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University of California Office of the President December 15, 1989

It is long-standing policy of the University of California to encourage and maintain the highest ethical standards in research. This Policy reaffirms the University's commitment to integrity in research.

Integrity in research includes not just the avoidance of wrongdoing, but also the rigor, carefulness, and accountability that are hallmarks of good scholarship. All persons engaged in research at the University are responsible for adhering to the highest standards of intellectual honesty and integrity in research. Faculty and other supervisors of research activities have a responsibility to create an environment which encourages those high standards and integrity in research. Open publication and discussion, emphasis on quality of research, appropriate supervision, maintenance of accurate and detailed research procedures and results, and suitable assignment of credit and responsibility for research and publications are essential for fostering intellectual honesty and integrity in research.

University policies set forth expectations for high standards of ethical behavior for faculty and students involved in research and provide procedures for addressing allegations of misconduct in research. These policies and procedures are set forth in the Academic Senate Bylaws, the University Policy on Faculty Conduct and the Administration of Discipline, and University Policies Applying to Campus Activities, Organizations, and Students--Part A, Student Conduct and Discipline. Procedures for administration of discipline also exist for other academic and staff employees in accordance with applicable personnel policies and collective bargaining agreements.

Misconduct 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. Misconduct does not include honest error or honest differences in interpretations or judgments of data.'

The University will continue to take prompt and vigorous action to investigate and address allegations of misconduct in research, based on the following principles:

Institutional and academic responsibility for selfregulation;

Mechanisms to protect to the greatest extent possible, the due process rights of the accused, the interests of those making allegations, and the public interest;

The highest degree of confidentiality compatible with an effective response and applicable sponsor reporting requirements; and Precautions against real or apparent conflict of interest.

1. The definition of misconduct is from the Public Health Service, Department of Health and Human Services (42 CFR Part 50, Subpart A, Responsibilities of PHS Awardee- and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science), and it is consistent with the ethical principles and types of unacceptable conduct regarding scholarship listed in the Faculty Code of Conduct and with the types of misconduct specified in the University Policy on Student Conduct and Discipline.

Campus and Laboratory Implementation

Campuses and Laboratories shall have necessary guidelines and procedures to provide appropriate response to allegations of misconduct in research. Such guidelines and procedures should specify how pertinent University policies and procedures will be used to address allegations of misconduct in research by faculty, students, and staff. Whenever extramural funds are involved, local guidelines and procedures also shall require compliance with conditions of the award, including applicable regulations issued by the sponsor of the research. Such regulations include, but are not limited to, the Responsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science (42 CFR, Part 50, Subpart A) and the National Science Foundation regulation on Misconduct in Science and Engineering Research (45 CFR, Part 689). Among their requirements, these regulations require specific reports to the sponsoring agency.

Chancellors and Laboratory Directors shall designate an official responsible for implementation of this Policy, which may include the consideration of initial reports of misconduct and, when necessary! the referral or initiation of formal investigations. Local guidelines and procedures should clarify available mechanisms for imposing appropriate sanctions or discipline on individuals when the allegation of misconduct has been substantiated.

Local guidelines or procedures may also address issues such as the responsibilities of research supervisors, assignment of credit for publications, training of research apprentices, education on research ethics, requirements for recordkeeping of experimental procedures, and data storage. Chancellors and Laboratory Directors may also designate ombudspersons to provide confidential advice to researchers, staff, and students with questions or problems related to research ethics.

Copies of local guidelines and procedures shall be sent to the Senior Vice President--Academic Affairs for review as to compliance with this Policy.

Rules and Regulations

months of the effective date of the final Phase 11 rule.

(E3) Progress reports shall be submitted to EPA at 6-month intervals beginning 6 months after of the effective date of the final Phase 11 rule and until the final report is submitted to EPA.

(g) Effective date. The effective date of the final Phase 11 rule is August 14.1987.

BILLING CODE 556040-M

NATIONAL SCIENCE FOUNDATION 45 CFR Part 689

Misconduct In Science and Engineering Research

AGENCY: National Science Foundation.

Actions: Final regulations.

SUMMARY: The National Science Foundation is issuing final regulations establishing what the NSF Q its staff should do if they team or possible misconduct under an NSF award and if they--find actual misconduct under an NSF award. Responsibilities of grantee institutions, which play a major role in handling misconduct'cases. are also set out.

EFFECTIVE DATE: July 1. 1987.

FOR FURTHER INFORMAMN CONTACT'

Robert M. Andersen or Art~~J. Kusinski. National Science Foundation. Office of the General Counsel. Room 501.1800 G Street NW.. Washington. DC 20550. Telephone: (202) 357-9435. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: Although the National Science Foundation (NSFJ has received relatively few allegations of misconduct or fraud occurring in NSF supported research. or in proposals for the support of research. allegations of this nature are serious enough to warrant establishing formal policies and procedures to haridle them. The Foundation believes that grantee institutions bear primary responsibility for preventing and detecting misconduct. and the proposed regulations set forth the role that institutions are expected to perform The regulations. in establishing policies and internal BASF procedures for handling allegations of misconduct. provide for interim administrative actions. final actions and appeals procedures. The regulations are similar to misconduct policies and procedures of the Public Health Service (PHS) of the Department of Health and HUMAN Services.

Analysis of Comments

NSF published proposed regulations in the Federal Register = February 10. 1987 (52 FR 41581 for public comment. The comment period ended on April 13. 1987. NSF received eleven letters. including one letter submitted after April 13 for which an extension had been granted- T letters were from professional associations. seven letters from universities and one from an individual who was famillar with the issues by virtue of his work experience.

Most letters were supportive of the proposed regulations in general- In particular. several applauded the recognition that the primary responsibility for pre venting. detecting. investigating. and correcting misconduct lies with the awardee University.

Specfic comments were on the following

1. Definition of -Misconduct". Several letters commented that the definition of ..misconduct" in a 689.1(a) was too vague or Over reaching

Response. The definition is based an the public Health Service (PIM proposed definition and was adopted for the purposes of uniformity. The NSF definition does go somewhat further to reach misconduct in proposing research to the Foundation and "failure to meet other material legal requirements governing research".

NSF added the first clause so that the regulations covered misconduct at every stage of the research process. from proposals through publication of Final results. PHS's failure to provide for misconduct at the proposal stage was deemed anomalous or an oversight.. The addition makes it clear that plagiarism. fabrication, or other misconduct associated with proposing research for NSF funding is misconduct.

