to be interviewed, to provide information, to be assisted by counsel, to challenge the membership of the Committee and experts based on bias or conflict of interest, and to comment on the draft Report; the fact that ORI will perform an oversight review of the report; and an explanation of the respondent's right to request a hearing before the DHHS Departmental Appeals Board if a finding of scientific misconduct is made.

D. Recording Admissions

If the respondent admits to the misconduct, he or she should be asked to write and sign a statement attesting to the occurrence and extent of the misconduct. The respondent should also acknowledge that the statement was voluntary. The admission may not be used as a basis for closing the Investigation unless the Committee has determined that the extent and significance of the misconduct and all procedural steps for completion of the Investigation have been met. The Committee may consult with the AIRIO or NIH counsel when deciding whether an admission has adequately addressed all of the relevant issues such that the Investigation can be considered completed. The Investigation should not be closed unless the respondent has been appropriately notified and given an opportunity to comment on the Investigation Report. If the case is considered complete, it should be forwarded to the ARILO with recommendations for appropriate NIH actions and then to ORI for review.

E. Appointment of the Investigation Committee

1. Committee Membership

The AIRIO, in consultation with other NIH officials as appropriate, will appoint the Investigation Committee and the Committee Chair within fourteen (14) calendar days of the notification to the respondent or as soon thereafter as practicable. The Investigation Committee should consist of at least five individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the NIH. All committee members must sign a statement indicating that no personal or professional conflicts of interest exist with respect to the respondent, complainant, or the case in question. Members of the CSCE with appropriate scientific expertise are not excluded from serving as members of the Investigation Committee.

A member of the CSCE, preferably with appropriate scientific expertise, will serve as Executive Secretary (non-voting) for the Committee. One member of the Investigation Committee will be a person of similar professional designation as the respondent (e.g., another postdoctoral fellow if the respondent is a postdoctoral fellow). None of the Investigation Committee members, including the Executive Secretary, will have served on the Inquiry Committee, but the Executive Secretary of the Inquiry Committee will be available for consultation.

2. Experts

Experts may be appointed (or carried over from the Inquiry if no objection is raised) to advise the Committee on scientific or other issues. The respondent may suggest other experts.

3. Objection to Committee or Experts by Respondent

The AIRIO will notify the respondent of the proposed Committee membership as soon as it has been established. If the respondent objects to the Committee's suggested membership, a written objection must be submitted to the AIRIO within seven (7) calendar days. The AIRIO will then determine whether there is any bias or conflict of interest that would necessitate replacing the challenged member with a qualified substitute. The Investigation process will begin as soon as the Committee membership has been finalized.

F. Charge to the Committee and the First Meeting

1. Charge to the Committee

The AIRIO will provide a written charge to the Committee that describes the allegations and related issues identified during the Inquiry, defines scientific misconduct, and identifies the name of the respondent. The charge will state that the Committee is to evaluate the evidence and testimony of the respondent, complainant, if any, and key witnesses to determine whether, based on a preponderance of the evidence, scientific misconduct occurred and, if it did, its seriousness and who was responsible.

During the Investigation, if additional information becomes available that changes the subject matter of the Investigation or would suggest additional respondents, the Committee will notify the AIRIO. The AIRIO will notify the respondent of the new subject matter and will make the decision, after consultation with the Committee and obtaining the views of the respondent, as to whether the new charges justify inclusion in the current Investigation or initiation of a new Investigation. If the decision is to incorporate the charges into the current Investigation, the AIRIO will provide notice to any additional respondents and determine whether additional committee members and/or experts are needed.

The AIRIO must be advised of any necessary interim actions needed to protect human or animal subjects, or other steps required by regulation or policy.

The AIRIO and NIH counsel should be consulted throughout the Investigation on compliance with these procedures and PHS regulations, appropriate investigatory and interviewing methods and strategies, legal issues, and the standard of proof. NIH counsel will be present at all interviews and meetings throughout the Investigation to advise the Committee.

2. The First Meeting

The AIRIO, with the assistance of NIH counsel, will convene the first meeting of the Investigation Committee to review the charge, the Inquiry Report, and the prescribed procedures and standards for the conduct of the Investigation, including the necessity for confidentiality and for developing a specific investigation plan. The Investigation Committee will be provided with a copy of the NIH Policies and Procedures for Investigating Scientific Misconduct.

