Recombinant DNA Advisoiy Committee - 09/14-15/92 
for such injuries in the near future, the Office of Protection from Research F and the 
President's Commission endorsed the recommendation of the Ethics Advisor}' Board. 
Namely, research subjects should be informed as to whether or not a research institution 
is prepared to provide compensation in the event of unforeseen injury. Consequently, 
informed consent documents are required to state if compensation for injury t a may be 
research related will be provided. Although several institutions in the U.S. c / 
insurance to cover such compensation, the majority do not regard themselves obliged 
to provide compensation in the event of research related injury. 
The Code of Federal Regulations does not permit exculpatory language. That is, a subject 
cannot waive his/her rights to bring lawsuits or seek compensation in the event of injury 
or harm. Therefore, subjects always have the option of bringing lawsuits against the 
sponsoring institution. Anecdotally, minor injuries related to research are always treated 
free of charge by the sponsoring institution. Long-range chronic injuries are not likely to 
be compensated. 
Discussion 
Dr. Parkman noted that a further complication to this issue is randomized clinical trials 
in which the patient may agree to participate in a protocol but not have a choice 
regarding the type of therapy that will be received. Would the institution be required to 
cover injury related to the standard treatment because it was included as a part of the 
experimental randomization? 
Dr. Krogstad asked if there have been any instances in which non-negligent injury that 
has caused serious injury or death has been disputed and gone on to litigation in which 
the courts have had to make a judgement. Dr. McCarthy stated that he was not aware 
of any such cases where negligence was not an issue. Mr. Capron added that there have 
been a number of lawsuits resulting from the absence of informed consent. For example, 
at the University of Chicago, women were given diethylsibesterol (DES) experimentally 
for the prevention of miscarriage without their knowledge. While the women receiving 
DES had no complications from the drug, untoward effects were observed a generation 
later in their offspring. As for the case of non-negligence, most attorneys woi probably 
advice against litigation because the recovery is likely to be small. 
Mr. Capron noted that one of the drawbacks of the Worker’s Compensation m for 
the payment of non-negligent research related injury is that a typical Worker 
Compensation claim is made by a normal subject. In the case of research subjects with 
disease, one must consider treating the natural course of their disease as a contributing 
factor. Sponsoring institutions may end up paying for events resulting from est in 
addition to the treatment. 
Recombinant DNA Research, Volume 16 
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