Research Misconduct SOPs

General Description: As research projects become larger, more multidisciplinary and more multifaceted, allegations of misconduct in research may also require action in other regulated areas of research (i.e. human subjects, animal care and use, conflicts of interest, biosafety). It is critical that the institutional response be properly coordinated so the proper things are done in the right order. Procedures:

1. Receipt of the allegation and determination of what regulatory areas may be involved. This function is performed by the RIO. It is then the RIO’s responsibility to inform immediately the administrators (i.e. IRB chair and IO) of the other involved regulatory areas.
2. Determination of the Precedence of Proceedings. Subject to the RIO’s ability to stay the misconduct procedures in special circumstances, review of an allegation of research misconduct shall precede all other internal institutional proceedings that relate to or arise out of the alleged misconduct. However, the RIO should have the authority, in consultation with the institution’s legal counsel, to stay any proceeding under the misconduct policy if the RIO determines that other institutional procedures mandated by law must be completed prior to the institution’s further review of the allegation of misconduct. Such governmentally-mandated procedures may involve regulatory actions such as the protection of human subjects of research. The ordered principles that should guide the RIO’s determination: A. Protect public health and safety and the safety and well-being of research subjects. B. Protect evidence necessary to review an allegation of misconduct or alleged violations under other regulated areas of research. C. Protect the Public Interest. D. Review the allegation of research misconduct under institutional procedure.
3. Other considerations. A. Criminal Investigation. If an allegation of misconduct is also the subject of a criminal investigation or proceeding and the pertinent governmental authority advises the institution that its review of the allegation of misconduct may prejudice or interfere with the criminal investigation or proceeding, the RIO or Designated Official in consultation with the institution’s general counsel may stay the misconduct proceeding, while making every effort to assure that the evidence necessary for its review of the misconduct allegation is protected and the chain of custody preserved. B. Allegation involving a Research Collaborator at another institution. When an allegation involves a respondent at the institution and a research collaborator at another institution, the RIO has the authority to consult the RIO of the other institution, share evidence, and even conduct a joint review of the allegation when appropriate. C. Agency Investigation. Certain governmental agencies may have the option of initiating their own investigation of an allegation of misconduct involving research supported by that agency. In that event, the RIO should consult that agency and in concert with the Designated Official, determine whether to suspend the institution’s review of the allegation.

General Description: 42 CFR 93.318 requires that institutions notify ORI immediately if, in the handling of an allegation of misconduct in research, any of the “special circumstances” detailed in this arise when PHS funding is involved. Other federal funding agencies have similar expectations and this list is pertinent whatever the source of funding. Procedures:

1. The RIO will review this list on receipt of new allegations and thereafter as new circumstances arise. It may lead to reporting to ORI or other federal agency and internal discussions with those managing other research regulations per SOP 1.1 Triage and Precedence of Procedures. (a) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects. (b) HHS, other sponsor, or institutional resources or interests are threatened. (c) Research activities should be suspended. (d) There is reasonable indication of possible violations of civil or criminal law. (e) Federal action is required to protect the interests of those involved in the research misconduct proceeding. (f) The research institution believes the research misconduct proceeding may be made public prematurely so that HHS or other federal agency may take appropriate steps to safeguard evidence and protect the rights of those involved. (g) The research community or public should be informed.
2. The RIO will consult with legal counsel and advise the Deciding Official prior to taking any action notifying external agencies or administrators managing other research regulations. Interim action might include: (a) additional monitoring of the research process and the handling of federal funds and equipment, (b) reassignment of personnel or of the responsibility for the handling of federal funds and equipment, or (c) additional review of research data and results or delaying publication.
3. The RIO shall, at any time during a research misconduct proceeding, notify funding agencies immediately if there is reason to believe that any of the following conditions exist: (a) health or safety of the public is at risk, including an immediate need to protect human or animal subjects; (b) federal resources or interests are threatened; (c) research activities should be suspended; (d) there is a reasonable indication of possible violations of civil or criminal law; (e) federal action is required to protect the interests of those involved in the research misconduct proceeding; (f) the research misconduct proceeding may be made public prematurely and federal action may be necessary to safeguard evidence and protect the rights of those involved; or (g) the research community or public should be informed.

