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Research-Related Policies
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Rules
and Procedures for
Responding to Allegations of Research Misconduct
Source:
Policies and Procedures of the MCG General Faculty Assembly,
Approved: April 19, 1990; Revised December 2003, Approved May 20, 2004
Section 1. Purpose
The purpose of these procedures is
to assure the integrity of research conducted on behalf of the Medical College
of Georgia by its faculty, technical staff, residents, fellows, students,
trainees, and individuals employed on a contractual basis by providing a process
for close scrutiny of alleged breaches of that integrity and for full protection
of the rights of any person so accused, as well as any person who makes such
accusations in good faith.
Section 2. Definitions and Procedural
Guarantees
A. Definition of Misconduct
Misconduct in research is defined to include the following acts:
1. 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 judgments of data. Fabrication is
making up results and recording or reporting them. Falsification is manipulating
research materials, equipment, or processes, or changing or omitting data or
results such that the research is not accurately represented in the research
record. Plagiarism is the appropriation of another person’s ideas, processes,
results or words without giving appropriate credit, including those obtained
through confidential review of others’ research proposals and manuscripts.
2. Violation of the Medical College
of Georgia’s policies that have or could have an adverse effect on the
integrity of research or the safety of people, animals and property. This
includes the failure to obtain proper review and approval by the responsible
university committees for research involving human subjects (i.e., Human
Assurance Committee), animal subjects (i.e., Committee on Animal Use in Research
and Education), radioactive materials (i.e., Radiation Safety Committee),
chemical hazards (i.e., Institutional Chemical Committee), or biohazards (i.e.,
Institutional Biosafety Committee); and the failure to follow rules and
guidelines established by these committees.
3. Condoning of fraud in research or
violations of university research policy. This includes failure on the part of a
member of the university to notify university authorities if it becomes obvious
that misconduct in research has occurred, and failure to cooperate in an
investigation under these procedures.
B. Findings of Research
Misconduct
A finding of research misconduct requires that the allegation be proven by a
preponderance of the evidence.
C. Procedural Guarantees
1. Each person shall be free from any restraint, interference, coercion or
reprisal on the part of associates or supervisors in initiating any good-faith
charge or appeal, in accompanying or advising the person(s) making such a charge
or appeal, in appearing as a witness, or in seeking information pursuant to the
procedures described in this document. The above principle will apply with equal
force after a charge has been adjudicated. Should a violation of this principle
be brought to the attention of either the Executive Committee of the Academic
Council or the Vice President for Research, the committee or the Vice President
for Research shall bring the facts to the attention of the President of the
Medical College of Georgia and the chair of the Faculty Research Ethics
Committee and such conduct may result in disciplinary action.
2. The investigation of any charges of research misconduct and resulting written
reports are considered confidential information, subject to the requirements of
Georgia law regarding open records. MCG employees who make, receive, or learn of
an allegation of research misconduct will protect, to the maximum extent
possible, the confidentiality of information regarding the complainant,
respondent, and other affected individuals. Information concerning the
allegations and investigation should only be shared with involved parties when
necessary to obtain relevant information or counsel.
A. Purpose
The Faculty Research Ethics Committee will be responsible for carrying out a
full investigation of charges of research misconduct as determined to be
warranted by the dean (or Vice President for Research). Section 6 describes the
investigation process.
B. Appointment
The Faculty Research Ethics Committee shall be appointed by the Executive
Committee of the Academic Council, subject to the approval of the Council, from
the corps of instruction of the university, excluding department chairs and
associate deans. All appointees shall be selected for their expertise and good
character.
C. Composition and Term
The Faculty Research Ethics Committee shall consist of 10 members, including the
chair. The term of service shall be three years (staggered) with unlimited
eligibility for reappointment. The
chair of the committee is appointed for a three year term by the Executive
Committee of the Academic Council.
