Biomedical Engineering Reference
In-Depth Information
injury, disability, or death to the subject. Conforming to conditions of this sort probably
does limit the pace and extent of medical progress, but society's insistence on these condi-
tions is its way of saying that the only medical progress truly worth having must be consis-
tent with a high level of respect for human dignity. Of these conditions, the requirement to
obtain informed and voluntary consent from research subjects is widely regarded as one of
the most important protections.
A strict interpretation of the criteria mentioned above for subjects automatically rules
out whole classes of individuals from participating in medical research projects. Children,
the mentally retarded, and any patient whose capacity to think is affected by illness are
excluded on the grounds of their inability to comprehend exactly what is involved in the
experiment. In addition, those individuals having a dependent relationship to the clinical
investigator, such as the investigator's patients and students, would be eliminated based
on this constraint. Since mental capacity also includes the ability of subjects to appreciate
the seriousness of the consequences of the proposed procedure, this means that even
though some minors have the right to give consent for certain types of treatments, they
must be able to understand all the risks involved.
Any research study must clearly define the risks involved. The patient must receive a
total disclosure of all known information. In the past, the evaluation of risk and benefit in
many situations belonged to the medical professional alone. Once made, it was assumed that
this decision would be accepted at face value by the patient. Today, this assumption is not
valid. Although the medical staff must still weigh the risks and benefits involved in any
procedure they suggest, it is the patient who has the right to make the final determination.
The patient cannot, of course, decide whether the procedure is medically correct, since that
requires more medical expertise than the average individual possesses. However, once the
procedure is recommended, the patient then must have enough information to decide
whether the hoped-for benefits are sufficient to risk the hazards. Only when this is accom-
plished can a valid consent be given.
Once informed and voluntary consent has been obtained and recorded, the following
protections are in place:
It represents legal authorization to proceed. The subject cannot later claim assault and battery.
It usually gives legal authorization to use the data obtained for professional or research
purposes. Invasion of privacy cannot later be claimed.
It eliminates any claims in the event that the subject fails to benefit from the procedure.
It is defense against any claim of an injury when the risk of the procedure is understood
and consented to.
It protects the investigator against any claim of an injury resulting from the subject's
failure to follow safety instructions if the orders were well explained and reasonable.
CASE STUDY: CONFIDENTIALITY, PRIVACY, AND CONSENT
Integral to the change currently taking place in the United States health care industry is the
application of computer technology to the development of a health care information system. Most
major hospitals in the United States have now updated their systems to entirely electronic data-
bases. Patient medications are scheduled and followed by a nurse on a computer module present
