Future Directions in Research on Informed Consent

That a discrepancy seems to exist between what patients understand and their satisfaction with the informed consent process poses several research issues. First, what individuals should understand when they decide to participate in research needs to be clearly delineated and justified. As there is not agreement of what constitutes good informed consent, it is difficult to judge the current informed consent process. Some argue understanding of purpose, methods, risks, benefits, and alternatives to the research are essential components of valid informed consent. Others lessen the importance of understanding and argue good faith effort at disclosure in nontechnical language is all that is required for valid informed consent even if patients ultimately do not fully understand. Furthermore, the standards of valid informed consent need to be defined in different research contexts, because what is required for patients to understand may be different depending on the context of the particular study. For example, in a natural history trial studying factors leading to health disparities, good disclosure may be all that is required. Conversely, in a study involving bone marrow transplant with high-dose chemotherapy, total-body irradiation, and a high chance for peritransplant mortality with a potential for prolonged and numerous hospital admissions, a more complete understanding may be more important. Second, what information matters to individuals when making decisions about participating in research needs to be further studied. One reason research participants may not understand certain aspects covered in informed consent is that the details are not that important to or salient for them. If research design is unimportant to research participants' decision making, then it may be difficult, and even unnecessary, to improve their understanding of it.

Besides those discussed previously, in the Phase I context, two issues are particularly important for further research. Studies that delineate between issues of understanding and those of motivation are needed. More importantly, research that evaluates the role hope plays in patients' decisions to participate and whether this hope should be fostered or damped is needed.

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