[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50.104]

[Page 141-142]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 50--POLICIES OF GENERAL APPLICABILITY--Table of Contents
 
Subpart A--Responsibility of PHS Awardee and Applicant Institutions for 
        Dealing With and Reporting Possible Misconduct in Science
 
Sec. 50.104  Reporting to the OSI.

    (a)(1) An institution's decision to initiate an investigation must 
be reported in writing to the Director, OSI, on or before the date the 
investigation begins. At a minimum, the notification should include the 
name of the person(s) against whom the allegations have been made, the 
general nature of the allegation, and the PHS application or grant 
number(s) involved. Information provided through the notification will 
be held in confidence to the extent permitted by law, will not be 
disclosed as part of the peer review and Advisory Committee review 
processes, but may be used by the Secretary in making decisions about 
the award or continuation of funding.
    (2) An investigation should ordinarily be completed within 120 days 
of its initiation. This includes conducting the investigation, preparing 
the report of findings, making that report available for comment by the 
subjects of the investigation, and submitting the report to the OSI. If 
they can be identified, the person(s) who raised the allegation should 
be provided with those portions of the report that address their role 
and opinions in the investigation.
    (3) Institutions are expected to carry their investigations through 
to completion, and to pursue diligently all significant issues. If an 
institution plans to terminate an inquiry or investigation for any 
reason without completing all relevant requirements under 
Sec. 50.103(d), a report of such planned termination, including a 
description of the reasons for such termination, shall be made to OSI, 
which will then decide whether further investigation should be 
undertaken.
    (4) The final report submitted to the OSI must 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, and include the actual text or 
an accurate summary of the views of any individual(s) found to have 
engaged in misconduct, as well as a description of any sanctions taken 
by the institution.
    (5) If the institution determines that it will not be able to 
complete the investigation in 120 days, it must submit to the OSI a 
written request for an extension and an explanation for the delay that 
includes an interim report on the progress to date and an estimate for 
the date of completion of the report and other necessary steps. Any 
consideration for an extension must balance the need for a thorough and 
rigorous

[[Page 142]]

examination of the facts versus the interests of the subject(s) of the 
investigation and the PHS in a timely resolution of the matter. If the 
request is granted, the institution must file periodic progress reports 
as requested by the OSI. If satisfactory progress is not made in the 
institution's investigation, the OSI may undertake an investigation of 
its own.
    (6) Upon receipt of the final report of investigation and supporting 
materials, the OSI will review the information in order to determine 
whether the investigation has been performed in a timely manner and with 
sufficient objectivity, thoroughness and competence. The OSI may then 
request clarification or additional information and, if necessary, 
perform its own investigation. While primary responsibility for the 
conduct of investigations and inquiries lies with the institution, the 
Department reserves the right to perform its own investigation at any 
time prior to, during, or following an institution's investigation.
    (7) In addition to sanctions that the institution may decide to 
impose, the Department also may impose sanctions of its own upon 
investigators or institutions based upon authorities it possesses or may 
possess, if such action seems appropriate.
    (b) The institution is responsible for notifying the OSI if it 
ascertains at any stage of the inquiry or investigation, that any of the 
following conditions exist:
    (1) There is an immediate health hazard involved;
    (2) There is an immediate need to protect Federal funds or 
equipment;
    (3) There is an immediate need to protect the interests of the 
person(s) making the allegations or of the individual(s) who is the 
subject of the allegations as well as his/her co-investigators and 
associates, if any;
    (4) It is probable that the alleged incident is going to be reported 
publicly.
    (5) There is a reasonable indication of possible criminal violation. 
In that instance, the institution must inform OSI within 24 hours of 
obtaining that information. OSI will immediately notify the Office of 
the Inspector General.