General Description: 42 CFR 93.300 requires institutions to protect complainants, witnesses and committee members from potential or actual retaliation by respondents and other institutional members. Retaliation is defined in 42 CFR 93.226 as “an adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to-- (a) A good faith allegation of research misconduct; or (b) Good faith cooperation with a research misconduct proceeding”. Mason takes these responsibilities very seriously and applies these actions no matter the source of funding related to the research misconduct allegation. Procedures:

1. The RIO has the authority and responsibility to caution everyone connected to a misconduct case against retaliation or the appearance of retaliation and to investigate evidence or allegations of retaliation whenever they arise. When the allegations of retaliation appear to have substance, the RIO will refer the evidence to the Office of University Counsel for handling under Virginia’s Whistleblower Retaliation or other appropriate state or institutional rules.
2. The RIO will make notice of the institution’s retaliation policy a standard part of his or her initial conversation/interviews with complainants, witnesses, respondents, and the initial briefings of committees and to invite any of those persons to contact the RIO immediately whenever they have questions or concerns about actual or potential retaliation.
3. The RIO has the authority and responsibility to require interim actions by other administrators during the pendency of the review of an allegation of misconduct to protect those who, in the RIO’s judgment, are at high risk for retaliation or may already have been retaliated against. This may require reassigning employees to work in other locations.
4. The RIO has the authority and responsibility to assess for potential conflicts of interest any institutional official or other employee assigned to play a role in protecting a complainant, witness or committee member from retaliation and to ask that institutional official or employee to recuse him/herself when, in the RIO’s judgment, a real or apparent conflict exists.
5. The Deciding Official, upon advice from the RIO, has the authority to require senior administrators to appoint someone to monitor the well-being of a person who has been reassigned to new employment and to report to the RIO and the senior administrators who appointed her/him about any concerns with the welfare of the reassigned person.
6. At closure of the misconduct case, the Deciding Official and the RIO will take necessary actions to protect and, if necessary, restore the reputations of person who may have been retaliated against or persons charged with retaliation, but exonerated after review.

General Description: 42 CFR 93 defines good faith and prescribes protections for complainants and witnesses acting in good faith. On the other hand, bad faith frivolous or malicious allegations, if not handled correctly, can extend, delay and in worst cases disrupt misconduct proceedings. One example is the indefatigable ‘whistleblower’ who pursues a target respondent; when one of her/his allegations is processed and dismissed s/he simply files another. A second example is the respondent who begins to file counter-allegations to obstruct or delay the proceedings. There are others. “Good Faith” and “Bad Faith” are defined in the regulation at 93.210: Good Faith: “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 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 research misconduct proceeding by carrying out the duties assigned impartially for the purpose of helping an institution meet its responsibilities. 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.” This definition permeates many other aspects of the regulation. For example: 93.203 Complainant. “Complainant means a person who in good faith makes an allegation of research misconduct.” And: 93.226 Retaliation “An adverse action taken against a complainant, witness, or committee member by an institution or one of its members in response to: (a) A good faith allegation of research misconduct; or (b) Good faith cooperation with a research misconduct proceeding”. Procedures: Policy 4007 includes the requirement for complainants, witnesses, and committee members to act in good faith as defined above.

1. The RIO has the authority and responsibility to investigate instances of possible bad faith on the part of a complainant, witness, or committee member and to provide evidence of possible bad faith to the Deciding Official.
2. The RIO has the ability to warn complainants, witnesses, or committee members against bad faith allegations.
3. The Deciding Official may take or recommend disciplinary action outlined in university policies and procedures against individuals acting in bad faith.
4. The RIO’s investigation report may be shared with the respondent or any other member of Mason’s community harmed by bad faith allegations to enable brining a grievance under the grievance provisions of the Faculty Handbook.
5. The RIO’s investigation and/or Deciding Official’s findings of bad faith allegations may be shared outside of the university to enable restoration of reputations for individuals harmed by bad faith allegations.

