On June 16, 2005, the Public Health Services’ (PHS) final rule on research misconduct, first published on May 1, 2005, went into effect (the June 2005 Rule). The June 2005 Rule is the latest effort by the federal government to respond to increasing concerns about the integrity and independence of federally funded research, following closely on the heels of a decision by the National Institutes of Health to overhaul its rules regarding conflicts of interest. The June 2005 Rule will have far-reaching effects on the way institutions respond to allegations of scientific misconduct and the repercussions for institutions who do not.
Though the scientific process necessarily builds upon trust and integrity, a recent survey conducted by an independent scientific team reports that one-third of American biomedical scientists have reported engaging in some level of scientific misconduct ("Surveyed Scientists Admit Misconduct," Boston Globe, June 9, 2005). According to a widely referenced federal definition, research misconduct involves fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results (see 42 C.F.R. 93.103). Although the federal government has regulated the reporting, investigation and resolution of allegations of scientific misconduct involving federally funded research since as early as 1989, concern over the reliability of research data and the independence and integrity of the clinical trial enterprise has intensified in recent years. With patient advocacy groups and regulators increasingly focusing on conflicts of interest, demanding greater public access to completed and prematurely terminated clinical trials, and criticizing the alleged lack of transparency of adverse clinical trial data, there has been a recent push for tighter regulations governing research misconduct.
Updates to Public Health Services Research Misconduct Policies
These comprehensive regulations set new standards on how entities conducting federally funded research must investigate and resolve allegations of research misconduct. The June 2005 Rule supercedes the former regulation, "Responsibilities of Awardees and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science" (see former section 42 CFR Part 50, subpart A) and replaces it with "Public Health Service Policies on Research Misconduct" (see 42 CFR Part 93). The June 2005 Rule integrates the December 6, 2000 White House Office of Science and Technology Policy’s government-wide Federal Policy on Research Misconduct and incorporates the recommendations of the U.S. Department of Health and Human Services (DHHS) Review Group on Research Misconduct and Research Integrity, approved by the Secretary of DHHS on August 25, 1999. Given increased governmental and institutional scrutiny on scientific misconduct and related issues, such as conflicts of interest, it is likely that the June 2005 Rule will be more strictly enforced than its predecessor and affected institutions may have to act quickly to reach compliance.
The June 2005 Rule defines what constitutes research misconduct, establishes the responsibilities of regulated institutions to respond to research misconduct issues, and sets forth the general types of administrative actions DHHS and PHS may take in response to reports of research misconduct (see 42 C.F.R. 93.101). The Rule requires that, as of the effective date, recipient institutions comply with the June 2005 Rule. Compliance with the Rule would require development and implementation of policies and procedures for reporting and responding to allegations of research misconduct, as well as providing DHHS with an "Assurance" that the entity is in compliance with the Rule (see 42 C.F.R. 93.101). Receipt of federal research funding is conditional on the DHHS Office of Research Integrity’s (ORI) receipt of this Assurance. The June 2005 Rule expands the type of federal funding triggering the Rule’s effect to include support provided through contracts and direct funding of PHS intramural research programs (the prior regulations limited the scope to grants and cooperative agreements) (see 42 C.F.R. 93.102). In addition, the June 2005 Rule extends its application to scientific misconduct occurring during any stage of the research process—for example, plagiarism of any research record during the journal peer review process would constitute scientific misconduct covered by the Rule even though the study in question might be closed and no longer under review by the institution’s institutional review board or other review committee (see 42 C.F.R. 93.102).
Although institutions may develop internal standards of conduct different from the standards for research misconduct set forth in the June 2005 Rule, most will likely opt for streamlining the process by simply adopting the June 2005 Rule as their own as the Rule requires they still apply the Rule’s definitions, standards and procedures (see 42 C.F.R. §93.103). In addition, though the Rule only applies to research funded at least in part by PHS, it would be cumbersome for an institution to develop a parallel policy for non-federally funded research. Thus, it is likely that institutions conducting even a small number of federally funded studies will use the policies and procedures developed in response to the Rule for all research conducted at their facilities (see C.F.R. § 93.102). As a result, the June 2005 Rule, already broader in scope than its predecessor, is likely to have a far-reaching effect within institutions and come to govern much, if not all, of the research conducted using institutional resources, staff and facilities.
Sanctions for Noncompliance
ORI may determine that an institution is not in compliance with the June 2005 Rule if the institution is thought to show a disregard for, or inability or unwillingness to implement, its requirements (see 42 CFR 93.412). In making its decision on institutional noncompliance, ORI may consider, but is not limited to considering, an institution’s failure to establish and comply with policies and procedures of the Rule, failure to respond appropriately when allegations of misconduct arise, failure to report to ORI all investigations and findings of research misconduct, failure to cooperate with ORI’s review of research misconduct proceedings, or any other actions or omissions that may have a material effect on reporting and responding to allegations of research misconduct (see 42 C.F.R. 93.412).
In the case where an institution fails to comply with the June 2005 Rule, the regulations provide significant sanctions (see42 C.F.R. 93.413). ORI, charged with enforcing the Rule, may impose a range of disciplinary sanctions, ranging from issuing a letter of reprimand, to placing the institution on special review status, to revoking the institution’s assurance (see42 C.F.R. 93.413) Without an approved assurance, institutions may no longer receive PHS funds (see 42 C.F.R. 93.301).
In addition, potential damage to an institution’s reputation from failure to comply with the June 2005 Rule can be significant. ORI may make public its findings of institutional noncompliance, as well as ORI actions in response to the noncompliance, on the ORI website (see 42 C.F.R. 93.301). Allegations of scientific misconduct are also likely to generate media interest, and institutions may struggle to rebuild their research programs in the aftermath of such negative publicity.
Research institutions should consider the following steps to reduce the risk of violating the June 2005 Rule:
Inventory current research misconduct policies
- Designate the required official who will act to promote research misconduct standards according to 42 C.F.R. 93.301. On behalf of the institution, the responsible official must assure ORI that the institution has written policies in compliance with the June 2005 Rule for inquiring into and investigating allegations of research misconduct and that it complies with its own policies and procedures and the requirements of the updated regulation
- Update existing institutional policies to reflect new features and requirements of the June 2005 Rule. At minimum, these policies should include all of the following elements:
- obligations to employees, medical staff members, and other affiliates to report scientific misconduct
- procedures to respond to each allegation of research misconduct in a fair, competent and objective manner
- commitment to foster a research environment that promotes the responsible conduct of research, research training and activities related to that research and discourages research misconduct
- procedures to maintain adequate records for research misconduct reports, meetings, hearings, and disciplinary efforts
- Assess the overall clinical research program, including a) conflicts of interest to ensure adequate committee structure and up-to-date policies dealing with institutional and individualized conflicts; b) appropriate drafting and implementation of clinical trial agreements and clinical trial subsidy agreements; c) the constitution and governance of a scientific review committee; and d) oversight of the program by the general institutional compliance team.
An institution must file an annual report with ORI which contains information specified by ORI on the institution’s compliance (see 42 C.F.R. 93.302). ORI recognizes, however, that the June 2005 Rule is not as easily applicable to smaller organizations. Eligible organizations may file a "Small Organization Statement" with ORI in place of the formal institutional policies and procedures detailed and required by §93.301 and §93.304 (see 42 C.F.R. 93.303). However, most institutions will not qualify as a Small Organization and will have to meet the full complement of requirements under the June 2005 Rule. Accordingly, most institutions receiving federal funds will have to file their first annual report by March 31, 2006 certifying their compliance.