Neither Informed Not Consenting

Neither informed nor consenting

By Sonia Shah

Since fewer than 1% of Indians have health insurance, most people pay upfront for care and a personal relationship with a physician is highly prized. The balance of power between doctor and patient is therefore different from the way it is in the West. Farhad Kapadia, a clinical investigator at Hinduja Hospital in Mumbai, says that only those who "have absolutely no choice" agree to forsake the judgment of their physician for a protocol randomly selected by a computer which would leave them ignorant about what is being administered to them. So those who take part in clinical trials are the poorest, living in a different world from socially powerful doctors.

US Food and Drug Administration officials claim to have confidence in the ability of trial subjects to protect themselves by giving or withholding consent. Dr Robert Temple, the FDA's medical director, says questioning the ability of poor patients to exercise informed consent is patronising: "You can't treat them as incapable of pursuing their own ends." Illiteracy and poverty are not insurmountable barriers: scientific concepts in clinical research might be foreign but they are not incomprehensible.

Medical anthropologists have devised a simple way of verifying that consent in a trial is informed. Questionnaires handed to 33 Thai participants in an HIV vaccine trial revealed 30 of them were misinformed. All the subjects in a contraceptive study in Brazil were found to be misinformed. In an HIV transmission trial in Haiti, 80% were found to have misunderstood the basic outlines of the trial. "Informed consent is a joke," an investigator told the National Bioethics Advisory Commission. Another said: "It is not possible to claim that a person who has never heard of a bacteria or virus is informed." Another: "This concept of consent of the individual… doesn't exist. People do what they are told."

Since 2001 the FDA has been slowly trying to distance itself from the Declaration of Helsinki, because it deems the protections too stringent. The FDA refused to incorporate new restrictions on placebo trials in 2001, and it continues to oppose several paragraphs in the declaration. The zeitgeist was summed up last year, when the leading scientific advisory body in the US, the Institute of Medicine, recommended lifting bans on trials on prisoners, describing as "myopic" the concerns about informed consent that have prevented experiments on prisoners for decades.

Le Monde Diplomatique