PURPOSE
The purpose of this policy is to establish procedures to thoroughly, timely, objectively, and fairly evaluate, investigate, and respond to allegations of research misconduct to protect the health and safety of the public and promote the integrity of research, research training, or activities related to that research or research training conducted at Ting Therapeutics and to protect Federal funds and equipment, as appropriate.
POLICY
Ting Therapeutics fosters a research environment that promotes the responsible conduct of research, research training, and activities related to that research or research training. Ting Therapeutics shall promptly respond to all allegations or evidence of possible research misconduct according to this policy and shall report, as required by law, any investigation and finding of research misconduct by any researcher, staff, student, or agent of Ting Therapeutics. Ting Therapeutics shall promulgate this policy through annual meetings.
SCOPE
This policy applies to researchers, staff, students, and agents of Ting Therapeutics engaged in research, research training, or activities related to research or research training for which Federal funds, including, but not limited to, US Public Health Service (“PHS”) funds, are requested or provided (“Federal funds”). This policy applies to allegations of research misconduct in research, research training, or related activities, and research misconduct involving applications or proposals for Federal funding of research, research training, or related activities. It also applies to any research proposed, performed, reviewed, or reported, or any research record generated from that research, regardless of whether an application or proposal for Federal funding resulted in a grant, contract, cooperative agreement, or other form of support. This policy also addresses claims of retaliation for filing good faith claims of research misconduct or participating in a research misconduct process under this policy.
DEFINITIONS
Complainant means any person who in good faith makes an allegation of research misconduct.
Respondent means the person against whom an allegation of research misconduct is made, and is the subject of a research misconduct proceeding.
Preponderance of the Evidence means proof by information that, compared with opposing information, leads to the conclusion that the fact at issue is more probably true than not. Research misconduct shall be deemed to have occurred where it is established, by a preponderance of evidence, that the respondent has intentionally, knowingly, or recklessly had research records and destroyed them; had the opportunity to maintain the records but failed to do so; or maintained the records, but failed to produce them in a timely manner, and that respondent’s conduct constitutes a significant departure from accepted practices of the relevant research community. Claims of retaliation for reporting research misconduct shall be deemed to have occurred where it is established, by a preponderance of the evidence, that the respondent retaliated against an individual who filed a good faith report of research misconduct.
Research means a systematic experiment, study, evaluation, demonstration, or survey designed to develop or contribute to general knowledge (basic research) or specific knowledge (applied research), including, but not limited to, research relating broadly to public health by establishing, discovering, developing, elucidating, or confirming information about, or the underlying mechanism relating to, biological causes, functions or effects, diseases, treatments, or related matters to be studied, and research in engineering, mathematics, economics, education, linguistics, psychology, physical sciences, social sciences, and statistics.
Research Record means the record of data or results that embody the facts resulting from scientific inquiry, including, but not limited to, research proposals, laboratory records (both physical and electronic), progress reports, abstracts, oral presentations, internal reports, journal articles, and any documents and materials provided by the Respondent during the course of the research misconduct proceeding.
Research Misconduct means fabrication, falsification, or plagiarism (as those terms are defined below) in proposing, performing, reviewing research or in reporting research results, or destroying or failing to provide research records. It does not include honest error or differences of opinion. It does include claims of retaliation for reporting of research misconduct, which claims may be investigated and heard as a separate claim under this policy.
Retaliation means any actions of discipline, hiring, firing, pay, assignment or other actions taken against an employee or student who reports, in good faith, allegations of research misconduct or who participates in a research misconduct process under this policy.
Fabrication is making up data or results and recording or reporting them.
Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
PROCEDURE
1. General Responsibilities
a. Notices. Notices required under this policy are sent to the Research Compliance Officer.
b. Ensuring Cooperation During the Research Misconduct Proceeding. Researchers, staff, students, and agents, including Complainant(s), Respondent(s), and witnesses, shall cooperate in the research misconduct proceedings, including, but not limited to, being present as requested during the research misconduct proceeding and providing relevant and truthful information and research records and evidence.
