Awards and Award Management: Policies
ETHICAL STANDARDS IN RESEARCH
I. Institutional Goals
A. It is in the best interest of the public and of academic medicine to prevent misconduct in research and to deal effectively and responsibly with an instance when misconduct is suspected or substantiated. The maintenance of public trust requires adherence to the ethical principles that govern scientific research, and is the responsibility of the faculty, staff and administration of an academic medical center. This policy provides the procedures under which possible research misconduct by will be investigated and resolved. Other lapses in professional or academic conduct are addresses through other institutional policies and procedures.
B. Research misconduct means fabrication, falsification, plagiarism, in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinions. [93.103]
1. Fabrication is making up data or results and recording or reporting them.
2. 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.
3. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
II. Procedures when Possible Misconduct is Reported
A. General
1. The procedures for evaluating and responding to allegations of research misconduct proceed in three stages.
a. A preliminary assessment of the allegations to determine if the report requires further inquiry
b. An inquiry to determine if there is sufficient credible evidence to justify an investigation
c. An investigation to make definitive findings of fact and reach conclusions
B. Referral of Other Issues
1. Questions and issues related to financial improprieties, human research subjects, the use of animals in research will be reviewed and governed by the Internal Audit Office, Institutional Review Board and Institutional Animal Care and Use Committee respectively under the relevant policies, regulations and ethical standards. Criminal acts will be referred to and handled by the appropriate law enforcement agency.
C. Requirements for finding research misconduct
1. A finding of research misconduct made under this part requires:
a. That there be a significant departure from accepted practices of the relevant research community;
b. The misconduct be committed intentionally, knowingly or recklessly; and
c. The allegation be proven by a preponderance of the evidence.
III. Preliminary Assessment of Allegations
A. Allegation Assessment
1. Any allegation of possible misconduct will be reported to the Research Integrity Officer, who will determine if the allegations fall under the definition of research misconduct and whether the report requires further attention and inquiry.
a. Following a good faith report of research misconduct, the Institution will take interim administrative actions, as appropriate, to protect Federal funds and ensure that the purposes of the Federal financial assistance are carried out.
B. Assessment Process
1. To conduct a preliminary assessment of allegations the Research Integrity Officer may discuss the allegation with the person(s) accused of misconduct, interview individuals they determine may have knowledge or information they deem to be relevant and review any documents, records and/or materials they deem to be relevant
2. The Research Integrity Officer may consult with the Institutional Legal Department, and/or other individuals as they feel appropriate to decide if the report warrants further inquiry. The Research Integrity Officer may decide to appoint a fact-finding team to assess and to advise.
C. Disposition
1. If the Research Integrity Officer finds that there is a reasonable basis for concluding that the allegations fall within the definition of research misconduct, and are sufficiently credible and specific so that potential evidence of research misconduct may be identified the Research Integrity Officer will begin an inquiry.
2. If the Research Integrity Officer finds that there is not a reasonable basis for concluding that the allegations fall within the definition of research misconduct, or that they are not sufficiently credible and specific so that potential evidence of research misconduct may be identified the Research Integrity Officer will notify the Complainant of the that the allegations are not supported.
3. The Research Integrity Officer will document the determination related to the preliminary assessment of all allegations, regardless of their disposition, in sufficiently detail to permit later assessment for that determination.
IV. Inquiry
A. Purpose and Initiation f the Inquiry
1. If the Research Integrity Officer determines that the preliminary assessment of the allegations of misconduct warrants further follow-up he/she will initiate the inquiry process. The purpose of the inquiry is to conduct an initial evaluation of the available evidence, and testimony of the Complainant, Respondent and key witnesses to determine whether there is sufficient evidence of possible misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible. The Research Integrity Officer may consult at any time with other individuals regarding the appropriate procedures to be followed.
2. As soon as practicable after the Research Integrity Officer determines that an inquiry is required he/she will:
a. Clearly identify the allegations and any related issues that will be evaluated in the inquiry
b. Secure the relevant research records
c. Notify the appropriate Institutional officials, Institutional legal office, the respondent and, as required by regulation, contract or other agreement, the study sponsor.
d. Appoint and charge an inquiry committee
B. Sequestration of Records
1. As soon as practicable possible after the initiation of the Inquiry the Research Integrity Officer will take custody of all research records, relevant to the inquiry. As new evidence becomes known, the Research Integrity Officer will take custody of any additional research records and evidence relevant to the inquiry. Research records and evidence are not limited to those of the Respondent, but include all research records and evidence the Research Integrity Officer determines to be relevant to the Inquiry. The Research Integrity Office may obtain the assistance of other individuals to assist in obtaining and sequestering records.
