Tag: Arlene Davis

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with...

Mark Baumgarten and Tyler Clay will join the Clinical Ethics Discussion Group as student leaders, and the Hospital Ethics Committee as student members, in January 2019. Center for Bioethics faculty members Arlene Davis and Eric Juengst are advisors to the student group and Arlene Davis co-chairs the Hospital Ethics Committee.  ...

This pilot study reports on a survey regarding recruitment, appointment, and training of members for health care ethics committees (HCECs). Background: Past studies have examined HCECs, but have focused on the roles of the committees and the broad makeup of membership. Thus, our study fills an important knowledge gap in...

This pilot study reports on a survey regarding recruitment, appointment, and training of members for health care ethics committees (HCECs). Background: Past studies have examined HCECs, but have focused on the roles of the committees and the broad make-up of membership. Thus, our study fills an important knowledge gap in...

Aims: Do biobanks enact policies and plans that allow them to anticipate and respond to potential challenges? If a biobank has one such policy or plan, is it likely to have more? Using survey data from 456 U.S. biobanks, we assess four possible indicators of such “forward-thinking.” Methods: We present...

BACKGROUND: Advances in genomics have led to calls for returning information about medically actionable genes (MAGs) to patients, research subjects, biobank participants, and through screening programs, the general adult population. Which MAGs are returned affects the harms and benefits of every genetic testing endeavor. Despite published recommendations of selection criteria...

The regulations governing human subjects research (Common Rule) remain largely unchanged since their adoption. As a first step in their revision, the federal government published the Advance Notice of Proposed Rule Making (ANPRM) in 2011. The public responded with over 1100 comments. We selected a random sample of 300 comments,...

This chapter explores some of the linguistic aspects of informed consent to genetic biobanking, defined as the collection and storage of DNA samples and derived information for present and future research purposes. Drawing on the linguistic literature, the chapter examines informed consent from the perspective of speech act theory. Qualitative...

Advances in genomics have led to calls for developing population-based preventive genomic sequencing (PGS) programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control...