Tuesday, November 15, 2005


In the USA, institutional review boards (IRBs) must meet federally mandated requirements. In Pittsburgh University, where I worked until recently, my last IRB submission ran over 60 pages, included two consent forms, one of which was 13 pages long, and I was required to submit 26 copies. The 24 members of the IRB would meet to discuss applications at regular intervals. After review, the board would require resubmission of the entire application, including a memo describing amendments addressing the board's concerns. The board could then reconvene to reconsider the application or the chairman could be empowered to approve the application directly. This process can take as little as two months but typically takes between six and 12 months.

Ethics applications in the UK are starting to look more like those in the USA, especially applications that pass through the NHS. Ask any medical researcher in the UK about their experiences with NHS ethics and you are unlikely to hear any positive words. The introduction of a patient leaflet, for example, designed to improve older patients' involvement in GP consultations, was reviewed by an NHS committee with an estimated five days of preparatory work .

For a more involved multicenter clinical trial, an investigator must submit copies of the study protocol to each of the participating centres ethics committees. For one trial, this resulted in up to 21 copies of the protocol being submitted to 125 local research ethics committees. Eighty-four of these committees withheld approval until the researchers had made amendments. This process can take years to complete. Another clinical trial involving 51 centres needed over 25,000 pieces of paper, 62 hours of photocopying and 170 hours of investigator time. This is an entirely different matter to basic peer review to ensure subject care and safety. Ethics review within the USA and the British NHS has become completely irrational.

But the problem is not just that ethics committees provide formidable technical barriers for researchers. It's also that they undermine medical ethics. There are three main problems with these committees: they place barriers between patients and potentially beneficial treatment; they distance the researcher from thinking about ethics; and they offset responsibility for the conduct of the research on to the patient. As such, they are a danger to both patient and investigator and should be abolished.

Let me illustrate the first point. If you are unfortunate enough to enter hospital with a recent onset heart attack, you are likely to receive a combination treatment of streptokinase and aspirin. Patients who received this combination treatment in a trial of 17,187 patients had a mortality rate of eight percent. Patients who received placebo had a mortality rate of 13 percent. The treatment therefore provides for significant improvements in survival. Relative to the USA, recruitment into the trial was quicker in the UK and thus the benefits were seen earlier and the treatment adopted earlier. Whatever it was that slowed recruitment into the American trial has been estimated to have caused 10,000 unnecessary deaths. Erecting barriers to the progress of research, in the absence of any benefit and with evidence of harm, is surely unethical.

The second problem is that ethics committees distance medical professionals from their ethical responsibilities. Partly this is just a natural response to the burgeoning amount of paperwork that an investigator has to submit before embarking on a study or change in practice. No one person is likely to be able to have the time and expertise necessary to submit multiple protocols to multiple committees. Consequently, increasing numbers of senior investigators are employing administration staff or students to complete the necessary paperwork. Rather than being something the investigator thinks about and addresses, ethics becomes a technical exercise that is placed, as much as possible, into the hands of junior colleagues.

Alternatively, investigators simply avoid ethics applications through technical dodges, such as claiming the research to be an audit that is exempt from review (5), or through an avoidance of research altogether.

Investigators are also becoming ideologically distanced from the process of ethical review. The purpose of ethical review is to ensure that the investigators, particularly the senior members of any research team, consider how their proposed procedures might impact upon the wellbeing of their volunteers and patients. Whether or not a particular procedure should be performed or a particular treatment tested can turn on many quirky factors that can only ever be fully known by those directly involved. The expert judgment of medical professionals should not be replaced by mouthing answers to committees' formulaic questions.

Many years ago I was involved in a trial investigating the effects of pain following the extraction of wisdom teeth. We were particularly interested in the performance deficits that the pain caused during a simple card sorting task and the effects of morphine on their task performance.

The extraction procedure was always completed in the morning and the patients were then taken to an overnight ward to recuperate. The intention was to wait until the anaesthetic was no longer effective and then begin the card-sorting task. All procedures had to be completed before 5pm when our medical collaborator left for the day, which meant that we had to begin the testing by 4pm. It soon became clear that some patients were waiting us out. A patient would steadfastly deny any pain, despite fairly obvious signs to the contrary, but would promptly announce their pain at 4:05pm. (I suspect that they either did not want to actively withdraw from the study, or they falsely believed they would not get pain relief if they did actively withdraw from the study.) We resolved the problem by offering the patients pain relief at regular intervals after they arrived on the ward and by regularly reminding them that they were under no obligation to complete the study.