. NSF added the final clause to reach serious misconduct not covered by I 689.1(a)(1) and (2). Since a violation of a specific legal requirement governing research must be shown to support a finding of misconduct under 6~&I(a)(31. that provision is not impermissibly vague. Moreover. a breach of legal requirements governing research must be material to constitute misconduct

2. Anonymity of an informant and protection of the accused Several letters were concerned that maintaining the anonymity of an informant under § 689.4(b) could lead to malicious. frivolous. or unsubstantiated allegations of misconduct. Other letters asserted that the regulations give insufficient protection to accused individuals and institutions. Several argued that an accused hid a right, founded on traditional notions of due process. to confront his or her accusers.

Response. Confidentiality for informants under I 6M.4(b) is not absolute. NSF has added confidentiality provisions for the subjects of inquiries and investigations as a result of the comments. In addition several amendments have clarified the rights or subjects of inquiries and investigations

An informant's name will be kept confidential only -to. the extent possible." During the initial stages of an investigation. it may be essential to keep all sources of information confidential so that the subject of the. investigation does not take actions designed to frustrate the investigative process. Moreover. maintaining the confidentiality of sources prevents retaliation against "whistle blowers" and others who may be working under the supervision of the subject of the investigation. Confidentiality may not however. be possible or desirable throughout the entire course of the misconduct proceeding.

We recognize that someone formally accused of misconduct has a right to know hilly the charges. the evidence supporting the charges. and the source of the allegations For more serious forms of misconduct. which might require imposition of stringent sanctions. the full procedures of the debarment and suspension regulations are afforded the accused under

In most other cases the accusers will be the Government or the awardee institution and the charges will be based on evidence developed from an investigation and administrative proceeding that affords the accused due process both in procedure and substance. Where this would require that an individual informant or supplier of evidence be named, we expect that it will be done.

NSF will also afford the subjects of inquiries or investigations discrete and confidential treatment. to the extent practicable and allowed by law. This intent is already conveyed by § 689.4(a). For clarity, we have added the following sentence to § 669.4(b): "To the extent allowed by law. documents and riles maintained by NSF during the course of an inquiry or investigation of misconduct will be treated as investigative files exempt from mandatory public disclosure upon request under the Freedom of Information AcL"

Some commenters apparently believe that the rights Of a subject of inquiry or investigation should be coextensive with those of an accused in a criminal proceeding. While we cannot agree that a civil misconduct proceeding is the equivalent of a criminal prosecution. we realize how serious charges of misconduct are. and the important implications that a finding of misconduct may have for a career. Therefore. NSF has added the following clarification regarding the rights of subjects of misconduct proceedings to § 09-2:

(d) For those cases governed by the debarment and suspension regulations. the standards of proof contained in those regulations shall control. Otherwise. NSF will take no Final action under this section without a finding of misconduct supported by a preponderance of the relevant evidence.

3. Use of qualifying words or phrases.

Several letters objected to the use of qualifying words or phrases in provisions which establish notification and other rights for the accused. such as .. normally- in I 589.1(d~ and "except in unusual circumstances in I 689Ac)(1). The fear was expressed that such qualifiers could be used to deprive an accused of fundamental rights of procedural due process.

Response The procedural right of due process is inherently flexible. Whatprocedural safeguards must be afforded depends on the circumstances of individual cases. The qualifying words. such as those cited above. are used to provide for those cases where a criminal investigation may be or is involvedUnder such circumstances a right to demand certain information could compromise the criminal proceedings of other law enforcement bodies.

Moreover, immediate NSF action, based on the court conviction of a researcher for criminal conduct under an NSF grant, requires little in the way of additional due process- The doctrines of resjudicola and issue preclusion apply.

There is no intent to deprive an individual or institution of any due process rights, and where the Foundation can make information available, it will do so. To clarify NSFs intent in this regard. and to distinguish between situations where NSF is conducting the investigation rather than relying on the investigation of institutions of other agencies, a technical amendment has been moo I e to § W 9. 1(d]. The amended section now reads.

(d) Before NSF makes any final finding of Misconduct or takes any final action on such a finding. NSF will normally afford the accused individual or institution notice. a chance to provide comments and rebuttal. and a chance to appeal. In structuring procedures in individual cases, NSF may take into account procedures already followed by their entities investigating the same allegation of misconduct.

4. Time limitations. Two letters commented that the time limitations set out in § 689.3(c) may be too short.

Response: The time limitations were based on the PHS proposal and adopted fur the sake of uniformity. We do not think. however. that extending the time limits. thus making the NSF and PHS regulations different in that respect. would cause any difficulties. ne regulations have been changed to increase the time in § W9.3(c) from 30 days and 120 days to 90 days and 280 days. respectively.

5. Requirement that university notify NSF of misconduct. Two letters questioned the conditions of § 689.3(b) under which the university should notify NSF of its Own inquiry into an allegation of misconduct. thereby deferring an independent inquiry or investigation by NSF. One commented that NSF should be notified of such an inquiry only when it is completed and a final report issued. The other suggested that NSF be notified only when a serious charge is made against a principal investigator/projed director. and no others: there is substantive evidence of serious misconduct-, and the evidence indicates that the misconduct would have an ongoing material effect on the project in which NSF has a legitimate concern.

Response- We cannot accept the suggestion that NSF be notified only after an investigation has been completed and final action taken by the university. This would be a serious abrogation of our responsibility to protect Federal property and to oversee the proper administration of awards of public funds. The suggestion is unrealistic. too. because these matters often do become public before any final determinations are made.

The Foundation fully recognizes that not every minor complaint involving trivial matters made to a university need be reported to NSF. Institutional handling of allegations is divided into two phases: an inquiry phase and an investigatory phase. Only cases which proceed beyond the inquiry phase must be brought to NSF*s attention. Section 689.3(b)(1) is intended to convey our belief that NSF should be notified only after the university determines.' following its own initial inquiry, that the evidence is sufficient to support a formal investigation. If the evidence is otherwise. or if there is no evidence at all. then the matter may be closed without notification to NSF. assuming none of the conditions in § 689-3(b)(3)
are present. These procedures assume that the university will have used its best judgment and discretion we do not intend to substitute our judgment for that of the university's unless the evidence is clearly to the contrary. 6. interim Actions. One letter expressed concern that since interim actions are not appealable. an institution was unprotected from unreasonable extensions of the effective period of the interim action. The commenter suggested a time limit which could be extended if the university or other investigational period were extended. Response Section 689.7(b) provides for periodic reviews of interim actions and their modification as warranted. This is a flexible procedure. and if a university (or any other interested party) believes that continuation of an interim, action is unreasonable. it can request a review and modification or termination of the action. For clarity, we have added a final sentence to § 6 6aZ(bl: "An interes.'adpcrty may,"equest a review and modification oicny interim action 7. Integration of misconduct procedures with debarment and suspension procedures.One co rtmenter noted that based on his experience as a lawyer working in this area. it a debarment action is likely or anticipated. the reguliaticris should be modified to permit the integration of the preliminary procedures under the misconduct regulations with the formal debarment proceedings under debarment regulations. Otherwise. the procedures of the misconduct regulations could unduly delay a debarment action.

