The Ethical Review of Health Care Quality Improvement Initiatives: Findings From the Field

Based on surveys, examines the review mechanisms of quality improvement initiatives, including frequency; type, such as use of independent review boards; and consideration for ethical issues such as minimal risk and patient privacy and confidentiality

The Ethical Odyssey in Testing HIV Treatment as Prevention

Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HPTN 052, the multinational clinical trial addressing this issue that has profound public health implications

Evaluating community engagement in global health research: the need for metrics.

CAPRISA, 2015.Abstract available in pdf

The significance and expectations of HIV cure research among people living with HIV in Australia.

Most people living with HIV (PLHIV) with reliable access to antiretroviral treatment (ART) have a life expectancy similar to uninfected populations. Despite this, HIV can negatively affect their social and psychological wellbeing. This study aimed to enhance understanding of the expectations PLHIV hold for HIV cure research and the implications this has for HIV cure research trials. We interviewed 20 Australian PLHIV about their expectations for HIV cure research outcomes and the impact a potential cure for HIV may have on their everyday lives. Data were analysed thematically, using both inductive and deductive approaches. The significance of a cure for HIV was expressed by participants as something that would offer relief from their sense of vigilance or uncertainty about their health into the future. A cure was also defined in social terms, as alleviation from worry about potential for onward HIV transmission, concerns for friends and family, and the negative impact of HIV-related stigma. Participants did not consider sustained medication-free viral suppression (or remission) as a cure for HIV because this did not offer certainty in remaining virus free in a way that would alleviate these fears and concerns. A cure was seen as complete elimination of HIV from the body. There is an ethical need to consider the expectations of PLHIV in design of, and recruitment for, HIV cure-related research. The language used to describe HIV cure research should differentiate the long-term aspiration of achieving complete elimination of HIV from the body and possible shorter-term therapeutic advances, such as achieving medication free viral suppression

Bioethics Consultation in the Private Sector

The members of a task force on bioethics consultation report their conclusions. The task force was convened by the American Society for Bioethics and Humanities and the American Society of Law, Medicine, and Ethics, although these groups do not endorse the group\u27s conclusions. Two commentaries follow, and an essay by science reporter Nell Boyce sets the scene

Consulting Communities When Patients Cannot Consent: A Multi-Center Study of Community Consultation for Research in Emergency Settings

OBJECTIVE: To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent (EFIC) research and understanding of the proposed study. DESIGN: A cognitively pre-tested survey instrument was administered to 2,612 community consultation participants at 12 US centers participating in a multi-center trial of treatment for acute traumatic brain injury (TBI). SETTING: Survey nested within community consultation for a Phase III, randomized controlled trial of treatment for acute TBI conducted within a multi-center trial network and using EFIC. SUBJECTS: Adult participants in community consultation events. INTERVENTIONS: Community consultation efforts at participating sites. MEASUREMENTS AND MAIN RESULTS: Acceptance of EFIC in general, attitude toward personal EFIC enrollment, and understanding of the study content were assessed. 54% of participants agreed EFIC was acceptable in the proposed study; 71% were accepting of personal EFIC enrollment. Participants in interactive versus non-interactive community consultation events were more accepting of EFIC in general (63% vs. 49%) and personal EFIC inclusion (77% vs. 67%). Interactive community consultation participants had high-level recall of study content significantly more often than non-interactive consultation participants (77% vs. 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs. 45%) but less likely to recall potential risks (56% vs. 69%). CONCLUSIONS: Interactive community consultation methods were associated with increased acceptance of EFIC and greater overall recall of study information but lower recall of risks. There was also significant variability in EFIC acceptance among different interactive consultation events. These findings have important implications for IRBs and investigators conducting EFIC research and for community engagement efforts in research more generally

Ethical Implications of Modifying Lethal Injection Protocols

Teresa Zimmers and colleagues argue that it is difficult to conceive how lethal injection research activities could be carried out in a fashion consistent with ethical norms

Improving Informed Consent: The Medium Is Not the Message

An important type of research on informed consent involves empirically testing interventions designed to improve the consent process. Here we report on the experience of eight teams that conducted research involving interventions designed primarily to impact one of three categories: decision-making, knowledge, and the therapeutic misconception