Tuesday, March 20, 2012

Human Subjects Experimentation Directives Ignored in the Grand Health IT Experiment?

The following represents some very inconvenient truths that have long been ignored.

Health IT is an experimental technology. The literature in 2012 remains conflicting on benefits and risks (the latter which is acknowledged, but whose magnitude is uncertain).

At NIH study sections, for example, research proposals that involve health IT (even modifications to existing applications) are subjected to far more scrutiny around human subjects protections, of both patients and investigators, than the typical wide-scale hospital implementation of enterprise health IT systems. The latter are validated and approved by - nobody.

How many of these directives are ignored in the Grand Health IT Experiment?

I've bolded the issues that I believe are ignored.

See "Reading list on health IT" for more information on conflicts in the literature:

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Directives for Human Experimentation

NUREMBERG CODE

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice [that is, to opt-out - ed.], without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person [information on HIT risk exists, such as on this blog - ed.] which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study [such as small scale controlled clinical trials with full informed consent and opt-out provisions- ed.], and not random and unnecessary in nature.
  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. [The magnitude of HIT risks are unknown - ed.]
  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
  8. The experiment should be conducted only by scientifically qualified persons. [Yet the HIT field is filled with amateurs - ed.] The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end [go back to paper - ed.] if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage [go back to paper - ed.], if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.

I'd thought these issues were settled after WW2, but apparently not.

-- SS

2 comments:

Becky said...

The Nuremberg Code was being broken by the US as it was being implemented. Informed Consent in psychiatry is barely paid lip service---and it is more than obvious that the drugs used are not as safe or efficacious as has been claimed. I understand this is a comment that is not on IT--however I have been pointing out repeatedly that my son's treatment by a lead researcher for NIMH and administrator of Washington State's only State-run psych. facility for children drugged my once brilliant son (my son's IQ was 146 at the age of 7 and could do triple digit addition in his head--w/o using his fingers) into a state of profound disability in spite of my vehement protests---He said I had NO SAY in what he was doing. He diagnosed him w/ schiz.---excluding Temporal Lobe Epilepsy by removing dx from his medical record. A founding member of CAFETY told me that, "Any parent who did not agree,"(give consent for their child to take psychotropic drugs)"would at best be perceived as ill-informed, and at worst as impaired themselves."

Rethinking Informed Consent in Research (Alexander Capron) from The Hastings Center http://youtu.be/B-hCsG_d62c

Anonymous said...

I am horrified by the atrocities inflicted on the innocent dependent patients who enter hospitals wired by HIT devices, who get care that benefits the vendors of CPOE and EHR systems, and get the risks of being guinea pigs in the HIT experiment.

The FDA has abrogated its responsibilities. They have become nothing but suits.

As for the first commenter, we know from Grassley investigations and reports on this blog by Dr. Poses that psychiatry researchers are known to be conflicted and unscrupulous in their use of patients. She should file suit against the manufacturer and the doctor, she should press the Office of Human Research Protection, and keep making waves.