Table of Contents

I. General Policy

II. Applicability

III. Definitions

IV. Employee Responsibilities Regarding Allegations of Research Misconduct

A. Duty to Report Research Misconduct
B. Duty to Protect Reporting Individuals
C. Duty to Protect Respondents
D. Duty to Report Retaliation
E. Duty of Confidentiality
F. Duty to Report Variation from this Policy
G. Duty of Employee Cooperation

V. General Guidelines for Responding to Allegations of Research Misconduct

A. Duties of Research Integrity Officer
B. Evidentiary Standards
C. Completion of Process

VI. Pre-Inquiry

A. Notification
B. Purpose
C. Procedure

VII. Inquiry

A. Initial Notification
B. Purpose
C. Inquiry Committee
D. Procedure
E. Inquiry Decision
F. Inquiry Report
G. Notification Following Inquiry
H. Reporting to Sponsors
I. ORI Requirements

VIII. Investigation

A. Purpose of the Investigation
B. Notification
C. Formation of Investigation Committee
D. Procedure
E. Investigation Report
F. Comments on the Draft Investigation Report
G. Finalizing the Investigation Report
H. Investigation Decision and Notification
I. Time Limit for Completing the Investigation
J. Requirements for Reporting to ORI

IX. Administrative Actions by the University

X. Other Considerations

A. Termination of Employment Prior to Completing Inquiry or Investigation
B. Restoration of the Respondent's Reputation
C. Protection of the Reporting Individual and Others
D. Allegations Not Made in Good Faith

XI. Record Retention

UNIVERSITY OF GEORGIA POLICY ON RESPONSIBLE CONDUCT
IN RESEARCH AND SCHOLARSHIP

I. General Policy

It is the policy of the University of Georgia to maintain the highest standards of integrity in research without regard to the type of research or the source of its funding. It is, therefore, the responsibility of the administration, faculty, staff, and students of the University of Georgia to maintain the highest ethical standards in conducting and reporting research. This responsibility is owed not only to the University of Georgia, but also to the worldwide academic community, to private and public institutions that sponsor research, and to the public at large.

The administration, faculty, staff, and students of the University of Georgia also share the responsibility to assure that misconduct in research, which includes fabrication, falsification, and plagiarism, is reported timely and accurately. At the same time, the University must assure that allegations of research misconduct are handled fairly and effectively, while preserving the reputation of the University, as well as the reputation of those individuals who in good faith file allegations of misconduct and, to the extent possible, those charged falsely.

The purpose of the University of Georgia Policy on Responsible Conduct in Research and Scholarship is to provide the University of Georgia community guidelines for reporting and investigating allegations of research misconduct.

II. Applicability

The University of Georgia Policy on Responsible Conduct in Research and Scholarship applies to all individuals at the University of Georgia engaged in scientific and scholarly research, including scientists, faculty, graduate students, technicians, and other staff members, undergraduate students employed in research, fellows, guest researchers, visiting faculty or staff, faculty or staff on sabbatical leave, adjunct faculty when performing University work, and faculty or staff on leave without pay. This Policy does not apply to students in all circumstances, but shall apply only when an allegation of misconduct arises out of a student’s employment with or service to the University. In cases in which the status of a student charged with research misconduct is unclear, the Research Integrity Officer for the University shall elect whether the University shall employ this Policy or other procedures available for the investigation and adjudication of alleged academic misconduct by students, such as, for example, the University of Georgia Academic Honesty Policy, available on the Internet at http://www.uga.edu/ovpi/honesty/ah.pdf.

The Public Health Service (“PHS”) and the National Science Foundation (“NSF”) have published formal regulations regarding the investigation of allegations of misconduct involving research-related activities funded by these agencies. (The regulations applicable to the Public Health Service appear in 42 CFR 50, Subpart A and implement Section 493 of the Public Health Service Act. The regulations applicable to the National Science Foundation appear in 45 CFR 689.) The University of Georgia Policy on Responsible Conduct in Research and Scholarship complies with the regulations applicable to the Public Health Service and the National Science Foundation. However, the application of this Policy shall not be limited to allegations of research misconduct arising out of federally funded research.

III. Definitions

For the purpose of this Policy, the terms identified below shall have the following definitions:

A. Allegation means any written or oral statement or other indication of possible research misconduct made to the University of Georgia.

B. Employee means any person paid by, under the control of, or affiliated with the University of Georgia or any individual at the University of Georgia engaged in scientific and scholarly research, including but not limited to, faculty, scientists, fellows, guest researchers, visiting faculty or staff, graduate students, trainees, technicians, support staff, and other faculty or staff members, undergraduate students employed in research, faculty or staff on sabbatical leave, adjunct faculty when performing University work, and faculty or staff on leave without pay.

