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$50.101 Applicability.

This subpart applies to each entity which applies for a research, researchtraining, or research-related grant or cooperative agreement under the Public Health Service (PHS) Act. It requires each such entity to establish uniform policies and procedures for investigating and reporting instances of alleged or apparent misconduct invo ing research or research training plications for support of research search training, or related resear tivities that are supported made available under

Subpart D-Public Health Service Grant

Appeals Procedure

50.401 What is the purpose of this subpart? 50.402 To what programs do these regula

tions apply? 50.403 What is the policy basis for these pro

cedures?

This subpart does not supersede and is not intended to set up an alternative to established procedures for resolving fiscal improprieties, issues concerning the ethical treatment of human or animal subjects, or criminal matters. $ 50.102 Definitions.

As used in this subpart:

Act means the Public Health Service Act, as amended, (42 U.S.C. 201 et seq.).

Inquiry means information gathering and initial factfinding to determine whether an allegation or apparent instance of misconduct warrants an investigation.

Institution means the public or private entity or organization (including federal, state, and other agencies) that is applying for financial assistance from the PHS, e.g., grant or cooperative agreements, including continuation awards, whether competing or noncompeting. The organization assumes legal and financial accountability for the awarded funds and for the performance of the supported activities.

Investigation means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred.

Misconduct or Misconduct in Science means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

OSI means the Office of Scientific Integrity, a component of the Office of the Director of the National Institutes for Health (NIH), which oversees the implementation of all PHS policies and procedures related to scientific misconduct; monitors the individual investigations into alleged or suspected scientific misconduct conducted by institutions that receive PHS funds for biomedical or behavioral research projects or programs; and conducts investigations as necessary.

OSIR means the Office of Scientific Integrity Review, a component of the Office of the Assistant Secretary for Health, which is responsible for establishing overall PHS policies and proce

dures for dealing with miscondos 1 science, overseeing the activities! PHS research agencies to ensure 3 these policies and procedures an * plemented, and reviewing all final ports of investigations to assure any findings and recommendations i sufficiently documented. The os also makes final recommendations : the Assistant Secretary for Health whether any sanctions should be in posed and, if so, what they should be any case where scientific miscono has been established.

PHS means the Public Health &* ice, an operating division of the D partment of Health and Human Ser ices (HHS). References to PHS incios organizational units within the PE that have delegated authority to art financial assistance to supports entific activities, e.g., Bureaus, Inst tutes, Divisions, Centers or Offices.

Secretary means the Secretary Health and Human Services and other officer or employee of the De partment of Health and Human Sert ices to whom the authority involv may be delegated. 850.103 Assurance-Responsibilities of

PHS awardee and applicant instite

tions. (a) Assurances. Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research mus have an assurance satisfactory to the Secretary that the applicant:

(1) Has established an administrative process, that meets the requirements of this Subpart, for reviewing, inve tigating, and reporting allegations misconduct in science in connection with PHS-sponsored biomedical and be havioral research conducted at the ap* plicant institution or sponsored by the applicant; and (2) Will comply with its own adminis

, trative process and the requirements of this Subpart.

(b) Annual Submission. An applicant or recipient institution shall make an annual submission to the OSI as follows:

(1) The institution's assurance shall be submitted to the OSI, on a form prescribed by the Secretary, as 8000 da

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ible after November 8, 1989, but no · than January 1, 1990, and updated ially therefter on a date specified SI. Copies of the form may be reted through the Director, OSI. An institution shall submit, along its annual assurance, such aggre

information on allegations, inies, and investigations as the Sec-ry may prescribe. ) General Criteria. In general, an apant institution will be considered e in compliance with its assurance

) Establishes, keeps current, and in request provides the OSIR, the I, and other authorized Departntal officials the policies and proceces required by this subpart. 2) Informs its scientific and administive staff of the policies and proceres and the importance of complice with those policies and proceres. (3) Takes immediate and appropriate tion as soon as misconduct on the rt of employees or persons within the ganization's control is suspected or leged. (4) Informs, in accordance with this ibpart, and cooperates with the OSI ith regard to each investigation of ossible misconduct. (d) Inquiries, Investigations, and ReprtingSpecific Requirements. Each aplicant's policies and procedures must rovide for: (1) Inquiring immediately into an algation or other evidence of possible nisconduct. An inquiry must be comleted within 60 calendar days of its nitiation unless circumstances clearly varrant a longer period. A written resort shall be prepared that states what vidence was reviewed, summarizes rel>vant interviews, and includes the conplusions

of the inquiry. The Individual(s) against whom the allegation was made shall be given a copy of the report of inquiry. If they comment on that report, their comments may be made part of the record. If the inquiry takes longer than 60 days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the 60-day period.