G. Developing an Investigation Plan

At the initial meeting, the Committee will begin development of its Investigation Plan and complete it as soon as reasonably possible, preferably within seven (7) calendar days. The Investigation Plan will include, but is not limited to: an inventory of all previously secured evidence and testimony; a determination of whether additional evidence needs to be secured; what witnesses need to be interviewed, including the complainant and respondent, and other witnesses with knowledge of the research or events in question; a proposed schedule of meetings, briefing of experts, and interviews; anticipated analyses of evidence (scientific, forensic, or other); and a plan for the Investigation Report.

H. Reviewing the Evidence

The Investigation Committee will obtain and review all relevant documentation and perform or arrange to have carried out necessary analyses of the evidence, including scientific, forensic, statistical, or other analyses.

The Investigation Committee will conform to the following guidelines:

1. Preparing for Interviews

The Investigation Committee will prepare carefully for each interview. All relevant documents and research data should be reviewed in advance and specific questions or issues that the Committee wants to cover during the interview should be identified. The Committee may appoint a committee member to take the lead on each interview. If significant questions or issues arise during an interview that require Committee deliberation, the Committee should take a short recess to discuss the issues. Committee deliberations must never be held in the presence of the interviewee.

2. Conducting Interviews

The Investigation Committee will conduct the interviews as described in section VI.E. At the Investigation stage, interviews should be in-depth and all significant witnesses should be interviewed. All interviews will be conducted in a professional and objective manner. Each witness should have the opportunity to respond to inconsistencies between his or her testimony and the evidence or other testimony, subject to the need to take reasonable steps to maintain the confidentiality of the testimony of the respondent and other witnesses.

Members of the Committee and experts will agree in writing to protect the confidentiality of the proceedings and any information or documents reviewed as part of the Investigation. Outside of the official proceedings of the Committee, they may not discuss the proceedings with the respondent, complainant, witnesses, or anyone not authorized by the AIRIO to have knowledge of the Investigation.

The respondent has the right to bring counsel or an advisor to interviews by the Investigation Committee. However, that person may participate only by advising the respondent, not by asking or answering questions of the Committee. If necessary, an interpreter will also be present.

All interviews will be recorded, for later transcription as necessary, and summarized. A transcript or summary of the interview will be provided to each witness for review and correction of errors. Witnesses may add comments or additional information, but changes to the transcript or summary will only be made to correct errors in transcription.

I. Committee Deliberations

1. Burden and Standard of Proof

In reaching a conclusion on whether there was scientific misconduct and who committed it, the burden of proof is on the NIH to support its conclusions and findings by a preponderance of the evidence.

2. Sufficient Evidence

The Committee will consider whether there is sufficient evidence such that the NIH can meet its burden of proving misconduct by a preponderance of the evidence; whether the misconduct was committed intentionally, knowingly, or recklessly; and whether it represents significant departure from accepted practices of the relevant research community. The Committee will also consider whether there is evidence of honest error or honest differences in interpretations or judgments of data, such that scientific misconduct cannot be proven by a preponderance of the evidence.

J. The Investigation Report

The Committee shall assemble a Report in the following fashion. A dissenting minority may submit a parallel report outlining the reasons for dissent.

1. Outline for an Investigation Report

The following annotated outline may prove useful in preparing the required Investigation Report, except when special factors suggest a different approach.

a) Background

Include sufficient background information to ensure a full understanding of the issues that concern the PHS under its definition of scientific misconduct. This section should detail the facts leading to the NIH Inquiry, including a description of the research at issue, the persons involved in the alleged misconduct, the role of the complainant, and any associated public health issues. All relevant dates should be included.

b) Allegations

List the allegations of scientific misconduct that were investigated and any additional scientific misconduct allegations that arose during the Inquiry and Investigation. The source and basis for each allegation or issue should be cited except where the identity of the source is irrelevant or unnecessary. The allegations identified in this section will form the structure or context in which the subsequent analysis and findings are presented.

c) Inquiry: Process and Recommendations

A copy of the Inquiry Report should be attached.

d) Investigation: Process

Summarize the Investigation process, including the composition of the Committee (names, degrees, I/C lab/branch affiliation, and expertise), and the charge to the Committee. List the persons interviewed, any additional evidence secured and reviewed and the measures taken to ensure its security, the policies and procedures used and any other factors that may have influenced the proceedings.

e) Investigation: Analysis of Each Allegation

Describe the particular matter (e.g., experiment or component of a clinical protocol) in which the alleged misconduct occurred and why and how the issue came to be under investigation.

