In Loco Parentis Minimal Risk as an Ethical Threshold for Research upon Children

Abstract

To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.

Perception of risk associated with asthma research procedures among adolescents, parents, and pediatricians

“…4,5 The formal definition of minimal risk in biomedical research is ''risks ordinarily encountered in daily life.'' 6 Although there are examples of minimal-risk research, the definition is again vague, 7 with local institutional review boards (IRBs) given the ultimate responsibility for interpretation, resulting in substantial disagreement, confusion, and variability in the application of federal guidelines. 1 The IRB Guidebook provides several benchmark examples of minimal research procedures, including venipuncture.…”

Research involving the vulnerable sick

“…The threshold concept of minimal risk, as argued by Freedman et al (1993), applies only to non-therapeutic risks. Thus, Abramson's concern for the "side effects of the experimental therapy" is entirely irrelevant to the determination of minimal risk.…”

In Defense of a Single Standard of Research Risk for all Children

“…However, the concept of a ''scrupulous parent'' is a social (not psychological) construct that reflects a considered judgment about the level of risk to which a parent should expose a child. 8 As such, the concept of a ''scrupulous parent'' provides a richer moral context with which to judge ''socially acceptable risk'' than that provided by Wendler and Emanuel. 5 The argument presented by Wendler and Emanuel 5 in favor of the ''socially acceptable risk'' standard operates on the well-documented ambiguity in the interpretation of minimal risk.…”

“…Rather, the ''scrupulous parent'' standard should be interpreted to incorporate both minimal risk and a minor increase over minimal risk within a single ethically justified standard. 8,11 To accomplish this, Subpart D should be amended to include a child-specific definition of minimal risk rather than rely on the general definition found in the Common Rule. 12 We offer for consideration a modification of the definition of minimal risk proposed by Ackerman: 11 ''the probability [and magnitude] of physical [or] psychological harm is no more than that to which it is appropriate [for a scrupulous parent] to intentionally expose a child for educational purposes in family life situations.''…”