[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: 42CFR93.307]

[Page 597]
 
                         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. 93.307  Institutional inquiry.

    (a) Criteria warranting an inquiry. An inquiry is warranted if the 
allegation--
    (1) Falls within the definition of research misconduct under this 
part;
    (2) Is within Sec. 93.102; and
    (3) Is sufficiently credible and specific so that potential evidence 
of research misconduct may be identified.
    (b) Notice to respondent and custody of research records. At the 
time of or before beginning an inquiry, an institution must make a good 
faith effort to notify in writing the presumed respondent, if any. If 
the inquiry subsequently identifies additional respondents, the 
institution must notify them. To the extent it has not already done so 
at the allegation stage, the institution must, on or before the date on 
which the respondent is notified or the inquiry begins, whichever is 
earlier, promptly 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.
    (c) Review of evidence. The purpose of an inquiry is to conduct an 
initial review of the evidence to determine whether to conduct an 
investigation. Therefore, an inquiry does not require a full review of 
all the evidence related to the allegation.
    (d) Criteria warranting an investigation. An inquiry's purpose is to 
decide if an allegation warrants an investigation. An investigation is 
warranted if there is--
    (1) A reasonable basis for concluding that the allegation falls 
within the definition of research misconduct under this part and 
involves PHS supported biomedical or behavioral research, research 
training or activities related to that research or research training, as 
provided in Sec. 93.102; and
    (2) Preliminary information-gathering and preliminary fact-finding 
from the inquiry indicates that the allegation may have substance.
    (e) Inquiry report. The institution must prepare a written report 
that meets the requirements of this section and Sec. 93.309.
    (f) Opportunity to comment. The institution must provide the 
respondent an opportunity to review and comment on the inquiry report 
and attach any comments received to the report.
    (g) Time for completion. The institution must complete the inquiry 
within 60 calendar days of its initiation unless circumstances clearly 
warrant a longer period. If the inquiry takes longer than 60 days to 
complete, the inquiry record must include documentation of the reasons 
for exceeding the 60-day period.