Wednesday, February 17, 2010

The Declaration of Helsinki

Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a]. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1).

Basic principles

The fundamental principle is respect for the individual (Article 8), their right to self determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9).

The right to informed decisions, AKA informed consent, is the ethical cornerstone of every bit of counseling clinicians provide. Tell me, do you think it was proper informed consent to leave out the prospect of the unnecessary diagnosis of breast cancer in the 30 years of screening mammogram counseling?

1 comment:

  1. Some critics have said that clinicians, consumers and payers need to know whether or not a new treatment is better than other existing comparable treatments, not a (is this better than nothing) placebo.

    The trials with people in this instance are ones who ought to be on some sort of medication. So providing them with nothing, rather than an existing drug, is a serious situation.

    It's been an ethical question for a long time here in the United States. Some cannot see that anyone would do something so unethical as set up a trial that did not offer the chance at the current standard of therapy versus a new drug.

    Being on a placebo for a few months means that a cancer seriously can progress to the point that treatment would no long benefit them. No thanks! I'd skip clinical trials.

    There are some medical oncologists utilizing cell-based bio-markers for years in their managment of their cancer patients that feel it is unethical not to use them, as opposed to "trial-and-error" treatment. Science is in the eye of the beholder. If you know something works better than nothing......