(2) Protecting, to the maximum extent possible, the privacy of those who

in good faith report apparent misconduct.

(3) Affording the affected individual(s) confidential treatment to the maximum extent possible, a prompt and thorough investigation, and an opportunity to comment on allegations and findings of the inquiry and/or the investigation.

(4) Notifying the Director, Osi, in accordance with $50.104(a) when, on the basis of the initial inquiry, the institution determines that an investigation is warranted, or prior to the decision to initiate an investigation if the conditions listed in $50.104(b) exist.

(5) Notifying the OSI within 24 hours of obtaining any reasonable indication of possible criminal violations, so that the OSI may then immediately notify the Department's Office of Inspector General.

(6) Maintaining sufficiently detailed documentation of inquiries to permit a later assessment of the reasons for determining that an investigation was not warranted, if necessary. Such records shall be maintained in a secure manner for a period of at least three years after the termination of the inquiry, and shall, upon request, be provided to authorized HHS personnel.

(7) Undertaking an investigation within 30 days of the completion of the inquiry, if findings from that inquiry provide sufficient basis for conducting an investigation. The investigation normally will include examination of all documentation, including but not necessarily limited to relevant research data and proposals, publications, correspondence, and memoranda of telephone calls. Whenever possible, interviews should be conducted of all individuals involved either in making the allegation or against whom the allegation is made, as well as other individuals who might have information regarding key aspects of the allegations; complete summaries of these interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file.

(8) Securing necessary and appropriate expertise to carry out a thorough and authoritative evaluation of the relevant evidence in any inquiry or investigation.

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(9) Taking precautions against real making decisions about the axi or apparent conflicts of interest on the continuation of funding. part of those involved in the inquiry or (2) An investigation should orë investigation.

be completed within 120 days of a (10) Preparing and maintaining the tiation. This includes conducting documentation to substantiate the in- investigation, preparing the repu vestigation's findings. This documenta- findings, making that report ata tion is to be made available to the Di- for comment by the subjects of tā, rector, Osi, who will decide whether vestigation, and submitting the re that Office will either proceed with its to the OSI. If they can be idest own investigation or will act on the in- the person(s) who raised the allega stitution's findings.

should be provided with those pare (11) Taking interim administrative of the report that address their actions, as appropriate, to protect Fed- and opinions in the investigation. eral funds and insure that the purposes (3) Institutions are expected to a of the Federal financial assistance are their investigations through to com carried out.

tion, and to pursue diligently al (12) Keeping the OSI apprised of any nificant issues. If an institution developments during the course of the to terminate an inquiry or inves investigation which disclose facts that tion for any reason without comple may affect current or potential Depart

relevant requirements ment of Health and Human Services $50.103(d), a report of such planned funding for the individual(s) under in- mination, including a descriptio vestigation or that the PHS needs to the reasons for such termination. Se know to ensure appropriate use of Fed- be made to OSI, which will then dec eral funds and otherwise protect the whether further investigation sho public interest.

be undertaken. (13) Undertaking diligent efforts, as (4) The final report submitted to: appropriate, to restore the reputations OSI must describe the policies and of persons alleged to have engaged in cedures under which the investigat misconduct when allegations are not was conducted, how and from whom confirmed, and also undertaking dili- formation was obtained relevant to gent efforts to protect the positions investigation, the findings, and and reputations of those persons who, basis for the findings, and include t in good faith, make allegations.

actual text or an accurate summar! (14) Imposing appropriate sanctions the views of any individual(s) found on individuals when the allegation of have engaged in misconduct, as well! misconduct has been substantiated. a description of any sanctions taken!