Importantly, at no point were we in violation of our ethics approval. We had no objective evidence that patients were in excessive pain and no proof that they had misunderstood their access to pain medication. Had our concern for our patients stopped at the point of receiving ethical approval we may never have introduced any changes to our procedures. As the difficulty of receiving ethics approval increases and as the physical and mental distance between investigators and ethics committees widens, a lack of concern for patients is likely to increase.

The final problem is that responsibility is being offset on to volunteers through consent forms. Sometimes the displacement is so crude and obvious that it boggles the mind. When my wife went into labour last year, we arrived at the hospital at around 1am. Before she was allowed into triage she had to sign three separate consent forms. Neither of us read a single word. This mocks the term 'informed consent'. This is a bureaucratic exercise designed to ensure that the hospital avoids liability in the event of anything going wrong.

More here

The Disuniting of Europe -- and America

Americans might be forgiven for experiencing a sense of schadenfreude -satisfaction in the misery of others - at the rioting in France. The jihad is coming home, it would appear, to a corrupt French political elite that thought it could appease Muslim extremists by snubbing the United States in Iraq.

America, by contrast, is suffering no such anger in the streets. Around metropolitan Detroit, for example, home to one of the largest concentrations of ethnic Arabs and Muslims outside the Middle East, all is peaceful, despite strongly-held beliefs among community leaders and local imams that U.S. policy in the Middle East is badly misguided.

The reason is fairly clear: Detroit's Arab-American population, usually estimated at between 100,000 and 200,000, is a model of upward mobility, thanks to auto industry employment in the early days and, more recently, ability to capitalize on its own entrepreneurial energy. Americans of Arab descent have a strong stake in society. In France, by contrast, where overall unemployment has long hovered in the 10 percent range -and at least twice that for the ethnic Arab population -- despair and anger are rampant.

To this economic disorder has been added a severe moral disorder: an ideology of multiculturalism that is even more deeply entrenched in Europe than in America. It invites disaffected communities to dwell on their grievances and reject the common values that allow people of differing backgrounds to work together. The multicultural message: somebody else is responsible for your problems.

Before Americans wax too self-congratulatory, however, they should remember that similar forces are afoot here that, if unchecked, could unleash the same social toxins. Stubbornly high taxes and job-killing regulations - including union-backed minimum wage, prevailing wage and "living wage" schemes aimed at preventing willing workers from undercutting union wage levels -- make it difficult to sustain the economic growth that mutes social tensions.

And multiculturalism already is the official ideology among American elites: witness the fanatical allegiance to "diversity" within the education, political and business establishments. Virtually every establishment group in Michigan, for example, has already come out against a pending 2006 referendum that would outlaw racial preferences in university admissions and state hiring. Even businessman Dick DeVos, the odds-on favorite to be the Republican candidate for governor, has rushed to distance himself from the measure.

Affirmative action was invented mainly to help African Americans in the wake of the Jim Crow era. But now that official segregation is long behind us, it's being replaced by the more amorphous goal of "diversity." Almost any group with a grievance is being invited to join the racial spoils game. Talk about a perfect formula for producing what liberal historian Arthur Schlesinger, in a book attacking the separatism implicit in multiculturalism, termed "the disuniting of America."

Just as deadly are the taxes and regulations that suppress job formation - or drive it underground, where the jobs can only be filled with continuing streams of illegal immigrants, creating a potentially dangerous underclass like that in Europe. Many on the left and right want to deal with this by enacting tough new measures to seal the southern borders and send the estimated 10 million illegal immigrants already inside the United States packing. It's likely to be a dominant issue in 2006 and 2008.

But good luck trying to build and effectively patrol a wall along a 2,000-mile border, much less apprehending and expelling millions of Mexicans and others for the sin of taking jobs that in effect are created by government's burden on the economy. A more cogent immigration policy may be long overdue. But if we don't also learn the right lessons from Europe's experience, we may be doomed to repeat it.


No comments: