Preventing Misconduct

Suggestions for preventing and identifying research misconduct: 

  • The P.I., Lab director, etc. must establish a climate in the lab in which scientific integrity (and the reasons for it) are emphasized. 
  • All staff must be thoroughly trained in integrity principles and in conducting their portion of the protocol. 
  • The P.I. and other supervisors must maintain strong communication with staff and a “presence” in the study setting by personally verifying, at least, a sampling of the research records. 
  • Good research record documentation should be practiced in the following manner:
    • Data forms should be as simple as possible, yet with clear designation of the required information.
    • Any alterations on data forms must be done by striking through the original entry (no whiteout or writing over) and initialing and dating the new entry.
    • Staff should be questioned about data alterations in the research record (overwrites, erasures, whiteouts, changes in electronic records).
    • If possible, request informed consent permission to re-contact the patient for quality control reasons, and follow up with a sampling of these patients.
    • Copies of all laboratory reports should be retained by the originating facility (to be spot checked on a routine basis and for special audits).
  • Keep staff workloads reasonable.
  • Protocols should be designed with realistic requirements that can be met by both staff and patients.
  • In on-going studies, if possible, train more than one staff member to do follow-up.
  • Protocol sponsors should not pay bonuses based on number of subjects enrolled.