C. Fabrication means making up research data, results, or other information and recording or reporting the data, results, or other information.

D. Falsification means 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.

E. Good faith allegation means an allegation made with the honest belief that research 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.

F. Inquiry means an early stage of information-gathering and initial fact-finding to determine whether an allegation or apparent instance of misconduct in research warrants further investigation.

G. Institutional Advisor means a member of the University Office of Legal Affairs, or his/her designee, who represents the interests of the University during the Pre-Inquiry, Inquiry, and Investigation and is responsible for advising the Research Integrity Officer, the Inquiry and Investigation Committees, and the Vice President for Research on relevant legal issues.

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

I. ORI means the Office of Research Integrity, a component of the Office of the Director of the National Institutes for Health (NIH), which oversees the implementation of all Public Health Service (PHS) policies and procedures related to scientific misconduct, monitors the individual investigations into alleged or suspected scientific misconduct conducted by institutions that receive PHS funds for biomedical or behavioral research projects or programs, and conducts investigations as necessary.

J. Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

K. Pre-Inquiry means the process by which the Research Integrity Officer makes an initial determination as to whether an allegation of misconduct meets the definition of research misconduct such that this Policy is applicable in the Inquiry and possible Investigation of the allegation.

L. Research Integrity Officer means the University official responsible for initially assessing allegations of research misconduct, determining whether an allegation meets the definition of research misconduct, and overseeing Inquiries and Investigations. This position shall be held by the Associate Vice President for Research within the Office of the Vice President for Research.

M. Research misconduct means intentional, knowing, or reckless fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results. A finding of research misconduct requires that there be a significant departure from accepted practices of the relevant research community, and does not include honest error or honest differences in interpretations or judgments of data.

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 proposed, conducted, or reported research that is the subject of an allegation of research 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; and relevant research files.

O. Respondent means an Employee against whom an allegation of research misconduct is directed or a person who is the subject of an Inquiry or Investigation. There can be more than one Respondent in any Pre-Inquiry, Inquiry, or Investigation.

P. Reporting Individual means a person who makes an allegation of possible research misconduct.

Q. Retaliation means any action that is intended to and/or does adversely affect the employment or other status of an individual that is taken by the University or its Employees because the individual, in good faith, has made an allegation of research misconduct or has cooperated with a Pre-Inquiry, Inquiry, or Investigation of an allegation of research misconduct.

R. Sponsor support means grants, contracts, or cooperative agreements or applications for grants or contracts.

S. Sponsor refers to the agencies or public or private entities, or their representatives having oversight responsibility, which provide funding for research out of which an allegation of research misconduct arises.

IV. Employee Responsibilities Regarding Allegations of Research Misconduct

A. Duty to Report Research Misconduct

All University Employees, including Department Heads and Deans, who suspect research misconduct or who learn of an allegation of research misconduct shall immediately report the allegation to the Research Integrity Officer.

B. Duty to Protect Reporting Individuals

University Employees shall treat any individual who reports an allegation of possible research misconduct with fairness and respect. University Employees shall not retaliate and shall take reasonable steps to protect against retaliation in the position and reputation of the Reporting Individual or any other individuals who cooperate with the University in the Pre-Inquiry determination, Inquiry, or Investigation of allegations of research misconduct. Only the Vice President for Research or a superior may issue sanctions against an individual who, in bad faith, makes an allegation of research misconduct or participates in a Pre-Inquiry, Inquiry, or Investigation and only after providing the Reporting Individual with the appropriate due process. The University shall take precautions to protect the privacy of those who in good faith report apparent research misconduct, to the maximum extent possible under applicable federal and state law.

C. Duty to Protect Respondents

University Employees shall treat a Respondent with fairness and respect. University Employees shall not retaliate and shall take reasonable steps to protect against retaliation to the position and reputation of the Respondent. Only the Vice President for Research or a superior may issue sanctions against a Respondent found to have engaged in research misconduct. The University shall afford the Respondent a prompt and thorough investigation, the opportunity to comment on allegations and findings of the Inquiry and Investigation, and confidential treatment, to the maximum extent possible under applicable federal and state law.

D. Duty to Report Retaliation

All University Employees shall immediately report any alleged or apparent Retaliation to the Research Integrity Officer.

