Ethical Conduct in Research Policies & Procedures
- Process of Resolving an Allegation of Scientific Misconduct
To assure integrity in the conduct of research at Palo Alto Medical Foundation Research Institute, the following policies and procedures relating to the ethical conduct of research have been adopted.
The Research Institute will:
A. Disseminate information about its policies and procedures pertaining to scientific misconduct and will develop a process of education to help prevent misconduct in clinical, behavioral, policy, and basic science research; and
B. Respond to specific allegations or suspicion of misconduct in research in accordance with Department of Health and Human Services (DHHS) guidelines (42 CFR Part 93). Scientific misconduct is defined as the following:
- Fabrication, falsification, plagiarism, deception, or other practices by a researcher that deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
- Misconduct in research also includes material failure to comply with DHHS or institutional requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals. Likewise, misconduct includes failure by a researcher to meet other material legal requirements governing research.
The responsibility to pursue an allegation of misconduct in research rests with the Research Institute. Each allegation must be resolved fully to answer any questions of the integrity of the research. The Research Institute Director will appoint a Research Integrity Officer (RIO) who will provide leadership in the pursuit and resolution of all allegations of scientific misconduct. The RIO will work with scientific and administrative staff to assure that the conduct of all activities related to an allegation of scientific misconduct be carried out with justice and fairness, demonstrate sensitivity to the reputations and vulnerabilities of all involved and provide protection for the positions and reputations of persons under investigation as well as persons who submit complaints of possible misconduct. In all activities related to allegations of scientific misconduct, scientific and administrative staff must:
A. Preserve the highest attainable degree of confidentiality compatible with an effective and efficient response to an allegation;
B. Avoid apparent or real conflicts of interest;
C. Secure appropriate expertise to carry out a thorough evaluation of an allegation;
D. Document all pertinent facts, evidence and actions at each stage of the process;
E. Maintain detailed, confidential and secured records for a period of seven years after the termination of an inquiry or an investigation;
F. Notify the DHHS Office of Research Integrity (ORI), in the designated time periods (stated in 42 CFR Part 93) of relevant information and decisions when federal grants or contracts are involved; and
G. Provide the researcher suspected of scientific misconduct (respondent) a confidential, prompt and thorough inquiry, and an opportunity to comment on allegations and findings of an inquiry or an investigation. Written comments from the respondent will be included in the records of an inquiry or an investigation.
Process of Resolving an Allegation of Scientific Misconduct
Any individual who believes that an act of scientific misconduct has occurred (the complainant) should inform the RIO, who will discuss the allegation with him or her. The RIO will also explain the review process to the complainant.
A. If alleged scientific misconduct is reported to research administrators, department chairs, institute directors, scientists or medical staff members, they must encourage the complainant to discuss his or her concerns with the RIO. The person to whom the alleged misconduct was revealed may, however, bring it to the attention of the RIO. Because of the potential damage to the reputation and rights of the respondent, great care must be taken in the reporting so as to preserve confidentiality, providing information only to those who need to know.
B. Even though a complainant may choose not to make a formal allegation, the RIO has the option to pursue the matter if there is sufficient cause to warrant an inquiry.
C. The RIO will decide the institutional process most appropriate to the situation. Alternative actions may include but are not limited to:
- Referral to appropriate department chair or institute director,
- Referral to PAMF’s Human Resources Department,
- Referral to the PAMF Institutional Review Board, and/or
- Initiation of an inquiry for dealing with possible scientific misconduct.
D. The Research Institute will continue an examination of the allegations to conclusion even if the subject of the allegation leaves the Research Institute or PAMF prior to resolution.
E. If the RIO has a conflict of interest, another impartial member of the scientific staff will be chosen to deal with the complaint.
The purpose of an inquiry is to gather factual information and to review the information expeditiously to determine if an investigation of a charge of misconduct is warranted. It is not a formal hearing.
Structure of the Inquiry
A . The RIO will appoint an inquiry committee to investigate the allegations. The RIO has the option to chair or to be a member of the inquiry committee.
B. The inquiry committee must be composed of persons who have appropriate scientific expertise thus assuring a sound knowledge base to judge the issues raised. If the inquiry involves human research activities, the chair of the PAMF Institutional Review Board (IRB) will be included as a member.
C. The inquiry committee will have at least one member from the Research Institute’s administrative staff.
D. PAMF legal counsel will be an ex officio member of the inquiry committee.
E. The chair and all members must be unbiased with no real or apparent conflicts of interest.
F. Absolute confidentiality is imperative to protect the rights of all involved.
Process of the Inquiry
A. The respondent must be notified within two weeks after the RIO decides that an inquiry will be conducted.
B. The involvement of the complainant will depend upon the nature of the allegation and the available evidence.
C. The RIO will disseminate to the inquiry committee in written form all available information (facts of the case). All documents will be secured at all times.
D. The respondent is obliged to cooperate by providing any requested material necessary to conduct the inquiry.
E. The respondent may be interviewed as a part of the inquiry. The respondent may have an advisor present but the advisor may not present the case or otherwise participate in the discussion. The respondent may make his or her own audiotape recording at the interview.
