Suchergebnisse

Genetic research can produce information that is beyond the aims of the research study yet may be of clinical or personal interest to study participants. We conducted semi-structured interviews with 44 researchers who were asked to describe how they would respond to a hypothetical vignette regarding the disclosure of findings with unanticipated clinical significance to research study participants. Interviews were transcribed and analyzed using content and thematic analyses. Researchers' decision-making processes about whether to disclose incidental findings were governed by potentially conflicting duties in three primary domains: Information quality, adherence to rules, and participant welfare. There are several actions researchers can take to prepare for incidental findings, including: Adding specific language in informed consent documents to state clearly how investigators will handle disclosure; exploring how prepared participants might be during the consent process to make decisions about how they would like to be approached in the event of incidental findings; developing procedures for appropriately communicating individual results and providing follow-up support based on participant preferences; and, in genetic research, having an awareness of the range of traits expressed by the genes under study.

The scientific and public health benefits of mandatory data-sharing mechanisms must be actively demonstrated. To this end, we manually reviewed 2724 data access requests approved between June 2007 and August 2010 through the U.S. National Center for Biotechnology Information (NCBI) database of genotypes and phenotypes (dbGaP). Our analysis demonstrates that dbGaP enables a wide range of secondary research by investigators from academic, governmental, and nonprofit and for-profit institutions in the United States and abroad. However, limitations in public reporting preclude the tracing of outcomes from secondary research to longer-term translational benefit.

The recent expansion of human genetics research has raised complex ethical and regulatory issues. However, few published reports describe the views of professionals involved in human subjects protection (HSP) regarding the risks and benefits of genetic research. This anonymous, web-based study elicited the opinions of 208 HSP professionals about review of genetic research. The majority of respondents felt that different guidance is needed for various aspects of genetic protocol review compared with other types of human subjects research. Importantly, opinions were divided on specific genetic research issues, such as what constitutes human subjects research, when to re-consent, and the likelihood and risks of research participant identification. Findings from this study illustrate the need for a collaborative approach to ethics oversight in the review and conduct of genetic research.

International health experts agree that China is on the verge of an AIDS crisis. In response, the Chinese government initiated the "Four Frees and One Care" policy in 2003 to decrease economic barriers and increase access to antiretroviral therapies for people with HIV. However, long-term treatment success requires not only access, but high rates of medication adherence. This qualitative interview study with 29 persons receiving HIV care at Beijing's Ditan Hospital identified barriers to and facilitators of medication adherence. The interviews were guided by an a priori conceptual model of adherence with four components: access, knowledge about medications, motivation, and proximal cues to action. Barriers to adherence were related to stigma and fear of discrimination; the medications themselves (including side effects and complicated dosing regimens); and other economic issues (i.e., costs of transportation, lab tests, and hospitalizations). Facilitators included participants' strong will to live, use of electronic reminders, and family support. These results support the conceptual model and suggest that successful interventions must minimize stigma as it negatively affects all components of the model for adherence.