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May 11, 2010
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Suspicious Minds

I am a school of medicine faculty member and I recently attended an annual society meeting where two of my Hopkins’ colleagues presented preliminary results of a phase III clinical trial involving a new cancer drug. Considering the information previously presented by them at institutional seminars, the survival rates that they reported just seemed too good to be true. I am an expert in the same field and my suspicions could easily be put to rest if I were allowed to review their data. How do I gain access?

Your question raises a number of issues. Preliminary results are presented at annual society meetings for many reasons, one of which is to solicit feedback from experts in the field that may help shape the research as it goes forward. When the data was reported at the meeting, did you ask a question of your colleagues? Perhaps your doubts could be easily addressed through open communication.

Even if you don’t feel comfortable challenging their preliminary results, you don’t have the right to demand access to your colleagues’ data for your own analysis. This data, part of a clinical trial, contains protected health information that must be carefully guarded to insure patients’ privacy. Without express permission of the patient, the investigators are prohibited from sharing this information with those who aren’t part of the research protocol.

While you are always advised to openly communicate with your colleagues, you aren’t expected to be a sleuth and make a case to prove or disprove your suspicions. The school of medicine has procedures to address misconduct allegations. Because any such accusation has the potential to damage one’s reputation, whether or not it finds any wrongdoing, we take each one very seriously and handle it with great attention to confidentiality.

You and all members of the Johns Hopkins research community have an obligation to report concerns of research misconduct, whether it involves fabrication, falsification or plagiarism. You should schedule a meeting with your department director to discuss.

The director must notify the vice dean for research upon receiving any allegations of research misconduct. The vice dean will first assess the claims, by consulting an unbiased subject matter expert if needed. If the accusations are found to have merit, a three-step process— inquiry, investigation, and adjudication—is followed, as dictated by federal regulations and Hopkins’ own policies. You, as the person who first raised the concerns, will be notified of the outcome.

Click here for details on the school’s procedures for handling research misconduct allegations.

 
            
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