Background -- Evaluating the worry -- Proposed justifications -- Human interests and human causes -- Our connection to our contribution -- The value of passive contributions -- Implications -- Objections and the potential for abuse.

There is widespread discussion concerning the safeguards appropriate for human research subjects. Less discussed is the fact that the safeguards one deems appropriate depend, in large part, on the model of research participation that one assumes. Therefore, to determine what safeguards are appropriate, it is necessary first to clarify the competing models of research participation. The ostensibly obscure debate over informed consent for research on stored biological samples is of particular interest in this regard because such research can involve varying (...) subsets of the three central elements of research involvement. As a result, analysis of this debate provides an opportunity to identify the competing models of research participation. Based on this analysis, this paper describes a new model of research participation that is emerging, and considers its implications for clinical research. (shrink)

: When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than "minimal" risks, according to guidelines accepted around the world. We need a new standard for what "minimal" risks are, howeve--one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.

When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than “minimal” risks, according to guidelines accepted around the world. We need a new standard for what “minimal” risks are, however—one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.

Pediatric research without the potential for clinical benefit is vital to improving pediatric medical care. This research also raises ethical concern and is regarded by courts and commentators as unethical. While at least 10 justifications have been proposed in response, all have fundamental limitations. This article describes and defends a new justification based on the fact that enrollment in clinical research offers children the opportunity to contribute to a valuable project. Contributing as children to valuable projects can benefit individuals in (...) two ways. First, individuals may come to ?embrace? the contributions they made as children. Second, contributing to valuable projects can lead to a better overall life. Because these potential benefits can outweigh small research risks, they provide a justification for pediatric research without the potential for clinical benefit, when it poses low risks and has the potential to benefit others in important ways. (shrink)

While an accurate assessment of risk is always important, it is especially so in pediatric research. Recognizing the pivotal nature of the minimal-risk standard, we set out to determine under what circumstances pediatric magnetic resonance imaging research does or does not meet this standard. We found that while the physical and psychological risks that attend the MRI procedure do not exceed minimal risk, the sedation and contrast enhancement that are sometimes associated with MRI research do, as both exceed the level (...) of risk encountered by typical, healthy children in their everyday experiences. (shrink)