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50.301 Applicability. 50.302 Definitions. 50.303 General rule. 50.304 Life of the mother would be endan

gered. 50.305 (Reserved) 50.306 Rape and incest. 50.307 Documentation needed by programs

or projects. 50.308 Drugs and devices and termination of

ectopic pregnancies. 50.309 Recordkeeping requirements. 50.310 Confidentiality. 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?

850.101 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 researc tivities that are supported made available under t?

This subpart does not supersede and is dures for dealing with miscondos . not intended to set up an alternative to science, overseeing the activits established procedures for resolving PHS research agencies to ensure fiscal improprieties, issues concerning these policies and procedures an: the ethical treatment of human or ani- plemented, and reviewing all final mal subjects, or criminal matters. ports of investigations to assure 5

any findings and recommendatiossi 850.102 Definitions.

sufficiently documented. The & As used in this subpart:

also makes final recommendatios Act means the Public Health Service the Assistant Secretary for Health: Act, as amended, (42 U.S.C. 201 et seq.). whether any sanctions should be

Inquiry means information gathering posed and, if so, what they should be and initial factfinding to determine any case where scientific miscope whether an allegation or apparent in- has been established. stance of misconduct warrants an in- PHS means the Public Health & vestigation.

ice, an operating division of the 2 Institution means the public or pri- partment of Health and Human Se vate entity or organization (including ices (HHS). References to PHS inclus federal, state, and other agencies) that organizational units within the PE is applying for financial assistance that have delegated authority to spa* from the PHS, e.g., grant or coopera

financial assistance to support & tive agreements, including continu- entific activities, e.g., Bureaus, Lisa ation awards, whether competing or tutes, Divisions, Centers or Offices. noncompeting. The organization as- Secretary means the Secretary sumes legal and financial accountabil- Health and Human Services and a ity for the awarded funds and for the other officer or employee of the De performance of the supported activi- partment of Health and Human Serr ties.

ices to whom the authority involt: Investigation means the formal exam- may be delegated. ination and evaluation of all relevant facts to determine if misconduct has 850.103 Assurance-Responsibilities o occurred.

PHS awardee and applicant instita Misconduct or Misconduct in Science

tions. means fabrication, falsification, plagia- (a) Assurances. Each institution that rism, or other practices that seriously applies for or receives assistance unde deviate from those that are commonly the Act for any project or program accepted within the scientific commu- which involves the conduct of bio nity for proposing, conducting, or re- medical or behavioral research mus porting research. It does not include have an assurance satisfactory to the honest error or honest differences in Secretary that the applicant: interpretations or judgments of data. (1) Has established an administrativa

OSI means the Office of Scientific In- process, that meets the requirements tegrity, a component of the Office of of this Subpart, for reviewing, inver the Director of the National Institutes tigating, and reporting allegations of for Health (NIH), which oversees the misconduct in science in connection implementation of all PHS policies and with PHS-sponsored biomedical and be procedures related to scientific mis- havioral research conducted at the ap conduct; monitors the individual inves- plicant institution or sponsored by the tigations into alleged or suspected sci- applicant; and entific misconduct conducted by insti- (2) Will comply with its own adminis tutions that receive PHS funds for bio- trative process and the requirements of medical or behavioral research projects this Subpart. or programs; and conducts investiga- (b) Annual Submission. An applicant tions as necessary.

or recipient institution shall make a OSIR means the Office of Scientific annual submission to the OSI as folIntegrity Review, a component of the lows: Office of the Assistant Secretary for (1) The institution's assurance shall Health, which is responsible for estab- be submitted to the OSI, on a form prelishing overall PHS policies and proce- scribed by the Secretary, as soon do

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ible after November 8, 1989, but no in good faith report apparent misr than January 1, 1990, and updated conduct. ually therefter on a date specified (3) Affording the affected OSI. Copies of the form may be re- individual(s) confidential treatment to sted through the Director, OSI.

the maximum extent possible, -) An institution shall submit, along prompt and thorough investigation, h its annual assurance, such aggre

and an opportunity to comment on ale information on allegations, in- legations and findings of the inquiry ries, and investigations as the Sec- and/or the investigation. zry may prescribe.

(4) Notifying the Director, OSI, in ac=;) General Criteria. In general, an ap

cordance with $50.104(a) when, on the Frant institution will be considered

basis of the initial inquiry, the institube in compliance with its assurance

tion determines that an investigation t:

is warranted, or prior to the decision to 1) Establishes, keeps current, and

initiate an investigation if the condion request provides the OSIR, the

tions listed in $ 50.104(b) exist. I, and other authorized Depart

(5) Notifying the OSI within 24 hours ntal officials the policies and proce

of obtaining any reasonable indication res required by this subpart.

of possible criminal violations, so that 2) Informs its scientific and adminis

the OSI may then immediately notify 2tive staff of the policies and proce

the Department's Office of Inspector

General. res and the importance of complice with those policies and proce

(6) Maintaining sufficiently detailed

documentation of inquiries to permit a res.

