[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR93.310]

[Page 598-599]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 93_PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT--
Table of Contents
 
               Subpart C_Responsibilities of Institutions
 
Sec. 93.310  Institutional investigation.

    Institutions conducting research misconduct investigations must:
    (a) Time. Begin the investigation within 30 days after determining 
that an investigation is warranted.
    (b) Notice to ORI. Notify the ORI Director of the decision to begin 
an investigation on or before the date the investigation begins and 
provide an inquiry report that meets the requirements of Sec. 93.307 
and Sec. 93.309.
    (c) Notice to the respondent. Notify the respondent in writing of 
the allegations within a reasonable amount of time after determining 
that an investigation is warranted, but before the investigation begins. 
The institution must give the respondent written notice of any new 
allegations of research misconduct within a reasonable amount of time of 
deciding to pursue allegations not addressed during the inquiry or in 
the initial notice of investigation.
    (d) Custody of the records. To the extent they have not already done 
so at the allegation or inquiry stages, take all reasonable and 
practical steps to obtain custody of all the research records and 
evidence needed to conduct the research misconduct proceeding, inventory 
the records and evidence, and sequester them in a secure manner, except 
that where the research records or evidence encompass scientific 
instruments shared by a number of users, custody may be limited to 
copies of the data or evidence on such instruments, so long as those 
copies are substantially equivalent to the evidentiary value of the 
instruments. Whenever possible, the institution must take custody of the 
records--
    (1) Before or at the time the institution notifies the respondent; 
and
    (2) Whenever additional items become known or relevant to the 
investigation.
    (e) Documentation. Use diligent efforts to ensure that the 
investigation is thorough and sufficiently documented and includes 
examination of all research records and evidence relevant to reaching a 
decision on the merits of the allegations.
    (f) Ensuring a fair investigation. Take reasonable steps to ensure 
an impartial and unbiased investigation to the maximum extent 
practicable, including participation of persons with appropriate 
scientific expertise who do not have unresolved personal, professional, 
or financial conflicts of interest with those involved with the inquiry 
or investigation.
    (g) Interviews. Interview each respondent, complainant, and any 
other available person who has been reasonably identified as having 
information regarding any relevant aspects of the investigation, 
including witnesses identified by the respondent, and record or 
transcribe each interview, provide the recording or transcript to the 
interviewee for correction, and include the recording or transcript in 
the record of the investigation.
    (h) Pursue leads. Pursue diligently all significant issues and leads 
discovered

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that are determined relevant to the investigation, including any 
evidence of additional instances of possible research misconduct, and 
continue the investigation to completion.