ReviewInformed consent in clinical trials
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Cited by (44)
Informed consent: how much and what do patients understand?
2009, American Journal of SurgeryCitation Excerpt :Regarding the important issue of voluntarism, however, half of the studies that provided relevant data revealed an adequate rate of understanding among the participating subjects. This could be related to patients' preference to defer the decision of participation to their physicians70 or to fear of being deprived of adequate clinical care. However, it should be mentioned that the concept of randomization was highly understood by most subjects in only half of the studies that provided relevant data.
Determination of required content of the informed consent process for human participants in biomedical research conducted in the U.S.: A practical tool to assist clinical investigators
2008, Contemporary Clinical TrialsCitation Excerpt :Study Sponsors, local IRBs, and study team members may provide assistance to the Principal Investigator with regard to the consent documents and consent conferences, however, the Principal Investigator is ultimately responsible for the entire consent process. There is an extensive literature related to the informed consent process for clinical research study participants and the use of informed consent forms (articles and books with useful bibliographies [1–8]); it is one of the relatively few areas of clinical research ethics that has received in-depth attention from bioethicists and researchers. Despite this well-deserved attention, there exist significant practical questions and issues pertaining to the implementation of U.S. regulatory requirements and international guidelines and to the actual practice of performing consent processes.
Multimedia educational aids for improving consumer knowledge about illness management and treatment decisions: A review of randomized controlled trials
2008, Journal of Psychiatric ResearchCitation Excerpt :We excluded studies that focused on theoretical healthcare decisions because of potential concerns regarding the validity of hypothetical medical conditions. It has been suggested by some that people make different decisions when the treatment prospect is theoretical versus real (Schain, 1994; Verheggen and van Wijmen, 1996). In addition, investigations focusing on caregivers and children were also excluded because such studies are complicated by the fact that two parties (patient plus caregiver or parent) are involved, and require valid assessment procedures for both of the groups.
Monetary Incentives Improve Recall of Research Consent Information: It Pays to Remember
2009, Experimental and Clinical Psychopharmacology