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Policies - Regulations

A: The final rule will become effective 30 days after the date of its publication in the Federal Register. The final rule was published on May 17, 2005; thus, it will become effective on June 16, 2005. For any allegation received after May 16, the institution should follow the rules in the new regulation.

A: The current regulation defines "misconduct in science" as "fabrication, falsification, plagiarism, or other practices . . . for proposing, conducting, or reporting research." In contrast, the OSTP government-wide policy and the final rule define "research misconduct" in relation to "proposing, performing, or reviewing research, or in reporting research results." The final rule uses the term "performing" instead of "conducting" and expands coverage to include misconduct occurring in connection with reviewing research. This is consistent with the intent of the HHS internal review group and the OSTP policy to include the process of submitting a funding application (proposing), and the peer review of an application or a journal article (reviewing). The definition of research misconduct as "fabrication, falsification, or plagiarism" (FFP) is retained, but the OSTP description of each of these terms is adopted and the "other practices" clause in the current definition is dropped. Consistent with the OSTP policy, the final rule would require that FFP be a "significant departure" from accepted practices as opposed to the "serious deviation" standard in the current regulation.

A: Yes. The final rule expands the type of PHS support beyond grants and cooperative agreements to include support provided through contracts and through direct funding of PHS intramural research programs. In addition, the final rule applies to the plagiarism of any research record generated with PHS-supported research, including plagiarism during the journal peer review process.

A: The scope of the misconduct regulation is limited to cases in which the alleged research misconduct occurred within 6 years of the date HHS or an institution receives an allegation or research misconduct. With a few exceptions, no inquiry or investigation could proceed where the alleged misconduct occurred outside this 6 year limitation period. This standard is modeled after the limitation period used in the qui tam provision of the False Claims Act and after the procedures used by the Office of the Inspector General (OIG) in its Medicare and Medicaid exclusion cases.

A: Yes. Although an institution must apply the regulatory definitions, standards, and requirements in evaluating and reporting an allegation of research misconduct to ORI, it may also apply its internal definition or standards in determining whether misconduct has occurred at the institutional level. An institution may find misconduct under its internal standards and impose administrative sanctions based on that finding, regardless of whether the institution or ORI makes a finding of research misconduct under the HHS standard.

A: No. The HHS OIG will conduct the HHS investigations but may be assisted by ORI's scientific and other technical experts.

A: The final rule uses a new term, "complainant," defined as a person who in good faith makes an allegation of research misconduct. The role of the complainant is limited by the final rule. Once the complainant has made a formal allegation of research misconduct, that person does not participate in the proceeding other than as a witness. A complainant is not the equivalent of a "party" in a private dispute. In conformance with the OSTP policy, the HHS internal review group, and current agency practice, the final rule provides that an institution has an obligation to pursue allegations of research misconduct independent of the complainant's role. The institution may, but would no longer be required to, give the complainant an opportunity to comment on the reports of the inquiry and investigation committees.

A: Yes. Since 1990, ORI has permitted institutions determined to be too small to conduct research misconduct proceedings effectively or without the appearance of a conflict of interest to submit a "Small Organization Statement" under which they agree to work with ORI to develop an alternate way to handle research misconduct allegations. The final rule codifies this practice. In the past this alternative for small institutions has been applied to institutions with 10 employees or less, but the final rule does not define the term "small institution" so that ORI and the institutions will have some flexibility in addressing this issue.

A: Yes. The hearing process is modeled upon the current regulation, at 42 CFR 1005, governing the Office of Inspector General hearing process for the exclusion of health care providers, with modifications to reflect current practice, knowledge, and experience in research misconduct proceedings. The proposed hearing process has the following key features:

• Administrative Law Judges. The hearing would be conducted by a single ALJ appointed from the Departmental Appeals Board (DAB) Administrative Law Judges. This would be a change from the current practice of using a panel of three members of the DAB's Appellant Division.

• Recommended Decision. The ALJ's decision on the misconduct findings and proposed administrative actions is a recommendation to the Assistant Secretary for Health. Under current practice the DAB's decision, other than for debarment, constitutes final agency action. Under the final rule, the ASH may modify or reject the recommended decision in whole or in part after determining it, or the part modified or rejected, to be arbitrary and capricious or clearly erroneous. If debarment or suspension from eligibility for Federal financial assistance and/or contracts is proposed, the ALJ's ruling constitutes proposed findings of fact to the HHS Debarring Official. If the Debarring Official agrees with the ASH decision to modify or reject the recommended decision, the ASH decision will be the final agency action.

• Scientist Experts. The ALJ is authorized to engage an expert in the relevant area of science to advise the ALJ and would have to engage such an expert, if requested by either party. Under the current system a panel may have up to two scientist members, but to date most panels have had either one or no scientist member.

• De Novo Proceedings. The final rule codifies the current practice of providing a de novo hearing to consider challenges to the ORI findings of research misconduct and proposed administrative actions. A respondent is permitted to waive an in-person hearing and have the case decided on the basis of the administrative record.

• Standardization of Requirements. The final rule informs respondents of exactly how the hearing process works. The rule includes requirements for the content of the hearing request, time frames for conducting preliminary conferences, discovery, submission of witness lists and exhibits, and the post-hearing process. These standard procedures, and the respondents' knowledge of them, will promote a fair, timely, efficient, and less costly process for all parties.

• Limited Discovery. Consistent with the Administrative Procedure Act and other HHS hearing procedures, discovery is limited to an exchange of documents. Following discussion at a prehearing conference, the ALJ could order the parties to develop stipulations and admissions of fact. Under current practice broader discovery has been permitted. Limiting discovery will result in a more efficient process that reduces costs for all parties.

A: The new hearing process described in Subpart E of the final rule will take effect for any hearing request made after June 16.

A: Yes. The final rule provides that HHS may settle a research misconduct proceeding at any time in the best interests of the Federal Government and the public health or welfare. Settlement agreements are publicly available, regardless of whether ORI makes a finding of research misconduct.

A: Many institutions contact ORI in advance when they are considering settlement. Sometimes, ORI, the institution, and the respondent will join in a three-way agreement to settle the alleged misconduct. Under the final rule, an institution must notify ORI in advance if the institution plans to close a case at the inquiry, investigation, or appeal stage on the basis that the respondent has admitted guilt, a proposed settlement with the respondent has been reached, or for any other reason, except that this notification requirement does not apply to the closing of a case at the inquiry stage on the basis that an investigation is not warranted or to a finding of no misconduct at the investigation stage, which must in any event be reported to ORI as part of the submission of the investigation report consistent with current practice and regulation.