Can fabrication or falsification of data by lower-level staff who conduct surveys or interviews or administer questionnaires with human subjects constitute research misconduct? The answer is "yes."

The Public Health Service (PHS) has made findings of research misconduct in several ORI cases involving this type of data. These misconduct cases involved the acquisition of data through questionnaires or interviews, administered face-to-face, over the telephone, or through the use of a computer interface. The data were used in a variety of research situations, ranging from epidemiological studies of diseases to the assessment of the effectiveness of therapeutic interventions, or of health services delivery systems.

Since questionnaires are often administered by individuals who are not members of the faculty or the professional senior research staff, institutional officials have questioned whether these individuals were actually members of the "scientific community" subject to PHS regulations on research misconduct.

The PHS regulations apply to any individual involved in proposing, conducting, or reporting research supported by PHS funds or proposed in applications for PHS funds, regardless of their position.

Institutional officials have also asked ORI about the relationship of common "data quality control" problems and possible research misconduct-that organizations involved in the conduct of surveys expect a certain incidence of "curbstoning" (i.e., fabrication or falsification of data "on the street"). When detected by regular "quality control" measures, the problem is often handled by purging the tainted data from the database.

Such "quality control" measures may serve a preventive and a detection function and ORI encourages their continued use. However, the data should not be destroyed because it might provide evidence of research misconduct. When evidence of intentional fabrication or falsification of data in PHS-related research is detected in this way, the institutions should handle the case through the normal procedures for dealing with PHS research misconduct. Any investigative findings in these cases must be reported to ORI as required by PHS regulations.