CRS-8 implement the regulatory directives of Section 493 of the Health Research Extension Act. However, on September 19, 1988, it did issue a proposed rule entitled "Responsibilities of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science." (emphasis added) T his rule would implement the regulatory directives as they pertain to institutions applying for PHS grants. A proposed rule covering institutions applying for contracts is to be published at a later date. Public comments on the proposed rule were due November 18, 1988. The Public Health Service, after addressing major issues which arose during the public comment period, has sent a revised proposed rule to the Office of Management and Budget for a final review. In terms of substance, key elements of the rule are as follows: Timely Inquiry-generally an institution is to initiate an inquiry soon after an allegation is reported and complete the inquiry within 60 days of initiation; Confidentiality--an institution is to protect "to the maximum extent Notification of the Funding Agent-an institution is to report in writing a case of alleged misconduct to the director of the appropriate funding body if an initial inquiry shows that the allegation has substantial merit. During the investigation (which generally should take no longer than 120 days), it should keep the funding agency informed of any significant developments; Protection of Federal Funds--an institution may take interim administrative action to protect Federal funds from potential misuse; Features of an Investigation-if an inquiry substantiates an allegation, an institution is to initiate an investigation within 30 days after conclusion of the inquiry, secure the expertise required to conduct a thorough evaluation of the evidence, and guard against conflicts of interest (real and apparent) among the parties involved; and 8 The rule defines misconduct in science as (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 related to the conduct of research. • Federal Register v. 53, no. 181, p. 36347. CRS-9 Documentation--an institution is to prepare and maintain Much of the substance of this proposed rule comes from misconduct guidelines PHS had adopted in 1986 for it extramural program. NIH's Guidelines with regard to Investigations. In 1982, the Assistant Secretary for Health, Department of Health and Human Services directed NIH to coordinate the development of policies and procedures for responding to allegations of scientific misconduct which would be effective for all research funded, conducted, or regulated by a Public Health Service (PHS) agency.10 Such guidelines were finally approved by Donald MacDonald, Acting Assistant Secretary for Health, April 8, 1986. These guidelines were/are designated as "interim" policies and consist of a compilation of four documents: (1) A general policy statement which affirms PHS' commitment to (2) Policies and Procedures for Agencies and Programs Authorized to Make Awards for Research and Research Training (Extramural Research Program);" (3) A Summary of Procedures Affecting Regulated Research; and (4) Policies and Procedures for Agencies Authorized to Conduct Research (Intramural Research Program) 12 As indicated, portions of the guidelines established for PHS's extramural program constitute the substance of the September 19, 1988, proposed rule. In addition, they do the following: (1) specify options for sanctions (e.g., a 10 The Public Health Service agencies are, the Alcohol, Drug Abuse, and Mental Health Administration, the Centers for Disease Control, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health. 11 A draft version of this document entitled "Public Health Service Policies for Handling Misconduct in Science: Operating Policies and Procedures for Awarding Agencies and Programs" had been developed as early as Oct. 20, 1983. 12 NIH Guide for Grants and Contracts: Special Issue--Policies and Procedures For Dealing with Possible Misconduct in Science, July 18, 1986, v. 15, no. 11. CRS-10 simple reprimand, the imposition of special reporting conditions, and debarment of individuals or institutions); (2) require that each PHS agency designate a Misconduct Policy Officer (whose responsibilities are to oversee the implementation of these guidelines and to coordinate agency investigations); and (3) spell out policies and procedures to enable PHS funding agencies to conduct inquiries and investigations. The guidelines for PHS responsibilities in the area of investigations are similar to those developed for awardee institutions. However, they also indicate that the role of the funding agencies regarding inquiries and investigations is secondary to the institutions. They state that as a general rule the awardee institutions are responsible for initiating inquiries into allegations of misconduct and that PHS agencies may defer their own fact-finding activities/investigation until they have received the report of the institution's investigation, if the investigation has been initiated promptly. The Advanced Notice of Proposed Rulemaking (ANPRM), the Office of Scientific Integrity, and the Office of Scientific Integrity Review. Prior to the publication of the proposed rule regarding the responsibilities of awardee institutions in the matter of scientific misconduct, the Office of Management and Budget (OMB) gave the proposed rule a critical review. Among other things, it was concerned that the rule dealt with the issue of misconduct, as opposed to fraud, and that it did not deal with the issue of detection. Hence, it suggested that PHS replace the proposed rule with a notice announcing that it is considering regulations around some broader issues. 