When there have been substantial failures by institutional leadership in their oversight responsibility to protect research integrity, the public should demand that these be recognized and addressed by the institution itself, or the funding bodies. This commentary discusses a case of research failures in developing genomic predictors for cancer risk assessment and treatment at a leading university. In its review of this case, the Office of Research Integrity, an agency within the US Department of Health and Human Services, focused their (...) report entirely on one individual faculty member and made no comment on the institution’s responsibility and its failure to provide adequate oversight and investigation. These actions missed an important opportunity to emphasize the institution’s critical responsibilities in oversight of research integrity and the importance of institutional transparency and accountability. (shrink)

Ethical conduct is an essential component in research, especially in medical research. Statistical methods for design and analysis are powerful research tools if used properly. Abuse of these principles and methods are just as unethical as other laboratory or clinical misconduct. Inadequate research design can produce worthless results and thus wastes effort and valuable resources. For clinical research, patient resources are wasted. Inappropriate analysis of data can also produce misleading results and conclusions. For clinical research, inferior therapy might be given (...) to patients as a consequence. These ethical concerns can have implications for and affect the individuals responsible for the statistical design and analysis. Examples are provided which illustrate some possible abuses and inappropriate pressures. (shrink)