E. Duty of Confidentiality

All University Employees who make or learn of an allegation of research misconduct shall protect, to the maximum extent possible consistent with the laws of the United States and the State of Georgia, the confidentiality of the identity and other personal information regarding the Respondent, the Reporting Individual, and other individuals affected by an allegation of research misconduct. The Research Integrity Officer may establish reasonable conditions and procedures to ensure the confidentiality of such information.

F. Duty to Report Variation from this Policy

Employees shall report significant deviations from the requirements of this Policy to the Research Integrity Officer.

G. Duty of Employee Cooperation

University Employees shall cooperate with the Research Integrity Officer and other institutional officials in their duties related to a Pre-Inquiry, Inquiry, or Investigation. Employees have an obligation to provide relevant evidence regarding allegations of research misconduct to the Research Integrity Officer or other institutional officials charged with enforcing this Policy. Employees may be asked to cooperate in a Sponsor’s investigation of research misconduct. Cooperation may include providing evidence, testimony, or any other information needed to assist in the preparation and presentation of the Sponsor’s investigation and findings. Employees should consult with the Research Integrity Officer or Institutional Advisor prior to responding to a Sponsor’s request for cooperation.

V. General Guidelines for Responding to Allegations of Research Misconduct

A. Duties of Research Integrity Officer

Using the procedures outlined in this Policy, the University shall inquire immediately into an allegation or other evidence of possible research misconduct. In responding to allegations of research misconduct, the Research Integrity Officer and any other institutional official with an assigned responsibility for handling such allegations shall make diligent efforts to ensure that any Pre-Inquiry, Inquiry, or Investigation is conducted in a timely, objective, thorough, and competent manner; and that reasonable precautions are taken to avoid bias and real or apparent conflicts of interest on the part of those involved in conducting a Pre-Inquiry, Inquiry, or Investigation.

With respect to allegations of research misconduct that involve Public Health Service support or sponsorship, the Research Integrity Officer and University Employees shall take all reasonable steps to ensure compliance with the procedural safeguards and reporting requirements contained 42 C.F.R. 50, Subpart A. For example, the Research Integrity Officer shall, after consultation with the Institutional Advisor, if possible, notify the ORI within 24 hours of obtaining any reasonable indication of possible criminal violations, so that the ORI may then immediately notify the Office of Inspector General. In addition, the University shall take interim administrative actions, as appropriate and after affording due process, to protect federal funds and ensure that the purposes of the federal financial assistance are carried out. Any significant variations from the provisions of this Policy should be explained in any reports submitted to the ORI.

B. Evidentiary Standards

The University shall bear the burden of proof in making a finding of research misconduct pursuant to this Policy, and any finding of research misconduct shall be made by a preponderance of the evidence. This means that the evidence must show that it is more likely than not that the Respondent engaged in research misconduct.

C. Completion of Process

The Research Integrity Officer is responsible for ensuring that the Pre-Inquiry, Inquiry, and Investigation and all other steps required by this Policy are completed even in those cases where a Respondent either leaves the University after allegations are made or has left the University before the allegations were made.

VI. Pre-Inquiry

A. Notification

When the Research Integrity Officer learns of an allegation of possible research misconduct, the Research Integrity Officer shall promptly notify in writing the Vice President for Research and the Provost of the University.

B. Purpose

The purpose of the Pre-Inquiry is to determine if an allegation of misconduct meets the definition of research misconduct set forth in this Policy, and, if not, to determine if the allegation was made by the Reporting Individual in bad faith.

C. Procedure

Upon receipt of an allegation of research misconduct, the Research Integrity Officer shall promptly assess the allegation to determine if the alleged misconduct meets the definition of research misconduct set forth in this Policy.

1. If the Research Integrity Officer determines that an allegation of misconduct does not meet the definition of research misconduct set forth in this Policy, then the Pre-Inquiry shall come to an end and the Research Integrity Officer shall notify the Vice President for Research of the allegation and the decision that the allegation does not meet the definition of research misconduct set forth in this Policy. The Research Integrity Officer shall make a written record of the allegation and the decision and this written record shall be maintained in a file regarding the matter.

When the Research Integrity Officer determines that an allegation of misconduct does not meet the definition of misconduct set forth in this Policy, the Research Integrity Officer may, in some cases, report the allegation to another appropriate office, agency, or other entity for further action. Specifically, the Research Integrity Officer shall report alleged criminal acts in violation of Health and Human Services regulations to Health and Human Services; shall report violations of Human and Animal Subject regulations to the Office for Protection from Research Risks, National Institutes of Health; shall report violations of Food and Drug Administration regulations to the Food and Drug Administration Office of Regulatory Affairs; and shall report fiscal irregularities to the appropriate Sponsor or cognizant audit agency.