Section 4. Procedures for Investigating Claims
of Misconduct in Research
A. Submission of an Allegation
Any individual who believes that he or she has knowledge of misconduct in
research at MCG shall have the option of submitting a written allegation to the
appropriate department chair or to the chair of the Faculty Research Ethics
Committee or the Vice President for Research. If there is a question as to how
an allegation should be filed, the individual should contact the Vice President
for Research or the chair of the Faculty Research Ethics Committee. When a
written allegation is made, it will immediately be reported to the dean in the
school where the alleged misconduct occurred. A dean who has been notified of a
charge of misconduct shall inform the Vice President for Research and the
appropriate department chair if the chair has not been previously notified.
B. Outline of Procedures
- Written
allegation made; dean (or Vice President for Research) notified.
- Preliminary assessment made by dean (or Vice President for
Research) (5 days).
- Inquiry phase will be conducted by two faculty members; this phase
will not last longer than 60 days from time of receipt of written allegation
by dean (or Vice President for Research).
- If investigation is required, this must be completed within 90 days
after its initiation.
- Investigation committee recommends action to President of the
Medical College of Georgia.
Section 5. Inquiry
A. Preliminary Assessment of the
Allegation
Upon receipt of any written charge of research misconduct in his or her school
or college, a dean shall conduct a preliminary assessment sufficient in detail
to determine if there is sufficient factual evidence to warrant the appointment
of a committee to conduct an inquiry into the charges. The preliminary
assessment shall take no longer than 5 days. If the claims of misconduct include
the primary dean, or research in which that dean has participated, those claims
shall be reported immediately by the department chair to the Vice President for
Research, who shall perform the preliminary assessment and conduct an inquiry in
lieu of the dean.
B. Inquiry
1. If, on the basis of the
preliminary assessment, it is decided that a more extensive inquiry is
necessary, the dean (or Vice President for Research) will select two faculty
members, other than those serving on the Faculty Research Ethics Committee, to
serve as an inquiry committee. The faculty selected will have necessary and
appropriate expertise and will have no real or apparent conflicts of interest in
the inquiry case. The dean (or Vice President for Research) may appoint
individuals who are not MCG faculty to the inquiry committee, if necessary, to
obtain the appropriate level of expertise.
2. The university legal advisor will
provide advice and counsel to the dean (or Vice President for Research)
throughout the proceedings.
3. If at any time the dean (or Vice
President for Research) determines that there are immediate health hazards
involved, or there is a need to protect funds or equipment or individuals
affected by the inquiry, or if the alleged incident is likely to be publicly
reported, the appropriate agencies, including the Office of Research Integrity (ORI),
Public Health Services (PHS), will be immediately notified. If reasonable
indication of possible criminal violation is found, appropriate agencies,
including ORI, PHS, must be notified within 24 hours. If at any time the dean
(or Vice President for Research) considers it necessary to secure the records of
research under investigation, steps will be taken to secure such records.
Appropriate administrative actions will be taken to protect federal or other
funds, and to ensure that the purposes of the federal and other financial
assistance are being carried out.
4. The inquiry, including the
preliminary assessment of the charges by the dean (or Vice President for
Research), shall take no longer than 60 days from the receipt of the written
allegation.
C. Procedures to be followed by
the Inquiry Committee
The charge to this committee is to
recommend whether or not the evidence presented warrants a full investigation.
1. Interview with the Complainant
During initial discussions with the complainant, the inquiry committee will
specify the allegations regarding scientific misconduct, identify the key issues
on which the allegations are based, and identify key witnesses who can provide
information about events and behaviors at issue.
2. Interview with the Respondent
The specific allegations of research misconduct will be presented to the
respondent, along with the committee’s understanding of the key issues to be
addressed. The respondent will be given an opportunity to reply, both then (if
desired) and later, to present information requested or proffered. The inquiry
committee and the respondent may request or suggest interviews with other
parties who can provide information that would clarify issues.
3. Reply by the Parties
Both parties will be given a reasonable opportunity to provide documentation and
present witnesses.
4. Review of Documents
The inquiry committee will review all relevant documents.
5. The inquiry committee shall
determine whether the alleged misconduct involves research or research training,
applications for support of research training, or related activities supported
by PHS funds.