2. The Respondent should be notified simultaneously with the sequestration, but not before, of the Inquiry. The Respondent and others will assist the Research Integrity Officer with location and identification of research records relevant to the Inquiry. Research records produced by any individual during the course of their employment or other contractual relationship with the Institution, or that are produced with the use of Institutional resources, equipment, funds, space, time or facilities belong to the Institution. Individuals can not interfere with the Institution’s right access, obtain and sequester them. The destruction, alteration, failure to maintain, or failure to provide research records adequately documenting the questioned research constitutes a serious departure from accepted practices of the research community. Such practices constitute manipulation of research material, equipment, or process, or changing or omitting data or results such that the research is not accurately represented in the research record.
3. Upon obtaining research records, the Research Integrity Officer will inventory, record and secure them. Access to sequestered records should be such that loss, alteration or fraudulent creation of records is prevented.
C. Notifications
1. The Research Integrity Officer will notify the Respondent in writing as soon as reasonably possible of the Inquiry. This notification establishes the beginning of the inquiry process. The notification should identify the research project in question, the specific allegations and issues, define scientific misconduct, address the Respondent’s obligation as an employee or agent of the Institution to cooperate, describe the Institutional policy on non-retaliation, and describe the need to maintain confidentiality during the Inquiry.
2. The notification to the Respondent will be copied to, the Deciding Official, the Dean of the School of Medicine, the Associate Dean for Research, the Respondent’s departmental chair and other appropriate Institutional officials.
D. Designation of an Inquiry Committee
1. The Research Integrity Officer, in consolation with appropriate Institutional officials, will appoint an Inquiry committee, consisting of at least three faculty members at the level of Associate Professor or above who have the necessary expertise to evaluate the evidence and issues related to the allegations. The Research Integrity Officer will designate one member to chair the Committee. The Research Integrity Officer will serve as an ex officio member of the inquiry committee. Administrative assistance will be provided or secured by the Office of Research as needed. Institutional Legal Counsel will be available to advise the committee.
2. The Research Integrity Officer, in consultation with the Committee, will determine whether additional experts other than those appointed to the Committee need to be consulted during the inquiry to provide special expertise to the Committee regarding the analysis of specific evidence. In this case, the experts provide a strictly advisory function to the Committee; they do not vote and generally do not interview witnesses. The experts chosen may be from inside or outside of the Institution.
3. The Research Integrity Officer will take reasonable steps to ensure that the members of the Committee and any experts have no bias, personal or professional conflict of interest with the Respondent, Complainant, or the case in question. In making this determination, the Research Integrity Officer will consider whether the individual (or any members of his or her immediate family):
a. Has any financial involvement with the Respondent or Complainant;
b. Has been a coauthor on a publication with the Respondent or Complainant;
c. Has been a collaborator or co-investigator with the Respondent or Complainant;
d. Has been a party to a scientific controversy with the Respondent or Complainant;
e. Has a supervisory or mentor relationship with the Respondent or Complainant;
f. Has a special relationship, such as a close personal friendship, kinship, or a physician/patient relationship with the Respondent or Complainant; or
g. Falls within any other circumstance that might appear to compromise the individual's objectivity in reviewing the allegations.
4. Members of the Committee and experts will agree in writing to observe the confidentiality of the proceeding and any information, documents, materials, testimony or other evidence reviewed as part of the Inquiry. Outside of the official proceedings of the Committee, they may not discuss the proceedings with the Respondent or Complainant, witnesses, or anyone else not authorized by the Research Integrity Officer to have knowledge of the Inquiry.
5. The Research Integrity Officer will replace any Committee member or expert who for what ever reason becomes unable to participate in the proceedings or who is found at any time during the proceedings to have an actual or potential conflict of interest.
6. At the first meeting, the Research Integrity will provide a charge for the Committee that describes the allegations and any related issues, and state the purpose of the Inquiry.
E. General Approaches to Conducting the Inquiry
1. The Committee should take reasonable steps to ensure an impartial and unbiased inquiry and to conduct the inquiry in a professional and objective manner.
2. The Committee should conduct proceedings in a confidential manner. Witnesses should be advised that proceedings are confidential and that they should not discuss the Inquiry or their interview with anyone else.
