I. Introduction

The Department of Health and Human Services and the National Science Foundation (NSF) have proposed regulations which define the responsibilities of Public Health Service (PHS) and NSF research grant awardees for dealing with and reporting possible misconduct in research efforts (42CFR, Part 50, Subpart A and 45CFR, Part 689). The Public Health Service Act requires that each agreement for a grant, contract or cooperative arrangement for the conduct of biomedical or behavioral research must have, as part of it, assurances that the institution has established an administrative process to review reports of scientific misconduct in connection with biomedical and behavioral research conducted at or sponsored by the institution. In addition, The National Science Foundation has similar regulations governing the conduct of researchers supported by NSF grants. Implicit in these requirements is an understanding that the institution reports any investigation of scientific misconduct which appears to be substantiated.

The policy and associated procedures will normally be followed when an allegation of possible misconduct in science is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interests of the institution and PHS or NSF. Any change from normal procedures also must provide for the fair treatment of the subject of the inquiry or investigation. Any significant variation should be approved in advanced by the Deciding Official (see definition below).

II. Definitions

A number of important terms are used in this policy and shall be defined as follows:

A. Allegation means any written or oral statement or other indication of possible scientific misconduct made to an institutional official.

B. Complainant means a person who makes an allegation of scientific misconduct.

C. Conflict of interest means the real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.

D. Deciding Official means the institutional official (i.e., the Vice President for Research) who makes final determinations on allegations of scientific misconduct and any responsive institutional actions. The Deciding Official will not be the same individual as the Research Integrity Officer and should have no direct prior involvement in the institution's inquiry, investigation, or allegation assessment.

E. Employee means, for the purpose of this policy only, any person paid by, under the control of, or affiliated with the institution, including but not limited to scientists, physicians, trainees, students, fellows, technicians, nurses, support staff, and guest researchers.

F. Good faith allegation means an allegation made with the honest belief that scientific misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation.

G. Inquiry means gathering information and initial fact-finding to determine whether an allegation or apparent instance of scientific misconduct warrants an investigation.

H. Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred, and, if so, to determine the responsible person and the seriousness of the misconduct.

I. ORI means the Office of Research Integrity, the office with the Department of Health and Human Services (DHHS) that is responsible for the scientific misconduct and research integrity activities of the U.S. Public Health Service.

J. PHS means the U.S. Public Health Service, an operating component of the DHHS.

K. PHS regulation means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of scientific misconduct, which is set forth at 42 C.F.R. Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science."

L. PHS Support means PHS grants, contracts, or cooperative agreements or applications therefor.

M. Research Integrity Officer means the institutional official, e.g., the Associate Vice President for Research or senior faculty member, responsible for assessing allegations of scientific misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations.

N. Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of scientific misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

O. Respondent means the person against whom an allegation of scientific misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.

P. Retaliation means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has in good faith, made an allegation of scientific misconduct or of inadequate institutional response thereto, or has cooperated in good faith with an investigation of such allegation.

Q. Scientific misconduct or misconduct in science means fabrication, falsification, plagiarism, or other practices that seriously 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 judgements of data. In addition, the institution reserves the right to require adherence to other definitions of scientific misconduct as required by contractual obligations with external sponsors of research.

III. General Principles

1. The institution shall establish and keep current standards of research conduct policies and procedures intended to avoid or prevent the occurrence of scientific misconduct. The scientific and administrative staff shall be informed of these policies and procedures and apprised of the need to comply.
   
2. Immediate and appropriate action should be taken as soon as misconduct on the part of (an) investigator(s) is suspected or alleged. All employees or individuals associated with Drexel must report observed, suspected, or apparent misconduct in science to the Research Integrity Officer. If an individual is unsure whether a suspected incident falls within the definition of scientific misconduct, h/she may call the Research Integrity Officer to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of scientific misconduct, the Research Integrity Officer will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.
   
3. Drexel employees will cooperate with the Research Integrity Officer and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the Research Integrity Officer or other institutional officials on misconduct allegations.
   
4. The institution, through the Research Integrity Officer, will monitor the treatment of individuals who bring allegations of misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The Research Integrity Officer will protect these persons from retaliation with respect to the terms and conditions of their employment or other status at the institution and will review instances of alleged retaliation for appropriate action. Employees should immediately report any alleged or apparent retaliation to the Research Integrity Officer.
   
