"Human experimentation.

The concomitant problems of underenrollment and selective enrollment limit the efficiency of many randomized controlled trials (RCTs). In addition, the traditional informed consent process is often inadequate to respect research participants' autonomy. Past efforts to overcome these problems are not universally applicable. A new method, called prospective preference assessment (PPA), is suggested as a way to simultaneously enhance participant accrual, identify groups of patients to whom a trial's results may apply, and promote participants' interests. PPA is a method by which investigators would evaluate potential trial participants' motivations for and concerns about enrolling in a planned trial prior to formal recruitment. The information provided by PPA would then be used to (1) modify the final trial design and conduct to make enrollment more attractive, and (2) identify ways in which the patients who do enroll may differ from those who do not, thereby elucidating the trial's generalizability. The methodologic and ethical advantages of this method are described, and potential barriers to the method's implementation are addressed. The added costs of prospectively assessing the views of potential research participants prior to initiating RCTs are considered in relation to the method's ability to enhance the value of the information to be obtained. It is concluded that PPA is a feasible approach to a more democratic and efficient research process and that its adoption would be consistent with current trends in health care.

Human Experimentation↗

PubMed2001

The concept of risk in biomedical research involving human subjects.

An established ethical principle of biomedical research involving human subjects stipulates that risk to subjects should be proportionate to an experiment's potential benefits. Sometimes this principle is imprecisely stated as a requirement that 'risks and benefits' be balanced. First, it is noted why this language is imprecise. Second, the persistence of such language is attributed to how it functions as a rhetorical trope. Finally, an argument is made that such a trope is infelicitous because it may not achieve its intended persuasive purposes. More importantly, it should be avoided because it masks the important role that chance plays in clinical research. Risk is the possibility of harm. As a precondition of harm it is unintended and undesirable in projects of biomedical research. It requires ethical vigilance. As a vehicle of chance, however, it is both intended and desirable. It requires methodological appreciation.

Human Experimentation↗