c. Federal Agency Notice. Notice of Company investigation findings and actions related to the research misconduct proceeding is sent to any applicable Federal agency that funds or has oversight of the research activity involved in the research misconduct proceedings or its designee. The Research Compliance Officer shall provide all required notices to Federal agencies under this policy. At any time during a research misconduct proceeding, the Research Compliance Officer shall immediately notify the relevant Federal agency or its designee if it has reason to believe that:
i. Research activities should be suspended;
ii. The health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
iii. Federal agency resources or interests are threatened;
iv. Federal action is required to protect the interests of those involved in the research misconduct proceeding;
v. The research community or public should be informed;
vi. There is reasonable indication of possible violations of civil or criminal law; or
vii. The research misconduct proceedings may be made public prematurely so that the appropriate Federal agency can take appropriate steps to safeguard evidence and protect the rights of those involved.
d. Identity of Participants in Research Misconduct Proceedings. Disclosure of the identity of Respondents, Complainants, and witnesses involved in research misconduct proceedings is limited to those who need to know, to the extent possible, consistent with a thorough, competent, objective, and fair research misconduct proceeding, and as allowed or required by law.
e. Records and Evidence. Except as otherwise required by law, confidentiality of all records and evidence from which research subjects might be identified shall be maintained. Disclosure of such information is limited to those who have a need to know to carry out a research misconduct proceeding. f. Gathering and Custody of Records. The Research Compliance Officer shall obtain and maintain custody of all research records and evidence collected during the allegation stage to the Ad Hoc Inquiry Committee. Any additional evidence gathered or submitted after the allegation stage shall be subject to Section 1, subsections e, f and g.
g. Committee Access to Records. The Ad Hoc Inquiry Committee and the Ad Hoc Investigative Committee shall have the right to receive copies of or reasonable supervised access to the research records gathered and maintained by the Research Compliance Officer. Such access shall continue for as long as those committees have ongoing duties under this policy.
h. Respondent Access to Records. During and after the inquiry stage, Respondent(s) and their legal counsel (if any) shall have the right to receive copies of or reasonable supervised access to the research records.
i. Safeguards. The rights, privacy, positions and reputations of all parties involved in the research misconduct proceedings shall be protected. No one shall retaliate against any Complainant, witness, or committee member who, in good faith, participates in a research misconduct proceeding.
i. All reasonable and practical efforts shall be taken to restore the position and reputation of Respondents in cases in which there is no finding of research misconduct.
ii. All reasonable and practical efforts shall be taken to restore the position and reputation of any Complainant, witness, or committee member and to counter potential or actual retaliation against these individuals.
iii. Disciplinary action will be taken, in accordance with Ting Therapeutics’ policy, against anyone who fails to act in good faith in either bringing an allegation of research misconduct, cooperating during the research misconduct proceedings (i.e., providing evidence), or serving as a member of either the Ad Hoc Inquiry or Ad Hoc Investigative Committee. 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. 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.
2. Allegation of Research Misconduct Stage. A good faith report of possible research misconduct may be made, either verbally or in writing, to the Research Compliance Official, including, but not limited to, the reporting individual’s supervisor, administrator, or any other official with knowledge of the research misconduct policy. A report of possible research misconduct is not in good faith if it is made with knowing or reckless disregard for information that would negate the allegation. The report of possible research misconduct shall be documented (if not already documented by the Complainant) and immediately sent to the Research Compliance Officer. The Research Compliance Officer shall be responsible for determining whether an inquiry is warranted, setting the inquiry date, and appointing members to the Ad Hoc Inquiry Committee, and where necessary, the Ad Hoc Investigative Committee.
3. Review of Allegation by Research Compliance Officer. The Research Compliance Officer shall review the allegation of research misconduct to determine whether the research, research training, or activities related to research or research training involve Federal funds, and whether an inquiry is warranted. Normally, such review shall be done within 30 days of receipt of the allegation. An inquiry is warranted if the allegation falls within the definition of research misconduct under the “Definitions” section of this policy and it is sufficiently credible and specific that potential evidence of research misconduct may be identified. If the research, research training, or activities related to research or research training does/do not involve Federal funds or the allegation does not fall within the definition of research misconduct hereunder, the Research Compliance Officer will refer to the policy on Misconduct in Non-Federally Funded Scholarly and Scientific Research. In the event the allegation of research misconduct involves the Research Compliance Officer or the Research Compliance Officer has a real or apparent conflict of interest in the matter, the determination of whether an inquiry is warranted and the completion of all other responsibilities set forth for the Research Compliance Officer herein will be completed by the Ting Therapeutics founder or his/her designee.