5. The institution will protect the privacy of those who report misconduct in good faith to the maximum extent possible. For example, if the complainant requests anonymity, the institution will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws, if any. The complainant will be advised that if the matter is referred to an investigation committee and the complainant's testimony is required, anonymity may no longer be guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.
   
6. Inquiries and investigations will be conducted in a manner that will provide for the fair treatment of the respondent(s) in the inquiry or investigation and will maintain confidentiality to the extent possible without compromising public health and safety or the ability to thoroughly carry out the inquiry or investigation. Caution will be taken to avoid real or apparent conflicts of interest on the part of all involved in the investigation process. Institutional employees accused of scientific misconduct may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the legal counsel or non-lawyer personal adviser to interviews or meetings on the case, but these individuals may not participate in the proceedings.
   
7. The institution will comply with the reporting requirements of the funding agency, if applicable. If PHS funds are involved, immediate notification is provided to ORI if:

   a) there is an immediate health hazard involved;

   b) there is an immediate need to protect Federal funds or equipment;

   c) there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any;

   d) it is probable that the alleged incident is going to be reported publicly;

   e) the allegation involves a public health sensitive issue, e.g., a clinical trial;

   f) there is a reasonable indication of a possible Federal criminal violation. In this instance, the institution must inform ORI within 24 hours of obtaining that information.

8. When the institution's review of the allegation identifies non-scientific misconduct issues, the institution, through the Research Integrity Officer, should refer these matters to the proper institutional or Federal office for action. Issues requiring referral include potential violation of criminal law under DHHS grants and contracts, potential violation of human or animal subject regulations, potential violations of Food and Drug Administration regulated research requirements, potential violations of cost principles or other fiscal irregularities.

IV. Process

The process for responding to an allegation of scientific misconduct is outlined below. The actual procedures to be followed when responding to an allegation of scientific misconduct are described in the document entitled "Drexel Procedures for Responding to an Allegation of Scientific Misconduct".

A. Informal Phase:

1. Initial perception of scientific misconduct.
   
2. Submission of allegation of scientific misconduct to Research Integrity Officer.
   
3. Determination by Research Integrity Officer as to whether an inquiry is warranted.

B. Inquiry Phase:

1. Where appropriate, secure relevant research records.
   
2. Notify appropriate institutional officials, the respondent, and the ORI (if the request to open the inquiry originated from ORI).
   
3. Appoint and charge the Inquiry Committee.
   
4. Notify ORI if any of the conditions listed above under Section III, part 7 are present.
   
5. Inquiry Committee conducts interviews with respondent, complainant and witnesses.
   
6. Inquiry Committee evaluates evidence and testimony and generates a written Inquiry Report.
   
7. Inquiry Committee provides respondent with copy of Inquiry Report for comment.
   
8. Inquiry Committee submits Inquiry Report to Deciding Official (within 60 calendar days of the inquiry's initiation).
   
9. Decision by Deciding Official as to whether an investigation of scientific misconduct is warranted.

C. Investigation Phase:

1. Begin investigation within 30 calendar days of the completion of the inquiry.
   
2. Notify ORI of investigation (if PHS funds involved).
   
3. Sequester additional research records (if appropriate or necessary).
4. Notify respondent of investigation.
   
5. Appoint and charge an Investigation Committee.
   
6. Investigation Committee develops an investigation plan.
   
7. Investigation Committee reviews evidence and conducts interviews with respondent, complainant, and witnesses.
   
8. Summaries of interviews provided to interviewed parties for comment.
   
9. Investigation Committee evaluates evidence and testimony and prepares an Investigation Report.
   
10. Investigation Report sent to respondent for comment.
    
11. Investigation Report sent to Deciding Official and ORI (if PHS funds involved) within 120 calendar days of the investigation's initiation.
    
12. Decision by Deciding Official as to whether scientific misconduct has occurred.
    
13. Notify respondent and complainant of final decision in writing.

D. Institutional Administrative Actions

1. If, in the judgment of the Deciding Official, scientific misconduct has been substantiated by the findings, the Deciding Official, after consultation with the Research Integrity Officer, will decide on the appropriate actions.
   
2. If the institution finds no misconduct, (and, where applicable, ORI concurs) after consulting with the respondent, the Research Integrity Officer will undertake reasonable efforts to restore the respondent's reputation.
   
3. The Deciding Official will determine, after consulting with the complainant, what steps, if any, are needed to restore the position or reputation of the complainant (unless the allegations were not made in good faith, whereby the Deciding Official will determine whether any administrative action should be taken against the complainant).