3. The Committee should use diligent efforts to ensure a sufficient evaluation of the available evidence, and testimony of the Complainant, Respondent and other persons who have been reasonably identified as having information regarding relevant aspects of the allegation to determine whether there is reasonable basis for concluding that the allegations fall within the definition of research misconduct. However, since the purpose of an inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation, a full review of all the evidence related to the allegation is not required.
4. The Respondent will be provided an adequate opportunity to explain and defend his/or her actions, to provide a written statement, to provide additional information and to be advised by counsel or other adviser.
5. After deliberation and consultation the Committee members will decide whether there is sufficient evidence of possible research misconduct to recommend an Investigation. The scope of the Inquiry does not include deciding whether misconduct occurred or conducting exhaustive interviews and analysis. The decision whether or not to recommend proceeding to an Investigation will be made based on a simple majority vote of all Committee members.
6. Documentation of all proceedings will be maintained in sufficient detail to permit a later assessment, if necessary, of the Committee’s determinations.
F. Inquiry Report
1. A written inquiry report must be prepared that states the name and title of the committee members and experts, if any; the allegations; the sponsor; 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; and the committee's determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. Institutional counsel will review the report for legal sufficiency. All relevant dates should be included in the report. The initial inquiry report will be a draft.
2. The Committee will submit a draft Inquiry report to the Research Integrity Officer, who will provide the Respondent with a copy of the draft report for comment and rebuttal. In addition, the Research Integrity Officer may provide the Complainant with those portions of the draft investigation report that address the Complainant’s role and opinions in the investigation The Respondent and Complainant will be allowed 7 calendar days to review and comment on the draft report. The written comments submitted by either will be attached to the final report. The Inquiry Committee will review any submitted comments, revise the report as they feel appropriate, and submit a final copy of the Inquiry Report to the Research Integrity Officer.
3. If the Committee is unable to make a definitive determination, the Chair shall so notify the Deciding Official. The Deciding Official may then accept the report’s findings and recommendations and proceed with their determination or return the report to the Committee for further fact-finding or analysis.
G. Decision by Deciding Official
1. The Research Integrity Officer will transmit the final report and any comments to the Deciding Official, who will make the determination of whether findings from the inquiry provide sufficient evidence of possible scientific misconduct to justify conducting an investigation. The Deciding Official will document the reasons for their decision in sufficiently detailed to permit later assessment for that determination. The inquiry is completed when the Deciding Official makes this determination, which will be made within 60 days of the first meeting of the inquiry committee.
H. Notification
1. The Research Integrity Officer will notify both the Respondent and the Complainant in writing of the Deciding Official's decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened. The Research Integrity Officer will also notify all appropriate Institutional officials of the Deciding Official's decision.
2. PHS Requirements
I. Time Limit for Completing the Inquiry Report
1. The inquiry committee will complete the inquiry and submit its report in writing to the Research Integrity Officer no more than 60 calendar days following its first meeting, unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for the extension will be entered into the records of the case and the report. The Respondent will also be notified of the extension. The notice will include a copy of the final inquiry report and reference to this Institutional policy. For PHS supported research, the notice will include reference to the Public Health Service Policies on Research Misconduct, 42 CFR Part 93.
V. Investigation
A. Purpose and Initiation f the Investigation
1. The Research Integrity Officer will initiate the Investigation process within 30 calendar days after the Respondent of the Deciding Official has determined that an Investigation is warranted. 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 additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. The Research Integrity Officer may consult at any time with other individuals regarding the appropriate procedures to be followed.
B. Sequestration of Records
1. As soon as practicable possible after the initiation of the Investigation the Research Integrity Officer will take all reasonable and practical steps to obtain custody of obtain all research records and evidence needed to conduct the research misconduct proceeding, that were not previously sequestered. During the course of the investigation, the Research Integrity Officer will take custody of additional research records and evidence becomes known or relevant to the investigation. Research records and evidence are not limited to the Respondent, but include all research records and evidence the Research Integrity Officer determines to be relevant to the Inquiry. The Research Integrity Office may obtain the assistance of other individuals to assist in obtaining and sequestering records.
2. Whenever possible the Research Integrity Officer will take custody of research records and evidence before or at the time the Respondent is notified simultaneously of the Investigation. The Respondent and others will assist the Research Integrity Officer with locating and identifying relevant research records and evidence. Research records produced by any individual during the course of their employment or other contractual relationship with the Institution, or that are produced with the use of Institutional resources, equipment, funds, space, time or facilities belong to the Institution. Individuals can not interfere with the Institution’s right access, obtain and sequester them. The destruction, alteration, failure to maintain, or failure to provide research records adequately documenting the questioned research constitutes a serious departure from accepted practices of the research community. Such practices constitute manipulation of research material, equipment, or process, or changing or omitting data or results such that the research is not accurately represented in the research record.