Response:The suggestion is accepted. Section 6e9.1(e) has been changed to add a new final sentence staling:

*'Nothing in these regulations shall preclude integrated and concurrent procedures under these regulations and the debarment and Suspension regulations. "

8. General vagueness of the regulations. One commenter. comparing the proposed PHS policies and procedures with the NSF proposal. stated that the NSF regulations were ..vague and open-ended. and therefore subject to several interpretations.- The commenter suggested several sections which should be clarified.

Response: Several of the commenter's suggestions have already been discussed in the preceding analysis. We also should note that NSF deliberately streamlined the provisions of the PHS proposal. Reasonable men and women can disagree over what should remain and what may be left out. In our best judgment. the regulations as drafted are flexible. preserve the essential 24468 Federal Register / Vol. 52. No. 126 /. Wednesday. July 1. 1987 / Rules and Regulations requirements of due process. are understandable by the average. educated person who must use them. and are no( so vague as to be cons ti futiorm lly or legally flawed. Moreover. the more elaborate and detailed procedures for debarment and suspension are automatically invoked when serious sanctions might be invoked against an individual or institution.

9. Conflict with human subjects and animal welfare regulations. Two letters stated that procedures established under other authority for handling and reporting treatment of human subjects in research and for animal welfare were duplicative and perhaps contrary.

Response: We did not intend to override or contradict provisions of other regulations or policies. specifically the human subject and the animal welfare regulations or policies. The notification and other procedures set out in these regulations or policies will govern (see NEFF Grant Policy Manual (77--47. as revised 4-15-83), paragraph 710). However. a finding of a substantive violation 0 1 those regulations or policies will be considered to be "misconduct" under these regulations and grounds for taking action under § 689 .2.

Determinations.

I have determined that this is not a major rule as defined under sec-ion i(b) of E.O. 12- 191. Federal Regulation.

I have determined that this regulation will not have a significant economic impact on a substantial number of small entities because it affects primarily the internal procedures of a Federal agency.

List of Subjects in 45 CFR Part 639

Misconduct. Debarment and suspension, Fraud.

Dated: June 24. 1987.

National Science Foundation.

Erich Bloch. Director.

Accordingly. the National Science Foundation adds a new Part 689 of Title 45 of the Code of Federal Regulations as follows:

TITLE 45--CODE OF FEDERAL REGULATIONS-PUBLIC WELFARE

CHAPTER VI-NATIONAL SCIENCE FOUNDATION

PART 689-MISCONDUCT IN SCIENCE AND ENGINEERING RESEARCH

sec
689.1 General policies and responsibilities.
689.2 Actions.
689.3 Role ofawardee institutions.

scr689.4 IniliaI NSF handling of misconduct matters. 689.5 Investigations 689.6 Pending proposals and awards. 669.7 Interim administrative actions. 6119.8 Dispositions. 689.9 Appeals.

Authority- Sec. 11(a) of the National Science Foundation Act of 1950. as amended (42 U.S.C. 1870(a)).

§ 689.1 General policies and responsibillties.

(a] -Misconduct" means (1) fabrication. falsification. plagiarism. or other serious deviation from accepted practices in proposing. carrying out. or reporting results from research: (2) material failure to comply with Federal requirements for protection of researchers, human subjects, or the public or for ensuring the welfare of laboratory animals: or (3) failure to meet other material legal requirements governing research.

(b) The NSF will take appropriate action against individuals or institutions upon a determination that misconduct has occurred under an NSF award. It may also take interim action during an investigation. Possible actions are described in section 689.2

(c) NSF will rind misconduct onlv after careful inquiry and investigation by an awardee institution. by another Federal agency, or by NSF. An "inquiry" consists of information-gathering and reliminary fact-finding to determine whether an allegation or apparent instance of misconduct warrants an investigation. An "investigation- is a formal examination and evaluation of relevant facts to determine whether misconduct has taken place or. if misconduct has already been confirmed. to assess its extent and consequences or determine appropriate NSF action.

(d) Before NSF makes any final finding of misconduct or takes any final action on such a finding. NSF will normally afford the accused individual or institution notice. a chance to provide comments and rebuttal. and a chance to appeal. In structuring procedures in individual cases. NSF may take into account procedures already followed by other entities investigating the same allegation of misconduct.

(e) Debarment, suspension. or termination of an award for misconduct will be imposed only after further procedures described in applicable debarment and suspension regulations. Nothing in these regulations shall preclude integrated and concurrent procedures under these regulations and the debarment and suspension regulations.

(Q The Division of Adult and Oversight (DAO) in the Office of budget. Audit. and Control. oversees and coordinates NSF activities related to misconduct. conducts any NSF inquiries and investigations into suspected or alleged misconduct. and except where otherwise provided. speaks and acts for NSF with affected individuals and institutions. The Office of the General Counsel (OCC) advises DAO and represents NSF on any current or potential criminal prosecution. current or potential litigation. or significant legal questions that arise.


(a) Possible final actions listed below for guidance range from minimal restrictions (Group 1) to the most severe and restrictive (Group 111). They are not exhaustive and do not include possible criminal sanctions.

(1) Group lActions. (i) Send a letter of reprimand to the individual or institution.

(ii) Require as a condition of an award that for a specified period an Individual department. or institution obtain special prior approval of particular activities from NSF.

(iii) Require for a specified period that an institutional official other then those. guilty of misconduct certify the accuracy of reports generated under an award or provide assurance of compliance with particular policies, regulations. guidelines. or special terms and conditions.

(2) Group 11Ac!Jons. [i) Restrict for a specified period designated activities or expenditures under an active award.

(ii) Require for a specified period special reviews of all requests for funding from an affected individual. department. or institution to ensure that I steps have been taken to prevent repetition of the misconduct.

(3) Group III Actions. (i) Immediately suspend or terminate an active award under appropriate NSF regulations.

(ii) Debar or suspend an individual. department or institution from participation in NSF programs for a specified period after further proceedings under applicable regulations.

(iii) Prohibit participation of an individual as an NSF reviewer. advisor. or consultant for a specified period.

(b) In deciding what actions are appropriate when misconduct is found. NSF officials should consider.

(1) How serious the misconduct was:

(2) Whether it was deliberate or merely careless:

(3) Whether it was an isolated event or part of a pattern:

(4) Whether it is relevant only to ' certain funding requests or awards or to all requests or awards involving an institution or individual found guilty of misconduct.