F. Uncooperative behavior on the part of the respondent, as determined by the RIO, may result in
- Immediate formal investigation,
- Notification of the ORI,
- Withdrawal of the privilege of conducting research at the Research Institute/PAMF, or
- Any other institutional sanctions or disciplinary actions as deemed necessary.
G. If at any time in the process of responding to an allegation of misconduct, reasonable indication of possible criminal violations is obtained, the Research Institute Director, the Director of Research Operations, the RIO and PAMF legal counsel must be notified within 24 hours. The ORI must be notified within 24 hours.
H. If at any time in the process of responding to an allegation of misconduct, reasonable indication is obtained indicating the presence of an immediate health hazard, the Research Institute Director, the Director of Research Operations and the RIO must be notified as soon as possible. The ORI must be notified within 24 hours.
I. When alleged scientific misconduct is reported, the Research Institute Director and the Director of Research Operations must take appropriate actions to protect research funds, equipment, data and individuals affected by the inquiry, as well as ensure that the purposes of the grant or contract can be carried out. The ORI will be notified of these actions as well as the possibility that the alleged incident may be publicly reported.
J. The inquiry must be completed within 60 days or less from notification of the respondent.
K. If the 60-day deadline cannot be met, a formal report explaining the reasons for the delay and the progress-to-date must be submitted in writing to the respondent, the Research Institute Director, PAMF legal counsel and any other appropriate individuals.
L. If the inquiry committee makes a decision to terminate an inquiry without completing all relevant requirements, a report describing its reasons shall be made to ORI.
Findings of the inquiry committee
A . The inquiry committee will submit a written report, including evidence reviewed, interview summaries, findings, conclusions, and recommendations to the RIO (if not a member or chair of the inquiry committee). The RIO will inform the respondent, complainant, the Director of Research Operations, the Research Institute Director, PAMF legal counsel, and other appropriate Individuals of the report. The report will be made available to the respondent.
B. If the RIO determines that the allegations are unsupported at the completion of the inquiry, no formal investigation will ensue.
1. Unsupported allegations brought in good faith will require no further action.
2. Disciplinary action will be brought against the complainant if the allegations are shown to have not been brought in good faith. The RIO will consult with the Research Institute Director and PAMF legal counsel to determine appropriate sanctions and document the conclusions.
3. Retaliation against the complainant who submitted allegations in good faith will not be tolerated and will be dealt with by the RIO in consultation with the Research Institute Director and PAMF legal counsel. Disciplinary actions or sanctions may ensue.
D. If the RIO determines that the allegations are supported at the conclusion of the inquiry, a formal investigation will be initiated.
The purpose of an investigation is to formally explore the allegations of scientific misconduct and to determine whether misconduct has been committed. Additional information may emerge that justifies broadening the scope of the investigation beyond the initial allegations. The respondent will be notified if the investigation is expanded or takes a new direction.
Structure of the Investigation
A. The RIO will appoint an investigative committee and provide formal written notification of the investigation to ORI, the Director of Research Operations, the Research Institute Director, the department chair of the respondent and PAMF legal counsel.
B. Unless there is a real or apparent conflict of interest, the RIO will chair the investigative committee.
C. The investigative committee will include at least one member of research administration, and at least one member of the inquiry committee. If the allegations involve human research, the PAMF IRB chair must be included on the investigative committee.
D. The investigative committee must have scientific expertise assuring a knowledge base appropriate to judge the issues raised.
F. The investigative committee will consult with, or have as a member, a person with prior experience in a scientific misconduct investigation.
G. The investigative committee may have as members or consult with persons from outside the Palo Alto Medical Foundation or the Palo Alto Medical Foundation Research Institute if the RIO deems this necessary.
H. Absolute confidentiality is imperative to protect the rights of all involved.
Process of the Investigation
A. The investigation must be initiated within 30 days of the date that the RIO receives the inquiry committee report.
B. The respondent and the complainant and any other appropriately involved parties must be notified of the investigation by certified mail.
C. If the allegation involves a federal grant or contract or if federal funds or equipment need to be protected, the RIO must inform the ORI that a formal investigation will be initiated. If funding is not federal, the RIO must notify the research sponsor that a formal investigation will be initiated.
D. All parties are obligated to provide information relative to the case. Failure to do so may lead to:
- Notification of ORI,
- Withdrawal of the privilege of conducting research at the Research Institute or PAMF, or
- Any other disciplinary actions or sanctions as deemed necessary.
E. The Research Institute Director will promptly advise ORI of any developments during the course of the investigation which disclose facts that may affect current or potential DHHS funding for individual(s) under investigation or that the PHS needs to know to ensure appropriate use of federal funds and otherwise protect the public interest.
F. If at any time in the process of responding to an allegation of misconduct reasonable indication of possible criminal violation is obtained, the Research Institute Director, the Director of Research Operations, the RIO and PAMF legal counsel must be notified within 24 hours. The ORI must be notified within 24 hours.
