Washington and Lee University Policy

                                                        for Responding to Allegations

                                                            of Research Misconduct

 

                                                                 Table of Contents

 

I.          Introduction.........................................................................................................................   1

A.        General Policy.........................................................................................................   1

B.         Scope.....................................................................................................................   1

 

II.         Definitions...........................................................................................................................   2

 

III.       Rights and Responsibilities...................................................................................................   5

A.        Research Integrity Officer........................................................................................   5

B.         Complainant............................................................................................................   6

C.        Respondent.............................................................................................................   6

D.        Deciding Official......................................................................................................   7

 

IV.       General Policies and Principles.............................................................................................   8

A.        Responsibility to Report Misconduct........................................................................   8

B.         Cooperation with Research Misconduct Proceedings................................................   8

C.        Confidentiality............................................................................................................ 8

D.        Protecting complainants, witnesses, and committee members...................................... 9

E.         Protecting the Respondent.......................................................................................   9

F.         Interim Administrative Actions and Notifying ORI of Special Circumstances..............   9

 

V.        Conducting the Assessment and Inquiry..............................................................................   10

A.        Assessment of Allegations........................................................................................ 10

B.         Initiation and Purpose of the Inquiry.......................................................................   10

C.        Notice to Respondent; Sequestration of Research Records.....................................   11

D.        Appointment of the Inquiry Committee...................................................................   11

E.         Charge to the Committee and First Meeting............................................................   11

F.         Inquiry Process .....................................................................................................   12

G.        Time for Completion................................................................................................ 12

 

VI.       The Inquiry Report............................................................................................................   13

A.        Elements of the Inquiry Report...............................................................................   13

B.         Notification to the Respondent and Opportunity to Comment..................................   13

C.        Institutional Decision and Notification...................................................................... 13

            1.  Decision by Deciding Official............................................................................. 13

            2.  Notification to ORI............................................................................................. 13

            3.  Documentation of Decision Not to Investigate..................................................... 14

                       

VII.      Conducting the Investigation................................................................................................ 14

A.        Initiation and Purpose............................................................................................. 14

B.         Notifying ORI and Respondent; Sequestration of Research Records........................ 14

C.        Appointment of the Investigation Committee............................................................ 15

D.        Charge to the Committee and the First Meeting....................................................... 15

            1.  Charge to the Committee.................................................................................... 15

            2.  First Meeting...................................................................................................... 16

E.         Investigation Process.............................................................................................. 16

F.         Time for Completion................................................................................................ 17

           

VIII.     The Investigation Report..................................................................................................... 17

A.        Elements of the Investigation Report........................................................................ 17

B.         Comments on the Draft Report and Access to Evidence.......................................... 18

            1.  Respondent........................................................................................................ 18

            2.  Complainant....................................................................................................... 18

            3.  Confidentiality..................................................................................................... 18

C.        Decision by Deciding Official.................................................................................. 19

D.        Notice to ORI of Institutional Findings and Actions.................................................. 19

E.         Maintaining Records for Review by ORI.................................................................. 19

 

IX.       Completion of Cases; Reporting Premature Closures to ORI............................................... 20

 

X.        Institutional Administrative Actions...................................................................................... 20

 

XI.       Other Considerations.......................................................................................................... 20

A.        Termination or Resignation Prior to Completing Inquiry or Investigation.................... 20

B.         Restoration of the Respondent's Reputation............................................................. 21

C.        Protection of the Complainant, Witnesses and Committee Members........................ 21

D.        Allegations Not Made in Good Faith....................................................................... 21

 

Appendix A—Research Integrity Office Responsibilities................................................................... 22

I.          Introduction^**

 

A.        General Policy

 

Faculty engaged in research at Washington and Lee University will adhere to the highest professional standards in the execution of their work and the reporting of its results.  Misconduct in research and reporting is inconsistent with the most basic values of Washington and Lee University and the international community of science.  Evidence of misconduct will be investigated by the Provost according to the procedures adopted pursuant to this policy.