(c) Interim actions may include, but are not limited to:

(1) Totally or partially suspending an existing award;

(2) Totally or partially suspending eligibility for NSF awards in accordance with debarment-and-suspension regulations:

(3) Proscribing or restricting particular research activities, as, for example. to protect human or animal subjects:

(4) Requiring special certifications, assurances, or other administrative arrangements to ensure compliance with applicable regulations or terms of the award,

(5) Requiring more prior approvals by NSF-,

(6) Deferring funding action on continuing grant increments;

(7) Deferring a pending award.

(6) Restricting or suspending use of individuals as NSF reviewers. advisors, or consultants.

(d] For those cases governed by the debarment and suspension regulations, the .9 standards of proof contained in those regulations shall control. Otherwise. NEFF will take no final action under this section without a finding of misconduct supported by a preponderance of the relevant evidence.

(e) Awardee institutions bear primary responsibility for prevention and detection of misconduct. In most instances. NSF will rely on awardee Institutions to promptly:

(1) Initiate an inquiry into any suspected or alleged misconduct;

(2) Conduct a subsequent investigation, if warranted:- and

(3) Take action necessary to ensure the integrity of research, the rights and interests of research subjects and the public, and the observance of legal requirements or responsibilities.

(b) If an institution wishes NSF to defer independent inquiry or investigation, NSF expects it to:

(1) Inform NSF immediately if an initial inquiry supports a formal investigation.

(2) Keep NSF informed during such an investigation.

(3) Notify NSF even before deciding to initiate an investigation or as required during an investigation (i) if the seriousness of apparent misconduct warrants: (ii) if immediate health hazards are involved; (iii) if NSF'S resources. reputatiom or other interests need protecting; (iv) if Federal action may be needed to protect the interests of a subject of the investigation or of others potentially affected: or (v) if the scientific community or the public should be informed.

(4) Provide NSF with the final report from any investigation.

(c) If an institution wishes NSF to defer independent inquiry or investigation. it should complete any inquiry and decide whether an investigation is warranted within 0-0 days. It should similarly complete any investigation and reach a disposition within 180 days. If completion of an inquiry or investigation is delayed. but the institution wishes NSF deferral to continue, NSF may require submission of periodic status reports.

(d) Awardee institutions should maintain and effectively communicate to their staffs appropriate policies and procedures relating to misconduct. which should indicate when NSF must or should be notified.


(a) NSF staff who learn of alleged misconduct will promptly and discreetly in!Orm DAO or refer informants to DAO.

(b) To the extent possible the identity of informants who wish to remain anonymous will be kept confidential. To the extent allowed by law, documents and files maintained by NSF during the course of am inquiry or investigation of misconduct will be treated as investigative files exempt from mandatory public disclosure upon request under the Freedom of Information Act.

(c) If alleged misconduct may involve a crime, DAO will promptly consult with OCC. which will determine whether any criminal investigation is already pending or projected. If not, OCC and DAO will determine whether the matter should be referred to the Department of justice.

(d) Otherwise DAO may.

(1) Inform the awardee institution of the alleged misconduct -and encourage it to undertake an inquiry

(2] Defer to inquiries or investigations of the awardee institution or of another Federal agency-,

(3) At any time proceed with its own inquiry.

(e) If DAO proceeds with its own inquiry it will normally complete the Inquiry no more than 80 days after initiating it.

(f) On the basis of what It learns from an inquiry and in Consultation as appropriate with other NSF offices. DAO will decide whether a formal NSF investigation is warranted.

(a) When an awardee institution or another Federal agency has promptly initiated its own investigation. DAO may defer any NSF inquiry or investigation until it receives the results of that external investigation. If it does not receive the results within 1110 days, DAO will ordinarily proceed with its own investigation.

(b) If DAO decides to initiate an NSF investigation. it must give prompt written notice to the individuals or institutions to be investigated. unless notice would prejudice the investigation or unless a criminal investigation is underway or under active consideration. If notice is delayed. it must be given as soon as it will no longer prejudice the investigation or contravene requirements of law or Federal lawenforcement policies.

(c) If a criminal investigation by the Department of justice, the Federal Bureau of Investigation. or another Federal agency is under-way or under active consideration by these agencies or the NSF, OCC will advise DAO what information, if any, may be disclosed to the subject of the investigation or to other NSF employees.

(d) An NSF investigation may include:

(1) Review of award riles, reports. and other documents already readily available at NSF or in the public domain;

(2) Review of procedures or methods and inspection of laboratories, laboratory materials, specimens, and records at awardee institutions.

(3) Interviews with parties or witnesses;

(4) Review of any documents or other evidence provided by or properly obtainable from parties, witnesses, or other sources:

(5) Cooperation with other Federal a8encies;

(6) Opportunity for the subject of the investigation to be heard; and

(7) Full adjudicatory hearings or other formal proceedings. a-s described in appropriate regulations.

(e) NSF may invite outside consultants or experts to participate in an NSF investigation. They should be appointed in a manner that ensures the official nature of their involvement and provides them with legal protections available to federal employees.

(f) DAO will make every reasonable effort to complete an NSF investigation and to report within 120 days after initiating it. If DAO cannot report within 120 days, it should submit to the Deputy Director within 90 days an interim report and an estimated schedule for completion of the final report.
24470 Federal Register / Vol. 52, No. 126 / Wednesday. July 1. 1987 / Rules and Regulations

§ 689.6 pending proposals and awards.

(a) Upon learning of alleged misconduct DAO will identify potentially implicated awards or proposals and. when appropriate. will ensure that program and DGC Officials handling them are informed (subject to J 689.5(c)).

(b) Neither a suspicion or allegation of misconduct nor a pending inquiry or investigation will normally delay review of prop03al3. To avoid influencing reviews. reviewer3 or panelists Will not be informed of allegations or of ongoing inquiries or investigations. However. if allegations, inquiries. or investigations have been rumored or publicized. the responsible Assistant Director may, in consultation with DAO, either defer review or inform reviewers of the status of the matter.

J 689.7 Interim administrative actions

(a) After an inquiry or during an external or NSF investigation the Deputy Director may order that interim actions (as described in J 689.2(c)) be taken to protect Federal resources or to guard against continuation of any suspected or alleged misconduct. Such an order will normally be issued on recommendation from DAO and in consultation with DGC, OCC, the responsible Directorate, and other parts of the Foundation as appropriate.

(b) Such interim actions may be taken whenever information developed during an investigation indicates a need to do so. Any interim action will be reviewed periodically during an investigation and modified as warranted. An interested party may request a review and modification of any interim action.

(c) The Deputy Director will make and DAO will retain a record of interim actions taken and the reasons for taking them.

(d) Interim administrative actions are not final agency actions subject to appeal.