(15) Notifying the OSI of the final the institution. outcome of the invest ation.

(5) If the institution determines to

it will not be able to complete the 3 850.104 Reporting to the OSI.

vestigation in 120 days, it must subo (a)(1) An institution's decision to ini

to the osi a written request for an tiate an investigation must be reported

tension and an explanation for in writing to the Director, OSI, on or delay that includes an interim report before the date the investigation be- on the progress to date and an estima gins. At a minimum, the notification for the date of completion of the report should include the

of the and other necessary steps. Any consi person(s) against whom the allegations eration for an extension must balanse have been made, the general nature of the need for a thorough and rigoron the allegation, and the PHS applica

examination of the facts versus the tion or grant number(s) involved. Infor- terests of the subject(s) of the inte mation provided through the notifica- tigation and the PHS in a timely reso tion will be held in confidence to the lution of the matter. If the request extent permitted by law, will not be granted, the institution must file per disclosed as part of the peer review and odic progress reports as requested y Advisory Committee review processes, the OSI. If satisfactory progress is not but may be used by the Secretary in made in the institution's investigatio

name

OSI may undertake an investiga- this subpart may result in enforcement of its own.

action against the institution, includUpon receipt of the final report of ing loss of funding, and may lead to the stigation and supporting mate- OSI's conducting its own investigation. , the OSI will review the informain order to determine whether the Subpart B-Sterilization of Persons stigation has been performed in a

in Federally Assisted Family ly manner and with sufficient obivity,

Planning Projects thoroughness and comnce. The OSI may then request 8 50.201 Applicability. ification or additional information · if necessary, perform its own in

The provisions of this subpart are ap igation. While primary responsibil

plicable to programs or projects for for the conduct of investigations

health services which are supported in inquiries lies with the institution,

whole or in part by Federal financial Department reserves the right to

assistance, whether by grant or conform its own investigation at any

tract, administered by the Public e prior to, during, or following an

Health Service. titution's investigation.

8 50.202 Definitions. 1) In addition to sanctions that the titution may decide to impose, the

As used in this subpart: partment also may impose sanctions Arrange for means to make arrangeits own upon investigators or insti- ments (other than mere referral of an cions based upon authorities it pos- individual to, or the mere making of an ses or may possess, if such action appointment for him or her with, anrms appropriate.

other health care provider) for the perb) The institution is responsible for formance of a medical procedure on an tifying the OSI if it ascertains at individual by a health care provider y stage of the inquiry or investiga- other than the program or project. on, that any of the following condi- Hysterectomy means a medical proceons exist:

dure or operation for the purpose of re(1) There is an immediate health haz- moving the uterus. d involved;

Institutionalized individual means an (2) There is an immediate need to individual who is (1) involuntarily conotect Federal funds or equipment; fined or detained, under a civil or (3) There is an immediate need to criminal statute, in a correctional or 'otect the interests of the person(s) rehabilitative facility, including laking the allegations or of the mental hospital or other facility for dividual(s) who is the subject of the the care and treatment of mental illllegations as well as his

her co-inves- ness, or (2) confined, under a voluntary Igators and associates, if any;

commitment, in a mental hospital or (4) It is probable that the alleged in- other facility for the care and treatident is going to be reported publicly. ment of mental illness.

(5) There is a reasonable indication of Mentally incompetent individual means lossible criminal violation. In that in- an individual who has been declared tance, the institution must inform mentally incompetent by a Federal, DSI within 24 hours of obtaining that State, or local court of competent junformation. OSI will immediately no- risdiction for any purpose unless he or ify the Office of the Inspector General. she has been declared competent for

purposes which include the ability to 50.105 Institutional compliance.

consent to sterilization. Institutions shall foster a research Public Health Service means the Office environment that discourages mis- of the Assistant Secretary for Health, conduct in all research and that deals Health Resources and Services Adminforthrightly with possible misconduct istration, National Institutes of associated with research for which PHS Health, Centers for Disease Control, funds have been provided or requested. Alcohol, Drug Abuse and Mental An institution's failure to comply with Health Administration and all of their its assurance and the requirements of constituent agencies.

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