The analysis should take into account all the relevant statements, claims (e.g., a claim of a significant positive result in an experiment), rebuttals, documents, and other evidence, including circumstantial evidence, related to the issue. The source of each statement, claim, or other evidence should be cited (e.g., laboratory notebook with page and date, medical chart documents and dates, relevant manuscripts, transcripts of interviews, etc.).

Any use of additional expert analysis should be noted (forensic, statistical, or special analysis of the physical evidence, such as similarity of features or background in contested figures).

Relevant statements, including rebuttals, made by the complainant, respondent, and other pertinent witnesses should be summarized or quoted and the appropriate individuals referenced/cited. Each argument against the scientific misconduct allegation that the respondent raised in his or her defense should be summarized and the source of each argument cited. Inconsistencies in the statements of the respondent, the complainant, other witnesses, or experts, should be noted.

The analysis should be consistent with the PHS definition of scientific misconduct. It should describe the relative weight given to the various witnesses and pieces of evidence, noting inconsistencies, credibility, and persuasiveness.

Any evidence that shows that the respondent acted with intent, that is, any evidence that the respondent knowingly engaged in the alleged falsification, fabrication, or plagiarism, should be described.

Similarly, the evidence supporting the possibility that honest error or differences of scientific opinion occurred with respect to the issue should be described.

f) Conclusions/Findings of Misconduct or No Misconduct

The Investigation Committee's finding for each identified issue should be concisely stated. The Investigation Report should make separate findings as to whether or not each issue constitutes scientific misconduct, using the PHS definition.

A finding of scientific misconduct should be supported by a preponderance of the evidence. If the Investigation Committee finds scientific misconduct on one or more issues, the report should identify the type of misconduct for each issue (fabrication, falsification or plagiarism). The report should indicate the extent and seriousness of the fabrication, falsification, or plagiarism, including its effect on research findings, publications, research subjects, and the laboratory or project in which the misconduct occurred. Under no circumstances should a finding of scientific misconduct be treated as negotiable.

g) Recommended NIH Actions

Based on its findings, the Investigation Committee should recommend administrative actions that it believes the NIH should take consistent with its policies and procedures, including appropriate actions against the respondent, such as a letter of reprimand, special supervision, probation, termination, etc. (See Section VIII. B). The Investigation Committee should also identify any published research reports or other sources of scientific information (such as databases) that should be retracted or corrected.

If the Investigation Committee believes that the complainant raised bad faith allegations, the Committee will incorporate this into its Report and should recommend appropriate administrative actions that NIH should take consistent with the Whistleblower policies and procedures (Whistleblower Protection Act, 5 U.S.C. 2302). The AIRIO would refer these recommendations to the appropriate authority.

h) Documenting the Investigation File

The purpose of the documentation is to substantiate the Investigation's findings.

The Investigation Committee should maintain an index of all the relevant evidence it secured or examined in conducting the Investigation, including any evidence that may support or contradict the report's conclusions. Evidence includes, but is not limited to, research records, transcripts or recordings of interviews, committee correspondence, administrative records, grant applications and awards, manuscripts, publications, and expert analyses.

i) Attachments

Copies of all significant documentary evidence that is referenced in the Report should be appended to the Report, if possible (relevant notebook pages or other research records, relevant committee or expert analyses of data, transcripts or summary of each interview, respondent and complainant responses to the draft report(s), manuscripts, publications or other documents, including grant progress reports and applications, etc.). A "List of Attachments" should be included.

Allegedly false statements, misrepresentations in figures or parts of figures, areas of plagiarism, etc., on a copy of the page or section of the questioned document (e.g., a page from a research notebook) should be identified. A side-by-side comparison with the actual data or material that is alleged to have been plagiarized should be included.