639.8 Dispositions

(a) After receiving a report from an external investigation by an awardee institution or another Federal agency DAO will assess the accuracy and. completeness of the report and whether the investigating entity followed usual and reasonable procedures. It will either recommend adoption of the findings in whole or in part or, normally within 30 days, initiate a new investigation.

(b) When any satisfactory external investigation or an NSF investigation fails to confirm alleged misconduct and the Deputy Director concurs,

(1) DACI will notify the subject of the investigation and. if appropriate. those who reported the suspected or alleged misconduct. This notification may include the investigation report.

(2) Any interim administrative restrictions that were imposed will be lifted.

(c) When any satisfactory investigation confirms misconduct. (1) Except in unusual circumstances. the investigation report will be provided by DAO to the subject of the investigation. who will be invited to submit comments or rebuttal. Comments or rebuttal submitted within the period allowed, normally thirty days. will receive full consideration and may lead to revision of the report or of a recommended disposition.

(2) Normally within 45 days after completing an NSF investigation or receiving the report from a satisfactory external investigation. DAO will submit to the Deputy Director the investigation reporL any comments or rebuttal from the subject of the investigation. and a recommended disposition- The recommended disposition will propose any final actions to be taken by NSF. Section 689.2 lists possible final actions and considerations to be used in determining them.

(d) The Deputy Director will review the investigative report and DAO's recornmended disposition. Before issuing a disposition the Deputy Director may initiate further hearings or investigation. Normally within thirty days after receiving DAO's recommendations or after completion of any further proceedings. the Deputy Direc*or will send the affected individual or institution a written disposition, specifying actions to be taken. The decision will include instructions on how to pursue an appeal.

689.9 Appeals.

(a) In case of debarment. suspension. or termination of an award for misconduct. the appeals provided for in NSF regulations will be available. In all other cases, an affected individual or institution may appeal to the Director in writing within 30 days after receiving the Deputy Directos's written decision. The Deputy Director's decision becomes a final administrative action if it is not appealed within the 30 day period.

(b) The Director may appoint an uninvolved NSF officer or employee to review an appeal and make recommendations.

(c) The Director will inform the appellant of a final decision within 30 days after receiving the appeal. That decision will be the final administrative action of the Foundation. Findings from completed investigations may be shared with scientific review groups if the information bears directly on an

investigator's scientific integrity or if necessary to provide an accurate account of relevant facts.

[FR Doc 87-14863 Red 6-30-87. &-45 aml

BILUNG CODE 754%41-m

FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 73

IMM Docket No. 86-313; FIM-53421

Radlo BroadcastIng Services; Grand Marais MN

AGENCY: Federal Communications Commission. Ac-nom: Final rule.

SUMMARY. This document allocates Channel 263 to Grand Marais.Minnesota as that community's first roadcast service, in response to a petition filed by Timothy D. ' Ma rtz. Supporting comments were filed by the petitioner. Concurrence of the Canadian government has been obtained for the allotment of Channel 263 at Grand Marais. With this action. this proceeding
is terminated. DATES: Effective August 10, 1987.7ne window period for filing applications will open on August 11. 1987, and close on September 9. 1987.
FOR FURTHER INFORMATION CONTACT Kathleen Scheuerle. Mass Media Bureau. [202) 634-6330.

SUPPLEMENTARY INFORMATION This is a summary of the Commission's Report and Order, lvt\i Docket No. H-313. adopted \larch V. 1987, and released June 24. 1987. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Dockets Branch (Room 230). 19192M Street. NW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors. International Transcription Service. (202) 857-3800, 21COM Street NW., Suite 140, Washington. DC 20037.

list of Subjects in 47 CFR Part 773 Radio broadcasting.

PART73-4AMENDED]

1. The authority citation for Part 73 continues to read as follows:

Authority: 47 Uar- 254.303.

173.202 [Amended)

2. Section 73-M2(bl. the Table of FIM Allotments for Minnesota 13 amended by adding Grand Marais, Channel 263.
32446 Federal Register / VoL K No. isi / Tuesday . August 8, 1989 / Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PublIc Health services

42 CFR Part 50

RIN OWS-AB91

Responsibilities of Awardee and Applicant Institutions for dealing with and Reporting posssible Misconduct in science

AGENCY Public Health Service. DHHS. Final rule.

SUMMARY To implement section 493 of the Public Health Service (PHS) Act (and also section 501(f) of the PHS Act as amended by section 2OM(a)(2)(C) of the Anti-Drug Abuse Act of 1988). this Final Rule adds a new Subpart A to 42 CFR part 50. The new Subpart A sets forth the responsibilities of PHS awardee and applicant institutions for dealing with and reporting alleged or suspected misconduct in science involving research. research training, applications for support of research or research training, or related activities for which PITS funds have been provided or requested. EFFECTNE DATE: November & 19W. FOR FURTHER IMFORMATION ClONTACT Brian Kimes. Phl), Acting Director, Office of Scientific Integrity, Bldg. 31Room Bl-C34. National Institutes of Health. Belthesda. Maryland 20892telephone (301) 496-2824. ClInis is not a toll-free n=ber.)

Reported instances of scientific mismriduct appear to represent only a small fraction of the total number of research and research training awards funded by the PHS. Nevertheless, even a am" number of instances of scientific misconduct is unacceptable and could threstem the continued public confidemce in the integrity of the scientific process and in the stewardship of Federal funds. The PHS has adopted interim policies to provide guidance for desh with allegations and invesdgatio= based on experience with a number of casm These interim policies were published for the information of the public in the JUJY 18, 19W. issue of the"NIH Guide for Grants and Contracts" and became part of the PHS Grants Administration Manual on September 1. IN&

The PHS also recently established two new offices for dealing with scientific misconduct (see 54 Fk 110ft March 16, 1989). The Office of Scientific Integrity Review (OSIR). established in the Office of the Assistant Secretary far Health. is responsible for establishing overall P1~5

policies and procedures; for dealing with misconduct in science. overseeing the activities of PHS research agencies to ensure that these policies and procedures are implemented. and reviewing all final reports of investigations to assure that any findings and recommendations are sufficiently documented. The OSM also makes final recommendations to the Aisistant Secretary for Health on whether any sanctions should be imposed and. if so, what they should be in any case where scientific misconduct has been established. When necessary, OSIR may conduct independent investigations

In addition. the Office of Scientific Integrity (OSI], established in the Office of the Director, National Institutes of Health (NIFfl, 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.

The PHS Grants Administration Manual will be revised to accommodate the establishment of the these offices.

The PHS Act directs the Secretary to establish procedures requiring that entities receiving funds from the PHS for the conduct of biomedical and behavioral research submit assurances on an annual basis that:

(1) These entities have established (based upon regulations prescribed by the Secretary an administrative process to review reports of scientific misconduct *in biomedical or behavioral research. and (2) they will report to the Secretary any investigation of alleged scientific misconduct that appears substantial. The Secretary also has authority to respond to information received with respect to possible scientific misconduct involving projects under the PHS Act and to take appropriate action in response to such misconduct.

