In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval. Community consultation is a particularly common method of involving communities. However, the fundamental ethical goals of community consultation have not been delineated, which makes it difficult for investigators, sponsors, and institutional review boards to design and evaluate consultation efforts. Community consultation must be tailored to the communities in which it is conducted, but the purposes of consultation-the ethical goals it is designed to achieve-should be universal. We propose 4 ethical goals that give investigators, sponsors, institutional review boards, and communities a framework for evaluating community consultation processes.
Most organizations pay some research subjects, but few have written policies on payment. Because investigators and institutional review boards make payment decisions with little specific guidance, standards vary.
Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals.
Background
The importance of respecting patients and participants in clinical research is widely recognised. However, what it means to respect persons beyond recognising them as autonomous is unclear, and little is known about what patients find to be respectful.
Objective
To understand patients’ conceptions of respect and what it means to be respected by medical providers.
Design
Qualitative study from an academic cardiology clinic, using semistructured interviews with 18 survivors of sudden cardiac death.
Results
Patients believed that respecting persons incorporates the following major elements: empathy, care, autonomy, provision of information, recognition of individuality, dignity and attention to needs.
Conclusions
Making patients feel respected, or valued as a person, is a multi-faceted task that involves more than recognising autonomy. While patients’ views of respect do not determine what respect means, these patients expressed important intuitions that may be of substantial conceptual relevance.
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