If the Research Integrity Officer determines that an allegation of misconduct does not meet the definition of research misconduct and if the Research Integrity Officer determines that the Reporting Individual made the allegation in bad faith, then the matter shall be referred to the Vice President for Research and the Vice President for Research shall determine what disciplinary action, if any, shall be imposed upon the Reporting Individual, after providing the Reporting Individual with the appropriate due process.

2. If the Research Integrity Officer determines that an allegation of misconduct meets the definition of research misconduct set forth in this Policy, then the Research Integrity Officer shall promptly initiate an Inquiry. In addition, in the case of federal funding, the Research Integrity Officer shall notify the Director of the ORI, in accordance with 42 CFR 50.104(a), and after consultation with the Institutional Advisor, if possible, of the alleged research misconduct without undue delay if there is an immediate health hazard involved; there is an immediate need to protect federal funds or equipment; there is an immediate need to protect the interests of a Reporting Individual or Respondent as well as other individuals, if any, who may be significantly and negatively affected by the allegation of research misconduct; it is probable that the alleged incident of research misconduct is going to be reported publicly; the allegation involves a public health sensitive issue, for example, a clinical trial; or there is a reasonable indication of a possible federal criminal violation, in which case the Research Integrity Officer must inform the ORI within 24 hours of obtaining that information.

VII. Inquiry

A. Initial Notification

As soon as practicable after the Research Integrity Officer determines that an Inquiry is necessary, but no later than 20 days after such determination, the Research Integrity Officer shall notify the following individuals in writing that an Inquiry is necessary: the Vice President for Research, the Provost, the Dean and Department Head of the Respondent, the University advisor, the Respondent, and the Sponsor if the request to open the Inquiry originated from the Sponsor.

B. Purpose

The purpose of the Inquiry is to allow an Inquiry Committee to make a preliminary evaluation of the allegation primarily based upon the written record. The Inquiry Committee shall review the allegation and the relevant research materials to determine if the allegation is well-founded. The Inquiry Committee may find that there is sufficient evidence to determine that no research misconduct has occurred. Alternatively, the Inquiry Committee may determine that there are additional questions of fact regarding the allegation that must be addressed in an Investigation before a determination may be made as to whether research misconduct has occurred. However, the Inquiry Committee is not charged with making a finding that research misconduct has, in fact, occurred. This determination may only be made after an Investigation.

C. Inquiry Committee

For each Inquiry, the Research Integrity Officer shall appoint three individuals to serve as the Inquiry Committee. The Research Integrity Officer shall take reasonable precautions to ensure that the individuals appointed to the Inquiry Committee have the relevant expertise, lack any real or apparent bias or conflicts of interest, and can conduct an impartial review of the evidence available to them.

D. Procedure

1. Research Integrity Officer

As soon as practicable after the Research Integrity Officer determines that an Inquiry is necessary, the Research Integrity Officer shall secure the relevant research records and make them available to the Inquiry Committee. In initiating an Inquiry, the Research Integrity Officer should identify clearly to the Inquiry Committee the original allegation and any related issues or allegations that, in the discretion of the Research Integrity Officer, should also be evaluated by the Inquiry Committee.

2. Inquiry Committee

The Inquiry Committee shall review the allegation or allegations and the relevant research materials including, but not limited to, any laboratory notebooks, research data, and publications. The Inquiry Committee shall review this written record to determine if it is possible that the allegation or allegations of research misconduct may be well-founded. In its sole discretion, the Inquiry Committee may interview the Respondent and/or the Reporting Individual, and the Inquiry Committee may seek expert assistance in its review of the relevant evidence.

The Inquiry Committee shall complete the Inquiry and submit the final Inquiry Report in writing to the Research Integrity Officer no more than 60 calendar days following the Research Integrity Officer’s notification that an Inquiry was necessary, unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for the extension, and any documentation thereof, shall be entered into the records of the matter and included in the final Inquiry Report. The Respondent shall also be notified of any extension.

E. Inquiry Decision

1. If the Inquiry Committee determines that the allegation of research misconduct is not well-founded, the Inquiry Committee shall recommend to the Vice President for Research that no Investigation is necessary.

2. If the Inquiry Committee determines that the allegation of research misconduct may be well-founded, then the Inquiry Committee shall recommend to the Vice President for Research than an Investigation is necessary.

3. The Inquiry is completed when the Vice President of Research determines whether an Investigation is necessary. This determination shall be made within 15 days of the Vice President for Research’s receipt of the final Inquiry Report. Any extension of time should be based on good cause and recorded in the Inquiry file on the matter.