The provisions of section 403 of the PHS Act contemplate that there will be a close working relationship between the awardee institutions and the Department in resolving allegations of scientific misconduct- Section 403 envisions that the awardee institutions will have the primary responsibility for preventing detecting; investigating reporting and resolving allegations of scientific misconduct. The Department. however. retains the ultimate responsibility and authority for monitoring such investigations and becoming involved in those investigations if appropriate or necessary,

In order to carry our his formal re sporizi bili Lies under section 491 the Secretary published a Notice of Proposed Rule making on September 19, 19a8 (53 FR 36W). That document set forth for public comment proposed responaibilities of applicant and awardee Institutions. including requirements that they establish policies and procedures for investigating and reporting allegations of scientific misconduct involving research. research training. or related activities for which HIGHS funds have been awarded or requested. Proposed 150.104 specified an appropriate Lime and method for notifying the HIGHS of instances of possible misconduct. Proposed J 1C3 specified that. if there is a reasonable indication of a criminal violation, the Department's Office of Inspector General would be notified within 24 hours.

This final rule applies only to institutions applying for or receiving financial assistance from the PHS. A separate proposed rule amending 48 CFR part 3 will be published in the Fed" Registar to cover entities applying for contracts

Institutions are urged to develop, as soon as possible. policies and procedures for dealing with and reporting possible misconduct in science within their institution. After the effective date of this Rule-, each institution must have in place &a assurance for dealing with scientific misconduct as outlined by this rule Updated information with respect to assurances will be due each year. on a date to be specified by OSL Assurances should be submitted for approval to the Director. Office of Scientific Integrity, at the above-cited address.

As stated. this final rule implements section 493 requiring the Department to issue regulations concerning investigation and reporting of "scientific fraud-. (See subsequent text in this preamble regarding use of the terms "fraud" and misconduct in this context.) Consequently. the rule does not contain specific measures to foster scientific integrity. Other issues remain to be addressed. including: retention of laboratory data, author-ship practices. the role of grantee tristito onz and funding agencies in the performance of audits or studies to prevent the occurrence of scientific misconduct. and the consistency of such policies across federal agencies. HHS will continue to monitor Institutions' , and propose policies as may be necessary in the future. Such action may be based in part on the advance notice of proposed rulemaking published in the Federal Register on September ig, ima (s3 FR 3&344). In addition. consistency of policies in this area across Federal agencies will be monitored by the Office of Management and Budget in cooperation with the Office of Science and Technology Policy.

Summary of Comments

As noted. the Secretary published a proposed rule in the Federal Register on September 19, 19M (53 FR 36U7) for public comment. The comment period was open through November 1& 1988. One hundred thirty-nine responses were received that addressed a wide spectrum of issues concerning the proposed rule and scientific misconduct in general. The respondents included 80 institutional representatives, 37 individual staff or faculty members, 20 representatives of professional associations, 16 representatives of research institutes or faculty groups, three individuals from Federal offices. two private citizens, and one representative of a scientific journal. The responses were generally supportive of the PHS's efforts and of the proposed rule. Most respondents emphasized that the main responsibility for investigating or preventing cases of scientific misconduct should remain with the institution.

The following is a summary of other main points contained in the comments on the proposed rule. and the Departmental responses.

Applicability and Definition of "Misconduct in Science."

The proposed rule defined "misconduct in science" to mean (1) fabrication. falsification. plagiarism. deception or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research: or (2) material failure to comply with federal requirements that uniquely relate to the conduct of research." The comments and suggestions received were particularly helpful in refining this proposed definition A number of respondents pointed out that to the extent the second clause in the definition was largely intended to deal with violations of human and animal experimentation requirements, these areas are already covered by existing regulations and policies. Other commenters requested that honest error be excluded from the definition. Still others urged omission of the word "deception" inasmuch as deception can be an acceptable component of specific types of research.

Some cornmenters disagreed with the section of the definition that addressed "other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing. conducting. or reporting research" and proposed that this portion of the definition be deleted. On the other hand. some commenters suggested expanding the definition to include duplicate publication and Intellectual piracy. Some cornmenters preferred the term "fraud" rather than - misconduct."

Response. The definition has been modified considerably in light of the comments. The term "deception" has been deleted. The second clause, referring to material failure to comply with federal requirements that uniquely relate to the conduct of research. has also been deleted in order to avoid duplicative reporting of violations of human and animal experimentation requirements. Further. a sentence has been added to make it clear that the definition does not include "honest error or honest differences in interpretations or judgments of data." At the same time. the language "other practices that seriously deviate" has been retained to assure coverage of any serious misconduct that might not technically be considered "fabrication. falsification. or plagiarism " With regard to the comments preferring "fraud" over "misconduct" the word "misconduct" Is coming into increasing use because it avoids confusion with corn n law fraud. which contains certain unique chars eterfs tics that have no applicability to what has commonly come to be known as scientific misconduct For this re awn - the term "misconduct" in being retained.

Assurances The notice of proposed rulemaking stated that an institution applying for or receiving PHS support must have an assuranct satisfactory to the secretary regarding procedures for dealing with misconduct in ' tics. Most respondents agreed wiLk the assurance mechanism This final rule in 1 5&1= specifies that the assurance on a form prescribed by the Secretary, must be submitted to the OSI as good as possible after November & 1 9N. and no later than January 1. 19K and be updated thereafter on an annual basis. This will enable PHS to assure that institutions are establishing procedures that are consistent with the requirements of 42 CFR part 50.The' assurance will consist of a series of affirmative statements, to be provided on the form prescribed by the Secretary. The 051 will also review annually a. sample of institutions. policies and procedures.

Investigations and Reporting Most of the respondents agreed with the overall proposed timing for completion of the inquiry and investion phases. However. the need for flexibility was stressed in recognition of the complex and heterogeneous nature of individual cases. Five respondents said the proposed time schedule was too short, and three others suggested following the National Science Foundation's timetable. The need to request formally an extension was questioned. and there were two suggestions to include "Inquiries" in the title of this section.

Response. After considering all the comments. the PHS believes the proposed timetable for conducting inquiries and investigations is reasonable. The PHS agrees that a certain degree of flexibility also is appropriate but disagrees with the contention that institutions should not be required to request an extension if the investigation cannot be completed within the specified time period Therefore. the proposed language for this purpose in I 50.104(a) is retained

PHS expects that as institutions refine and enhance their policies and procedures and gain collective experience in conducting Investigations the quality and timeliness of such investigations will improve. Where institutions fail to carry out their responsibilities as specified in the rule, the Department will use whatever remedies may be available under the circumstances If problems persist. PHS will consider rulemaking to establish additional sanctions; such.as restrictions on reduction in indirect funding gain@ in an institution charges for the costs of investigations that have to be performed by the OSL

The term "Inquiries" has been added to the title of this section. since the rule includes a specified time period for this activity. This section also be.& been expanded to give more sped& guidance' regarding the scope of inquiries.. investigations and reports.