13 PHS did not replace the proposed rule (stating that it is a necessary first step "intended simply to secure institutional commitments to comply with the basic terms of section 493)." However, it did issue the suggested notice, "Announcement of Development of Regulations Protecting Against Scientific Fraud or Misconduct; Request for Comments," on September 19, 1988. Indicating that more detailed regulations may be necessary, the announcement stated that "the Secretary is contemplating (1) formalizing and centralizing the procedures that the Department uses in responding to allegations of misconduct, (2) adopting policies to deter misconduct, (3) implementing procedures that would better enable the institutions and the Department to detect misconduct, and (4) imposing sanctions on those awardee institutions that fail to discharge their responsibilities under section 493." Public comment period on this announcement ended on December 19, 1988. One of the issues about which PHS solicited comments in the ANPRM concerned the establishment of an Office of Scientific Integrity within DHHS. The office would consist of an investigative branch and an adjudicative branch. The former could be responsible for receiving allegations of scientific 13 Federal Register v. 53, no. 181, p. 36344-363447. 14 Ibid. CRS-11 misconduct, monitoring awardee institution investigations, conducting investigations when necessary, and discussing each case with the Office of Inspector General. The latter branch would "consist of a pool of scientists from which panels would be convened to review in depth and adjudicate those allegations thought to have merit by the investigative branch."16 Until March 16, 1989 the activities of the proposed Office of Scientific Integrity were managed by the Institutional Liaison Office in NIH's Office of Extramural Programs. On March 16, 1989, DHHS announced the establishment of two new offices, the Office of Scientific Integrity (OSI) and the Office of Scientific Integrity Review (OSIR).16 These offices appear to have been vested with some of the responsibilities of the Office of Scientific Integrity described in the ANPRM. OSI, located in the office of the NIH Director, oversees the investigations of all PHS-awardee institutions, as well as conducts investigations, when necessary. In addition, it is charged with promoting high standards of scientific research through a prevention and education program. However, these duties may be delegated to the Institutional Liaison Office."7 OSIR, in the Office of HHS' Assistant Secretary for Health, among other things, (1) develops policies and procedures regarding allegations of misconduct; (2) reviews investigations (it may establish ad hoc panels to do the review when it deems it necessary); and (3) recommends to the Assistant Secretary appropriate sanctions. In 1981, NIH The PHS ALERT System for Misconduct in Science. initiated a system called ALERT to enable Institute Directors to track individuals who are under investigation for possible misconduct or who have been sanctioned for misconduct. The system does not bar individuals who are under investigation from receiving awards. Rather, it provides the appropriate funding authorities with information so that an informed funding decision can be made. In 1986, the system was expanded into a PHS-wide mechanism. Access to this system is limited. Agency directors and Misconduct Policy Officers (MPOs) have access to the system on a "need to know" basis. The Division of Management Survey and Review (DMSR), the division which manages the system, usually sends a written notification to the director of the PHS agency which is considering doing business with a person who is on the system; and an MPO can make a direct request. Besides the agency directors 16 Ibid. 16 Federal Register, v. 54, no. 50, p. 11080-11081. 17 Newburgh, Janet. Institutional Liaison (Misconduct Policy) Officer to Extramural Research at NIH. Personal communication, May 12, 1989. CRS-12 and the MPOs, those who have been placed on the system are the only other persons who have access to the information through the Privacy Act." Guidelines Regarding Financial Conflicts of Interest. On April 25, 1989, the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration announced that they were in the process of developing guidelines concerning financial conflicts of interests for investigators receiving Federal funds. The two funding agencies will hold a public meeting on June 27 and 28, 1989. Topics of discussion will include financial disclosure requirements, restrictions on financial interests in organizations that produce products that are evaluated in awards, and possible exceptions to restrictions. 19 The National Science Foundation: Misconduct in Science and Engineering On July 1, 1987, the National Science Foundation (NSF) issued final regulations outlining the responsibility of the NSF and its staff for addressing allegations of misconduct in science and engineering research.20 For the most part, the regulations promulgated by NSF are procedures that had been informal and instituted on a case-by-case basis over the past years. Similar to misconduct policies issued by the Public Health Service (PHS) of the Department of Health and Human Service (HHS), the regulations define scientific misconduct, establish responsibilities of grantee institutions for investigating and reporting misconduct, outline the range of penalties for proven misconduct, and establish procedural protection for the whistleblowers and the accused. The NSF's definition of misconduct derives from common law principles of intentional tort, liability, and gross negligence. The definition includes actions at the proposal stage of an award, an element that is absent from the NIH regulations. Actionable misconduct includes: (1) fabrication, falsification, plagiarism or other serious deviation from accepted practices in proposing, carrying out, or reporting results from research; 18 Hyatt, Howard. Director of Division of Management Survey and Review, NIH. Personal communication, May 23, 1989. 19 Federal Register, v. 54, no. 78, p. 17828. 20 U.S. National Science Foundation. Misconduct in Science and Engineering Education. Federal Register, v. 52, no. 126, July 1, 1987. p. 24466-24470. |