Institutional review boards (IRBs) are integral to the US system of protection of human
research participants. Evaluation of IRBs, although difficult, is essential. To date, no …

Context: Federal regulations mandate independent review and approval by an “institutional
review board”(IRB) before studies that involve human research subjects may begin …

Informed consent should be seen as an essential part of health care practice; parental
permission and childhood assent is an active process that engages patients, both adults and …

BACKGROUND: Despite the fact that many pregnant women are affected by a range of
serious health conditions and take medications for these conditions, there is widespread …

Social networking web sites are popular among adolescents and may represent a new
venue for conducting adolescent health research. Conducting research by using social …

The unique vulnerability of children as research subjects came to light when Henry Beecher
1 published a landmark article in the New England Journal of Medicine entitled,“Ethics and …

The ethical ideal of respect for all persons supports respect for the developing autonomy of
children and adolescents in decisions about their participation in research. 1-5 This respect …

Purpose: Over the last 50 years, direct communication about cancer with adults has shifted
from an approach of not telling to one of telling. Less is known about communication …

Obtaining assent is an important part of research involving children, both from an ethical and
regulatory perspective. Current practice for documenting assent is derived largely from …

In this article, I scrutinize the process by which scientific research on human subjects is
regulated by Institutional Review Boards (IRBs). At the outset, let us agree that at least some …