Whistleblowers and the Exposure of Clinical Research Misconduct
When conducted according to ethical, legal, and scientific standards, medical research minimizes risks to research participants, respects informed decision-making by prospective study participants, eliminates coercion from decisions to participate in clinical studies, complies with standards governing privacy and confidentiality of medical records, and ensures that conflicts-of-interest are eliminated, disclosed, or otherwise addressed in a responsible manner.
Acknowledging how medical research is supposed to be conducted, clinical research studies evaluating safety and efficacy of investigational new drugs, biologics, medical devices, and clinical procedures are not always performed as they should be. In some cases, medical researchers fail to disclose study-related risks to research subjects, coerce vulnerable individuals into clinical studies, fabricate or falsify data, conceal conflicts-of-interest, use unscientific study designs to generate desired results, and attach their names to ghost-written publications. When researchers deliberately engage in scientific misconduct they have a vested interest in concealing such behaviour from institutional review boards, regulatory bodies, funding agencies, and journal editors.
In many cases, the first public indication that misconduct has occurred is when a whistleblower begins challenging the integrity of scientific research. Whistleblowers emerge from all ranks of biomedical research institutions, extending from junior research assistants to senior administrative officials. However, comparatively junior employees are particularly vulnerable to threats from senior and 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 the existence of legislation protecting whistleblowers from retaliation, there are many cases where whistleblowers have suffered severe consequences as a result of drawing attention to research misconduct. For example, at the University of Minnesota, a junior research assistant was fired after she reported that the study’s principal investigator was fabricating clinical data. Well after she was fired, her allegations were determined to be true and the faculty member was charged, convicted, and sentenced to prison. More recently, Professor Carl Elliott, a faculty member at the University of Minnesota’s Center for Bioethics, was subjected to harassment and intimidation as a result of his efforts to expose research misconduct in the University of Minnesota’s Department of Psychiatry. At the University of California Los Angeles (UCLA), Dr. Robert Pedowitz, the former Chair of the Department of Orthopedic Surgery, was dismissed from his position after he reported concerns about financial conflicts-of-interest of researchers in his department. Last month, UCLA paid Dr. Pedowitz $10 million to settle a whistleblower retaliation lawsuit. At the University of Toronto, Dr. Nancy Olivieri, a haematologist, was informed by Apotex, the drug company sponsoring a clinical trial she was conducting, that she had signed a confidentiality agreement and could not disclose to research participants what she regarded as a newly identified study-related risk. Olivieri violated the confidentiality agreement with the study sponsor, disclosed the newly identified risk to research subjects and her hospital’s institutional review board, and then was subjected to litigation, significant harassment, and referral to a physicians’ disciplinary board. By disclosing research misconduct, whistleblowers help protect research subjects from harm and promote integrity of research. Sometimes they are honored for their actions.
However, whistleblowers—even when their allegations of research misconduct are determined to be accurate—have suffered loss of employment, demotion, ridicule, marginalization, ostracization, and threat of legal action. Awareness of the fate that often befalls whistleblowers can promote a culture of silence at universities, hospitals, and academic health centres. This workshop will examine the phenomenon of whistleblowers exposing clinical research misconduct. In particular, it will explore in detail particular cases in which whistleblowers have disclosed violations of scientific, moral, and legal norms. It will include presentations by whistleblowers and scholars who study research ethics and misconduct in clinical trials. The workshop will address five questions.
These questions are:
- 1) Why do laws and institutional policies often fail to protect whistleblowers from retaliation?
- 2) Why do senior administrators at universities, academic medical centers, and hospitals sometimes seek to dismiss, harass, silence, and intimidate whistleblowers while shielding from critical scrutiny researchers engaging in scientific misconduct?
- 3) What general lessons can be learned from careful study of particular cases of whistleblowing in Canada, Europe, the United States, and elsewhere?
- 4) How does responsible, evidence-based whistleblowing help protect the integrity of medical research and safety of research subjects?
- 5) Given the harms many whistleblowers suffer, what are the moral wellsprings or considerations of justice and fairness that prompt some individuals to reveal research misconduct?
Exposing scientific misconduct, protecting research subjects from additional harm, and promoting integrity of biomedical research often causes substantial harm to individuals who engage in whistleblowing.
Drawing upon particular cases and disciplinary perspectives from such areas of study as bioethics, law, medicine, sociology, philosophy, and history, this workshop will explore the moral, social, and legal phenomenon of whistleblowers exposing clinical research misconduct.
18 novembre 2015 - 20 novembre 2015 à Hermance (Suisse).