 

B.         Scope

 

This policy is intended to carry out Washington and Lee University’s responsibilities under the Public Health Service (PHS) Policies on Research Misconduct, 42 C.F.R. Part 93.  This policy applies to allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results) involving:

·        A person who, at the time of the alleged research misconduct. was employed by, was an agent of, or was affiliated by contract or agreement with this institution;[1] and

·        (1)  PHS supported biomedical or behavioral research, research training or activities related to that research or research training, such as the operation of tissue and data banks and the dissemination of research information, (2) applications or proposals for PHS support for biomedical or behavioral research, research training or activities related to that research or research training, or (3) plagiarism of research records produced in the course of PHS supported research, research training or activities related to that research or research training.  This includes any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in a grant, contract, cooperative agreement, or other form of PHS support.[2]

 

This policy and the associated procedures do not apply to authorship or collaboration disputes and apply only to all allegations of research misconduct that occurred within six years of the date Washington and Lee University or HHS received the allegation, subject to the subsequent use, health or safety of the public, and grandfather exceptions in 42 CFR § 93.105(b).

 

II.        Definitions

 

A.        Allegation means a disclosure of possible research misconduct through any means of communication.  The disclosure may be by written or oral statement or other communication to an institutional or HHS official.[3]

 

B.         Complainant  means a person who in good faith makes an allegation of research misconduct[4].

 

C.        Deciding Official (DO) shall be the Provost, who will make final determinations on allegations of research misconduct and any institutional administrative actions.

 

D.        Evidence means any document, tangible item, or testimony offered or obtained during a research misconduct proceeding that tends to prove or disprove the existence of an alleged fact.[5]

 

E.         Good faith as applied to a complainant or witness, means having a belief in the truth of one’s allegation or testimony that a reasonable person in the complainant’s or witness’s position could have based on the information known to the complainant or witness at the time.  An allegation or cooperation with a research misconduct proceeding is not in good faith if it made with knowing or reckless disregard for information that would negate the allegation or testimony.  Good faith as applied to a committee member means cooperating with the purpose of helping an institution meet its responsibilities under 42 CFR Part 93.  A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.[6]

           

            F.         HHS means the United States Department of Health and Human Services.

           

G.        Inquiry means preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of 42 CFR §§ 93.307-93.309.[7]

 

H.        Institutional member means a person who is employed by, is an agent of, or is affiliated by contract or agreement with an institution.  Institutional members may include, but are not limited to, officials, tenured and untenured faculty, teaching and support staff, researchers, research coordinators, clinical technicians, postdoctoral and other fellows, students, volunteers, agents, and contractors, subcontractors, and subawardees, and their employees.[8]

I.          Investigation means the formal development of a factual record and the examination of that record leading to a decision not to make a finding of research misconduct or to a recommendation for a finding of research misconduct which may include a recommendation for other appropriate actions, including administrative actions.[9]

 

J.          Office of Research Integrity or ORI means the office to which the HHS Secretary has delegated responsibility for addressing research integrity and misconduct issues related to PHS supported activities.[10]

 

K.        Preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not.[11]

 

L.         Public Health Service or PHS means the unit within HHS that includes the Office of Public Health and Science and the following Operating Divisions:  Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and the Substance Abuse and Mental Health Services Administration, and the offices of the Regional Health Administrators.[12]

 

M.        PHS support means PHS funding, or applications or proposals therefore, for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or training, that may be provided through:  PHS grants, cooperative agreements, or contracts or subgrants or subcontracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts.[13]

 

N.        Records of research misconduct proceedings means:  (1) the research records and evidence secured for the research misconduct proceedings pursuant to this policy and 42 CFR §§ 93.305, 93.307(b), and 93.310(d), except to the extent the RIO determines and documents that those records are not relevant to the proceeding or that the records duplicate other records that have been retained; (2) the documentation of the determination of irrelevant or duplicate records; (3) the inquiry report and final documents (not drafts) produced in the course of preparing that report, including the documentation of any decision not to investigate, as required by 42 CFR § 93.309(c); (4) the investigation report and all records (other than drafts of the report) in support of the report, including the recordings or transcripts of each interview conducted; and (5) the complete record of any appeal within the institution from the finding of research misconduct.[14]

O.        Research Integrity Officer (RIO) means the institutional official responsible for: (1) assessing allegations of research misconduct to determine if they fall within the definition of research misconduct, are covered by 42 CFR Part 93, and warrant an inquiry on the basis that the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified; and (2) overseeing inquiries and investigations; and (3) the other responsibilities described in this policy.