3. Upon obtaining any additional research records, the Research Integrity Officer will inventory, record and secure them. Access to sequestered records should be such that loss, alteration or fraudulent creation of records is prevented.
C. Notifications
1. The Research Integrity Officer will notify the Respondent in writing as soon as reasonably possible after the determination is made to open an Investigation. The notification should identify the research project in question, the study sponsor, the specific allegations and issues, define scientific misconduct, address the Respondent’s obligation as an employee or agent of the Institution to cooperate, describe the Institutional policy on non-retaliation, and describe the need to maintain confidentiality during the Inquiry. A copy of the final Inquiry report will be provided as an attachment to the notice.
2. The notification to the Respondent will be copied to, the Deciding Official, the Dean of the School of Medicine, the Associate Dean for Research the Respondent’s departmental chair and other appropriate Institutional Officials.
3. For PHS supported research the notice will also include the source of PHS funding; the fact that ORI will perform an oversight review of the report regarding PHS issues; and an explanation of the respondent’s right to request a hearing before the DHHS Departmental Appeals Board if there is an ORI finding of misconduct under the PHS definition. The Research Integrity Officer will notify the ORI Director of the decision to begin an investigation on or before the date the investigation begins and provide an inquiry report that meets the requirements of § 93.307 and § 93.309.
D. Designation of an Investigation Committee
1. The Research Integrity Officer, in consultation with appropriate Institutional Officials, will appoint an Investigation committee, consisting of at least three faculty members at the level of Associate Professor or above who have the necessary expertise to evaluate the evidence and issues related to the allegations. The Research Integrity Officer will designate one member to chair the Committee. The Research Integrity Officer will serve as an ex officio member of the Committee. Administrative assistance will be provided or secured by the Office of Research as needed. Institutional Legal Counsel will be available to advise the Committee. Individuals appointed to the Investigation Committee may also have served on the inquiry committee.
2. The Research Integrity Officer, in consultation with the Committee, will determine whether additional experts other than those appointed to the Committee need to be consulted during the Investigation to provide special expertise to the Committee regarding the analysis of specific evidence. In this case, the experts provide a strictly advisory function to the Committee; they do not vote and generally do not interview witnesses. The experts chosen may be from inside or outside of the Institution.
3. The Research Integrity Officer will take reasonable steps to ensure that the members of the Committee and any experts have no bias, personal or professional conflict of interest with the Respondent, Complainant, or the case in question. In making this determination, the Research Integrity Officer will consider whether the individual (or any members of his or her immediate family):
a. Has any financial involvement with the Respondent or Complainant;
b. Has been a coauthor on a publication with the Respondent or Complainant;
c. Has been a collaborator or co-investigator with the Respondent or Complainant;
d. Has been a party to a scientific controversy with the Respondent or Complainant;
e. Has a supervisory or mentor relationship with the Respondent or Complainant;
f. Has a special relationship, such as a close personal friendship, kinship, or a physician/patient relationship with the Respondent or Complainant; or
g. Falls within any other circumstance that might appear to compromise the individual's objectivity in reviewing the allegations.
4. Members of the Committee and experts will agree in writing to observe the confidentiality of the proceeding and any information, documents, materials, testimony or other evidence reviewed as part of the Investigation. Outside of the official proceedings of the Committee, they may not discuss the proceedings with the Respondent or Complainant, witnesses, or anyone else not authorized by the Research Integrity Officer to have knowledge of the Investigation.
5. The Research Integrity Officer will replace any Committee member or expert who for what ever reason becomes unable to participate in the proceedings or who is found at any time during the proceedings to have an actual or potential conflict of interest.
6. At the first meeting, the Research Integrity will provide a charge for the Committee that describes the allegations and any related issues, and state the purpose of the Investigation.
E. General Approaches to Conducting the Investigation
1. The Committee should take reasonable steps to ensure an impartial and unbiased investigation, and to conduct the investigation in a professional and objective manner.
2. The Committee should conduct proceedings in a confidential manner. Witnesses should be advised that proceedings are confidential and that they should not discuss the Inquiry or their interview with anyone else.
3. The Committee should use diligent efforts to ensure that the investigation is through and includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations.
