Tag: Arlene Davis

The likelihood of benefit is fundamental to decision making about newborn screening. But benefit is construed in different ways by different stakeholders. This article begins with a review of benefit as considered historically by various expert panels and organizations. We then show how 78 conditions fared when experts recently rated...

Appelbaum and colleagues first described the “therapeutic misconception” in 1982. There has been much discussion since then about whether and why some patients who enter clinical trials confuse research with treatment and overestimate the nature or likelihood of benefit to them from research in which they enroll, and about whether...

We report on a study of potential sources of therapeutic misconception in early phase gene transfer research, examining how investigators and their consent forms represent the prospect for direct benefit. Our analysis demonstrates that even though half of PIs said they expected direct medical benefit for their subjects, they did...

The critique of vulnerability offered by Levine et al. (2004) affirms recent discussions about the disutility of this imputed characteristic of individuals and groups for protecting research subjects. Being “too broad,” vulnerability stereotypes whole categories of individuals, and everyone might be considered vulnerable. Being “too narrow,” vulnerability’s focus on group...

Over the past decade, the number of clinical trials registered with the Food and Drug Administration (FDA) has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns...

There are increasing expectations about the potential of medical research to produce clinically significant benefits. And the increasing public demand to participate in clinical research reflects expectations that individuals can directly benefit from research participation. At the same time, there is growing concern about the adequacy of the system of...

On 2 October 1996 the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) each published a final rule allowing emergency research to proceed without the consent of its participants in a strictly limited circumstance. This waiver of informed consent applies to “research activities that...