6. Conclusions of Inquiry Committee
Based on results of 1-5, the inquiry committee may find the allegations do not
warrant an investigation, or decide that the allegations be expanded or the
allegations deserve a formal investigation. In addition, they may choose to
revise the initial allegations, including the addition of new allegations for
investigation.
D. Report of Inquiry Committee
1. A written report will be prepared
by the inquiry committee and submitted to the dean (or Vice President for
Research). At the same time, a copy of the report will be provided to the
complainant and respondent. The complainant and respondent will have 5 days from
receipt of the written report to submit any written comments to the dean (or
Vice President for Research). Any comments will become part of the record.
2. To the extent allowed under
applicable law, including Georgia’s Open Record Act, the report shall be
treated as confidential and all reasonable efforts will be employed by the
institution, the respondent, and the complainant to protect this confidentiality
(see Section 2C, Procedural Guarantees, paragraph 2).
3. The written report of the inquiry
committee shall include, at a minimum, the following:
- Summary of all witnesses interviewed;
- Summary of all evidence considered, including copies of relevant
documents;
- Statement of whether or not federal funding supported any of the
research in question;
- A detailed, reasoned analysis linking evidence to findings of fact
and recommendations; and
- A recommendation to the dean (or Vice President for Research) of
whether formal investigation is warranted or not.
4. Report of
Dean (or Vice President for Research)
Following receipt of comments from the complainant and respondent, the dean (or
Vice President for Research) will review the report of the inquiry committee
along with the complainant’s and respondent’s responses and make a
determination as to whether a full investigation is or is not warranted. The
report of the dean (or Vice President for Research) will document that the
inquiry report was provided to the complainant and respondent, and that their
comments were considered. The report of the dean must be submitted to the Vice
President for Research and the chair of the Faculty Research Ethics Committee
within 60 days of receipt of written allegations, unless circumstances clearly
warrant a longer period. If the inquiry phase takes longer than 60 days to
complete, documentation of the reasons for exceeding the 60-day period will be
provided.
5. If the dean (or Vice President
for Research) concludes that there are no substantive grounds for the
allegation, the chair of the Faculty Research Ethics Committee and the Vice
President for Research shall certify to the President that an adequate inquiry
has been conducted. Alternately, the Vice President for Research and the chair
of the Faculty Research Ethics Committee may recommend that the matter proceed
to full investigation. If the inquiry determines that an investigation is not
warranted, detailed documentation (records of the inquiry) will be maintained
for at least three years in the Office of the Vice President for Research. Such
records will be provided to authorized personnel, including ORI, PHS, upon
request.
6. If the dean (or Vice President
for Research) concludes that there are grounds for any of the allegations, the
Vice President for Research shall inform the President and direct the chair of
the Faculty Research Ethics Committee to convene the committee to appoint an ad
hoc investigation committee. When a decision to initiate an investigation is
made, sponsors will be notified as legally required. Specifically, initiation of
investigations regarding U.S. Public Health Service-supported research will be
reported to the ORI, PHS. If federal funding is involved, it will be the
responsibility of the Vice President for Research to make a written report to
the director of ORI on or before the date the investigation begins. At a
minimum, the notification shall include the name of the person against whom the
allegations have been made, the general nature of the allegations, and the grant
numbers involved.
7. If for any reason an inquiry is
terminated without completing all relevant requirements of sponsoring agencies,
specifically those required by 42CFR, part 50, Subpart A, Section 50.103(d), a
report of planned termination, including a description of reason(s) for such
termination, shall be made to the appropriate sponsoring agency, including ORI,
PHS.