4. Setting the Date of Institutional Inquiry and Appointment of Ad Hoc Committee. If the Research Compliance Officer determines that an inquiry is warranted pursuant to section 3 above, a date(s) for the company inquiry shall be scheduled. The Research Compliance Officer shall then appoint an Ad Hoc Inquiry Committee to conduct an initial review of the evidence to determine whether to conduct an investigation. If necessary, the Research Compliance Officer shall also appoint an Ad Hoc Investigative Committee. The Research Compliance Officer shall make every effort to appoint persons with appropriate knowledge and expertise to the Ad Hoc Committees and shall ensure that anyone appointed to either Ad Hoc Committee does not have unresolved personal, professional, or financial conflicts of interest with the Complainant(s), Respondent(s), or witnesses. The Ad Hoc Committees shall be composed of at least five and no more than 9 members. At least two (2) members shall be from outside the Company. Members of the Ad Hoc Investigative Committee may include some or all of the members from the Ad Hoc Inquiry Committee, as well as other members as may be appointed by the Research Compliance Officer. Individuals from the department of the Complainant(s) or Respondent(s) should not participate in either Ad Hoc Committee. The Research Compliance Officer shall designate one of the Ad Hoc Committee members to act as Chair for each Ad Hoc Committee. The Ad Hoc Committees may rely upon consultants with expertise or knowledge in the area of research under inquiry and/or investigation.
a. Notice to Respondent(s) of Allegation. The Research Compliance Officer shall notify the presumed Respondent(s), in writing, of the allegation of research misconduct prior to the start of the institutional inquiry. A copy of the notice shall be sent to the Respondent’s departmental chairperson, administrator, or supervisor, and the founders of Ting Therapeutics.
b. Custody of the Records. On or before the date on which the Respondent(s) is notified, the Research Compliance Officer, in consultation and cooperation with Ting Therapeutics Officials, shall take all reasonable and practical steps to obtain custody of all known research records and evidence, inventory the records and evidence, and hold them in a secure manner to be available for the research misconduct proceedings. 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. Any additional evidence gathered or received during the course of the investigation and review shall also be inventoried and held in a secure manner.
5. Institutional Inquiry Stage: Review by Ad Hoc Inquiry Committee
The Ad Hoc Inquiry Committee shall conduct an initial review of the evidence to determine if sufficient evidence exists to conduct an investigation. The Committee’s decision as to whether to conduct an investigation shall be based on the preponderance of the evidence. A full review of the evidence related to the allegation is not required at this stage. The inquiry must be completed within 60 calendar days (including the opportunity for Respondent’s review and comment, section c.ii. below) of its initiation, unless circumstances warrant a longer period, in which case the inquiry record must include documentation of the reasons for exceeding the 60-day period.
a. Criteria Warranting an Investigation. The Ad Hoc Inquiry Committee shall determine an investigation is warranted if there is:
i. A reasonable basis for concluding that the allegation falls within the definition of research misconduct under this policy and involves research, research training, or activities related to that research or research training, and ii. Preliminary information gathering and fact finding from the inquiry indicates that the allegation may have substance.
b. Inquiry Report
i. Draft Report
The Ad Hoc Inquiry Committee shall prepare a written draft report that shall include the following information:
1. The name and position of the Respondent(s);
2. A description of the allegations of research misconduct;
3. A determination of whether an investigation is warranted; and
4. The basis for the Committee’s determination.
ii. Opportunity to Comment
The Ad Hoc Inquiry Committee shall provide a copy of the written inquiry report to the Respondent(s) for review and comment. The Respondent shall have ten (10) days from receipt of the report to submit any written comments. iii. Final Report
The final report shall include any written comments received from the Respondent(s) within the time period set forth in paragraph b above. The final report shall be made to the Research Compliance Officer
c. Notice of Final Inquiry Results
i. Notice to Respondents. The Ad Hoc Inquiry Committee shall provide its final report to the Respondent(s) with copy to the Research Compliance Officer. Such report shall include a copy of this policy.
ii. Notice to Complainant(s). The Research Compliance Officer shall notify the Complainant(s) of the Ad Hoc Committee’s findings as to whether an investigation is warranted. The notice may include relevant portions of the inquiry report.
iii. Notice to Institutional Officials. The Research Compliance Officer shall promptly provide a copy of the final inquiry report to Ting Therapeutic founders if applicable, and the Respondent’s Administrator or Supervisor. Names of Complainants, witnesses, and research subjects shall be redacted to maintain confidentiality.