4. The Committee should interview, if possible, the Complainant, Respondent and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation. Interviewees will be provided an adequate opportunity to explain and defend his/or her actions, to provide a written statement, to provide additional information and to be advised by counsel or other adviser. The Committee will record or transcribe each interview. The interviewee will have 7 calendar days to review the recording or transcript and correct any factual errors. The recording or transcript will be included in the record of the investigation.
5. The Committee should pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct. The investigation should be continued to completion.
6. Documentation of all proceedings will be maintained in sufficient detail to permit later assessment, if necessary, of the Committee’s determinations.
F. Committee Deliberations
1. After considering the evidence the Committee will decide whether research misconduct, meaning fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting results occurred and if so who committed it. To make a finding of research misconduct the Committee must find there was a significant departure from accepted practices of the relevant research community and the misconduct was committed intentionally, knowingly, or recklessly. A finding of research misconduct must be proved by a preponderance of the evidence. The decision will be based on a simple majority vote of all Committee members.
2. The Institution has the burden of proof for making a finding of research misconduct. The destruction, absence of, or Respondent’s failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution establishes by a preponderance of the evidence that the Respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the Respondent’s conduct constitutes a significant departure from accepted practices of the relevant research community.
3. The Respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised.
4. The Respondent has the burden of going forward with and proving by a preponderance of the evidence any mitigation factors that are relevant to a decision to impose administrative actions following a research misconduct proceeding.
G. Investigation Report
1. The Committee will prepare a written Investigation report within 90 calendar days of beginning the investigation. The report will contain the name and title of the committee members and experts, if any; a description of the nature of the allegations of research misconduct; the sponsor/support; a description of the specific allegations of research misconduct considered in the investigation; a list and summary of the research records and evidenced reviewed; a list of any evidence take into custody but not reviewed; a statement of findings; and any comments made by the Respondent or Complainant on the report. A copy of the institutional policies and procedures under which the investigation was conducted will be included as an attachment. The initial inquiry report will be a draft.
2. The Committee will submit a draft Investigation report to the Research Integrity Officer, who will provide the Respondent with a copy of the draft report for comment and rebuttal. In addition, the Research Integrity Officer may provide the Complainant with those portions of the draft Investigation report that address the Complainant’s role and opinions in the investigation The Respondent and Complainant will be allowed 30 calendar days to review and comment on the draft report. The written comments submitted by either will be attached to the final report. The Committee will review any submitted comments, revise the report as they feel appropriate, and submit a final copy of the Inquiry Report to the Research Integrity Officer.
3. If the Committee is unable to make a definitive determination, the Chair shall so notify the Deciding Official. The Deciding Official may then accept the report’s findings and recommendations and proceed with their determination or return the report to the Committee for further investigation or analysis.
H. Decision by Deciding Official
1. The Research Integrity Officer will transmit the final Investigation report and any comments to the Deciding Official who will determine whether the allegations of research misconduct are substantiated by the findings and if so by whom. The Deciding Official will document the reasons for their decision in sufficiently detailed to permit later assessment for that determination.
I. Institutional Actions
1. If the Deciding Official determines that the findings of research misconduct are substantiated, the Dean will then decide on the appropriate actions to be taken. Such action may include, without limitation, removal from a specific project; letter of reprimand; special monitoring of future work; probation; suspension; salary reduction; demotion; or termination. In consultation with the Institutional Legal Department, institutional administrators may release appropriate information to the public about the incident, particularly when public funds were used in supporting the research.
J. Finding of no misconduct
1. If the allegations of research misconduct are not substantiated by a thorough investigation, diligent efforts will be undertaken to restore the reputations of the Respondent, others whose conduct has been investigated and, as appropriate, the Complainant or committee members. In addition, appropriate disciplinary action may be taken against any party whose involvement in leveling unfounded charges was demonstrated to have been malicious or intentionally dishonest.
K. Notification
1. The Research Integrity Officer will notify both the Respondent and the Complainant in writing of the Deciding Official's decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened. The Research Integrity Officer will also notify all appropriate institutional officials of the Deciding Official's decision.
2. Institutions and sponsoring agencies with which the individual has been affiliated will be notified if there is reason to believe that the validity of previous research might be questionable.
L. Time Limit for Completing the Investigation
1. All aspects of the Investigation, including conducting the investigation, preparing the report of finding, providing the draft report for comments and distribution of the final report must be completed within 120 days of beginning the Investigation.
2. If the Investigation can not be completed within 120 days an extension of the time limit may be requested in writing. The request should be made to ORI for PHS Sponsored research, or the Deciding Official or other sponsor for non-PHS sponsored research.
