II: Research Compliance Guidelines

Federal Compliance, Ethical Standards

Federal Compliance: IACUC and IRB

Ursinus College is committed to the safety of all who are involved in research. To ensure appropriate protection of all research subjects at Ursinus College, we have established two committees to address specific issues related to research of both humans and animals. These groups follow federally mandated procedures and have established guidelines consistent with federal policies.

The guidelines set forth by the Institutional Animal Care and Use Committee (IACUC) apply to all research involving animals. IACUC policies and procedures can be found through the IACUC Chair or the Biology Department Administrative Assistant.

The guidelines of the evolving Institutional Review Board (IRB) apply to all research involving humans, including, but not limited to, questionnaires, observations, and direct experimentation. IRB policies and procedures can be found at http://academic.ursinus.edu/irb/.

Responsible Conduct of Research Training

In accordance with the NSF mandate, effective 1/4/10, requiring all funded students and postdocs undergo training in the responsible conduct of research (RCR), Ursinus College has added RCR modules to its already existing CITI training course currently used by the IRB. All researchers, including faculty and students collecting data or those who have access to the resulting data, must complete training in human subjects protection every four (4) years, prior to submission of a proposal for external funding. A copy of the certification of completion for each investigator, including student investigators, will be printed and kept on file with the designated office. An electronic copy will automatically be sent to the IRB.

Maintaining High Ethical Standards of Honesty and Integrity: Scholarly Misconduct

Policy Guidelines

Ursinus College is committed to promoting a community whose members faithfully adhere to high ethical standards of honesty and integrity. The College expects faculty and other personnel to avoid misconduct in scholarly research. Misconduct violates not only the relationship between a researcher and Ursinus College but also damages the reputations of those involved and of the entire research and scholarly community. While breaches in such standards are rare, all parties must deal with these promptly and fairly in order to preserve the integrity of the research community and of the College. Therefore, it is the responsibility of every research investigator to assure integrity in the collection of data, storage of records and proper assignment of credit in publication. It is also the responsibility of all faculty and personnel to report instances of misconduct, as well as instances of retaliation against those who, in good faith, bring charges of scholarly misconduct.

Scope

  • This policy applies to all scholarly work conducted at Ursinus College.
  • This policy applies to any person paid by, subject to the rules and policies of, or affiliated with Ursinus College including faculty, trainees, technicians and other staff members, administrators, fellows, visiting scholars or other collaborators at Ursinus College.
  • This policy is limited to misconduct occurring within six years of the date on which the College receives the allegation of misconduct, unless otherwise determined by federal guidelines.
  • This policy is based on and incorporates the federal guidelines put forth by the U. S. Department of Health and Human Services Office of Research Integrity (ORI) in the area of scientific misconduct. These guidelines shall be considered amended by all current changes in federal laws and regulations.

Definitions

  • Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results.
    • Fabrication is making up data or results and recording or reporting them.
    • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  • Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
  • Misconduct includes a violation of regulations or ethical codes for the treatment of human and animal subjects.
  • Misconduct does not include honest error or differences of opinion.
  • Misconduct includes serious misappropriation of research funds, including but not limited to diversion of such funds to personal or non-College use. The term “serious misappropriations” is not contemplated to include minor deviations within budget categories.

Procedures

Reporting Misconduct

All employees or individuals associated with Ursinus College shall immediately report observed, suspected, or apparent scholarly misconduct, or retaliation for having made such allegations (“Complainant”), to the senior academic official of the College (the Dean) or the Dean’s appointed representative (“Dean’s representative”). The report will be made in writing and signed by the Complainant. The confidentiality of those who, in good faith, report apparent misconduct will be protected to the fullest extent possible. The role of the Complainant is limited. Once the Complainant has made an allegation of research misconduct, that person does not participate in the proceeding other than as a witness. Any comments made by the Complainant on the draft report must be included in the final investigation report.

Initial Inquiry

Acknowledging that misunderstanding between individuals is often the basis of such allegations, the Dean’s representative will attempt to resolve the issue through discussions with both parties. After review of the situation, the Dean’s representative will make an initial determination whether there are sufficient grounds to indicate that these allegations have validity or if no further reporting of the incident is required. The Dean’s representative shall complete this initial inquiry within fifteen (15) days, after which a written report shall be prepared which states what evidence was reviewed, summarizes the relevant interviews, and includes the conclusions of the inquiry. The individual(s) against whom the allegations of research misconduct was directed (“Respondent”) shall be informed of the inquiry at the time of or before the inquiry begins. The Respondent will be given a copy of the inquiry report which includes the Dean’s decision, and also has the right to make written comments to attach to the inquiry report. The confidentiality of the Respondent will be protected to the fullest extent possible. In addition, any research subjects identifiable from research records or evidence will also be protected to the fullest extent possible.

Due to federal requirements, the College will implement an additional step at this point for any scientific misconduct:

The College will use the pre-established appeals committee with the addition of two extra members for a second inquiry stage. The purpose of these additional members is to ensure that the group has the scientific knowledge to adequately review these allegations in a thorough, competent, objective, and fair manner, and issue a timely response in that spirit and within all appropriate regulations. Precautions will be taken to ensure that individuals responsible for carrying out these proceedings do not have any unresolved personal, professional, or financial conflicts of interest with the Complainant, Respondent, or Witnesses. One of these additional members will be chosen by the Respondent(s) and the other member will be chosen by the appeals committee. If this group finds sufficient evidence to suggest that the allegations may be true, a full investigation will ensue. If an Investigative Committee is appointed, the Dean shall inform in writing the Respondent, any involved collaborators, and the Office of Research Integrity, U. S. Department of Health and Human Services (“ORI”) that an investigation will be conducted and shall present to them a statement of the allegations.