2. Comments on the Draft Report

a) Respondent

The AIRIO will provide the respondent with a copy of the draft Investigation Report for comment and rebuttal. The respondent will be allowed thirty (30) calendar days to review and comment on the draft Report. Any comments that the respondent submits on the draft Report will become part of the final Investigation Report and record. Based on the comments, the Investigation Committee may revise the Report as appropriate.

b) Complainant

The complainant will be allowed thirty (30) calendar days to review and comment on those portions of the draft Investigation Report that address the complainant's role and statements in the Investigation. Any comments that the complainant submits on the draft Report will become part of the final Investigation Report and record. Based on the comments, the Investigation Committee may revise the Report as appropriate.

c) NIH Counsel

The draft Investigation Report will be transmitted to NIH counsel for a review of its legal sufficiency. Comments should be incorporated into the Report as appropriate.

d) Confidentiality

In distributing the draft Report, or portions thereof, to the respondent and complainant, the AIRIO will establish appropriate conditions for review to protect the confidentiality of the draft Report.

3. Transmittal of the Final Investigation Report to the Deciding Official

After comments have been received, the Committee will have fourteen (14) calendar days to finalize the Investigation Report and transmit it, with attachments including the respondent's and complainant's comments, to the ARILO, through the AIRIO.

4. Time Limit for Completing the Investigation Report

The final Investigation Report will be submitted to the ARILO within 150 calendar days of the first meeting of the Investigation Committee, unless the Investigation Committee submits a written request for extension and the AIRIO grants the extension.

After completion of a case and all ensuing related actions, the AIRIO will prepare a complete file, including the records of the Inquiry and Investigation and copies of all documents and other materials furnished to the AIRIO or committees. The AIRIO will keep the file for five (5) years after completion of the case to permit later assessment of the case. Authorized DHHS personnel will be given access to the records upon request.

5. Protection against Retaliation

No NIH staff member shall subject another staff member to harassment nor take any action against that staff member as a reprisal for making a complaint or providing any information pursuant to this policy (NIH Manual Chapter 1754). However, if the complaint was made in bad faith, any administrative action against the staff member based on the complaint would not constitute a reprisal action.

Individuals working in the Intramural Research Program, including fellows and students, who believe that they have been subject to retaliation prohibited by this policy may wish to discuss their concerns informally with the NIH Ombudsman, and may formally present their concerns to the Scientific Director of their IC, following NIH Intramural Research Program procedures for conflict resolution. Federal employees who believe that they have been subject to retaliation also have the option of filing an administrative grievance within the NIH personnel system, or filing a complaint with the Merit Systems Protection Board under the Whistleblower Protection Act, 5 U.S.C. 2302.

K. NIH Review and Decision

The ARILO will make the final determination whether to accept the Investigation Report, its findings, and the recommended NIH actions. If this determination differs from that of the Investigation Committee, the ARILO will explain in detail the basis for rendering a decision different from that of the Investigation Committee. The ARILO's explanation should be consistent with the PHS definition of scientific misconduct, the NIH's policies and procedures, and the evidence reviewed and analyzed by the Investigation Committee. The ARILO may also return the report to the Investigation Committee with a request for further fact-finding or analysis. The ARILO's determination, together with the Investigation Committee's Report, constitutes the final Investigation Report.

When a final decision on the case has been reached by the ARILO, the AIRIO will notify both the respondent and the complainant, if any, in writing. In addition, the ARILO will determine whether law enforcement agencies, appropriate regulatory agencies, professional societies, professional licensing boards, editors of journals in which falsified reports were published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case.

The ARILO will submit a report on the Investigation to ORI for review. ORI will have 240 days to review the report to determine whether the investigation was fair, objective, and competent. If a finding of misconduct was made, ORI will also review the finding of misconduct and supporting evidence, as well as any NIH sanctions recommended. ORI will then forward ORI recommendations for sanctions to the HHS Assistant Secretary of Health (ASH), who will issue a final decision regarding ORI's proposed sanctions.

If the ASH makes a finding of scientific misconduct, the respondent may request, within thirty (30) calendar days of receipt of the notification of findings, a hearing before the HHS Departmental Appeals Board.