General Description: The university owns research data generated by university employees during the course of carrying out their official university duties and owns university equipment, including computers and telephones, and facilities. All data generated on sponsored programs is owned by the university. 42 CFR 93.305 specifies: “(a) Either before or when the institution notifies the respondent of the allegation, inquiry or investigation, promptly 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; (b) Where appropriate, give the respondent copies of, or reasonable, supervised access to the research records; (c) Undertake all reasonable and practical efforts to take custody of additional research records or evidence that is discovered during the course of a research misconduct proceeding” Procedures: When an Allegation is Received, the RIO may:

1. Sequester immediately any evidence that the Complainant or other witness may provide in the initial interview. Issue signed receipts for these materials.
2. Use the initial interview with the Complainant and any other witnesses (before the Respondent has notice of the Allegation) to identify any evidence pertinent to the allegation, where that evidence is and who likely has custody of that evidence.

In advance of sequestration of evidence the RIO may:

1. Assemble a set of subject-matter advisors from key disciplines whom the RIO can call upon confidentially to review allegations and, when necessary, help plan and even participate in sequestration.
2. Prepare sequestration team which may include the RIO, RIO assistants, university legal counsel, subject matter/disciplinary expert, IT experts, security.
3. Prepare for secure storage of sequestered data including preparing chain of custody forms and location for storage of any sequestered materials.
4. Identify the data/evidence the team knows about, its location and custody.
5. Develop maps of laboratories or other facilities that can be used to indicate probable location of evidence.
6. Review with subject matter experts what the evidence will consist of/look like and any special arrangements that will have to be made for sequestration/secure storage, e.g. biologicals, hazardous substances.
7. If evidence is likely to be in multiple locations, decide the order of the sequestration, keeping in mind the requirement to sequester evidence before or simultaneously with notice to the Respondent (and before the Respondent receives news of the allegation and sequestration if at all possible).
8. Discuss provisions for sequestering data that may be off campus or otherwise out of the institution’s immediate control.
9. Discuss electronic evidence/data that may be pertinent (including e-mail) and where it is stored. For data in central facilities (e.g. university e-mail, shared data storage facilities), sequester immediately using appropriate technology and practice.
10. Review provisions for handling Respondent resistance to sequestration.
11. Plan to sequester broadly; consider what data that hasn’t yet been identified might consist of and where it might be - e.g. review recent grant proposals, publications by Respondent and collaborators, if any.

During the Sequestration the RIO will:

1. Take appropriate members of the team.
2. Plan so that the Respondent and others whom you may need to talk with about data are likely to be there, but other personnel absent.
3. Engage the Respondent while the RIO assistant or legal counsel is talking to and watching others in the lab/office.
4. Try to accomplish a number of things. Among the RIO’s goals is to seek the Respondent’s cooperation in identifying and helping RIO sequester data pertinent to specific parts of the Allegation.
5. Proceed to sequester data in other locations and/or in the custody of others based on the priority list above.
6. Always provide itemized (to the extent possible), signed and witnessed receipts for evidence sequestered.
7. Arrange to make and provide to Respondent/others copies of data they may need for their work as quickly as possible, asking them to identify the data they need most quickly.
8. In cases where research equipment and instruments are shared by a number of users, the RIO will make forensic images wherever possible to minimize disruption to other users.

After Sequestration the RIO will:

1. Itemize and catalogue evidence carefully.
2. Store data securely, plan for chain-of-custody use.
3. Debrief with sequestration team, discussing problems that need to be addressed, additional sequestration that may have to be done.
4. Provide copies of, or reasonable supervised access to, the research records to the respondent(s) and others who participated in the work.
5. During pendency of the case, repeat sequestration as needed.

