Recombinant DNA Advisory Committee - 09/14-15/92 
Ms. Buc said that in the few reported cases of litigation, almost all of the patients have 
been denied recovery. If the informed consent document is clear and accurate, there 
should be no negligence on the part of the investigator or the sponsoring institution. 
Mr. Capron explained that one of the conclusions of the task force is that the reason for 
the low incidence of injury claims is probably due to the level of care that research 
subjects generally receive. Under normal circumstances, patients usually receive better 
care in the research setting than under the care of a primary physician. Negligence can 
occur by withholding something that is desirable, applying something that is desirable in 
an incorrect way, or by giving something that is undesirable. Mr. Barton stated that he is 
not as confident about the low number of liability cases as other RAC members. It is 
this fear of liability that is serving as a major deterrent to development of major research 
products, such as vaccines. Occasionally legislation is submitted to shift the responsibility 
for liability to the Federal Government to cap liability claims; however, other than the 
Swine Influenza legislation, none of these efforts have been realized. 
Dr. McCarthy addressed the responsibilities of IRBs and the sponsoring institutions. The 
IRB is advisory to the institution except for the case when a protocol has been rejected. 
In that case, the IRB has veto power over research involving human subjects. The 
IRB/institution relationship is analogous to the RAC/NIH Director. Theoretically, the 
NIH Director would have the authority to approved a protocol that has been rejected by 
the RAC. However, such an outcome is unlikely. 
Dr. Chase inquired if subjects are compensated for lost wages during the time that they 
participate in a research study and would receipt of such a payment alter their capacity 
to recover damages in a lawsuit. Dr. McCarthy responded that payment to a participant 
in a research study does not prevent them from initiating litigation. With regard to 
compensation for participation in a study, the Code of Federal Regulations are very vague 
stating that the amount of money offered to a subject should not be coercive. This 
amount of compensation is largely a judgement call by the IRB as to whether it is 
coercive with respect to the patient population. NIH generally compensates for travel 
expenses and lost wages during treatment. 
Dr. Zallen asked if the Task Force, President's Commission, or any of the various 
committees ever made a distinction between therapeutic and non-therapeutic research. 
Dr. McCarthy said that a distinction was attempted; and at the time of the study, no 
injuries had been attributable to non-therapeutic research. Often, the distinction 
between therapeutic and nontherapeutic is unclear. For that reason, the terminology was 
changed to refer to research that is directly intended to benefit the patient versus not 
intended to benefit the patient. Dr. Zallen noted that the issue of compensation for 
research related injury was discussed at the November 21-22, 1991, Human Gene 
Therapy Subcommittee (HGTS) meeting. She and Ms. Buc drafted a resolution 
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Recombinant DNA Research, Volume 16 
