Draft Policy: Emerson College Policy and Procedures for Addressing Allegations of Research Misconduct Involving PHS-Supported Research
NOTE: The following policy has been drafted for consideration by the College’s Policy Committee and is being posted here for informational purposes only.
Policy Statement
Emerson College is committed to upholding the highest standards of scientific rigor in research. This institution is committed to fostering an environment that promotes research integrity and the responsible conduct of research, discourages research misconduct, and deals promptly with allegations or evidence of possible research misconduct. As an institution supported by Public Health Services (PHS) funding, Emerson College is responsible for ensuring it has policies and procedures in place for addressing allegations of research misconduct that meet the requirements of the Public Health Services (PHS) Policies on Research Misconduct (42 CFR Part 93).
Reason for the Policy
Emerson College strives to reduce the risk of research misconduct, support all good-faith efforts to report suspected misconduct, promptly and thoroughly address all allegations of research misconduct, and seek to rectify the scientific record and/or restore researchers’ reputations, as appropriate. Emerson College has established the following policies and procedures for responding to allegations of research misconduct related to PHS-supported research, consistent with the requirements outlined in 42 CFR Part 93. These policies and procedures apply to allegations of research misconduct involving:
- Applications or proposals for PHS support for biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training.
- PHS-supported biomedical or behavioral research.
- PHS-supported biomedical or behavioral research training programs.
- PHS-supported activities that are related to biomedical or behavioral research or research training, such as, but not limited to, the operation of data banks or the dissemination of research information.
- Research records produced during PHS-supported research, research training, or activities related to that research or research training.
- Research proposed, performed, reviewed, or reported, as well as any research record generated from that research, regardless of whether an application or proposal for PHS funds resulted in an awarded grant, contract, cooperative agreement, subaward, or other form of PHS support.
These policies and procedures apply only to research misconduct occurring within six years of the date that either the Department of Health and Human Services (DHHS) or Emerson College receives an allegation of research misconduct, subject to specific exceptions:
- The six-year time limitation does not apply if the respondent continues or renews any incident of alleged research misconduct that occurred before the six-year period through the use of, republication of, or citation to the portion(s) of the research record alleged to have been fabricated, falsified, or plagiarized, for the potential benefit of the respondent (“subsequent use exception”). For alleged research misconduct that appears subject to this subsequent use exception, but Emerson College determines is not subject to the exception, the institution will document its determination that the subsequent use exception does not apply and will retain this documentation for the later of seven years after completion of the institutional proceeding or the completion of any HHS proceeding.
- The six-year time limitation also does not apply if the DHHS Office of Research Integrity (ORI) or Emerson College, following consultation with ORI, determines that the alleged research misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.
Allegations of research misconduct that do not involve PHS funding may be addressed by the procedures outlined in the College’s Research Misconduct policy.
Definitions
- Research Misconduct: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion.
- Accepted practices of the relevant research community: Practices established by 42 CFR Part 93 and by PHS funding components, as well as commonly accepted professional codes or norms within the overarching community of researchers and institutions that apply for and receive PHS awards.
- Administrative record: The administrative record comprises: 1) the institutional record; 2) any information provided by the respondent to ORI, including but not limited to the transcript of any virtual or in-person meetings under § 93.403(b) between the respondent and ORI, and correspondence between the respondent and ORI; 3) any additional information provided to ORI while the case is pending before ORI; and 4) any analysis or additional information generated or obtained by ORI. Any analysis or additional information generated or obtained by ORI will also be made available to the respondent.
- Allegation: The disclosure of possible research misconduct through any means of communication and brought directly to the attention of an institutional or HHS official.
- Assessment: The consideration of whether an allegation of research misconduct appears to fall within the definition of research misconduct; appears to involve PHS-supported biomedical or behavioral research, biomedical or behavioral research training, or activities related to that research or research training; and is sufficiently credible and specific so that potential evidence of research misconduct may be identified. The assessment only involves the review of readily accessible information relevant to the allegation.
- Complainant: an individual who in good faith makes an allegation of research misconduct.
- Fabrication: Making up data or results and recording or reporting them.
- Falsification: 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.
- Inquiry: a preliminary information-gathering and preliminary fact-finding that meets the criteria and follows the procedures of § 93.307 through § 93.309.