G. If at any time in the process of responding to an allegation of misconduct reasonable indication is obtained indicating the presence of an immediate health hazard, the Research Institute Director, the Director of Research Operations and the RIO must be notified as soon as possible. The ORI must be notified within 24 hours.
H. When alleged scientific misconduct is reported, the Research Institute Director and the Director of Research Operations must take appropriate actions to protect research funds, equipment and individuals affected by the inquiry, as well as ensure that the purposes of the grant or contract can be carried out. The ORI will be notified of these actions as well as the possibility that the alleged incident may be publicly reported.
I. All necessary documents and other information will be provided to the respondent in a timely manner to facilitate preparation of a response.
J. The respondent must be given an opportunity for a formal hearing with the investigative committee.
K. The respondent may have an advisor present at the formal hearing who may consult with the respondent, but may not present the case or otherwise participate in the discussion. The respondent may make an audiotape recording at the formal hearing.
L. The investigative process will be completed within 120 days unless the volume and nature of the research and allegations to be reviewed makes this deadline impossible to meet. In this event, the RIO will submit a written request to the ORI with a full explanation and progress report.
M. A report describing the findings, conclusions and recommendations will be submitted in writing to the Director of Research Operations and the Research Institute Director. The report of the investigative committee will include one of the following:
- A finding of misconduct;
- A finding that culpable misconduct was not committed, but that serious scientific errors were discovered, and, therefore, further action is required; or
- A finding that no misconduct, fraud or serious error was committed.
N. If applicable, the report of the investigative committee will also include recommendations for appropriate sanctions.
O. The RIO, the Director of Research Operations, and the Research Institute Director in consultation with PAMF legal counsel will jointly determine the nature and severity of the sanctions or disciplinary actions. This may include, but is not limited to:
- A letter of reprimand,
- Removal from a research project,
- Returning research funds to the sponsor,
- Probation or suspension from participating in research projects,
- Special monitoring of future research,
- Salary reduction, and/or
- Termination of employment.
- Special action may be taken by the PAFMG Executive Committee if the researcher is a member of the PAMF Medical Staff.
- If the investigation is terminated prematurely, the ORI will be notified of the reasons (if NIH funding is involved). Other research sponsors will also be notified as appropriate.
Findings of the Investigation
A. Between 60 days and 120 days after completion of the investigation, the respondent will receive by certified mail a full report of the investigation and any disciplinary actions or sanctions that are imposed.
B. Within 120 days of completing the investigation, the report must be submitted to the ORI describing:
- The policy and procedures under which the investigation was conducted,
- How and from whom information was obtained relevant to the investigation,
- The findings,
- The basis for the findings,
- The actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct, and
- A description of any sanctions taken by the institution.
The respondent may appeal the decisions of the investigative committee. The appeal will be restricted to the body of evidence presented thus far. New evidence will warrant a new investigation. Grounds for an appeal will be limited to: 1) failure to follow appropriate procedures during the investigation, 2) arbitrary or capricious decision making and 3) inappropriate disciplinary actions or sanctions.
Process of the Appeal
A . The respondent must submit a written request for an appeal to the Director of Research Operations within ten working days after receiving the final report of the investigative committee.
B. The appeal hearing must be held within 30 working days after the filing of the appeal request.
C. The hearing will be before an appeals committee selected by the Director of Research Operations in consultation with the Research Institute Director, the RIO, PAMF legal counsel and the PAFMG Chief Medical Officer.
- The appeals committee will be chaired by the PAFMG Chief Medical Officer.
- It will have six members including the Director of Research Operations and one member of the IRB.
- Three members representing the scientific ranks of the Research Institute will be selected.
- One member will be from the PAFMG Medical Staff.
- All members of the appeals committee shall not have served on the inquiry or investigative committees.
- PAMF legal counsel will be an ex officio member.
D. The decision of the appeals committee will be final.
The RIO will notify all organizations and agencies involved with the research work of the decisions made in conjunction with the formal investigation. These may include but are not limited to:
- Sponsoring agencies or funding sources,
- Co-authors, co-investigators or collaborators,
- Editors of journals in which fraudulent research was published,
- Professional licensing boards and societies,
- Law enforcement authorities, when appropriate, if criminal activity is believed to have occurred.
The RIO, the Director of Research Operations, the Research Institute Director and the PAMF CEO in consultation with PAMF legal counsel will determine the manner in which information about a finding of scientific misconduct will be released.
1 . 42 CFR Part 93.
2. Hilgartner, Stephen. Research Fraud, Misconduct, and the IRB. Human Subjects Research. Volume 12, No.1, January-February, 1990. .
3. Executive Council, Association of American Medical Colleges. Framework for Institutional Policies and Procedures to Deal with Misconduct in Research Revised Edition, September, 1992: Washington, D.C.
4. American Association for the Advancement of Sciences and the Association of American Medical Colleges. Responding to Allegations of Research Misconduct: A Practice. Manual produced for the workshop held December 14, 1992. San Francisco, California.
5. Mishkin, Barbara. Responding to Scientific Misconduct: Due Process and Prevention. JAMA, Vol. 260, No. 13,, pp 1932-1940,1988.