 

P.         Research misconduct means 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 differences of opinion.[15]

 

            Q.        Research misconduct proceeding means any actions related to alleged research misconduct that is within 42 CFR Part 93, including but not limited to, allegation assessments, inquiries, investigations, ORI oversight reviews, hearings and administrative appeals.[16]

 

R.         Research record means the record of data or results that embody the facts resulting from scientific inquiry, including but not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, journal articles, and any documents and materials provided to HHS or an institutional official by a respondent in the course of the research misconduct proceeding.[17]

 

S.         Respondent means the person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.[18]

 

T.         Retaliation means an adverse action taken against a complainant, witness, or committee member by this institution or one of its institutional members in response to (1) a good faith allegation of research misconduct; or (2) good faith cooperation with a research misconduct proceeding.[19]

III.       Rights and Responsibilities

 

A.        Research Integrity Officer

                       

The Dean of the College or designee will serve as the RIO who will have primary responsibility for implementation of the institution’s policies and procedures on research misconduct.  The RIO will be an institutional official who is well qualified to administer the procedures and is sensitive to the varied demands made on those who conduct research, those who are accused of research misconduct, those who make good faith allegations of research misconduct, and those who may serve on inquiry and investigation committees.

 

A detailed listing of the responsibilities of the RIO is set forth in Appendix A.  These responsibilities include the following duties related to research misconduct proceedings:

 

·        Consult confidentially with persons uncertain about whether to submit an allegation of research misconduct;

·        Receive allegations of research misconduct;

·        Assess each allegation of research misconduct in accordance with Section V.A. of this policy to determine whether it falls within the definition of research misconduct and warrants an inquiry;

·        As necessary, take interim action and notify ORI of special circumstances, in accordance with Section IV.F. of this policy;

·        Sequester research data and evidence pertinent to the allegation of research misconduct in accordance with Section V.C. of this policy and maintain it securely in accordance with this policy and applicable law and regulation;

·        Provide confidentiality to those involved in the research misconduct proceeding as required by 42 CFR § 93.108, other applicable law, and institutional policy;

·        Notify the respondent and provide opportunities for him/her to review/comment/respond to allegations, evidence, and committee reports in accordance with Section III.C. of this policy;

·        Inform respondents, complainants, and witnesses of the procedural steps in the research misconduct proceeding;

·        Appoint the chair and members of the inquiry and investigation committees, ensure that those committees are properly staffed and that there is expertise appropriate to carry out a thorough and authoritative evaluation of the evidence;

·        Determine whether each person involved in handling an allegation of research misconduct has an unresolved personal, professional, or financial conflict of interest and take appropriate action, including recusal, to ensure that no person with such conflict is involved in the research misconduct proceeding;

·        In cooperation with other institutional officials, take all reasonable and practical steps to protect or restore the positions and reputations of good faith complainants, witnesses, and committee members and counter potential or actual retaliation against them by respondents or other institutional members;

·        Keep the Deciding Official and others who need to know apprised of the progress of the review of the allegation of research misconduct;

·        Notify and make reports to ORI as required by 42 CFR Part 93;

·        Ensure that administrative actions taken by the institution and ORI are enforced and take appropriate action to notify other involved parties, such as sponsors, law enforcement agencies, professional societies, and licensing boards of those actions; and

·        Maintain records of the research misconduct proceeding and make them available to ORI in accordance with Section VIII.F. of this policy.

 

B.         Complainant

 

The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation.  As a matter of good practice, the complainant should be interviewed at the inquiry stage and given the transcript or recording of the interview for correction.  The complainant must be interviewed during an investigation, and be given the transcript or recording of the interview for correction.[20]

 

C.        Respondent

 

The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation.  The respondent is entitled to:

 

·        A good faith effort from the RIO to notify the respondent in writing at the time of or before beginning an inquiry;[21]

·        An opportunity to comment on the inquiry report and have his/her comments attached to the report;[22]

·        Be notified of the outcome of the inquiry, and receive a copy of the inquiry report that includes a copy of, or refers to 42 CFR Part 93 and the institution’s policies and procedures on research misconduct;[23]

·        Be notified in writing of the allegations to be investigated within a reasonable time after the determination that an investigation is warranted, but before the investigation begins (within 30 days after the institution decides not to begin an investigation), and be notified in writing of any new allegations, not addressed in the inquiry or in the initial notice of investigation, within a reasonable time after the determination to pursue those allegations;[24]

·        Be interviewed during the investigation, have the opportunity to correct the recording or transcript, and have the corrected recording or transcript included in the record of the investigation;[25]