- Investigation: the formal development of a factual record and the examination of that record that meets the criteria and follows the procedures of §§ 93.310 through 93.317.
- Plagiarism: The appropriation of another person’s ideas, processes, results, or words, without giving appropriate credit.
- Respondent: The individual against whom an allegation of research misconduct is directed or the individual whose actions are the subject of the inquiry or investigation. There can be more than one respondent in an inquiry or investigation.
- Research Integrity Officer (RIO): The institutional official responsible for administering the institution’s written policies and procedures for addressing allegations of research misconduct.
- subsequent use exception:
- Institutional Deciding Official (IDO): The institutional official who makes final determinations on allegations of research misconduct and any institutional actions. The same individual cannot serve as the IDO and the RIO.
Statements of Elaboration of the Policy
- Roles, Rights, and Responsibilities
- Emerson College’s General Responsibilities
To the extent possible, the institution will limit disclosure of the identity of respondents, complainants, and witnesses while conducting the research misconduct proceedings. Such information will be shared strictly on a need-to-know basis. This limitation on disclosure no longer applies once the institution has made a final determination of research misconduct findings. Those who need to know may include institutional review boards, journals, editors, publishers, co-authors, and collaborating institutions.
Emerson College will respond to each allegation of research misconduct in a thorough, competent, objective, and fair manner. The institution will take all reasonable and practical steps to ensure the cooperation of respondents and other institutional members with research misconduct proceedings. Emerson, to the greatest extent possible, protect the complainant(s), witnesses, institutional officials, and any committee members against retaliation. Individuals engaging in acts of retaliation will be subject to grievance proceedings and/or disciplinary action.
- Responsibilities to the Complainant
Emerson College will provide confidentiality consistent with 42 CFR Part 93 for all complainants. The institution will also take precautions to ensure that individuals responsible for carrying out any part of the research misconduct proceeding do not have conflicts of interest with the complainant. The institution agrees to take all reasonable and practical steps to protect the positions and reputations of complainants and to protect these individuals from retaliation.
- Responsibilities to the Respondent
Emerson College will provide confidentiality consistent with 42 CFR Part 93 to all respondents. The institution will make a good-faith effort to notify the respondent(s) in writing of the allegations being made against them. Emerson College is responsible for giving the respondent(s) copies of or supervised access to the sequestered research records. The institution will notify the respondent whether the inquiry found that an investigation is warranted, provide the respondent an opportunity to review and comment on the inquiry report, and attach their comments to the inquiry report. If an investigation is commenced, the institution must notify the respondent, give written notice of any additional allegations raised against them not previously addressed by the inquiry report, and allow the respondent(s) an opportunity to review the witness transcripts. The institution will give the respondent(s) an opportunity to read and comment on the draft investigation report and any information or allegations added to the institutional record.
II. Procedures for Addressing Allegations of Research Misconduct
- Overview
After possible research misconduct is brought to the attention of the department chair, dean of the school, or another institutional official, the review process for the case of alleged misconduct consists of three phases: Assessment, Inquiry, and Investigation. Procedures for each phase are described below.
- Assessment
An assessment’s purpose is to determine whether an allegation warrants an inquiry. Upon receiving an allegation of research misconduct, the RIO or another designated institutional official will promptly assess the allegation to determine whether it:
- Falls within the definition of Research Misconduct under 42 CFR Part 93;
- Is within the applicability criteria of the regulation; and
- Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
This assessment will be documented in writing. If the RIO determines, in consultation with other institutional officials as appropriate, that the requirements for an inquiry are met, they shall document the assessment, promptly sequester all research records and other evidence, and promptly initiate the inquiry. If the requirements are not met, the RIO will keep detailed documentation of why Emerson College did not conduct an inquiry.
C. Inquiry
An Inquiry is warranted if the allegation meets the criteria above. An Inquiry’s purpose is to conduct an initial review of the evidence to determine whether an allegation warrants an Investigation. An inquiry does not require a full review of all related evidence. Emerson College will complete the Inquiry within 90 calendar days of initiation, unless circumstances warrant a longer period.
- Sequestering Evidence and Notifying the Respondent
Before or at the time of notifying the respondent(s), Emerson will obtain the original or substantially equivalent copies of all research records and other evidence that are pertinent to the proceeding, inventory these materials, sequester the materials in a secure manner, and retain them for seven years.
