Barbra Bluestone Rothschild

Clinical Trials and Medical Care: Defining the Therapeutic Misconception

A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment.

Return of results: not that complicated?

The return of results (ROR) to research subjects in genetic studies has generated tremendous controversy. It is a topic that has caught the attention of a wide range of stakeholders and opinion-makers and resulted in the spilling of voluminous ink. Indeed, this month we feature an issue entirely devoted to the subject. There are many difficult dilemmas to be confronted, which, along with a number of intriguing solutions, are presented in this special issue of Genetics in Medicine. At the risk of oversimplifying an admittedly highly complex set of issues, it may be worthwhile to start from first principles as we attempt to navigate this complicated topic. In this essay, we begin with a few well-accepted ethical principles, a consideration of the central intent of research, and the nature of those results likely to be generated in a genetic study. From that foundation, we attempt to formulate some coherent conclusions that might offer guidance to both researchers and potential subjects as we struggle with this topic. We start with the following principles that we suspect are relatively uncontroversial:

Parents' online portrayals of pediatric treatment and research options.

Parents of seriously ill children face difficult decisions when standard therapies are limited or ineffective. In their search for information, they may turn to websites created by other parents facing similar experiences. We conducted a qualitative content analysis of 21 websites created by families with children affected by cancer or genetic disease, two serious conditions with a range of treatment and clinical trial options. Our research questions address how parent authors portray serious pediatric illness, available options, parties to decision making, and sources of influence. In addition, we examine what these sites reveal about family vulnerability to various risks, particularly the risk of misunderstanding the distinction between standard treatment and research and the risk of overestimating the likely benefits of research participation, as well as whether vulnerability varies by type of condition. Our results demonstrate typically favorable views on research, but with inadequate distinctions between research and treatment and a complex set of trade-offs in consideration of research risks and potential benefits. While portraits of vulnerability emerge for both parents and children, so do portraits of strength and resilience. As a result, parents describe frustration with both under- and over-protection from research participation. Our discussion of these findings clarifies the potential for parent-authored websites to inform and influence families considering research and treatment options for their seriously ill children.