General Description: There are two goals for any misconduct proceeding: a) identifying individuals who may be responsible for research misconduct, and b) restoring the integrity of the research record. Most of the attention of institutions, scholars who study misconduct, and the press, when cases go public, is focused on the Respondent(s). Arguably, restoring the integrity of the research record is ultimately more important. Retraction of publications and grant proposals which have been plagiarized or which contain fabricated or falsified data is a critical part of that process. Procedures:

1. Scope of Institutional Review to Correct the Literature In general, the statute of limitations for assessing and investigating allegations of research misconduct is six years prior to the date that allegations are raised. Exceptions to this statute of limitations include: • Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the citation, republication or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized. • Health or safety of the public exception. If a federal agency or the institution, following consultation with a federal agency, determines that the alleged misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public. • Pattern of misconduct exception. Cases in which a respondent appears to have a pattern of committing fabrication, falsification, and/or plagiarism. In these circumstances, the RIO, inquiry committee, investigation committee, or Deciding Official may evaluate works that are older than six years. Committees should reach specific findings on each part of an allegation. Once a finding of misconduct is made, the committee should widen its review in thus far unquestioned publications or grants by that Respondent to see if any of those might be problematic. Some misconduct is a one-time occurrence, but very often one known instance of misconduct may be part of an extensive pattern of fabrication, falsification or plagiarism by that Respondent. At minimum, the review should look at all proposals and publications for the past six years. If an obvious pattern of misconduct emerges from this review, the scope should be expanded as far as necessary to capture all potential cases of misconduct.
2. Retraction and Correction of the Research Record Once the institution finds that a Respondent has fabricated or falsified data or plagiarized another’s work, the institution has an obligation to consider retracting any grant proposals, contracts or publications in which the fabricated, falsified, or plagiarized work is present. The RIO will exercise caution and ensure sufficient data is available for a full and accurate retraction. The RIO may need to work with the journal to determine the appropriate timing for a correction or retraction. Retraction of journal articles is sometimes more difficult since journals may insist that the corresponding and perhaps all the listed authors agree to the retraction. One of these will likely be the Respondent who may be reluctant to cooperate. In these cases, the RIO may discuss the case with the publisher and/or editor and provide the investigation report or other correspondence as needed. Once the decision that research misconduct has been committed, the institution may withdraw grant or contract proposals. The university will comply with all reporting requirements of, and provide information requested by, the funding agencies subject to any legal limitations on the disclosure of that information. When the institution imposes a sanction less than dismissal for an investigator found responsible for research misconduct in a case where there are publications that need to be retracted and/or funding agencies that need to be notified, the institution may require the Respondent to agree to and cooperate as a condition of continued employment. The institution may require the Respondent to identify all other places where the data/text in question has appeared so that can be retracted as well.

General Description: After Mason makes an internal finding of misconduct, and all appeals are exhausted, against one or more Respondents, it typically imposes sanctions (a.k.a. administrative actions) up to and including dismissal against those Respondents. These administrative actions are fully described in policy 4007, Misconduct in Research and Scholarship. Where dismissal is not sought, institutions may place Respondents on probation with specific conditions for specific periods. For example, the institution may limit the kinds of research those Respondents may engage in (e.g., research involving human participants), may require that a Respondent’s research activities be monitored and approved by others, may limit those Respondent’s use of specific internal or external research funds, may proscribe Respondents from supervising junior researchers and so on. Similarly, federal agencies such as PHS may debar convicted Respondents from receiving PHS funds for specific periods or may require that a Respondent’s research activities be supervised. Institutions may encounter difficulty - sanctions by funding agencies and legal liability - when they do not enforce administrative actions imposed at the end of misconduct cases. Procedures:

1. The investigative committee and deciding official should consult the RIO when considering imposition of sanctions on Respondents after a finding of misconduct because, among other reasons, RIOs are best equipped to discuss the relation of the seriousness of the misconduct to the proposed sanction in this case as compared to other previous cases.
2. Where a Respondent found responsible for misconduct remains at Mason and a federal agency, such as PHS, imposes additional sanctions on the Respondent, e.g., debarment from seeking federal funding for research for a specific period of time, those sanctions must be enforced by the institution.
3. The Deciding Official will determine responsibility for monitoring and oversight and assign an administrative team. The RIO will support and advise these administrative teams appropriate to each specific case to monitor internal and external administrative actions. Such teams might include a representative from the Office of Sponsored Programs, the Respondent’s department chairperson or dean, or other members of the faculty and staff. This team will check to see that the administrative actions are being enforced at regular intervals during the pendency of the probation or debarment and report to the RIO.
4. The RIO will create an administrative action calendar for each case where such actions are prescribed and check to see that the administrative teams report on schedule that the administrative actions are being enforced.