VIII. SANCTIONS

A. Recommendations for NIH Sanctions

If the Investigation Committee, in its report to the ARILO, includes a determination that scientific misconduct has occurred, the Investigation Committee will include recommendations to the ARILO and the appropriate IC Director for NIH sanctions to be applied.

Although sanctions on a particular individual may have consequences that are much broader (i.e., members of the laboratory may be indirectly or directly affected as well), the sanctions imposed must be consistent with the nature of the violation and should not be weakened because of their impact on other individuals. Consistency and fairness within and between Institutes and Centers should be sought.

In deciding what administrative actions are appropriate, the Investigation Committee should consider the seriousness of the misconduct, including whether the misconduct was intentional or reckless; was an isolated event or part of a pattern; had significant impact on the research record; and had significant impact on other researchers or institutions.

B. Possible Sanctions

Adapted from: Beyond the "Framework": Institutional Considerations in Managing Allegations of Misconduct in Research Adopted by the Executive Council of the Association of American Medical Colleges September 24, 1992. COPYRIGHT 1992 by the Association of American Medical Colleges 2450 N Street, NW, Washington, D.C. 20037. All material subject to this copyright may be photocopied for the noncommercial purpose of educational advancement. http://research.bcm.tmc.edu/other/admin/b_frame.txt

• removal from a particular project
• letter of reprimand to be included in the individual's personnel file
• special monitoring of work
• decrease in laboratory support (e.g., loss of a Fellow position or technical support position)
• probation
• suspension without pay
• denial of a raise in salary or salary/rank reduction
• termination of employment

C. Protections/Appeals re Sanctions

1. Any individual who is subject to a sanction will be afforded all procedures that would ordinarily apply before that sanction goes into effect.

2. For Federal employees, some of these sanctions must be implemented under Office of Personnel Management guidelines. OPM regulations provide for formal procedures, such as advance written notice, opportunity to comment, representation, and appeal, before the agency takes adverse actions such as suspension, removal, denial of a pay raise or promotion, or reduction in pay.

3. For IRTA Fellows, Visiting Fellows, and students, HHS regulations governing NIH traineeships state that an Institute Director may terminate a traineeship at any time if the trainee materially fails to comply with the terms and conditions of the training award.

Scientific misconduct is a basis for termination. NIH policies for training positions generally require that these individuals must be given notice and an opportunity to comment prior to termination.

D. Possible Actions by NIH when An Individual Accused of Scientific Misconduct Is Found Not Guilty

1. All individuals who knew of the allegation because they were involved in or knew of the Inquiry and Investigation (e.g., witnesses, attorneys, supervisors, lab members and colleagues of the defendant, journal editors who received complaints, etc.) should be formally notified of the exoneration.

2. The exoneration could be publicized more broadly (without repeating the initial allegation), but only upon request of the respondent (since publicity might do more harm than good from the respondent's perspective).

3. The IC should ensure that the respondent's NIH position and responsibilities have not been affected by the Investigation.

4. In the case of Fellows, the individual may be allowed to move his/her fellowship to another NIH laboratory. In addition, consideration should be given to the possibility that the fellowship be considered a new award without any penalty for the time spent in the original laboratory.

(42 C.F.R. Part 50, Subpart A)

* The procedures described in this document do not create any right or benefit, substantive or procedural, enforceable at law by a party against the institution, its agencies, officers, or employees.

Standard Format of the Investigation Report

The following outline should be used in preparing the Investigation Report, except when special factors suggest a different approach. The report should incorporate all of the elements described in section VII.J.

Background

• Chronology of events
• Public health issues
• Allegations

Institutional Inquiry: Process and Recommendations

• Copy of Inquiry Report

Institutional Investigation: Process

• Composition of committee
• Individuals interviewed
• Evidence sequestered and reviewed

Institutional Investigation: Analysis of Each Allegation

• Background
• Analysis of all the relevant evidence and specific identification of evidence supporting the finding

Conclusion: Scientific Misconduct or No Scientific Misconduct

Effect of Misconduct (e.g., potential harm to research subjects, reliability of data, publications that need to be corrected or retracted, etc.)

Recommended Institutional Actions

Attachments