An exercise in fatuity: research governance and the emasculation of HSR.

The ethical governance of health services research (HSR) is in a mess internationally. Policy-makers and research commissioners are unable to obtain prompt answers to their questions at reasonable and proportionate cost. Researchers adopt scientifically problematic methods, delivering less reliable and valid results, because of the ignorance and prejudices of ethics review committees ill equipped to deal with their projects. Excessive and inappropriate bureaucratic requirements soak up the expensive and valuable time of skilled investigators. When such problems are encountered globally, we cannot attribute them to the incompetence or ill will of particular national systems – indeed the problem is, in many ways, one of good intentions. Ethics review was introduced for the best of motives: criticizing the protection of human subjects is like criticizing motherhood and apple pie. However, this concern for protection arises from a history of abuses in biomedical research that have no counterpart in the social sciences that underlie HSR. The ethical analysis of, and institutional responses to, these abuses are irrelevant to HSR. Why has governance of ethics been established in biomedical research? The conventional story presents this as a simple response to the wartime medical experimentation of Nazi Germany. We often prefer not to recall exactly what this involved: dunking male prisoners in freezing water or strapping them to stretchers outdoors in sub-zero temperatures to induce hypothermia, and then warming them with intense sun lamps, internal irrigation with near-boiling water or sexual intercourse; twin studies involving forced gas inhalation to induce sputum, 2-L enemas preceding intestinal examination without anaesthetic and other procedures before the victims were killed by lethal injection and dissected. Other examples included sterilization with caustic substances injected into the uterus and deliberate infection with lethal diseases. However, historians have increasingly shown that Allied physicians did not have clean hands. The ‘moral consensus’ against which Nazi doctors were judged was hastily fabricated just before the opening of the Nuremberg Trial. Similar atrocities by Japanese doctors were covered up in the interests of post-war reconstruction and some of the wartime and post-war experiments conducted by the Allies have not withstood subsequent scrutiny. Whistleblowers like Henry Beecher and Maurice Papworth questioned the routine assumptions of medical research in the 1950s and 1960s, challenges that led ultimately to the present regimes for the regulation of biomedical research. It is hardly surprizing, then, that suspicion attaches to biomedical research. Professional or commercial interests necessarily compromise investigators’ motives and the potential for harm is significant. In this context, the desirability of a detailed independent review of research risks and benefits is understandable, as is the insistence on the voluntary informed consent of participants. However, what is it about either the past or present conduct of HSR that begins to compare with the hazards to which participants in biomedical studies have been, and are being, exposed? Where are the risks of death or serious, disabling and permanent injury? Clearly, there is potential for minor and transient emotional distress, for a degree of embarrassment and for some loss of privacy, although all are wellacknowledged problems with responses that do not depend on governance processes: if someone starts crying in an interview, then you suspend the questioning. HSR is not homeland security. However, there is another crucial difference between biomedical research and HSR, and that is the nature of the obligation to participate. Although it has been argued that there is a general duty to participate in clinical research on communitarian grounds, the obligation to take part in HSR derives from the basic conditions of illness as a social role. Half a century ago, the great American sociologist, Talcott Parsons, pointed out that sickness is essentially a dependency claim by those who are unable to perform normal social roles on those who can. For this claim to succeed, claimants – the sick – must constantly demonstrate their commitment to limiting the burden on the well. As others, particularly Eliot Freidson, have noted, this obligation presents difficult problems for the long-term or chronic sick. However, they do not escape it – Erving Goffman, for example, describes paralysed polio victims in iron lungs winking at medical and nursing staff to show that they are really trying to recover, to minimize their dependency claims, however desperate their situation. Economic growth over the years since Parsons first published his analysis has blunted its impact, but it returns to haunt us as we confront the limits of the willingness of the well to pay taxes or insurance premiums for the care of the sick. The UK government has signalled its desire to shift to a ‘something for something’ approach in relation to the support of the long-term sick and disabled, and its reluctance to continue funding future increases in health care expenditure at current rates. US national health expenditure is now 16% of gross domestic product and projected to rise to 18.7% by 2014, and it is hard to imagine that similar considerations can long be avoided.