Reporting Requirements Most of the concerns expressed by respondent with respect to the reporting requirements wen related to the issue of confidentiality and to possible damage to the reputations of innocent individuals They were concerned about the treatment of both the accused and accuser although eight respondents specifically called for the identification of the accuser Twenty-one respondents were concerned about the due process rights. of the accused during an inibbihanal inquiry and/or investigation. as well as the responsibilities of the PHS to protect individuals' privacy and the need to maintain information confidential. Many respondents stated that a report should be made to the PHS only if substantial evidence is found. and some respondents stated that only essential information should be reported.

Response. After considering the comments received regarding the reporting requirements. the PHS has concluded that these requirements should be retained as originally proposed. with the addition that the reports be made part of the assurance review process. The PHS understands. and agrees with. the need for the confidential handling of information relevant to investigations. The PHS accepts and pursues anonymous allegations. so long as sufficient information is provided to be able to initiate an inquiry. No information. o r than that which ordinarily is available, for example under the Freedom of Information Act. is released by the Department while an investigation is under way. except to Department personnel on a need-to-know basis.

The reporting requirements also have been changed to reflect the establishment of the OSI, which Dow is the focal point for all of the PHS for dealing with allegations of scientific misconduct involving research. research training, or related activities supported under the PHS Act All reports shall be sent to the OSL rather than to PHS as was stated in the Proposed Rule.

The PHS strongly encourages institutions to adopt procedures that will provide due process to the accused. Section 50.104 sets forth basic due process procedures to be followed during the investigation. such as assuring that the accused is interviewed and has an opportunity to comment on the findings of the investigation.

The MS believes the reporting requirements are not unduly burdensome and that they am necessary in order for the Department to carry out its responsibility under the statute far the stewardship of Federal funds As recipient institutions gain experience in the conduct of investigations and the preparation of the reports of those investigations. the PHS will continue to evaluate its monitoring function. However. at this initial stage of implementation. the PHS believe that an active monitoring role is Important and that the reports required under the regulation are essential to that role.

Impact Analyses

Executive Order 1=1 requires that a regulatory impact analysis be prepared for "major" rules which art defined in the Order as any rule that has an annual effect on the national economy of 80 million or more. or certain other specified effects.

The PHS does not believe that this regulation will have an annual economic - impact of $100 million or more or the other effects listed in the Order. For &.is reason. the PHS has determined that this regulation is not a major rule within the meaning of the Order.

The Regulatory Flexibility Act (5 U'S.C. 605(b)) requires that. for each rule With a significant economic impact an a substantial number of small entities.' an analysis be prepared describing the rule's impact on small entities and identifying any significant alternatives to the ru;e that would minimize the economic impact on small entities.

The Secretary certifies that this regulation will not have a significant economic impact on a substantial number of small entities.

Paper Work Reduction Act

This final rule contains information collections that are subject to review by the Office of management and Budget (01~0) under the Paperwork Reduction Act of 19M. The title. description. and respondent description of the information collection an shown below with an estimate of the annual reporting and record-keeping burden. Included in the estimate 13 the time for reviewing instructions, searching existing data sources. gathering and maintaning the data needed. and completing and reviewing the collection of information mine: Responsibilities of RES Awardee and Applicants instutions for Dearing with and Reporting Possible Misconduct in Science.

Description As required by the PHS Act. the Secretary shall require that applicant and awardee institutions receiving PS-M funding investigate and report any allegations of misconduct in. science.

Description of Respondents Manprofit Institutions, =all businesses or organizations for-profit organizations

• RECORD-KEEPING BURDENAs required by secdon r5o4b) of Lhe Paperwork Reduction Act of 19M the Department will submit for review by the Office of Management and Budget (O~.Q) the above-cited information collection requirements As ONIB control numbers are assigned. we will publish a Notice in &,a Federal Register announcing them. Organizations and individuals desiring to submit comments on the information- collection requirements should direct such comments to the above-cited information address.. and to the Office of Information and Regulatory Affairs OMB. New Executive Office Building (Room =).Washington DC 2025W (AM: RIchard A. EisinW~
  
  Catalog of Federal Domestic Assistance
  
  This rule affects a great -any PHS research programs. it would be wasteful and cumbersome to include a multi-page listing of them all here. Questions about Us rule should be directed to the information address above where individual programs listed in the catalog of Federal Domestic Assistance are affected.
  
  List of Subjects in 42 CFR Pzzt 35
  
  . 17,= . Administration practicr and,7W procedure American Samoa, Drags. 4 Family Planning, Grant Programs in I health. Guam. Northern Mariana Island, W Pacific Islands Territory, Virgin Wan ds.
  
  For the reasons set out in the preamble. Title 47- Sabchapter D. of the Code of Federal Regulations Is amended to add Subpart A to part 50, consisting of I J 50.101 through 50.1M to read as set forth below.
  
  PART 50-44X=ES OF GENERAL APPLICATION
  
  Subpart A-ResponsibUlty of PHS Award" :nd Applicant institutions for Dealing with and Reporting Possible Misconduct in
  Science
  
  Sec50.1(n Applicability, 50.102 Definitions 50.= Assurance-Responsibility des of PM Awardee and Applicant Institutions 50.104 Reporting to the OSL 50.105 Institutions compliance
  
  Subpart A-ResponsIblitty of PKS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct In Scion"
  
  Authority Se-- 4". Public Health Ser v i a Act at amended. 99 Sutt r, 4-V5 Kz U.S.C Z89b)-, Sec. WI(M P%Mc Healda S*rvicz Ac-* as amended 10:Z stat A= W U-S&C. 290aa(n).
  
  MWI 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 involving research. or research training, applications for support of research or research training or related research activities that are supported with funds made available under the FHS Act. This subpart does not supersede and is not intended to eel up an alternative to establIshed procedures for resolving fiscal improprieties, issues concerning the ethical treatment of human or animal subjects, or criminal matters.
  
  Definitions
  
  An used hi this subpart:
  
  "Act" means the Public Health Service Act. as amended. (42 U.&C. 2M ef seq.).
  
  "Inquiry" means information gathering and initial factfinding to determing whether an allegation or apparent instance of misconduct warrants an investigation.
  