At the time of or before beginning the inquiry, Emerson College will make a good-faith effort to notify the presumed respondent(s), in writing, that an allegation(s) of research misconduct has been raised against them, the relevant research records have been sequestered, and an inquiry will be conducted to decide whether to proceed with an investigation. If additional allegations are raised, the institution will notify the respondent(s) in writing.
When appropriate, the institution will give the respondent(s) copies of, or reasonable supervised access to, the sequestered materials. If additional respondents are identified, Emerson will provide written notification to the new respondent(s). All additional respondents will be given the same rights and opportunities as the initial respondent.
- Determining Whether an Investigation Is Warranted
The RIO will conduct a preliminary review of the evidence. The RIO shall utilize subject matter experts as needed to assist with the inquiry.In the process of fact-finding, the RIO may interview the respondent and/or witnesses. All interviews conducted during the inquiry should be recorded and transcribed where practicable, and transcripts should be provided to the interviewed party for comment or revision and included as part of the documentary record of the inquiry. The respondent must be given an opportunity to comment on the allegations during the inquiry and to respond to the inquiry findings, and his or her comments will be made part of the final inquiry record.
The RIO will not determine if research misconduct occurred, nor assess whether the alleged misconduct was intentional, knowing, or reckless; such a determination is not made until the case proceeds to an investigation.
- Documenting the Inquiry
At the conclusion of the inquiry, regardless of whether an investigation is warranted, the RIO or other designated institutional official will prepare a written inquiry report. The contents of a complete inquiry report will include:
- The names, professional aliases, and positions of the respondent and complainant(s).
- A description of the allegation(s) of research misconduct.
- Details about the PHS funding, including any grant numbers, grant applications, contracts, and publications listing PHS support.
- The name(s) and position(s) of any subject matter experts consulted.
- An inventory of sequestered research records and other evidence and description of how sequestration was conducted.
- Transcripts of interviews, if transcribed.
- Inquiry timeline and procedural history.
- Any scientific or forensic analyses conducted.
- The basis for recommending that the allegation(s) warrant an investigation, OR the basis on which any allegation(s) do not merit further investigation.
- Any comments on the inquiry report by the respondent or the complainant(s).
- Any institutional actions implemented, including internal communications or external communications with journals or funding agencies.
- Documentation of potential evidence of honest error or difference of opinion.
The final inquiry report will also be kept on file by the RIO for at least seven (7) years. This file will not become a part of the respondent’s employment or student record at the College, unless a subsequent investigation results in a final determination of research misconduct. To the greatest extent possible, the inquiry proceedings will be kept confidential in order to protect the rights of all parties involved.
- Completing the Inquiry
Emerson College will give the respondent a copy of the draft inquiry report for review and comment. The institution may, but is not required to, provide relevant portions of the report to a complainant for comment. Emerson will notify the respondent of the inquiry’s final outcome and provide the respondent with copies of the final inquiry report, the PHS regulation, and these policies and procedures. The institution may, but is not required to, notify a complainant whether the inquiry found that an investigation is warranted. If the institution provides notice to one complainant in a case, it must provide notice, to the extent possible, to all complainants in the case.
If an Investigation Is Not Warranted: If the RIO or other designated institutional official determines that an investigation is not warranted, Emerson will keep sufficiently detailed documentation to permit a later review by ORI of why the institution did not proceed to an investigation, store these records in a secure manner for at least seven years after the termination of the inquiry, and provide them to ORI upon request.
If an Investigation is Warranted: If the RIO or other designated institutional official determines that an investigation is warranted, Emerson must:
- within a reasonable amount of time after this decision, provide written notice to the respondent(s) of the decision to conduct an investigation of the alleged misconduct, including any allegations of research misconduct not addressed during the inquiry; and
- within 30 days of determining that an investigation is warranted, provide ORI with a copy of the inquiry report.
On a case-by-case basis, the College may choose to notify the complainant that there will be an investigation of the alleged misconduct, but is required to take the same notification action for all complainants in cases where there is more than one complainant.
D. Investigation
The purpose of an investigation is to formally develop a factual record, pursue leads, examine the record, and recommend finding(s) to the IDO, who will make the final decision, based on a preponderance of evidence, on each allegation and any institutional actions. As part of its investigation, Emerson College will diligently pursue all significant issues and relevant leads, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion.
