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Government Regulations

The general nature of the Nuremberg Code led the Food and Drug Administration (FDA) and the Department of Health, Education, and Welfare (DHEW) (now the Department of health and Human Services--DHHS) to promulgate regulations governing human experimentation. These regulations were greatly influenced by the adverse publicity from several unethical research projects that have recently come to light. The main requirement of the regulations is that all human research funded by the DHHS and the FDA be approved by an institutional review board (IRB). These boards are composed of scientists and laymen who review research proposals before they may be performed in an institutional. When the IRBs first came into wide use, their limitations were examined by Hershey and Miller in Human Experimentation and the Law:

the proceeding events [publicity surrounding unethical research] note the increasing recognition of a responsibility to conduct institutional review both prior to the commencement of research involving a human subject and during the performance of such research as an attempt to protect the rights and welfare of subjects from the potential for abuse by investigators. Although procedures, policy documents, and codes cannot in themselves guarantee the integrity of the investigator in the conduct of research, oversight through institutional processes by both professional peers and other persons aware of the rights of a subject diminishes the likelihood that ethical and legal abuses of the investigator-subject relationship will occur. Quite simple institutional review represents recognition of the dangers of relying on the investigator to assess and protect the interests of the subject when there is a potential or actual conflict of interest between the investigator's research interests and the interests between the investigator's research interests and the interests of those who would be subjects in the study. Whether formal institutional oversight procedures by their very existence unreasonably impugn the integrity of investigators may well be a question for legitimate debate. Yet, such oversight is for the purpose of bringing to bear objective assessment of proposals for research activities and their conduct. All regulation of activity conducted by humans can be taken to denote doubt that ethical and legal requirements will be met solely through the exercise of individual integrity, particularly when it involves contact with others, which as a potential for exploitation. Given the elements of the usual relationship between the investigator and the subject, it is perhaps surprising that institutional review of any rigor has been so late in coming and is (except for research supported by DHEW funds or submitted to the FDA) so far from universally mandated by law.

Institutional review requirements are not intended and should not be taken to imply any lessening of investigator responsibility to design and conduct a study consistent with ethical and legal principles. Rather they should be recognized as imposing a process in addition to the investigator's own consideration of a proposed study and of the risks that could be associated with participation in it. The approval of a study after institutional review procedures have been completed does not mean that the investigator is then insulated from personal liability for harm suffered by subjects in the study caused by negligence or malpractice. All manner of complex questions of the standard to be applied in determining whether negligence or malpractice occurred may be presented in litigation. However, an incisive institutional review process conducted by persons who understand and fulfil their responsibilities as members of the board or committee should reduce the potential risk of liability to which the investigator is exposed below that which might be anticipated when the investigator was not required to submit his proposal for such review. This is most likely with regard to liability based on failure to secure a subject's informed consent.

Recognition must also be given to the limits of institutional review procedures in safeguarding the rights and welfare of subjects. The typical institutional review board does not possess the means to determine whether the proposal as approved is adhered to by the investigator unless complaints or inquiries are brought to its attention. In large measure, the continuing oversight and periodic review depends on the information provided by the investigator to the institutional review board. The quality and completeness of the information, in turn, depend on the integrity and capability of the investigators and their willingness to abide by the ethical and legal principles of which they are assumed to be aware. since institutional review processes do not supplant the investigator's personal responsibility in the conduct of research, it is apparent that the investigator's liability under the law remains for harm resulting from conduct that fails to meet standards applicable to the activities in which he is engaged.

As IRBs have become a routine part of medical research, it has become clear that their effectiveness is extremely limited. Their primary weaknesses are their inability to monitor the actual conduct of experiments and the ability of researchers to avoid IRB review completely by conducting research under the guise of treatment. For these reasons, a quality control manager should not rely on the IRB to ensure that medical research is properly conducted in the institution.

The quality control manager should maintain a file of all human research projects going on in the institution. The projects should be divided into those with a high risk of injury and those with a low risk injury. If the hospital has a data-base management system to analyze and tabulate data from records like incident reports, a file should be established for each protocol. The investigator should provide the quality control manager with the names of all persons who are part of a research protocol. The names may then be monitored to detect adverse drug reactions, patient complaints, and other problems that arise in the course of treatment. This type of computer monitoring is a powerful method of detecting potential risks that arise in the course of research.

Computer analysis of utilization review data may facilitate the detection of unauthorized experimentation. The usual sign of unauthorized experimentation is an unusual pattern of tests or procedures. The nursing staff should be cautioned about the legal and ethical problems involved in unauthorized research. The nurses can provide the best safeguard against unauthorized experimentation if they realize the serious nature of the problem and are willing to cooperate in dealing with it.


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