Section 6. The Investigation
A. Investigation Committee
It shall be the responsibility of the chair of the Faculty Research Ethics
Committee to appoint five of its members as an ad hoc investigation committee
(one member appointed as chair) that shall conduct a thorough investigation of
all claims of misconduct assigned to it and make a written report of its
findings to the chair of the Faculty Research Ethics Committee, the complainant,
and the respondent. Only those with appropriate expertise and who do not have a
conflict of interest that would affect the investigation shall serve on the ad
hoc committee. The chair of the Faculty Research Ethics Committee or the chair
of the ad hoc investigation committee may add voting experts to the committee to
provide adequate specialized expertise. The university legal advisor will
provide advice and counsel throughout all proceedings conducted by the
committee. After receiving the report of the ad hoc investigation committee and
any responses from the complainant and respondent, the Faculty Research Ethics
Committee will either accept the report, revise the report, or extend the
investigation. The committee will prepare a final report that will be sent to
the Vice President for Research, the complainant, and the respondent and to the
President of the Medical College of Georgia for his final decision.
B. Investigation Procedures
The initiation of the investigation begins with the first meeting of the Faculty
Research Ethics Committee to review the allegations. The ad hoc investigation
committee shall establish its own procedures as may be necessary for a thorough
inquiry into all claims and evidence. These procedures shall, however, provide
for at least the following:
1. The purpose of the investigation
shall be to further explore the allegations and to determine whether misconduct
has been committed. If the committee finds that misconduct has been committed,
it is the responsibility of the committee to report its findings and
recommendations for appropriate disciplinary action to the chair of the Faculty
Research Ethics Committee.
2. Within 3 days of the appointment
of the ad hoc committee, notice shall be served by hand delivery or registered
mail to the individual(s) against whom the allegation has been made, and the
alleged basis for them. Such notification shall include a description of the
specific allegations; a copy of the report of the Dean’s inquiry; sources of
funding for the research; definition of research misconduct; procedures to be
followed during the investigation, including the opportunity to be interviewed,
seek the assistance of counsel, challenge the committee based on conflicts of
interest, and comment on the report; and a copy of this document. In addition,
the respondent should be notified of ORI oversight of the investigation, if any.
3. A thorough investigation of all
allegations of misconduct and all responses to those allegations shall begin no
later than 30 days after submission of the written report of the inquiry and be
completed no more than 90 days after the initiation of the investigation by the
Faculty Research Ethics Committee (e.g. the first meeting of the committee).
- The investigation will be conducted in two phases; first, an
independent investigation by members of the subcommittee, and second, a
formal hearing.
- The subcommittee members will be divided into two groups; one will
conduct the independent investigation and the second will conduct the
hearing and make the decision as to whether research misconduct has
occurred.
- The subcommittee members responsible for conducting the
investigation will not participate in the decision of the adjudication
subcommittee.
- All parties involved in the investigation may be accompanied by a
colleague and/or counsel of their choice. The role of these individuals will
be advisory, but not participatory.
- The committee shall provide at a formal hearing an opportunity for
the complainant to present the evidence against the respondent, for the
respondent to address fully all allegations, and for others determined
necessary to present evidence bearing on the case.
- The formal hearing shall be audio taped.
- An oath of affirmation shall be administered to all witnesses by
any person authorized by law to administer oaths in the state of Georgia.
- The investigation committee may grant adjournments to enable either
party to investigate evidence as to which a valid claim of surprise is made.
- Both parties shall be afforded a reasonable opportunity to obtain
necessary witnesses and documentary or other evidence.
- Both parties will be afforded the opportunity to question all
witnesses testifying at the hearing. If a witness cannot or will not appear
but the committee determines that the interests of justice require the
admission of said witness’ statement, the committee will identify the
witness, disclose the statement, and if possible, provide for
interrogatories.
- The investigation committee will not be bound by strict rules of
legal evidence and may admit any evidence, which is of probative value in
determining the issues involved. Every possible effort will be made to
obtain the most reliable evidence available. All questions relating to
admissibility of evidence or other legal matters shall be decided by the
chair or presiding officer of the investigation committee with support of
the university legal advisor.
- For the committee to determine that the evidence submitted supports
the finding of research misconduct, the allegations must be proven by a
preponderance of the evidence. In other words, the committee must find it
more likely than not that the misconduct occurred.
- In the course of the investigation, the committee may broaden the
scope of the investigation beyond the initial allegations.