·        Have interviewed during the investigation any witness who has been reasonably identified by the respondent as having information on relevant aspects of the investigation, have the recording or transcript provided to the witness for correction, and have the corrected recording or transcript included in the record of the investigation;[26] and

·        Receive a copy of the draft investigation report and, concurrently, a copy of, or supervised access to the evidence on which the report is based, and be notified that any comments must be submitted within 30 days of the date on which the copy was received and that the comments will be considered by the institution and addressed in the final report.[27]

 

The respondent should be given the opportunity to admit that research misconduct occurred and that he/she committed the research misconduct.  With the advice of the RIO and institutional legal counsel, the Deciding Official may terminate the institution’s review of an allegation that has been admitted if the institution’s acceptance of the admission and any proposed settlement is approved by ORI.[28]

 

As provided in 42 CFR § 93.314(a), the respondent will have the opportunity to request an institutional appeal if the institution’s procedures provide for an appeal.

 

D.        Deciding Official

 

The DO will receive the inquiry report and after consulting with the RIO, decide whether an investigation is warranted under the criteria in 42 CFR § 93.307(d).  Any finding that an investigation is warranted must be made in writing by the DO and must be provided to ORI, together with a copy of the inquiry report meeting the requirements of 42 CFR § 93.309, within 30 days of the finding.  If it is found that an investigation is not warranted, the DO and the RIO will ensure that detailed documentation of the inquiry is retained for at least 7 years after termination of the inquiry, so that ORI may assess the reasons why the institution decided not to conduct an investigation.[29]

 

The DO will receive the investigation report and, after consulting with the RIO and other appropriate officials, decide the extent to which this institution accepts the findings of the investigation and, if research misconduct is found, decide what, if any, institutional administrative actions are appropriate.  The DO shall ensure that the final investigation report, the findings of the DO and a description of any pending or completed administrative action are provided to ORI, as required by 42 CFR § 93.315.

 

IV.       General Policies and Principles

 

A.        Responsibility to Report Misconduct

 

All employees or individuals associated with Washington and Lee will report observed, suspected, or apparent research misconduct to the RIO.  Any official who receives an allegation of research misconduct must report it immediately to the RIO.  If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may meet with or contact the RIO at 540-458-8746 to discuss the suspected research misconduct informally, which may include discussing it anonymously and/or hypothetically.  If the circumstances described by the individual do not meet the definition of research misconduct, the RIO will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.

 

At any time, an institutional member may have confidential discussions and consultations about concerns of possible misconduct with the RIO and will be counseled about appropriate procedures for reporting allegations.

 

B.         Cooperation with Research Misconduct Proceedings

 

Institutional employees will cooperate with the RIO and other institutional officials in the review of allegations and the conduct of inquiries and investigations.  Institutional members, including respondents, have an obligation to provide relevant evidence to research misconduct allegations to the RIO or other institutional official.

 

C.        Confidentiality

 

The RIO shall, as required by 42 CFR § 93.108:  (1) limit disclosure of the identity of respondents and complainants to those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; and (2) except as otherwise prescribed by law, limit the disclosure of any records or evidence from which research subjects might be identified to those who need to know in order to carry out a research misconduct proceeding.  The RIO should use written confidentiality agreements or other mechanisms to ensure that the recipient does not make any further disclosure of identifying information.

 

D.       Protecting complainants, witnesses, and committee members

 

Institutional members may not retaliate in any way against complainants, witnesses, or committee members.  Institutional members should immediately report any alleged or apparent retaliation against complainants, witnesses or committee members to the RIO, who shall review the matter and, as necessary, make all reasonable and practical efforts to counter any potential or actual retaliation and protect and restore the position and reputation of the person against whom the retaliation is directed.

 

E.         Protecting the Respondent

 

As requested and as appropriate, the RIO and other institutional officials shall make all reasonable and practical efforts to protect or restore the reputation of persons alleged to have engaged in research misconduct, but against whom no finding of research misconduct is made.[30]

 

During the research misconduct proceeding, the RIO is responsible for ensuring that respondents receive all the notices and opportunities provided for in 42 CFR Part 93 and the policies and procedures of the institution.  Respondents may consult with legal counsel or a non-lawyer person adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case.

