2a. Federal research misconduct definition and policies

After a decade of sometimes spirited debate, in December 2000 the Office of Science and Technology Policy (OSTP) in the Executive Office of the President adopted a Federal Policy on Research Misconduct. The OSTP Policy is in most respects similar to earlier ones adopted by the Public Health Service (PHS) and the National Science Foundation (NSF), but it did recommend some significant changes to the definition of research misconduct. When it is finally implemented by all government research agencies (the target date of December 2001 was not met), all federally funded researchers will be subject to a uniform definition of research misconduct.

     Definition. The OSTP Policy defines “research misconduct” as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” (see accompanying box for details). It also sets the legal threshold for proving charges of misconduct.
To be considered research misconduct, actions must:

• represent a “significant departure from accepted practices”;
• have been “committed intentionally, or knowingly, orrecklessly”;
• and be “proven by a preponderance of evidence.”

These further stipulations limit the Federal Government’s role in research misconduct (fabrication, falsification, or plagiarism) to well-documented, serious departures from accepted research practices.

When using the common Federal definition to discussresearch misconduct, it is important to understand that it establishes a minimum standard for measuring acceptable behavior, not a standard for judging all research behavior. In particular, it does not imply that all other behaviors are acceptable. It also does not encompass criminal behavior, personal disputes, violations of grant management policies or other unacceptable behaviors not unique to research, such as discrimination or harrassment. The government’s main concern in establishing this definition is to assure that publicly funded research is accurate and appropriately represented by clearly stating that three practices, commonly referred to as “FFP,” are wrong.

     Reporting and investigation. Federal misconduct policy assumes that researchers and research institutions bear the primary responsibility for reporting and investigating allegations of misconduct. This assumption is consistent with the position, strongly supported by most researchers, that research is a profession and should regulate its own conduct (see Chapter 1).

Successful professional self-regulation depends onconscientious community participation. For individual researchers, this means they must assume responsibilityfor their own actions, take misconduct seriously, andreport apparent misconduct by other researchers.
Every institution that receives PHS funding must have procedures in place for receiving and investigating reports of research misconduct. These procedures must include:

• the designation of individuals who are authorized to receive and investigate allegations of misconduct,
• provisions for an initial inquiry to determine whether the allegations have any merit,
• provisions for a formal investigation to reach conclusions about the truth of the allegations,
• the designation of an individual who is authorized to weigh (adjudicate) the conclusions reached in the investigation and impose administrative actions to redress the misconduct (sanctions) or take steps to vindicate the person charged, and
• provisions for reporting findings to ORI.

Researchers should be familiar with these procedures and their institution’s definition of research misconduct(discussed below).

     Basic protections. Researchers who commit misconduct place their careers at risk. The Federal Government can debar researchers who commit misconduct from receiving Federal funds for a specified period of time. In most
instances, research institutions also take their own actions, such as terminating a researcher’s employment or requiringsupervision of future research activities. By like token, making allegations of misconduct—blowing the whistle—can sometimes place a whistleblower’s career at risk. Although by law institutions must not retaliate against whistleblowers who report in good faith, they sometimes do.

The new common Federal policy provides guidelines for protecting both parties—the whistleblower and the respondent—in research misconduct investigations. As a general rule, research misconduct allegations must not be made public until they have been fully investigated and confirmed. There are, however, exceptions to this rule. If the misconduct could pose a threat to public health or safety, such as misconduct in a clinical trial, it must immediately be brought to the attention of the person heading the trial, the person with oversight authority, or both. ORI and the Federal sponsor must also be notified immediately. In such cases, the names of the persons charged should remain confidential, but steps must be taken to safeguard the subjects in the trial.

Similarly, research institutions and researchers must not in any way penalize or take action against individuals who report research misconduct in good faith. Even if accusations are not sustained, as long as they are brought in good faith, informants must be protected and given support since they play a vital role in professional self-regulation.