The investigation will commence as soon as the RIO or other designated official determines there is a reasonable basis for concluding that the allegation falls within the definition of research misconduct, and preliminary information gathering indicates the allegation may have substance. Emerson College will notify ORI of the decision to investigate and begin the investigation within 30 days of the decision. The institution will complete all aspects of the investigation within 180 days.
- Notifying the Respondent and Sequestering Evidence
Emerson College will notify the respondent(s) of the allegation(s) within 30 days of determining that an investigation is warranted and before the investigation begins. If the institution identifies additional respondents during the investigation, it may choose to either conduct a separate inquiry or add the new respondent(s) to the ongoing investigation.
The institution will obtain the original or substantially equivalent copies of all research records and other evidence, inventory these materials, sequester them in a secure manner, and retain them for seven years after its proceeding or any HHS proceeding, whichever is later.
- Convening an Investigation Committee
After vetting investigation committee members for conflicts of interest and appropriate scientific expertise, Emerson College will convene a committee of three (3) faculty members, and ensure that the members understand their responsibility to conduct the research misconduct proceedings in compliance with the PHS regulation. The investigation committee will conduct interviews, pursue leads, and examine all research records and other evidence relevant to reaching a decision on the merits of the allegation(s).
- Process
The institution will use diligent efforts to ensure that the investigation is thorough, sufficiently documented, and impartial and unbiased to the maximum extent practicable. The committee’s investigation may consist of a combination of the following activities–
- Review and copying of data, proposals, correspondence, and other pertinent documents at the College, at the granting agency, or elsewhere.
- Review of published materials and of manuscripts submitted or in preparation.
- Inspection of laboratory or other facilities and/or materials.
- Interviewing of parties with an involvement in or knowledge about the case, including both the complainant(s) and the respondent(s), and any witnesses identified by the respondent. All interviews must be recorded and transcribed. The respondent will not be present during the witnesses’ interviews, but the institution will provide the respondent with a transcript of each interview, with redactions as appropriate to maintain confidentiality. Transcripts should be provided to the interviewed party for correction and included with any corrections in the investigation record.
All involved Emerson College parties are obligated to cooperate with the proceedings in providing information relating to the case. All relevant documentary information must be provided to the respondent in a timely manner to facilitate the preparation of a response. The respondent shall be provided the opportunity during the investigation to address the charges and evidence in detail. The complainant also should have the opportunity to review the evidence to ensure completeness.
To the greatest extent possible, the investigation proceedings will be kept confidential. However, it should be noted that confidentiality cannot be assured during an investigation, which is a much more formal, wide-ranging proceeding than an inquiry. In the course of an investigation, additional information may emerge that justifies broadening the scope of the investigation beyond the initial allegations. The respondent should be informed in writing of any additional allegations raised against them during the investigation, or when significant new directions of investigations are undertaken.
- Completing the Investigation
After completing the investigation activities, the committee will prepare a draft report of findings. The report must:
- Describe the procedure followed, the nature of the allegations and how and from whom information was obtained;
- Detail the facts and the analysis which support the conclusion and consider the merits of any reasonable explanation by the respondent, including any comments made by the respondent and complainant;
- Detail the findings and the basis for those findings, including whether the research misconduct was falsification, fabrication, or plagiarism, and whether it was committed intentionally, knowingly, or recklessly;
- Identify the funding agency, if any, including grant numbers, grant applications, contracts, and publications listing PHS support;
- Detail the recommendations for the resolution of the case, including correction of the research record if there is a finding of research misconduct or research error, and including sanctions recommended if there is a finding of misconduct; and
- Include the actual text or an accurate summary of the views of any individual found to have engaged in misconduct, and identify whether any publications need correction or retraction.
Emerson College will give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on. The respondent will submit any comments on the draft report to the institution within 30 days of receiving the report. If the College chooses to share a copy of the draft investigation report or relevant portions of it with the complainant(s) for comment, the complainant’s comments will be submitted within 30 days of the date on which they received the report. The institution will add any comments received to the investigation report.
The committee will then submit the final report to the DIO. The committee’s report should indicate one of the following findings for each allegation–
- No misconduct or serious research error was committed.
- No misconduct was committed, but serious scientific or other research errors were committed.
- Research misconduct was committed.
If the committee does not recommend a finding of research misconduct for an allegation, the investigation report will provide a detailed rationale for its conclusion.