 

F.         Interim Administrative Actions and Notifying ORI of Special Circumstances

 

Throughout the research misconduct proceeding, the RIO will review the situation to determine if there is any threat of harm to public health, federal funds and equipment, or the integrity of the PHS supported research process.  In the event of such a threat, the RIO will, in consultation with other institutional officials and ORI, take appropriate interim action to protect against any such threat.[31]  Interim action might include additional monitoring of the research process and the handling of federal funds and equipment, reassignment of personnel or of the responsibility for the handling of federal funds and equipment, additional review of research data and results or delaying publication.  The RIO shall, at any time during a research misconduct proceeding, notify ORI immediately if he/she has reason to believe that any of the following conditions exist:

 

·        Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;

·        HHS resources or interests are threatened;

·        Research activities should be suspended;

·        There is a reasonable indication of possible violations of civil or criminal law;

·        Federal action is required to protect the interests of those involved in the research misconduct proceeding;

·        The research misconduct proceeding may be made public prematurely and HHS action may be necessary to safeguard evidence and protect the rights of those involved; or

·        The research community or public should be informed.[32]

 

V.        Conducting the Assessment and Inquiry

 

A.        Assessment of Allegations

           

            Upon receiving an allegation of research misconduct, the RIO will immediately assess the allegation to determine whether it is sufficiently credible and specific so that potential evidence of research misconduct may be identified, whether it is within the jurisdictional criteria of 42 CFR § 93.102(b), and whether the allegation falls within the definition of research misconduct in this policy and 42 CFR § 93.103.[33]  An inquiry must be conducted if these criteria are met.

 

            The assessment period should be brief, preferably concluded within a week.  In conducting the assessment, the RIO need not interview the complainant, respondent, or other witnesses, or gather data beyond any that may have been submitted with the allegation, except as necessary to determine whether the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified.  The RIO shall, on or before the date on which the respondent is notified of the allegation, obtain custody of, inventory, and sequester all research records and evidence needed to conduct the research misconduct proceeding, as provided in paragraph C. of this section.

           

B.         Initiation and Purpose of the Inquiry

 

If the RIO determines that the criteria for an inquiry are met, he or she will immediately initiate the inquiry process.  The purpose of the inquiry is to conduct an initial review of the available evidence to determine whether to conduct an investigation.  An inquiry does not require a full review of all the evidence related to the allegation.[34]

 

            C.        Notice to Respondent; Sequestration of Research Records

 

At the time of or before beginning an inquiry, the RIO must make a good faith effort to notify the respondent in writing, if the respondent is known.  If the inquiry subsequently identifies additional respondents, they must be notified in writing.  On or before the date on which the respondent is notified, or the inquiry begins, whichever is earlier, the RIO must take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence and sequester them in a secure manner, except that where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.[35]  The RIO may consult with ORI for advice and assistance in this regard.

 

D.        Appointment of the Inquiry Committee

 

The RIO, in consultation with other institutional officials as appropriate, will attempt to appoint an inquiry committee and committee chair within 10 days of the initiation of the inquiry or as soon thereafter as practical.  The inquiry committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry and should include individuals with the appropriate scientific expertise to evaluate the evidence to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry.[36] 

 

E.         Charge to the Committee and the First Meeting

 

The RIO will prepare a charge for the inquiry committee that:

·        Sets forth the time for completion of the inquiry;

·        Describes the allegations and any related issues identified during the allegation assessment;

·        States that the purpose of the inquiry is to conduct an initial review of the evidence, including the testimony of the respondent, complainant and key witnesses, to determine whether an investigation is warranted, not to determine whether research misconduct definitely occurred or who was responsible;

·        States that an investigation is warranted if the committee determines: (1) there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct and is within the jurisdictional criteria of 42 CFR § 93.102(b); and (2) the allegation may have substance, based on the committee’s review during the inquiry.

·        Informs the inquiry committee that they are responsible for preparing or directing the preparation of a written report of the inquiry that meets the requirements of this policy and 42 CFR § 93.309(a).

 

At the committee's first meeting, the RIO will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee.  The RIO will be present or available throughout the inquiry to advise the committee as needed.

 

F.         Inquiry Process

 

The inquiry committee will normally interview the complainant, the respondent, and key witnesses as well as examining relevant research records and materials.  Then the inquiry committee will evaluate the evidence, including the testimony obtained during the inquiry.  After consultation with the RIO, the committee members will decide whether an investigation is warranted based on the criteria in this policy and 42 CFR § 93.307(d).  The scope of the inquiry is not required to and does not normally include deciding whether misconduct definitely occurred, determining definitely who committed the research misconduct or conducting exhaustive interviews and analyses.  However, if a legally sufficient admission of research misconduct is made by the respondent, misconduct may be determined at the inquiry stage if all relevant issues are resolved.  In that case, the institution shall promptly consult with ORI to determine the next steps that should be taken.  See Section III.C.

