United States: HHS Finalizes Policies on Research Misconduct

On May 17, 2005, the Department of Health and Human Services ("HHS") published its Final Rule in the Federal Register (70 Fed. Reg. 28370) that substantially revises existing regulations governing research misconduct at institutions applying for or receiving Public Health Service ("PHS") research funds. The new policy broadens the scope of the federal government's oversight and enforcement of federally-funded research, and is intended to ensure public confidence in the integrity of scientific research. The Final Rule implements research misconduct legislative and policy changes that have occurred over the past several years.

One significant change from the existing regulations is to replace the current definition of "scientific misconduct". with the broader term of "research misconduct." Under the new definition, misconduct occurring during the research review process, such as the peer review of an application or a journal article, is now covered by the regulations. However, the Final Rule eliminated a provision in a proposed regulation, which would have extended liability for research misconduct to individuals who plagiarize PHS funded research even if the individual or individual's research did not receive PHS funding. HHS has now acknowledged that it lacks jurisdiction over plagiarism if PHS funds are not involved. However, since most individuals who review research are generally recipients of PHS research funds, this change will have little practical effect.

The Final Rule clarifies and codifies the institutional and federal responsibilities in handling research misconduct allegations. Institutions continue to have primary responsibility for conducting inquiries and investigations, and are required to take reasonable steps to avoid conflicts of interest on the part of those involved in the inquiry or investigation. HHS will provide oversight for inquiries and investigations. HHS now has the discretion to take responsibility for responding to allegations of research misconduct at institutions which fail to properly handle such allegations.

Institutions are required to notify the Office of Research Integrity ("ORI") if they settle an accusation of research misconduct, or if a case is closed because the researcher has admitted misconduct; and although not required to do so, should consult with ORI before agreeing to any settlement. Institutions are not required to report preliminary investigations, so-called "inquiries," if they find that no research misconduct was committed.

Under the Final Rule, institutions and HHS have the burden to prove that research misconduct was committed intentionally, knowingly, or recklessly by a preponderance of the evidence. Honest error or difference of opinion (which is expressly excluded from the definition) is an affirmative defense that the researcher has the burden of proving, also by a preponderance of the evidence.

The Final Rule replaces the existing ad hoc appeals process with a formal administrative hearing procedure. An appeal will first be heard by an administrative law judge, rather than a three person panel under the existing process. The hearing process is very detailed, and designed to ensure: (1) more uniformity among institutions conducting misconduct proceedings, and (2) fair and uniform procedures for the researchers.

Notwithstanding the detail in the new regulations, several issues remain unanswered. For example, the regulations do not directly address bad faith allegations of research misconduct. HHS expects that these types of allegations will generally be handled pursuant to an institution's existing internal standards., however, HHS cautions that all policies should include procedures to ensure a fair determination of whether, in fact, there has been a bad faith allegation. HHS has also offered to work with the research community to develop guidance in this area.

The Final Rule does not address the issue of immunity from personal liability for institutions, committee members or witnesses who participate in research misconduct proceedings. HHS explains that federal legislation would be needed to provide immunity, and has urged interested parties to submit comments to it on this issue.

Whether researchers have the right to continue their research after allegations of misconduct have been leveled against them is left to the discretion of each institution. In considering this situation, HHS states that institutions should weigh various factors, including the: (1) health and safety risk to the public; (2) threat to HHS' resources and interests; (3) reasonable indication of possible violations of civil or criminal law; (4) importance of the research; and (5) whether the researcher has unique expertise.

A critical element in any institution's approach to research misconduct is the development, implementation, and dissemination of robust operational policies and procedures. Institutions must now establish written policies and procedures for investigating and reporting instances of alleged misconduct (which may be more stringent than those in the Final Rule), which must be provided to HHS and the public upon request. Although an institution must apply the HHS regulatory definitions, standards and requirements in evaluating allegations of research misconduct, it may follow its own policies and procedures at an institutional level. Thus, an institution may make findings and impose sanctions under its own policies and procedures, regardless of whether HHS makes a finding under the regulatory standards. If an institution fails to establish or comply with policies and procedures required by the Final Rule, it may be subject to an array of enforcement actions, including written reprimand, special oversight by HHS, specific corrective actions, or the imposition of an institutional integrity agreement.

Finally, HHS has delayed finalizing the Notice of Proposed Rulemaking, issued in December 2000 (that would require institutions that receive PHS funds to follow a nonretaliation policy against whistleblowers involved in cases of possible research misconduct) to ensure that those provisions are consistent with the new research misconduct regulations.

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