F. Inquiry Report

At the conclusion of the Inquiry, the Inquiry Committee shall prepare a written Inquiry Report. The Inquiry Report must contain the following information:

1. the name and title of each member of the Inquiry Committee;

2. the name and title of each expert, if any;

3. a summary of the Inquiry process used, including all relevant dates and noting any deviations from the process set forth in this Policy;

4. a list of the research materials and other written records and evidence reviewed and relied upon by the Inquiry Committee (alternatively, the research materials and other written records may be attached to the Inquiry Report);

5. a summary of each interview conducted;

6. a description of the evidence in sufficient detail to thoroughly explain the Inquiry Committee’s recommendation as to whether an Investigation is necessary;

7. the conclusions and recommendation of the Inquiry Committee as to whether an Investigation is necessary;

8. any additional recommendations of the Inquiry Committee.

The Institutional Advisor shall review a draft Inquiry Report for legal sufficiency before a final Inquiry Report is prepared. The draft report and all related documentation and evidence are to be considered confidential to the extent possible and consistent with the laws of the State of Georgia and federal law. See, for example, O.C.G.A. § 50-18-72(a)(5) (records of investigation become public records subject to Georgia Open Records Act request within ten days of completion of investigation).

The Inquiry Committee shall submit the final Inquiry Report to the Research Integrity Officer. The Research Integrity Officer shall submit the final Inquiry Report to the Vice President for Research. If the Vice President for Research determines that an Investigation is necessary, the Vice President for Research shall notify the Research Integrity Officer of this determination, and the Research Integrity Officer shall initiate an Investigation. If the Vice President for Research determines that an Investigation is not necessary, then the Research Integrity Officer shall note this decision in the file of the matter and the assessment of the allegation shall be concluded.

G. Notification Following Inquiry

The Research Integrity Officer shall provide the Respondent with a copy of the Inquiry Report. In addition, the Research Integrity Officer shall notify both the Respondent and the Reporting Individual in writing of the decision of the Vice President for Research as to whether an Investigation is necessary and shall remind the Respondent and the Reporting Individual of their obligation to cooperate in the event an Investigation is initiated. The Respondent and the Reporting Individual may comment on the Inquiry Report and any such comments shall be made a part of the record of the Inquiry. The Research Integrity Officer shall also notify any other appropriate institutional officials of the decision of the Vice President of Research regarding the outcome of the Inquiry.

H. Reporting to Sponsors

If the Vice President for Research decides that an Investigation will be conducted, the Research Integrity Officer shall notify the Sponsor(s) and shall forward a copy of the final Inquiry Report and this Policy to the Sponsor(s).

If the Vice President for Research decides not to proceed to an Investigation and the Inquiry was begun at the request of the Sponsor, the Research Integrity Officer will send a copy of the final Inquiry Report and the decision of the Vice President of Research to the Sponsor. Otherwise, the matter may be closed without notice to the Sponsor.

I. ORI Requirements (if applicable)

If an allegation involves Public Health Service support or sponsorship, the Research Integrity Officer shall notify the Director the ORI in accordance with 42 CFR 50.104(a) when, on the basis of the initial Inquiry, the Inquiry Committee determines that an Investigation is warranted.

The Research Integrity Officer shall maintain sufficiently detailed documentation of the Inquiry to permit a later assessment of the reasons for determining that an Investigation was not warranted, if that is the decision of the Vice President for Research. If ORI is performing an oversight review of the institution=s determination not to proceed to an Investigation, the Research Integrity Officer, if so requested, shall provide ORI with the final Inquiry Report and the Inquiry file including, but not limited to, the relevant research materials. Such records shall be maintained in a secure manner, to the extent allowed by applicable state and federal law, for a period of at least three years after the termination of the Inquiry or until the ORI has made a final decision on its oversight of the institutional Inquiry, whichever is longer. This documentation shall be provided to authorized personnel of the U.S. Department of Health and Human Services, upon request.

Information obtained during the Inquiry regarding allegations, other than research misconduct, involving Public Health Service funds, shall be referred to the responsible government agencies after consultation with the Institutional Advisor.

VIII. Investigation

A. Purpose of the Investigation

The purpose of the Investigation is to make a final decision as to whether research misconduct has occurred. The Investigation shall also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials or potential harm to human subjects or the general public or affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the Investigation shall be set forth in an Investigation Report.

