Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 2 - Procedures of the State Department of Health › Subchapter 31 - Human Subjects Protection › Section 310:2-31-26 - Conducting the investigation

Current through Vol. 41, No. 20, July 1, 2024
(a)
Purpose of the investigation.
The purpose of the investigation is
				to explore in detail the allegations, to examine the evidence in depth, and to
				determine specifically whether misconduct has been committed, by whom, and to
				what extent. The investigation will also determine whether there are additional
				instances of possible misconduct that would justify broadening the scope beyond
				the initial allegations. The findings of the investigation will be set forth in
				an investigation report.
(b)
Sequestration of the research records.
The RIO will immediately
				sequester any additional pertinent research records that were not previously
				sequestered during the inquiry.
(c)
Appointment of the Investigation Committee.
The RIO, in
				consultation with other OSDH officials as appropriate, will appoint an
				investigation committee and the committee chair within ten(10) days of the
				notification to the respondent that an investigation is planned or as soon as
				practicable. The makeup of the investigation committee will follow the same
				requirements outlined for the inquiry committee. Individuals appointed to the
				investigation committee may also have served on the inquiry committee. The RIO
				will notify the respondent of the proposed committee membership within five (5)
				days. If the respondent submits a written objection to any appointed member of
				the investigation committee or expert, the RIO will determine whether to
				replace the challenged member or expert with a qualified substitute.
(d)
Charge to the committee.
The
				RIO will define the subject matter of the investigation in a written charge to
				the committee that describes the allegations and related issues identified
				during the inquiry, defines scientific misconduct, and identifies the name of
				the respondent. The charge will state that the committee is to evaluate the
				evidence and testimony of the respondent, whistleblower, and key witnesses to
				determine whether, based on a preponderance of the evidence, scientific
				misconduct occurred and, if so, to what extent, who was responsible, and its
				seriousness. During the investigation, if additional information becomes
				available that substantially changes the subject matter of the investigation or
				would suggest additional respondents, the committee will notify the RIO, who
				will determine whether it is necessary to notify the respondent of the new
				subject matter or to provide notice to additional respondents.
(e)
Investigation process.
The
				investigation committee will be appointed and the process initiated within 30
				days of the completion of the inquiry and the determination that an
				investigation is warranted. The investigation will involve examination of all
				documentation including, but not necessarily limited to, relevant research
				records, computer files, proposals, manuscripts, publications, correspondence,
				memoranda, and notes of telephone calls. Whenever possible, the committee
				should interview the whistleblower(s), the respondents(s), and other
				individuals who might have information regarding aspects of the allegations.
				Interviews of the respondent should be tape recorded or transcribed. All other
				interviews should be transcribed, tape recorded, or summarized. Summaries or
				transcripts of the interviews should be prepared, provided to the interviewed
				party for comment or revision, and included as part of the investigatory
				file.