  -Institution" mean* the public or Private entity or organization (including federal state. and other agencies) that to applying for financial assistance from the PH& 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 am commonly accepted within the scientific community for proposing conducting, or reporting research. It does not include honest error or hones t differences In interpretations or judgemants of data,
  
  "OSI- means the Office of Scientific Integrity, a component of the Office of the Director of tin National Institutes fix Health (NIH). which oversees the implementation of all PHS policies and procedures related to scientific misconduct: monitors the indicidual investigations Into alleged or suspected scientific misconduct conducted by institutions that receive PI-15 funds Ayr biomedical or behavioral research projects or Program and conducts investigations as necessary.
  
  -OGM- means. the Office of Scientific integrity Review a component a? the Office of the Assistant Secretary for Health which is responsible fro establishing overall pHs policies and precedures for dealing with misconduct in science overseeing the activities " of PHS research agencies to aware that the" policies and procedures am implemented and reviewing a final reports of investigations to aaem that any findings and recommendations am sufficiently documented The OSak also makes final recommendations to the Assistant Secretary for Hein on whether any sanctions should be imposed and. if to, what they should be in any case where scientific misconduct has been established.
  
  PKS- means the Public Health service, an operating division of the Department of Health end Human
  Services R*E9. References, to PF?9 include organizational units within the PHS that have delegated authority to
  award financial resistance to support scientific activities. e.g.. Bureaus, Institutes. Division . centers or Offices
  
  Secretary means the Secretary of Health and Human Services and any other office 07 employees of the Department of Health and Human Services to whom the authority involved may be delegated

• (a) Assurances Each institution that applies for or receives assistance under the Ad for any project or Program which involves the conduct of biomedical or behavioural research must have an assurance satisfactory to the that the applicant
  
  (1) Has established an administrative process that meets the requirements of this Subpart for reveiwing investigating and reporting allegations of misconduct in science In connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant and
  
  (21 Will comply with its own adminis ative process and the requirements of this. Subpart
  
  (b) Annual Submission An applicant or receipient institution shall make an annual submission to the C61 is follows
  
  (1) The institution's assurances shall be submitted to the OSI on X form prescribed by the Secretary as 3ow as possible after November & 19M but no later than January 1 1990, and updated annually thereafter on a data specified by OSI. Copies of the form rwy be requested through the Director, CSI.
  
  (2) An institution shall submit with I its annual assurance rich aggregate information on allegations inquires and investigation as the Secretary mwy prescribe
  

(c) General Criteria In ganeraL an applicant institution will be considered to be in compliance with in assurance if

(1) Establishes keeps current and upon request provides the 0611. tin OSL and other authorized Departmantal officials the policies and procedures by this subpart.

(2.1 Informs he scientific &ad administrative staff of the policies and procedures and the importance of compliance with those policies and procedures,

(3) Takes immediate and appropriate a rtfryn U Won as misconduct a a the part of employees or persons within the ocps ti*Ws, r r ii , I is xwrpected or alleged

(41 Inform in accordances with this Subpart and cooperates with the 061 with regard to oath investigation of possible ajoceedget

(d) Inquires Investigations and Reporting- Specific Requirements Each

Rules and Regulations 'applicant's policies and procedures must provide for

(1) Inquiring immediately into an allegation or other evidence of possible misconduct An inquiry must be completed within 80 calendar days of its initiation 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 80-day period.

(2) Protecting. to the maximum extent possible, the privacy of those who in good faith report apparent misconduct.

(3) Affording the affected individuals 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. OSL in accordance with I 50.104(a) when. an 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 I M104(b) exist

(5) Notifying the 051 within Z4 hours of obtaining any reasonable indication of possible criminal violation& so that the OSI may then Immediately notify the Departments 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, inter- views 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.

(9) Taking precautions against real or apparent conflicts of interest on the past of those involved in the inquiry or investigation.

(10) Preparing and maintaining the documentation to substantiate the investigation's findings. 71" documentation is to be made available to the Director. OSL who will decide whether that Office will either proceed with its own investigation or will act on the institution's findings.

(11) Taking interim adminsitrative 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.

(a)(1) An institution's decision to initiate an investigation must be reported in writing to the Director. OSL 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, win 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 ba completed within 1M 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 OSL If they can be identified. the person(s) who raised the allegation should be provided with those portions at 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 92 significant issues. If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements under I 50.103(d), 4 report of such planned termination. including a description of the reasons for such termination. shall be made to OSL 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 far 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 IM days. it must submit to the OSI a written request for an extension and an explanation for the delay that includes an interim report oil the progress to date and an estimate for the date of completion of the report and other necessary steps. Any conside ration for an extension must balance the need for a thorough and rigorous 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 gramted. the institution must file periodic progress reports as requested by the * OSL 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. Mule 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 iudividual(s) who is the subject of the allegations as well as his/her coinvestigators and associates if any-,

(4) It is probable that the alleged incident is going to bereported 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 051 will Immediately notify the Office of the Inspector General.

Institutions Shan foster a research environment that discourages misconduct in all research and that deals fothrighly 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.

Association of American Universities

Office of Federal Relations memorandum

to: AAU Institutions

from: Carol R- Scheman

subject Final Rule: Responsibilities of Awardee and Applicant Institution for

• Dealing With and Reporting Possible Misconduct in Science.

date: August 30, 1989

The "Framework for Institutional Policies and Procedures to Deal With Fraud in Research" (Attachment I) was printed in November 1988. Since that time the PHS has completed conunent period and revision of the regulations to implement the 1986 NU-1 statute. This regulation (Attachment U) was published in the "Federal Register" August 8,1989. As anticipated the regulation requires some revision of the "Framework."

As noted in the "Federal Register", the PHS has established two new offices: Office of Scientific Integrity Review (OSIR) in the Office of the Assistant Secretary of Health (ASH) and Office of Scientific Integrity (OSI) in the NIH Office of the Director. Acting Director of OSIR is Dr. Lyle Bivens (301-443-5300); acting Director of OSI is Dr. Briar~ Kimes (301-496-2624). Permanent appointments are expected sometime this fall.

Please note that institutional assurances of compliance are required as of November 8, 1989. Institutions are urged to read the final rule and review and, as necessary, revise their policies in order to comply with this new regulation.

The final rule requires the following changes in the "Framework for Institutional Policies and Procedures to Deal With Fraud in Research."

1. Definition: (p.2-3) (all page #s refer to the November 4,1988 document)

"Material failure to comply with federal requirements . . . " has been deleted as duplicative of other federal regulation. The final definition is of "misconduct in science" and states"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.

U. Assurances

The final rule sets forward specific requirements for insitutional assurances of compliance. It sets the stage for specific requirements for data collection (of numbers and types of allegations, inquiries, and investigations). It does not give the PHS authority to approve or disapprove institutional policies.

III. Inquiry (pp. 5-6)