B. Notification

The Research Integrity Officer shall notify the Respondent as soon as reasonably possible after the Vice President of Research decides that an Investigation is necessary. With notification, the Respondent shall receive the following materials: a copy of the final Inquiry Report; the specific allegations; and a copy of this Policy. The Respondent shall also be notified of the members of the Investigation Committee, the sources of funding, and the opportunity of the Respondent to be interviewed, to provide information, to be assisted by a legal advisor, to challenge the membership of the Investigation Committee and experts based on bias or conflict of interest, and to comment on the draft Investigation Report.

If the allegation of research misconduct involves Public Health Service support or sponsorship, the Respondent shall also be notified that the ORI will perform an oversight review of the Investigation Report. In addition, the Respondent shall also be provided an explanation of the Respondent=s right to request a hearing before the Department of Health and Services Appeals Board if there is a finding by the ORI of misconduct under the Public Health Service definition of research misconduct.

C. Formation of Investigation Committee

The Research Integrity Officer shall appoint five people to serve as the Investigation Committee. At least one member of the Investigation Committee shall not be then affiliated with the University of Georgia. At least one member of the Investigation Committee shall have expertise in the particular discipline related to the allegation of research misconduct. The Research Integrity Officer shall take all reasonable precautions to ensure that the individuals appointed to the Investigation Committee have no real or apparent bias or conflict of interest and can conduct a thorough and impartial review of the evidence available to them.

D. Procedure

1. Research Integrity Officer

As soon as practicable after the Vice President for Research determines that an Investigation is necessary, the Research Integrity Officer shall secure any additional pertinent research records that were not previously obtained during the Inquiry. These additional records should be obtained at the time the Respondent is notified that an Investigation has begun. The need for additional records may occur for any number of reasons, including the University’s decision to investigate additional allegations not considered during the Inquiry or the identification of records during the Inquiry process that had not been previously secured.

2. Investigation Committee

The Investigation Committee shall begin the Investigation within 30 days of the date the Vice President for Research makes a final determination that an Investigation is required. In order to conduct its Investigation, the Investigation Committee shall review the final Inquiry Report and all relevant documentation and research materials including, but not limited to, any laboratory notebooks, research data and proposals, publications, correspondence, memoranda of telephone calls, and any additional documents that may be relevant. The Investigation Committee shall interview the Respondent, the Reporting Individual (if known), and any other relevant witnesses. Whenever possible, interviews of all individuals involved either in making the allegation, or against whom the allegation is made, should be conducted, as well as interviews of other individuals who might have information regarding key aspects of the allegations. Complete summaries of these interviews should be prepared, provided to the interviewed party for comments or revision, and included as part of the record and file of the Investigation. In its discretion, the Investigation Committee may request that the Research Integrity Officer retain an outside expert in the relevant discipline to advise the Investigation Committee as necessary to carry out a thorough and authoritative evaluation of the relevant evidence.

E. Investigation Report

At the conclusion of the Investigation, the Investigation Committee shall prepare a written Investigation Report. A draft Investigation Report shall go through the review set forth below and changes may be made. After this review is complete and any changes have been made, the Investigation Committee shall submit the final Investigation Report to the Research Integrity Officer.

The Investigation Report shall be organized according to the following outline, except when special factors suggest a different approach.

I. Background

A. Chronology of events
B. Include public health issues

II. Allegations

III. Sponsored Support or Application(s) (by Allegation)

IV. University Inquiry: Process and Recommendation

A. Composition of committee
B. Individuals interviewed
C. Evidence sequestered and reviewed

V. University Investigation: Process

A. Composition of Investigation Committee
B. Individuals interviewed
C. Evidence sequestered and reviewed

VI. Institutional Investigation: Analysis of each Allegation

A. Background
B. Analysis of all the relevant evidence and specific identification of evidence supporting the finding
C. Conclusion: research misconduct or no research misconduct
D. Effect of misconduct (for example, potential harm to research subjects, reliability of data, publications that need to be corrected or retracted, etc.)

VII. Recommendation of Investigation Committee

VIII. Attachments

F. Comments on the Draft Investigation Report

1. Institutional Advisor

The Research Integrity Officer shall provide the Institutional Advisor with a copy of the draft Investigation Report for a review of its legal sufficiency. The Institutional Advisor’s comments should be incorporated into the draft Investigation Report as appropriate.

2. Respondent

After the Institutional Advisor has reviewed the draft Investigation Report and the comments of the Institutional Advisor have been incorporated into the draft report as appropriate, then the Research Integrity Officer shall provide the Respondent with a copy of the draft report. The Respondent shall be allowed ten days to review and comment on the draft report and Respondent=s written comments shall be attached to the final Investigation Report. The findings of the final Investigation Report should take into account the Respondent=s comments, in addition to all the other evidence.