Maintenance and Custody of Research Records and Evidence

The College shall promptly take all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the misconduct proceeding, inventory those materials, and sequester them in a secure manner, except in the case where there records or evidences are shared by a number of users. In that case, limited copies of the data or evidence will be available to these other users. The respondent will have copies of, or reasonable, supervised access to the research records. The College shall also take custody of additional records and evidence uncovered during the proceeding, including at the inquiry and investigation stages.

Interim Protective Actions

At any time during the misconduct proceedings, the College shall take appropriate interim actions to protect public health, federal and other external funds and equipment, and the integrity of the scholarly process.

Investigative Committee

If the Dean’s representative finds sufficient evidence to suggest the allegations may be true, the senior academic official of the College will be consulted. Prior to the investigation, written notice will be given to ORI of any decision to open an investigation, in accordance with CF 42 93.304(d). An investigative body of impartial experts will be appointed by that official to conduct the formal examination and evaluation of all facts to determine whether research misconduct has taken place.

The Investigative Committee will consist of three to five members who have the appropriate background to judge the issues being raised. Standing committees that deal with research issues (e.g., Institutional Review Board for Human Subject Research, Institutional Animal Care and Use Committee) may be one source for members of this Investigative Committee. Committee members must have no real or apparent conflicts of interest bearing on the question. The need for impartiality and objectivity must be honored. All parties have the right to comment on the composition of the Investigative Committee and may raise questions concerning membership.

When the Investigation Committee is appointed, the senior academic official of the College shall inform in writing the Respondent(s) and any involved collaborators that an investigation will be conducted and shall present to them a statement of the allegations. The Respondent shall be informed of their right to have a campus colleague and/or legal counsel present for preparing and/or giving their responses in this and all subsequent phases of the investigation. The investigation must begin within thirty (30) days after determining the need for an investigation. The Respondent will be informed of the allegations in writing within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins. Any new allegations of research misconduct will also be provided in writing to the Respondent in a timely manner after the initial notice of investigation.

The Investigative Committee shall conduct a formal examination and evaluation of all facts to determine whether research misconduct has taken place.

  1. The Investigative Committee may call witnesses, examine research data (published and unpublished), and seek expert opinion both inside and outside the College to aid in a scientific audit.
  2. The Investigative Committee must interview the Complainant and the Respondent.
  3. If the inquiry subsequently identifies additional Respondents, the institution will notify them.
  4. The Investigative Committee will provide for all Witnesses and the Respondent the recording or transcript of their statements for correction, and include it in the record of the investigation.
  5. All parties involved shall strive to maintain confidentiality of information, of Respondents, Complainants, Witnesses, and research subjects identifiable from research records or evidence.
  6. Interim administrative actions appropriate to the allegations may be taken prior to completion of the investigation to protect public health, the welfare of human or animal subjects, research record, federal funds and equipment, and the integrity of the PHS supported research process.
  7. The investigation shall conclude within four (4) weeks, unless compelling circumstances dictate a delay. This includes preparing a report of the findings, providing the draft report for comment, and sending the final report to ORI.

The following are necessary for a finding of scholarly misconduct:

  1. There must be a significant departure from accepted practices of the relevant scholarly community.
  2. The misconduct must have been committed intentionally, knowingly, or recklessly.
  3. The allegations must be proven by a preponderance of evidence.
    1. A preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusions that the fact at issue is more probably true than not.
    2. The College has the burden of proving scholarly misconduct. However, the respondent must prove by a preponderance of the evidence that honest error or difference of opinion occurred.

The Investigative Committee shall submit its findings and recommendations in writing to the senior academic official of the College. The institution will take the following actions:

  1. The Respondent must receive a draft of the investigative report, and a copy of, or supervised access to, the evidence, and be given thirty (30) days for written comments. These comments must be considered by the College and included in the final report.
  2. A copy of the final report will be submitted to ORI in accordance of their guidelines.
  3. If scholarly misconduct is not confirmed, all participants shall be notified in writing. Diligent efforts will be undertaken to restore the reputations of the Respondent.
  4. Reasonable and practical efforts to protect or restore the position and reputation of any Complainant, Witness, or Committee Member, will also be taken. The institution will counter any potential or actual retaliation against these Complainants, Witnesses, and Committee Members.
  5. If the allegations of scholarly misconduct are confirmed, the Investigative Committee shall recommend a course of action to the senior academic official of the College. The recommendations may include sanctions, as well as adequate steps to insure that the institution meets its obligations to third parties, including collaborators and the scholarly community. The senior academic official of the College shall make those notifications, if any, that are required by any external grant or contract sponsors.
  6. The College may make a finding of research misconduct or other breaches of research integrity under internal policies and standards, even if no misconduct is found under the HHS ORI regulations.
  7. After considering the recommendations of this group, the senior academic official of the College shall follow established College procedures for taking disciplinary action against the Respondent.
  8. The institution will complete all aspects of the investigation within 120 days of beginning it.

The Respondent has the right to appeal, via standard College administrative procedures. Please see the Faculty Handbook, Section II Academic Freedom and Professional Concerns, Part C9 Appeals Procedure.

The institution shall maintain all documentation accruing from the investigation for a minimum of seven years from the conclusion of the investigation.

The institution shall fully cooperate with ORI during its reviews under Subpart D of 42 CFR Part 93 or any subsequent hearings or appeals under Subpart E of 42 CFR Part 93 under which the respondent may contest ORI findings of research misconduct and proposed HHS administrative actions. This includes providing, as necessary to develop a complete record of relevant evidence, all research records and evidence under the institution’s control, custody, or in the possession of, or accessible to, all persons within its authority.

This policy has been reviewed and accepted by the Governance Committee, the Grants Coordinator, the Dean and the President (June 1, 2017).