- If, in the course of the investigation or hearing, evidence is
discovered that would implicate parties other than the respondent in new
charges of research misconduct, those charges will be submitted to the
appropriate dean (or Vice President for Research) for the purpose of
initiating a new inquiry into these allegations, with the subcommittee
serving as complainant. If the responsible official finds that a full
investigation is warranted, a new ad hoc subcommittee will be formed, not to
include any members of the subcommittee submitting the allegations.
4. A full
written report of findings and recommendations shall be made to the chair of the
Faculty Research Ethics Committee within 5 days of completion of the ad hoc
committee’s investigation. Each member of the investigation committee shall
sign the report or submit a signed dissenting report.
5. All records of the ad hoc
committee’s activities and findings shall be conveyed to the chair of the
Faculty Research Ethics Committee. Those records shall be maintained in
accordance with Section 7 of these procedures.
C. Investigation Committee
Recommendations for Administrative Action
Upon completion of its deliberations, the investigation committee shall
recommend such administrative action as it deems just and appropriate and in
accordance with the statutes and bylaws of the faculty of the Medical College of
Georgia. While they are not intended to include all options hereby authorized,
the following suggestions of the Association of American Medical Colleges
(Framework for Institutional Policies and Procedures to Deal with Misconduct in
Research, March 1989) shall help to inform the committee in making its
recommendations for such actions:
1. If the alleged misconduct is
substantiated by a thorough investigation, the following actions should be
considered:
- The sponsoring agency should be notified by the Vice President for
Research of the findings of the investigation and appropriate restitution
should be made.
- All pending abstracts and papers emanating from the fraudulent
research should be withdrawn and editors of journals in which previous
related abstracts and papers appeared should be notified by the Vice
President for Research.
- Institutions and sponsoring agencies with which the individual has
been affiliated should be notified by the Vice President for Research if
there is reason to believe that the validity of previous related research
might be questionable.
- Appropriate disciplinary action shall be recommended to the
President of the Medical College of Georgia. This recommended action should
be consistent and commensurate with the nature of the proven acts of
misconduct. Examples include: removal from a particular project, letter of
reprimand, special monitoring of future work, probation, suspension, salary
reduction, rank reduction, or termination of employment. Serious
disciplinary action against faculty, such as suspension, salary reduction,
rank reduction, or termination of employment, will require application of
the Regent’s policy on dismissal of tenured faculty or non-tenured faculty
during the contract year (see MCG Statutes and the MCG Faculty Grievance
Procedure).
- Institutional administrators should consider, in consultation with
legal counsel, release of information about the incident to the public
press, particularly when public funds were used in supporting the fraudulent
research.
- If the alleged misconduct is not substantiated by a thorough
investigation, formal efforts should be undertaken to restore fully the
reputation of the respondent. In addition, appropriate action should be
taken against any parties whose involvement in leveling unfounded
allegations was demonstrated to have been malicious or intentionally
dishonest.
- If for any reason, an investigation is terminated without
completing all relevant requirements of sponsoring agencies, specifically
those required by 42CFR, Part 50, Subpart A, Section 50.103(d), a report of
planned termination, including a description of reason(s) for such
termination, shall be made to appropriate sponsoring agency, including ORI,
PHS.
2. When the
investigation is complete, the chair of the Faculty Research Ethics Committee
shall have the following responsibilities:
- The chair shall provide a copy of the ad hoc committee’s written
report by hand delivery or registered mail to the complainant and the
respondent. Within 10 days of receiving the committee’s report, these
individuals shall have the opportunity to provide written responses to the
report to the Faculty Research Ethics Committee;
- The chair shall present the complete written report, including the
findings and any recommendations for disciplinary action, to the full
Faculty Research Ethics Committee.
3. The Faculty
Research Ethics Committee has the following responsibilities:
- The committee shall receive the report of the ad hoc investigation
committee and any written responses from the complainant and respondent. It
will accept the report, revise disciplinary action recommended by the
investigation committee, or extend the investigation. In any event, the
final report will be prepared within 90 days of initiation of an
investigation.