3. Reporting Individual

After the Institutional Advisor has reviewed the draft Investigation Report and the comments of the Institutional Advisor have been incorporated into the draft report as appropriate, the Research Integrity Officer shall offer the Reporting Individual, if he or she is identifiable, an opportunity to review those portions of the draft Investigation Report that address the Reporting Individual’s role and opinions in the Investigation. The Reporting Individual shall be allowed ten days to review and comment on the draft Investigation Report. The Reporting Individual’s written comments shall be attached to the final Investigation Report. The draft Investigation Report should take into account the Reporting Individual’s comments, in addition to all other evidence.

4. Confidentiality

In distributing the draft Investigation Report, or portions thereof, the Research Integrity Officer shall inform each recipient of the confidentiality under which the draft Investigation Report is made available and may establish reasonable conditions consistent with laws of the State of Georgia and federal law to ensure such confidentiality during the Investigation.

G. Finalizing the Investigation Report

After the Investigation Committee has received comments to the Investigation Report, the Investigation Committee shall review those comments and make any changes to the Investigation Report that the Investigation Committee deems necessary. The Investigation Committee shall then issue its final Investigation Report. The Research Integrity Officer shall maintain a file containing the final Investigation Report and the documentation to substantiate the findings of the Investigation Committee.

H. Investigation Decision and Notification

1. If the Investigation Committee determines that, by a preponderance of the evidence, no research misconduct has occurred, then it shall recommend such a finding to the Vice President for Research.

2. If the Investigation Committee determines that, by a preponderance of the evidence, research misconduct has occurred, then it shall recommend such a finding to the Vice President for Research.

The Research Integrity Officer shall provide the Vice President for Research with a complete copy of the final Investigation Report. Based on a preponderance of the evidence, the Vice President for Research shall make the final determination as to whether to accept the recommendation of the Investigation Report, its findings, and recommended institutional actions, if any. The Vice President for Research may also return the Investigation Report to the Investigation Committee with a request for further fact-finding or analysis. The determination of the Vice President for Research, together with the Investigation Report, constitutes the final Investigation Report for purposes of a Sponsor’s review.

When a final decision has been reached, the Research Integrity Officer shall notify both the Respondent and the Reporting Individual in writing of that decision. In addition, the Vice President for Research shall, after consultation with the Institutional Advisor, determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the Respondent in the work, or other relevant parties should be notified of the outcome of the matter. If a Sponsor is involved, the Research Integrity Officer shall also notify the Sponsor of the Investigation and its outcome. The Research Integrity Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

I. Time Limit for Completing the Investigation

The Investigation Committee shall complete the Investigation and submit its Investigation Report to the Research Integrity Officer no more than 90 calendar days after the decision of the Vice President for Research that an Investigation was necessary, unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for the extension shall be entered into the records of the case and included in the final Investigation Report. The Respondent shall also be notified of any extension.

The Investigation is completed when the Vice President of Research determines whether research misconduct has occurred. This determination shall be made within 15 days of the Vice President for Research’s receipt of the Investigation Report. Any extension of time, or any request by the Vice President for Research that the Investigation Committee conduct additional investigation or analysis, should be based on good cause and incorporated into the final Investigation Report.

J. Requirements for Reporting to ORI (if applicable)

The Research Integrity Officer shall ensure compliance with the following requirements in those cases where an allegation of research misconduct involves Public Health Service support or sponsorship:

1. When an admission of research misconduct is made, the Research Integrity Officer may contact the ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. The University shall not accept an admission of scientific or research misconduct as the basis for closing a case or not undertaking an Investigation without prior approval from the ORI.

2. The decision of the University to initiate an investigation must be reported in writing to the Director of the 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. Information provided to the Director of the ORI through this notification will be held in confidence by ORI to the extent permitted by law, will not be disclosed as part of the peer review and Advisory Committee review processes, but may be used by the Secretary of Health and Human Services, and any other officer or employee of the Department of Health and Human Services to whom similar authority may be delegated, in making decisions about the award or continuation of funding.

3. If the University plans to terminate an Inquiry or Investigation for any reason without completing all relevant requirements under 42 CFR 50.103(d), the Research Integrity Officer shall submit to ORI a report of such planned termination, including a description of the reasons for such termination. ORI will then decide whether further investigation should be undertaken.

4. The Research Integrity Officer shall notify the ORI of the final outcome of the Investigation. The Research Integrity Officer shall make the Investigation Report and the documentation necessary to substantiate the findings of the Investigation Committee available to the Director of ORI, upon request. The Director, ORI, will decide whether ORI will either proceed on its own investigation or will act on the findings of the University. The final Investigation Report submitted to the ORI must 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.

