A. Research Integrity Officer
The Research Integrity Officer is responsible for implementation of the institution’s research misconduct policies and procedures. This individual must be capable of maintaining confidentiality and sensitive to the various individuals who are involved in research misconduct proceedings. Responsibilities range from pre-allegation advising of individuals to: receiving and assessing allegations, sequestering research evidence, making necessary notifications of, and reports to participants in proceedings, institutional officials, and the ORI, maintaining the research record, and making it available as required, ensuring that members of the Research Integrity Committee have no unresolved conflicts of interest that could impact on misconduct proceedings, assisting with the restoration of reputation of individuals and protection from retaliation of individuals needing this, and ensuring that actions taken by the institution and ORI are enforced and communicated to other involved parties including, but not limited to, sponsors, professional societies, licensing boards, and law enforcement agencies.
The complainant is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with the inquiry and investigation. The role of this individual after the allegation is made is limited principally to serving as a witness.
The complainant will be interviewed by the inquiry and investigation committees and have the opportunity to review portions of the inquiry and investigation reports pertinent to his/her allegations and testimony. S/he will be informed of the results of the inquiry and investigation, and protected from retaliation. Additional sections of the draft inquiry and investigation reports also will be given to this person for comment, at the discretion of the Research Integrity Officer, if pertinent information may be obtained.
The complainant must submit any comments on reports in a timely manner i.e. that will permit completion of the inquiry within 60 days (specific number of days to be determined on a case by case basis) and within 30 days of receipt of the draft investigation report. Comments received from the complainant will be included in the final investigation report.
The respondent is responsible for maintaining confidentiality and cooperating with the inquiry and investigation.
The respondent(s) will be notified in writing of the:
- Allegations of research misconduct, the initiation of an inquiry, the outcome of the inquiry, the decision to conduct an investigation before beginning it
- Policies and procedures of the institution regarding allegations of research misconduct
- Right to object to an inquiry or investigation committee member based on a conflict of interest. This must be done within seven days of notification of the composition of the committee. The institution will make the final determination of the existence of a conflict.
- Right to be interviewed by and present evidence to the inquiry and investigation committees
- Nature of any new allegations that were not addressed in the inquiry or included it the initial notice of the investigation, but which will be pursued during the course of the investigation
- Right to review and make written comments on the draft inquiry and investigation reports
- Right to have comments on the draft inquiry report attached to the report
- Right to have comments on the draft investigation report considered before the final report is written
- Right to receive advice during recesses from a legal counselor or personal advisor when interviewed during the inquiry and investigation. That individual, however, may not be a principal or witness in the case, and may not represent or speak for the respondent or question anyone at inquiry or investigation sessions.
- Right to receive copies of or reasonable, supervised access when appropriate to research records that have been sequestered [42 CFR § 93.305(b)]
- Right to copies of or supervised access to evidence on which the investigation report is based.
The respondent must submit any comments reports in a timely manner i.e. that will permit completion of the inquiry within 60 days (specific number of days to be determined on a case by case basis) and on the draft investigation report within 30 days of the receipt of the report.
The respondent has the responsibility of burden of proof by preponderance of evidence for any defenses raised including those of honest error or difference of opinion.
The respondent may admit that research misconduct has occurred and that s/he has committed it. The institutional review of the allegation may then be terminated by the Deciding Official after consultation with the RIO and University Counsel and if the ORI approves the acceptance of admission and any proposed settlement in cases involving PHS support.
If a finding of research misconduct is not made, the respondent has the right to receive institutional assistance [42 CFR § 93.304 (k)] in restoring his or her reputation.
D. Deciding Official (DO)
The DO will receive the inquiry report and, in consultation with the RIO, determine if an investigation is warranted [based on criteria in 42 CFR § 93.307(d)]. If this determination is made, the DO will ensure that ORI is provided with this decision in writing, along with a copy of the final inquiry report [fulfilling criteria in 42 CFR §93.309] within 30 days of the finding.
The DO will receive the investigation report and in consultation with the RIO and other appropriate officials, decide the extent to which the institution will accept the findings. If misconduct has been found, the responsible person(s) identified, and this finding is accepted, the DO will decide what, if any, administrative actions are appropriate. The DO will ensure that ORI is provided with the final investigation report including all attachments, the decision of the DO regarding the findings, and a detailing of any pending or completed administrative action [42 CRF § 93.315].
The DO will also ensure that records of research misconduct proceedings are maintained in a secure manner for seven years following completion of the proceedings under subparts D and E of 42 CFR Part 93, whichever is later. This will not apply if custody of the records has been transferred to ORI or ORI has advised the institution in writing that records do not need to be retained. The DO will make provisions for copies of these to be provided to ORI as requested for additional analysis, inquire, investigation, review, or other proceedings described in subparts D and E in cases where PHS support is involved. Responsibility for maintaining the records may be delegated to the RIO.