- The final report will be sent to the President of the Medical
College of Georgia for review and a final decision. Copies of the report
shall be sent at the same time to the Vice President for Research, the
primary dean, the complainant, and the respondent. The President will make
every effort to come to a final decision within 7 days of receiving the
final report. Each member of the Faculty Research Ethics Committee shall
sign the final report or submit a signed dissenting report. The final report
submitted by the Faculty Research Ethics Committee for transmission by the
Vice President for Research to appropriate sponsoring agencies, including
ORI, PHS, 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. The final report will include the actual text or an
accurate summary of the views of individual(s) found to have engaged in
misconduct, as well as a description of any sanctions taken by the
institution. The President may
exercise discretion in whether to report violations if the finding of
misconduct would not violate the definition of misconduct established by a
regulatory or accrediting body, and if the finding concerns an internal
procedural matter that did not have, and was not likely to have, an adverse
effect on the integrity or safety of research.
- The
contents of any reports distributed under this section shall be kept in
strictest confidence except that the Vice President for Research or the
President of the Medical College of Georgia shall provide such notice as the
contractual and equitable obligation of the university may require. A report
from the Medical College of Georgia will be submitted by the Vice President
for Research. If for any reason a final decision by the President cannot be
issued within 120 days of initiation of an investigation, a request for an
extension will be submitted by the Vice President for Research to the
sponsoring agency, including ORI, PHS. The extension request will include an
explanation for the delay, an interim report on progress to date, an outline
of what remains to be done, and an estimated date of completion.
4. Records and
Reports
- All records and reports of the ad hoc committee and the Faculty
Research Ethics Committee shall be considered confidential, subject to the
requirements of Georgia law regarding open records.
- All records received by the Faculty Research Ethics Committee or
generated by its own inquiry shall be maintained by the chair of the
committee using the facilities of the office of the Vice President for
Research pending their proper disposition at the end of the investigation
according to Section 7 below.
- The Faculty Research Ethics Committee shall report to the Executive
Committee of the Academic Council annually concerning its investigations of
misconduct in research. This report shall include a statement of the number
of cases of misconduct actually investigated by the investigation committee
appointed by the Faculty Research Ethics Committee and their disposition,
but will not disclose the confidential records in its possession.
Section 7. Disposition of Investigation-Related
Materials
The President of the Medical College
of Georgia shall retain all materials collected during an investigation and its
final reports for at least a period of 7 years after which time they may be
destroyed. These materials shall be kept in confidence in the Office of the Vice
President for Research (storage) and are to be made available upon request to
ORI, PHS, or other sponsoring agencies.
Section 8. Rights of Appeal
While due consideration of all
recommendations made by the Faculty Research Ethics Committee shall be given,
the final decision on any allegation of misconduct in research is the
responsibility of the President of the Medical College of Georgia. Final
decisions of the President may be appealed to the Board of Regents (The Policy
Manual, Board of Regents, Second Edition, section 201.08).
Section 9. Termination of Institutional
Employment or Resignation 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 scientific misconduct has been reported, will
not preclude or terminate these procedures. If the respondent, without admitting
to the misconduct, elects to resign his or 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 will 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 evidence.
Section 10. Dissemination of These Procedures
The definition of misconduct and the
availability of these policies and procedures shall be widely disseminated at
least semi-annually to all institutional personnel, as well as to those
individuals contracted by the institution to conduct research.
Section 11. Review and Revision of These
Procedures
Subsequent to the completion of an
investigation, faculty practices and institutional policies and procedures for
promoting ethical conduct of research and investigating allegations of
misconduct shall be scrutinized and modified by the Academic Council in light of
the experience gained.
This document shall provide ready
access to a process for assuring the integrity of research at the Medical
College of Georgia. It shall be reviewed and revised as appropriate. This review
and revision shall be done by the Faculty Research Ethics Committee and the
Executive Committee of the Academic Council, subject to approval by the Academic
Council.
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