PRP 6820 - Prior Version

PRP 6820 - Prior Version

Issued by: Dr. Wilson G. Bradshaw, VPAA

Effective Date: February 1998

Notes: Endorsed by BUCC February 21, 1990; approved by President as emergency interim policy May 30, 1990; title change endorsed by BUCC January 23, 1991; reissued as interim policy April 22, 1992; Revisions endorsed by BUCC December 2, 1992. Revisions endorsed by BUCC October 27, 1993. Revisions endorsed by Meet and Discuss March 4, 1994. Revisions endorsed by Forum on March 16, 1994. Revised by BUCC February 4, 1998. Revision endorsed by Forum on February 11, 1998.

Introduction

This policy applies to all types of faculty, student, and staff research at Bloomsburg University whether or not funded through an extramural grant. It also applies to anyone engaged in research at Bloomsburg University (such as guest researchers or collaborators) that is supported by or for which support is requested from the Public Health Service. The Public Health Service (PHS) has established an Office of Research Integrity for dealing with scientific misconduct. The PHS requires that institutions receiving federal funds for the conduct of biomedical and behavioral research submit an 'assurance of compliance' on an annual basis. PHS and Bloomsburg University define misconduct as "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 judgment of data" (NIH Guide for Grants and Contracts; Volume 18; Number 30; September 1, 1989; Special Issue). (For more detailed statements of the PHS guidelines, refer to the Federal Register; Volume 54; Number 151; August 8, 1989, or the NIH Guide for Grants and Contracts; Volume 18; Number 30; September 1, 1989; Special Issue which is on file in the Office of the Assistant Vice President for Graduate Studies and Research.)

Procedures

In order to initiate charges, written allegations of misconduct with supporting documentation shall be forwarded to the Dean of the College of the faculty member charged with alleged misconduct or the appropriate manager having jurisdiction. In the case of staff research and studies, allegations should be forwarded to the research office. Student research will be covered under PRP #3512 (Academic Integrity) and PRP #3592 (Academic Grievance Policy). For natural and behavioral sciences, the Dean will convene an Inquiry Board of three, comprising him/herself, the Chairperson of the Institutional Review Board (IRB) and the Chairperson of the Institutional Animal Care and Use Committee (IACUC). When needed or appropriate, the Chairperson of the Radiation Safety Committee3 may be asked to substitute for one of these Chairpersons. For other disciplines, the respective Dean (or the appropriate manager having jurisdiction) will convene an Inquiry Board of three, comprising him/herself, an appointed faculty member with appropriate background, and the Chairperson of the Institutional Review Board (IRB). In order to ascertain that allegations of misconduct are deserving of formal Investigation, an informal Inquiry will be initiated by the Inquiry Board to be completed within sixty (60) calendar days (including preparation of a written report only if the charges appear to have merit). If the inquiry takes longer than 60 days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period.

The Inquiry Board shall assure that full confidentiality of the Inquiry process is maintained, and that the identities of both the person who makes the charges and the researcher against whom charges are filed shall be protected to the maximum extent possible.

If, at any stage of an inquiry (or any resulting investigation), involving Public Health Service funding, the following conditions exist: (1) there is an immediate health hazard involved; (2) there is an immediate need to protect Federal funds or equipment; (3) 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; or (4) it is probable that the alleged incident is going to be reported publicly; then the Office of Research Integrity (ORI) will be notified. If there is a reasonable indication of possible criminal violation, ORI will be notified within 24 hours of obtaining that information. All appropriate administrative action will be taken to protect Federal funds and insure that the purposes of the Federal financial assistance are carried out.

The person(s) accused of misconduct shall be notified that an Inquiry is being conducted, shall be provided with copies of written allegations and all supporting documentation, shall have an opportunity to respond in person and/or in writing to any allegations, and shall be provided with the identity of the person(s) making the charges.

An Inquiry Board shall be directly responsible for the Inquiry. A written report shall be prepared, if required, that states what evidence was reviewed, summarizes relevant interviews of the individual(s) accused and the individual(s) making the allegation(s), and includes the conclusion of the Inquiry. The individual(s) against whom the allegation(s) was made shall be given a copy of the report. The individual(s) may comment on the report, and their written comments shall be affixed to the report. If warranted by the written report, the Inquiry Board shall recommend a formal Investigation. If it becomes evident to the Inquiry Board that outside sources need to be contacted (i.e. expert testimony, students, other faculty), then this also constitutes the need for a formal Investigation, and the Inquiry Board shall immediately end the informal Inquiry phase.

If at the informal stage the charges appear to be without merit, the Dean or the appropriate manager will notify the accused in writing and all personal records will be returned to the individuals who submitted them. Diligent efforts will be made, as appropriate, to restore the reputations of persons alleged to have engaged in misconduct when allegations are not confirmed, and also diligent efforts will be made to protect the positions and reputations of those persons who, in good faith, make allegations.