If the committee recommends a finding of research misconduct for an allegation, the investigation report will present a finding for each allegation. These findings will:
- identify the individual(s) who committed the research misconduct;
- indicate whether the misconduct was falsification, fabrication, and/or plagiarism;
- indicate whether the misconduct was committed intentionally, knowingly, or recklessly;
- identify any significant departure from the accepted practices of the relevant research community and that the allegation was proven by a preponderance of the evidence;
- summarize the facts and analysis supporting the conclusion and consider the merits of any explanation by the respondent;
- identify the specific PHS support; and
- state whether any publications need correction or retraction.
- IDO Review of the Investigation Report and Final Determination
The IDO will review the investigation report and make a final written determination of whether the institution found research misconduct and, if so, who committed the misconduct. In this statement, the IDO will include a description of relevant institutional actions taken or to be taken.
Emerson College will add the IDO’s written decision to the investigation report.
- Appeal
If the determination is against the respondent, the respondent may, within thirty (30) days of the distribution of that determination, file a written appeal with the President. An appeal must be restricted to the body of evidence already presented, and the grounds for appeal must be limited to failure to follow appropriate procedures in the investigation, or sanctions not in keeping with the findings. The decision of the President is the final College determination. The complete record of any institutional appeal also becomes part of the institutional record. Emerson will wait until the appeal is concluded to transmit the institutional record to ORI.
E. Resolution
No finding of Research Misconduct: All persons and agencies informed of the investigation must be notified promptly of the finding of no misconduct by the dean. If the unsubstantiated allegations of misconduct are found to have been maliciously motivated, appropriate grievance procedures or disciplinary action may be initiated against the complainant. If the allegations, however incorrect, are found to have been made in good faith, no disciplinary measures will be taken and efforts will be made to prevent retaliatory action against the complainant.
No Finding of Research Misconduct, but Finding of Serious Carelessness or Serious Scientific or Other Research Error: All persons and agencies/organizations informed of the investigation must be notified promptly of the finding of no misconduct by the RIO. The College will, however, consider means to correct the research record, such as notifying editors of journals in which the respondent’s research was published or to which manuscripts were sent, other institutions with which the respondent has been affiliated, collaborators, professional societies, state professional licensing boards (if applicable), etc.
Finding of Research Misconduct: All persons and agencies/organizations informed of the investigation must be notified promptly of the finding of research misconduct by the IDO. In the final report, the Provost will recommend specific sanctions to be imposed on the respondent(s).
Sanctions, discipline, or other actions will be administered through the College’s regular procedures, and in accordance with the Faculty Handbook. Sanctions or other actions may also be taken by funding agencies.
F. Creating and Transmitting the Institutional Record
After the IDO has made a final determination of research misconduct findings, Emerson College will add the IDO’s written decision to the investigation report and organize the institutional record in a logical manner.
The institutional record consists of the records that were compiled or generated during the research misconduct proceeding, except records the institution did not rely on. These records include documentation of the assessment, a single index listing all research records and evidence, the inquiry report and investigation report, and all records considered or relied on during the investigation. The institutional record also includes the IDO’s final decision and any information the respondent provided to the institution. The institutional record must also include a general description of the records that were sequestered but not considered or relied on.
If the respondent filed an appeal, the complete record of any institutional appeal also becomes part of the institutional record. For institutions with an internal appeals process, the [Institution Name] will wait until the appeal is concluded to transmit the institutional record to ORI.
After the IDO has made a final written determination, and any institutional appeal is complete, the institution must transmit the institutional record to ORI.
G. Records Retention
Emerson College will maintain all records related to research misconduct proceedings, including all documentation from the assessment, inquiry, and investigation phases, and all sequestered evidence, in a secure manner for seven years after the completion of the proceeding or the completion of any HHS proceeding, whichever is later, unless custody has been transferred to HHS. The University must keep a record of the inquiry for at least seven (7) years after its termination.
H. Other Procedures and Special Circumstances
Respondent Admissions. Emerson College will promptly notify ORI in advance if at any point during the proceedings it plans to close a research misconduct case because the respondent has admitted to committing research misconduct or a settlement has been reached48.Records Retention. Emerson College will maintain the institutional record and all sequestered evidence in a secure manner for seven years after the completion of the proceeding or the completion of any HHS proceeding, whichever is later.