Introduction:

When conducted according to ethical, legal, and scientific standards, clinical research minimizes risks to research participants, respects informed decision-making by prospective study subjects, complies with norms governing privacy and confidentiality of personal information, and responsibly addresses conflicts-of-interest.  Of course, clinical research is not always performed as it should be.  In some cases, medical researchers fail to disclose study-related risks to research subjects, fabricate or falsify data, conceal conflicts-of-interest, use unscientific study designs, attach their names to ghostwritten publications, or engage in overly aggressive recruitment practices.  When researchers deliberately engage in scientific misconduct they often attempt to conceal such behaviour from employers, institutional review boards, regulatory bodies, funding agencies, and journal editors. Sometimes the first public indication that misconduct has occurred is when a whistleblower emerges with credible questions and concerns or evidence of institutional wrongdoing.    

Whistleblowers can emerge from all ranks of research institutions, extending from junior employees to senior administrative officials. However, comparatively low-ranking employees are particularly vulnerable to threats from more powerful co-workers.  In many countries, laws and institutional policies are supposed to protect from retaliation whistleblowers making credible allegations of research misconduct.  Despite existence of whistleblower protection legislation, there are many cases where whistleblowers have suffered severe consequences as a result of drawing attention to research misconduct.

By disclosing research misconduct, whistleblowers help protect research subjects from harm, promote integrity of research, and expose wrongdoing.  Sometimes they are recognized and honoured for their actions. However, whistleblowers – even when their allegations of research misconduct are determined to be accurate – have suffered loss of employment, demotion, public ridicule, marginalization, and threat of legal action.  Awareness of the fate that sometimes befalls whistleblowers can promote a culture of silence at universities, hospitals, and academic health centres.  Specific acts of retaliation – and the prospect of further retaliation – can have powerful silencing effect and serve to isolate those individuals willing to publicly question acts of clinical research misconduct.    

Drawing upon particular cases and disciplinary perspectives from such areas of study as bioethics, law, sociology of medicine, and philosophy, this workshop will explore the moral, social, and legal phenomenon of whistleblowers exposing clinical research misconduct.  

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