later assessment of the reasons for de(3) Takes immediate and appropriate

termining that an investigation was ition as soon as misconduct on the

not warranted, if necessary. Such irt of employees or persons within the

records shall be maintained in a secure "ganization's control is suspected or

manner for a period of at least three leged.

years after the termination of the in(4) Informs, in accordance with this

quiry, and shall, upon request, be proibpart, and cooperates with the OSI

vided to authorized HHS personnel. ith regard to each investigation of

(7) Undertaking an investigation ossible misconduct.

within 30 days of the completion of the (d) Inquiries, Investigations, and Re

inquiry, if findings from that inquiry ortingSpecific Requirements. Each ap- provide sufficient basis for conducting licant's policies and procedures must

an investigation. The investigation rovide for:

normally will include examination of (1) Inquiring immediately into an al- all documentation, including but not egation or other evidence of possible necessarily limited to relevant renisconduct. An inquiry must be com- search data and proposals, publicaleted within 60 calendar days of its tions, correspondence, and memoranda nitiation unless circumstances clearly of telephone calls. Whenever possible, warrant a longer period. A written re- interviews should be conducted of all port shall be prepared that states what individuals involved either in making avidence was reviewed, summarizes rel- the allegation or against whom the alevant interviews, and includes the con- legation is made, as well as other indiclusions

of the inquiry. The viduals who might have information individual(s) against whom the allega- regarding key aspects of the allegation was made shall be given a copy of tions; complete summaries of these the report of inquiry. If they comment interviews should be prepared, provided on that report, their comments may be to the interviewed party for comment made part of the record. If the inquiry or revision, and included as part of the takes longer than 60 days to complete, investigatory file. the record of the inquiry shall include (8) Securing necessary and approdocumentation of the reasons for ex- priate expertise to carry out a thorceeding the 60-day period.

ough and authoritative evaluation of (2) Protecting, to the maximum ex- the relevant evidence in any inquiry or tent possible, the privacy of those who investigation

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

be completed within 120 days of 3 (10) Preparing and maintaining the tiation. This includes conducts documentation to substantiate the in- investigation, preparing the rescu. vestigation's findings. This documenta- findings, making that report ita tion is to be made available to the Di- for comment by the subjects of the rector, OSI, who will decide whether vestigation, and submitting the that Office will either proceed with its to the OSI. If they can be ident own investigation or will act on the in- the person(s) who raised the allsia stitution's findings.

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

tion, and to pursue diligently as (12) Keeping the OSI apprised of any nificant issues. If an institution developments during the course of the to terminate an inquiry or intesa investigation which disclose facts that tion for any reason without compie may affect current or potential Depart- all 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 descriptic vestigation or that the PHS needs to the reasons for such termination. know to ensure appropriate use of Fed- be made to OSI, which will then del eral funds and otherwise protect the whether further investigation 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 investigamisconduct when allegations are not was conducted, how and from whoc. confirmed, and also undertaking dili- formation was obtained relevant to co gent efforts to protect the positions investigation, the findings, and and reputations of those persons who, basis for the findings, and include in good faith, make allegations.

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

(15) Notifying the OSI of the final the institution, outcome of the investigation.

(5) If the institution determines i

it will not be able to complete the " 8 50.104 Reporting to the OSI.

vestigation in 120 days, it must sube (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 repom 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 repe should include the name of the and other necessary steps. Any Core: person(s) against whom the allegations eration for an extension must balan. have been made, the general nature of the need for a thorough and rigom 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 invet mation provided through the notifica- tigation and the PHS in a timely res 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 t? Advisory Committee review processes, the Osi. If satisfactory progress is nei but may be used by the Secretary in made in the institution's investigatio?

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

action against the institution, includ• Upon 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. 3, the OSI will review the informa

in order to determine whether the Subpart B-Sterilization of Persons estigation has been performed in a

in Federally Assisted Family ely manner and with sufficient ob

Planning Projects ivity, thoroughness and comence. The OSI may then request

$ 50.201 Applicability. ification or additional information s, if necessary, perform its own in

The provisions of this subpart are ap tigation. 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 je prior to, during, or following an

Health Service. titution's investigation.

850.202 Definitions. 7) 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 tions based upon authorities it pos- individual to, or the mere making of an (38es or may possess, if such action appointment for him or her with, anems appropriate.

other health care provider) for the per(b) 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. id involved;

Institutionalized individual means an * (2) There is an immediate need to individual who is (1) involuntarily conrotect Federal funds or equipment; fined or detained, under a civil or (3) There is an immediate need to criminal statute, in a correctional or rotect the interests of the person(s) rehabilitative facility, including laking the allegations or of the mental hospital or other facility for ndividual(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 possible criminal violation. In that in- an individual who has been declared 3tance, the institution must inform mentally incompetent by a Federal, OSI within 24 hours of obtaining that State, or local court of competent juinformation. OSI will immediately no- risdiction for any purpose unless he or tify the Office of the Inspector General. she has been declared competent for

purposes which include the ability to 3 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 Sassociated 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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