VI. Reporting to ORI prior to completion of inquiry or investigation
A. In the case of PHS-sponsored research, the Research Integrity Officer shall notify the Director, Office of Research Integrity (ORI), prior to completion of the inquiry or investigation when:
1. There is an immediate health hazard involved;
2. There is an immediate need to protect Federal funds or equipment;
3. There is an immediate need to protect the interests of the Complainant or of the Respondent as well as his/her co-investigators and associates, if any;
4. It is probable that the reported incident is going to be reported publicly; or,
5. There is a reasonable indication of possible criminal violation. In that instance, the Institution must inform ORI within 24 hours of obtaining that information. ORI will immediately notify the Office of the Inspector General, DHHS.
B. If the Research Integrity Officer plans to terminate an inquiry or investigation without completing all relevant requirements of the PHS regulation, the Research Integrity Officer will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination.
C. The Institution must notify ORI in advance if it plans to close a case at the inquiry, investigation or appeal stage because the Respondent has admitted guilt, a settlement with the Respondent has been reached, or for any other reason other than a finding that no inquiry is warranted, or no research misconduct has occurred
VII.Record Retention
A. The Institution will retain the research proceeding records in a secure place for seven years after completion of the proceeding.
B. For PHS Sponsored research, unless otherwise advised in writing by ORI, the Institution will retain the research proceeding records in a secure place for seven years after completion of the proceeding or any PHS proceeding, whichever is later.
VIII. Institutional Policies [93.304]
A. Prevention of Misconduct in research
1. The Institution strives to provide an open and stimulating environment for creativity and individual thought where a faculty member will develop independently and productively. It is intended that this climate will promote high ethical standards and enhance the research process. The Institution will provide training to staff and others involved in research to promote the responsible conduct of research and discourage research misconduct. To further discourage impropriety, the following Institutional policies and procedures relating to misconduct have been adopted
2. The Institution will foster a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct. [93.300(c)] The Institution will take all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings, including, but not limited to, their providing information, research records, and evidence [93.300(f)].
a. For PHS sponsored research, the Institution will cooperate with HHS during any research misconduct proceeding or compliance review [93.300(f)], assist in administering and enforcing any HHS administrative actions imposed on its institutional members [93.300(h)] and will have an active assurance of compliance [93.300(i)].
3. The Institution has adopted the procedures described below so that a report of possible research misconduct may be investigated and resolved in an expedious, fair, thoughtful, confidential and judicious manner.
4. Individual responsibilities
a. Each investigator has responsibilities relating to ethical conduct of research. These include awareness of Institutional policy; supervision of others; maintaining research records; collaborative efforts; and publication and other dissemination of research findings.
i. The faculty is encouraged to discuss research ethics and to heighten awareness of problems of misconduct in science
ii. The quality of research is more important than is quantity as a measure of productivity.
iii. The conduct of research is the responsibility of the principal investigator [and co-investigator(s)]. These individuals supervise support personnel and are in turn supervised by the section head or department chair.
iv. Research data will be recorded and appropriately authenticated by the investigator at the time the research is conducted. These data will be maintained in accordance with the Data Ownership policy of the Institution.
v. Responsibilities related to authorship are addressed in the Authorship policy of the Institution. Papers and abstracts with joint authors will be the work of those who have contributed significantly to the research. Each of the authors accepts the responsibility for the quality and veracity of the work reported.
B. Reporting Research Misconduct
1. Institutional members or others will immediately report any real, apparent or suspected research misconduct to the Research Integrity Officer.
C. No Retaliation
1. Institutional members who receive or learn of a report of research misconduct will treat the Complainant with fairness and respect and, when the report has been made in good faith, will take reasonable steps to protect the position and reputation of the complainant and other individuals who cooperate with the Institution against retaliation. Institutional members will immediately report any real or apparent retaliation to the Research Integrity Officer.
D. Confidentiality
1. Every effort will be taken to provide confidentiality. Disclosure of the identity of respondents and complainants in research misconduct proceedings is limited, to the extent possible, to those who need to know, consistent with a thorough, competent, objective and fair research misconduct proceeding, and as allowed by law. Confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who have a need to know to carry out a research misconduct proceeding. [93.108]
IX. Applicability
1. This policy applies to all Institutional Members (see Definitions).
2. This policy applies to allegations of research misconduct and research misconduct involving applications or proposals for, or conduct of biomedical or behavioral extramural or intramural 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; and plagiarism of research records produced in the course of sponsored 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 funds resulted in a grant, contract, cooperative agreement, or other form of support.
3.