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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 activi
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 misconduc science, overseeing the activiti PHS research agencies to ensure these policies and procedures are 2 plemented, and reviewing all finals ports of investigations to assure any findings and recommendations sufficiently documented. The 0 also makes final recommendations the Assistant Secretary for Health: whether any sanctions should be posed and, if so, what they should be any case where scientific miscond has been established.
PHS means the Public Health Ser ice, an operating division of the De partment of Health and Human Se ices (HHS). References to PHS inclus organizational units within the P that have delegated authority to ava financial assistance to support 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 Serv ices to whom the authority involve may be delegated.
§ 50.103 Assurance Responsibilities d PHS awardee and applicant instits
(a) Assurances. Each institution that applies for or receives assistance unde the Act for any project or program which involves the conduct of bie medical or behavioral research must have an assurance satisfactory to the Secretary that the applicant:
(1) Has established an administrativ process, that meets the requirements of this Subpart, for reviewing, inves tigating, and reporting allegations of 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 soon as
ible after November 8, 1989, but no Fr than January 1, 1990, and updated ually therefter on a date specified OSI. Copies of the form may be rested through the Director, OSI. ) An institution shall submit, along Ph its annual assurance, such aggree information on allegations, inries, and investigations as the Secary may prescribe.
) General Criteria. In general, an apant institution will be considered be in compliance with its assurance
Establishes, keeps current, and on request provides the OSIR, the I, and other authorized DepartEntal officials the policies and proceres required by this subpart.
2) Informs its scientific and adminisative 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 abpart, and cooperates with the OSI ith regard to each investigation of ossible misconduct.
(d) Inquiries, Investigations, and Reorting-Specific Requirements. Each aplicant's policies and procedures must rovide for:
(1) Inquiring immediately into an alegation or other evidence of possible nisconduct. An inquiry must be comleted within 60 calendar days of its nitiation unless circumstances clearly warrant a longer period. A written report shall be prepared that states what evidence was reviewed, summarizes relevant interviews, and includes the conclusions 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 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 rele ***idence in any inquiry or
(9) Taking precautions against real or apparent conflicts of interest on the part of those involved in the inquiry or investigation.
(10) Preparing and maintaining the documentation to substantiate the investigation's findings. This documentation is to be made available to the Director, OSI, who will decide whether that Office will either proceed with its own investigation or will act on the institution's findings.
(11) Taking interim administrative actions, as appropriate, to protect Federal funds and insure that the purposes of the Federal financial assistance are carried out.
(12) Keeping the OSI apprised of any developments during the course of the investigation which disclose facts that may affect current or potential Department of Health and Human Services funding for the individual(s) under investigation or that the PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.
(13) Undertaking diligent efforts, as appropriate, to restore the reputations of persons alleged to have engaged in misconduct when allegations are not confirmed, and also undertaking diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.
(14) Imposing appropriate sanctions on individuals when the allegation of misconduct has been substantiated.
(15) Notifying the OSI of the final outcome of the investigation.
§ 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 awar continuation of funding.
(2) An investigation should order be completed within 120 days of tiation. This includes conducting investigation, preparing the rept findings, making that report a for comment by the subjects of the vestigation, and submitting the r to the OSI. If they can be iden the person(s) who raised the allegat should be provided with those por of the report that address their and opinions in the investigation.
(3) Institutions are expected to their investigations through to comp tion, and to pursue diligently als nificant issues. If an institution to terminate an inquiry or investi tion for any reason without complet all relevant requirements § 50.103(d), a report of such planned 2 mination, including a descriptic the reasons for such termination. S be made to OSI, which will then dec whether further investigation s be undertaken.
(4) The final report submitted to OSI must describe the policies and F cedures under which the investiga was conducted, how and from whom formation was obtained relevant to investigation, the findings, and basis for the findings, and include actual text or an accurate summary the views of any individual(s) found have engaged in misconduct, as well a description of any sanctions taken the institution.
(5) If the institution determines th it will not be able to complete the vestigation in 120 days, it must sub to the OSI a written request for an tension and an explanation for delay that includes an interim rep on the progress to date and an estima for the date of completion of the rep and other necessary steps. Any consis eration for an extension must balan the need for a thorough and rigoro examination of the facts versus the terests of the subject(s) of the inve tigation and the PHS in a timely res lution of the matter. If the request granted, the institution must file per odic progress reports as requested t the OSI. If satisfactory progress is not made in the institution's investigation
OSI may undertake an investigaof its own.
Upon receipt of the final report of stigation and supporting mate3, the OSI will review the informa
in order to determine whether the estigation has been performed in a ely manner and with sufficient obivity, thoroughness and ence. The OSI may then request ification or additional information , if necessary, perform its own intigation. While primary responsibil, for the conduct of investigations inquiries lies with the institution, Department reserves the right to form its own investigation at any e prior to, during, or following an titution's investigation.
7) In addition to sanctions that the titution may decide to impose, the partment also may impose sanctions its own upon investigators or institions based upon authorities it possses or may possess, if such action ems appropriate.
(b) The institution is responsible for tifying the OSI if it ascertains at y stage of the inquiry or investigaFon, that any of the following condiFons exist:
(1) There is an immediate health hazd involved;
(2) There is an immediate need to rotect Federal funds or equipment;
(3) There is an immediate need to rotect the interests of the person(s) making the allegations or of the ndividual(s) who is the subject of the llegations as well as his/her co-invesigators and associates, if any;
(4) It is probable that the alleged inident 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 anformation. OSI will immediately notify the Office of the Inspector General.
$50.105 Institutional compliance.
Institutions shall foster a research environment that discourages misconduct in all research and that deals forthrightly with possible misconduct associated with research for which PHS funds have been provided or requested. An institution's failure to comply with its assurance and the requirements of
this subpart may result in enforcement action against the institution, including loss of funding, and may lead to the OSI's conducting its own investigation.
Subpart B-Sterilization of Persons in Federally Assisted Family Planning Projects
The provisions of this subpart are applicable to programs or projects for health services which are supported in whole or in part by Federal financial assistance, whether by grant or contract, administered by the Public Health Service.
As used in this subpart:
Arrange for means to make arrangements (other than mere referral of an individual to, or the mere making of an appointment for him or her with, another health care provider) for the performance of a medical procedure on an individual by a health care provider other than the program or project.
Hysterectomy means a medical procedure or operation for the purpose of removing the uterus.
Institutionalized individual means an individual who is (1) involuntarily confined or detained, under a civil or criminal statute, in a correctional or rehabilitative facility, including a mental hospital or other facility for the care and treatment of mental illness, or (2) confined, under a voluntary commitment, in a mental hospital or other facility for the care and treatment of mental illness.
Mentally incompetent individual means an individual who has been declared mentally incompetent by a Federal, State, or local court of competent jurisdiction for any purpose unless he or she has been declared competent for purposes which include the ability to consent to sterilization.
Public Health Service means the Office of the Assistant Secretary for Health, Health Resources and Services Administration, National Institutes of Health, Centers for Disease Control, Alcohol, Drug Abuse and Mental Health Administration and all of their constituent agencies.