5. If the University determines that it will not be able to complete the Investigation in 120 days, the Research Integrity Officer shall submit to the ORI 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 Investigation Report and other necessary steps. Any consideration for an extension must balance the need for a thorough and rigorous examination of the facts versus the interests of the Respondent 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 satisfactory progress is not made in the University’s Investigation, the ORI may undertake an Investigation of its own.

6. Upon receipt of the final Investigation Report and supporting materials, the ORI will review the information in order to determine whether the Investigation has been performed in a timely manner and with sufficient objectivity, thoroughness, and competence. The ORI may then request clarification or additional information and, if necessary, perform its own investigations.

7. In addition to sanctions that the University may decide to impose, the Department of Health and Human Services also may impose sanctions of its own upon investigators or the University based upon authorities it possesses or may possess, if such action seems appropriate.

8. The Research Integrity Officer shall 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 Public Health Service needs to know to ensure appropriate use of federal funds and otherwise protect the public interest.

IX. Administrative Actions by the University

The University shall take appropriate interim and/or administrative actions against individuals found to have engaged in research misconduct after affording the Respondent appropriate due process. If the Vice President for Research determines that research misconduct has occurred, he or she shall determine the appropriate actions to be taken, after consultation with the Research Integrity Officer and the Institutional Advisor. These actions may include:

1. withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found;

2. removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment; and/or

3. restitution of funds as appropriate.

When the decision of the Vice President for Research involves a recommendation for the dismissal of a faculty member with tenure, or a non-tenured faculty member before the end of the term specified in his/her contract, the Inquiry and Investigation outlined in these procedures will serve as the informal inquiry by an appropriate faculty committee pursuant to Board of Regents Policy 803.1101. The Investigation Committee’s recommendation to the Vice President for Research and the decision of the Vice President for Research to initiate formal dismissal proceedings shall be forwarded to the President pursuant to Board of Regents Policy 803.1101.

X. Other Considerations

A. Termination of Employment Prior to Completing Inquiry or Investigation

The termination of the Respondent’s institutional employment, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, will not preclude or terminate the misconduct procedures set forth in this Policy. If the Respondent, without admitting to the misconduct, elects to resign his/her position prior to the initiation of an Inquiry, but after an allegation has been reported, or during an Inquiry or Investigation, the Inquiry or Investigation should proceed. If the Respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the Respondent’s failure to cooperate and its effect on the committee’s review of all the evidence.

B. Restoration of the Respondent=s Reputation

If the University does not find that research misconduct has occurred, after consulting with the Respondent, the Research Integrity Officer shall undertake reasonable, diligent efforts, as appropriate, to restore the Respondent’s reputation. Depending on the particular circumstances, the Research Integrity Officer should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the Respondent’s personnel file. Any institutional actions to restore the Respondent’s reputation must first be approved by the Respondent and the Vice President for Research, after consultation with the Institutional Advisor.

C. Protection of the Reporting Individual and Others

Regardless of whether the University or a Sponsor determines that research misconduct has occurred, after consultation with the Reporting Individuals, the Research Integrity Officer shall undertake reasonable, diligent efforts, as appropriate, to protect the positions and reputations of the Reporting Individuals who made allegations of research misconduct in good faith and others who cooperate in good faith with Inquiries and Investigations of such allegations. Upon completion of an Investigation, the Vice President for Research shall determine, after consulting with the Reporting Individual, what steps, if any, are needed to restore the position or reputation of the Reporting Individual. The Research Integrity Officer shall be responsible for implementing any steps the Vice President for Research approves. The Research Integrity Officer also shall take appropriate steps during the Inquiry and Investigation to prevent any retaliation against the Reporting Individual.

D. Allegations Not Made in Good Faith

If relevant, the Vice President for Research shall determine whether the Reporting Individual’s allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Vice President for Research shall determine whether any administrative action should be taken against the Reporting Individual, after providing the Reporting Individual with appropriate due process.

XI. Record Retention

After completion of a matter and all ensuing related actions, the Research Integrity Officer shall prepare a complete file, including the records of any Pre-Inquiry, Inquiry, or Investigation and copies of all documents and other materials furnished to the Research Integrity Officer or the Inquiry and/or Investigation Committees. The Research Integrity Officer shall keep the file in a secure manner for at least seven years after completion of the matter in order to permit later assessment of the matter. If any allegation of research misconduct involves Public Health Service support or sponsorship, the records of the matter shall be provided, upon request, to authorized personnel in the U.S. Department of Health and Human Services.