The Assistant Vice President and Dean of Graduate Studies and Research will maintain sufficiently detailed documentation of inquiries to permit a later assessment of the reasons for determining that an investigation was not warranted, if necessary. Such records shall be maintained in a secure manner for a period of at least three years after the termination of the inquiry, and shall, upon request, be provided to authorized HHS personnel.

In cases involving Public Health Service funding, if the University plans to terminate an inquiry or investigation for any reason without completing all relevant requirements listed above (and under 42CFR50.103(d)), a report of such planned termination, including a description of the reasons for such termination, will be made to ORI.
If during the informal Inquiry stage, it becomes evident that the health and welfare of animal or human subjects may be at risk, there shall be an emergency meeting of the appropriate committee. The IACUC or the IRB will then determine the possibility of risk
and follow the stated procedures in PRP #3995 (Animal Subjects Research) and PRP #3990 (Human Subjects Research), findings from which may require stopping the research activity.

If the charges appear to have merit, the inquiry report, recommendations, and supporting materials shall then be forwarded to the Assistant Vice President and Dean of Graduate Studies and Research, who will be acting for the Provost and Vice President for Academic Affairs. The report and supporting materials of the Inquiry shall be reviewed by the Assistant Vice President and Dean of Graduate Studies and Research, who shall forward it with comments and recommendations to the Provost and Vice President for Academic Affairs. The Provost and Vice President for Academic Affairs shall forward the Inquiry report with recommendations to the President for review and action.

If a formal Investigation is initiated by the President as a result of the informal Inquiry, the Assistant Vice President and Dean of Graduate Studies and Research shall, in cases involving Public Health Service funding, report the decision to initiate an Investigation, in writing, to the Director, ORI, on or before the date the Investigation begins. At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation, and the PHS application or grant number(s) involved.

Upon receipt of advice of University Legal Counsel, the ORI shall also be notified within twenty-four (24) hours of obtaining reasonable indication of possible criminal violations. The Assistant Vice President will also promptly advise the ORI of any developments during the course of the Investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the funding agency needs to know to ensure appropriate use of federal funds or otherwise protect the public interest. The President of the University will notify the accused that a formal Investigation has been initiated.

If a formal Investigation is initiated, a committee of the faculty shall be appointed and shall begin its investigation within thirty (30) calendar days of the end of the Inquiry. The committee shall be composed of three (3) faculty members. Two (2) members shall be from the college of the faculty member against whom misconduct is alleged. The committee should be constituted in such a way to be as professionally qualified as possible to review
the specific research area involved. The third person on the committee will be an individual outside of the University who possesses an expertise that qualifies her/him to judge the relevant scientific data. Within fifteen (15) days of the end of the Inquiry, the Dean shall forward a list of not less than seven (7) individuals, including five (5) Bloomsburg University faculty and two (2) outside experts, as potential committee members to the Assistant Vice President and Dean of Graduate Studies and Research. The Assistant Vice President shall contact the individuals on the list in order to determine their willingness to serve. Additional candidates may be suggested by the Dean if necessary. No member of the committee should have any real or perceived conflict of interest. Membership of the committee may be challenged by the researcher only on the basis of bias or conflict of interest. The burden of proof will be on the challenger to show why the committee member should be removed. The Assistant Vice President and Dean of Graduate Studies and Research shall decide questions of challenged membership on the committee. In the event that no qualified Bloomsburg University faculty are available to constitute an investigation committee, the Assistant Vice President, in consultation with the Dean and the Chairperson of the researcher's department, shall appoint a committee of three (3) outside experts to constitute the committee.

All discussions by the committee shall be confidential. The committee will examine all pertinent evidence, interview all individuals involved in making the allegation, contact and interview other involved faculty or students, and hear any expert testimony. The committee shall be empowered by the President of the University to seek and obtain any information that is pertinent to the Investigation in accordance with the terms of the appropriate Collective Bargaining Agreement (CBA), and to obtain the full cooperation of all faculty and staff. During the Investigation, the researcher shall be notified by certified letter of the time and date of a hearing to be held by the committee. At this time, the researcher may present evidence and expert testimony on her/his behalf. The researcher may also have personal and/or APSCUF legal counsel at this meeting. Legal counsel may only advise, and shall not speak on behalf of, the researcher. Minutes of every committee meeting will be recorded in writing with the full knowledge of those present.

The Investigation should be completed within 120 calendar days of its initiation. In cases involving Public Health Service funding, if it is not possible to complete the Investigation in 120 days, a written request for an extension and an explanation for the delay that includes an interim report on the progress to date and an estimate for the date of completion of the report and other necessary steps must be submitted to the ORI. Any consideration for an extension must balance the need for a thorough and rigorous examination of the facts versus the interests of the subject(s) of the Investigation and the PHS in a timely resolution of the matter. If the request is granted, the University must file periodic progress reports as requested by the ORI. If the University plans to terminate the Investigation for any reason without completing all relevant requirements listed above (and under 42CFR50.103(d)), a report of such planned termination, including a description of the reasons for such termination, shall be made to ORI.

