HHS ANNOUNCES PLANS TO IMPROVE RESEARCH INTEGRITY
AND PREVENT RESEARCH MISCONDUCT

HHS Secretary Donna E. Shalala today announced she has accepted the recommendations of a special review group on research misconduct and research integrity involving research funded by agencies of the U.S. Public Health Service.

The recommendations include a more precise and useful definition of research misconduct, which is being adopted by agencies throughout the federal government. They are also aimed at improving the process for investigating allegations of misconduct, and at expanding educational efforts to prevent misconduct.

"The vast majority of PHS-funded research is conducted by scientists who maintain the highest level of integrity," Secretary Shalala said. "However, in those rare instances when misconduct may be involved, we must have a process that responds as quickly and as fairly as possible."

Under the proposals agreed to by the Secretary today:

• The Department will adopt through rulemaking a new definition of research misconduct, which focuses on improper behaviors related specifically to the conduct of research. The definition, proposed by the National Science and Technology Council, is expected to be adopted by all other federal agencies engaged in scientific research.
  
  
• Institutions that administer PHS-supported grants will maintain responsibility for conducting initial inquiries and investigations when misconduct is suspected or when allegations of misconduct are made. However, when further fact finding is required by the federal government, it will be carried out by the HHS Office of Inspector General rather than the Office of Research Integrity (ORI), as has previously been the case.
  
  
• Inquiries and investigations into potential research misconduct will be separated from the decision making process of determining if misconduct occurred. The ORI will review institutional findings and will recommend actions and sanctions, when supported by findings, to the Assistant Secretary for Health, who will make the final decisions regarding misconduct, subject to appeal.
  
  
• The Departmental Appeals Board (DAB) will continue to hear appeals from individuals who contest findings of misconduct. Each DAB appeals panel will include two scientists, and the appeals process will be streamlined with clarified procedures and rules for conducting hearings.
  
  
• Through ORI, the Department will require research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds.

The review group's report recommends clarifying and refining the definition of research misconduct by limiting misconduct to "fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting research results." Other types of misconduct (e.g. theft, harassment, discrimination) that might occur in the course of research are addressed through other laws and regulations.

ORI will continue to provide on-site technical assistance to institutional investigations where needed and oversight review of completed investigations. However, the review group recommended that the role and structure of ORI be changed to focus more on preventing misconduct and promoting research integrity through expanded education programs. The review group also encouraged the Department to develop consortia of third-party groups to perform investigations for those institutions that cannot or choose not to conduct their own. ORI will conduct a feasibility study on the use of such consortia during the coming year.

While some policy changes will occur immediately, the review group estimated that a one-year transition period would be necessary to fully restructure the Department's processes for addressing alleged or suspected research misconduct. Statutory and regulatory changes will be needed to implement the group's recommendations.

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