 

G.        Time for Completion

 

            The inquiry, including preparation of the final inquiry report and the decision of the DO on whether an investigation is warranted, must be completed within 60 calendar days of initiation of the inquiry, unless the RIO determines that circumstances clearly warrant a longer period.  If the RIO approves an extension, the inquiry record must include documentation of the reasons for exceeding the 60-day period.[37]

VI.       The Inquiry Report

 

A.        Elements of the Inquiry Report

 

A written inquiry report must be prepared that includes the following information: (1) the name and position of the respondent; (2) a description of the allegations of research misconduct; (3) the PHS support, including, for example, grant numbers, grant applications, contracts and publications listing PHS support; (4) the basis for recommending or not recommending that the allegations warrant an investigation; (5) any comments on the draft report by the respondent or complainant.[38]

 

Institutional counsel should review the report for legal sufficiency.  Modifications should be made as appropriate in consultation with the RIO and the inquiry committee.

 

B.         Notification to the Respondent and Opportunity to Comment

 

The RIO shall notify the respondent whether the inquiry found an investigation to be warranted, include a copy of the draft inquiry report for comment within 10 days, and include a copy of or refer to 42 CFR Part 93 and the institution’s policies and procedures on research misconduct.[39]  The institution may notify the complainant whether the inquiry found an investigation to be warranted and provide relevant portions of the inquiry report to the complainant for comment within 10 days.  A confidentiality agreement should be a condition for access to the report.

 

C.        Institutional Decision and Notification

 

1.         Decision by Deciding Official

 

The RIO will transmit the final inquiry report and any comments to the DO, who will determine in writing whether an investigation is warranted.  The inquiry is completed when the DO makes this determination.

 

2.         Notification to ORI

 

Within 30 calendar days of the DO’s decision that an investigation is warranted, the RIO will provide ORI with the DO’s written decision and a copy of the inquiry report.  The RIO will also notify those institutional officials who need to know of the DO's decision.  The RIO must provide the following information to ORI upon request: (1) the institutional policies and procedures under which the inquiry was conducted; (2) the research records and evidence reviewed, transcripts or recordings or any interviews, and copies of all relevant documents; and (3) the charges to be considered in the investigation.[40]

 

3.         Documentation of Decision Not to Investigate

 

            If the DO decides that an investigation is not warranted, the RIO shall secure and maintain for 7 years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by ORI of the reasons why an investigation was not conducted. These documents must be provided to ORI or other authorized HHS personnel upon request.

 

VII.     Conducting the Investigation

 

A.        Initiation and Purpose

 

The investigation must begin within 30 calendar days after the determination by the DO that an investigation is warranted.[41]  The purpose of the investigation is to develop a factual record by exploring the allegations in detail and examining the evidence in depth, leading to recommended findings on whether research misconduct has been committed, by whom, and to what extent.  The investigation will also determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations.  This is particularly important where the alleged research misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice.  The findings of the investigation will be set forth in an investigation report.

 

B.         Notifying ORI and Respondent; Sequestration of Research Records

 

On or before the date on which the investigation begins, the RIO must: (1) notify the ORI Director of the decision to begin the investigation and provide ORI a copy of the inquiry report; and (2) notify the respondent in writing of the allegations to be investigated.  The RIO must also give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of the investigation.[42]

 

The RIO will, prior to notifying respondent of the allegations, take all reasonable and practical steps to obtain custody of and sequester in a secure manner all research records and evidence needed to conduct the research misconduct proceeding that were not previously sequestered during the inquiry.  Where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.  The need for additional sequestration of records for the investigation may occur for any number of reasons, including 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.[43]

 

C.        Appointment of the Investigation Committee

 

The RIO, in consultation with other institutional officials as appropriate, will appoint an investigation committee and the committee chair within 10 days of the beginning of the investigation or as soon thereafter as practical.  The investigation committee must consist of individuals who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the investigation and should include individuals with the appropriate scientific expertise to evaluate the evidence and issues related to the allegation, interview the respondent and complainant and conduct the investigation.  Individuals appointed to the investigation committee may also have served on the inquiry committee. 

 

The RIO will notify the respondent of the proposed committee membership within 5 days of its formation.