After reviewing all data, the committee will decide if the charge of misconduct is or is not substantiated. At least two (2) of the three (3) committee members must agree that the researcher is guilty of misconduct before such a decision can be rendered. At the end of the Investigation, the committee shall submit a written decision of its findings and recommen- dations within ten (10) working days to the Assistant Vice President and Dean of Graduate Studies and Research. If a decision is not unanimous, and the faculty member is found to have committed misconduct, a minority report will be attached to the majority report outlining the reasons for dissent. The Assistant Vice President shall then notify, through the Provost, the President of the University, who shall in turn notify the researcher, the Dean, and the Chairperson of the researcher's department. If the committee and the Assistant Vice President deem it necessary, interim administrative actions will be taken to protect federal funds (e.g., freeze the researcher's funds) and to ensure that the purposes of the federal financial assistance are being carried out. The Assistant Vice President will keep the ORI apprised of any developments during the course of the Investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under Investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.

If charges of misconduct are substantiated, the investigating committee shall have the option of commenting in its report on the degree of the offense. The researcher(s) shall have the opportunity to comment in writing on the findings of the outcome of the Investigation, and the response shall be affixed to the final report submitted to the President. The President shall determine and enforce appropriate sanctions and will be responsible for notifying the person(s) charged. The degree of sanction shall be in relation to the degree of the offense. The Assistant Vice President and Dean of Graduate Studies and Research will also be responsible for reporting in writing the outcome of the investigation to the appropriate federal agency as specified by law.

If the formal Investigation committee finds the charge of misconduct unfounded, there shall be no mention of the charge or the review process in the researcher's personnel file. All records and minutes relating to the Investigation shall be kept in the Office of the Provost and Vice President for Academic Affairs for three (3) years after the Investigation terminates. All individuals related to the review process shall be notified that the charge of misconduct in research was unfounded, and all attempts shall be made to clear the researcher's name and restore the reputation of the persons alleged to have engaged in misconduct. The positions and reputations of persons who make allegations in good faith shall also be protected. However, if in the course of investigation the committee becomes convinced (by unanimous vote) that the allegations of misconduct were not made in good faith, the committee shall include that finding as part of its written report to the Provost and Vice President for Academic Affairs so that appropriate actions may be initiated.

If at any time during the informal Inquiry stage or the formal Investigation stage, an admission of misconduct is made, the details and circumstances of the admission of culpability will be summarized in writing by the Informal Inquiry Board or the Formal Investigation Committee. The procedures to be followed will be the same as those previously described for charges of misconduct that are substantiated by the investigating committee.
The Assistant Vice President and Dean of Graduate Studies and Research shall be responsible for informing the scientific and administrative staff of these policieS and procedures and the importance of compliance with these policies and procedures. In cases involving Public Health Service funding, the Assistant Vice President and Dean of Graduate Studies and Research shall also be responsible for preparing and maintaining the documentation to substantiate the Investigation's findings. This documentation will be made available to
the Director, ORI. The final report submitted to the ORI will describe the policies and procedures under which the Investigation was conducted, how and from whom information was obtained relevant to the Investigation, the findings, and the basis for the findings, and include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct, as well as a description of any sanctions taken by the University.

Nothing in this policy shall be construed as taking precedence over the CBA except as required by federal law.

1. PRP 3990 describes committee composition as follows:

IRB Membership - "The Human Subjects Research Committee shall be appointed by the Provost and Vice President for Academic Affairs. Federal guidelines indicate that members should possess a philosophical background to be able to look at ethical issues, and the Committee should contain a balance of males and females. An individual from outside the institution also serves on the Committee. Both scientific and non-scientific expertise must be included and, at a minimum, one individual must be an ethicist. Members will be selected as follows: 3 from the College of Business, 3 from the College of Professional Studies, and 3 from the College of Arts and Sciences. The term of office will be staggered three year terms. The Assistant Vice President and Dean of Graduate Studies and Research and the Director of the Office for Research and Sponsored Programs will serve as ex officio, non-voting members. Department(s), School, or College Human Subject Research Committee (HSRC) Chairpersons will serve as ex officio and voting members of the IRB."

2. PRP 3995 describes committee composition as follows:

IACUC Membership - "Members of the IACUC shall be appointed by the Provost and Vice President for Academic Affairs and the President of the University for a three year term. Federal guidelines require that the IACUC must consist of at least five members. At least one member must not be involved in animal research. At least one member must not be associated formally with the University. At least one member must be a veterinarian. The veterinarian may also serve as the member not affiliated with the University. The remaining members of the IACUC will be faculty actively involved in animal research. A chairperson will be elected by the members of the Committee and will serve for one year."

3. The Radiation Safety Committee and its chair are appointed by the Provost upon the recommendation of the Assistant Vice President and Dean of Graduate Studies and Research.