DOI: 10.1097/NCC.0b013e3181a05a7f
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PMID: 19411934
Issn Print: 0162-220X
Publication Date: 2009/05/01
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Excerpt
Business-like aspects include the required presence of an expert for the trial, who will provide complete and accurate information about the study, and the decision makers (the patient-standard for adult patients and variable for pediatric patients-and significant others), who must weigh the information and help make the decision about patient enrollment. In addition, a witness is present. This person's exact function can vary but may be as circumscribed as attesting to the signatures of the included participants on the consent documents. The regulated attention given to the consent documents (content, readability, understandability) and the careful attention given to the process of reviewing the documents with the eligible patients or participants, the signing and dating of the documents, as well as inserting the time of the signing in the designated locations all add to the formal, serious tone of the consent process. These and other aspects of consent are guided by federal regulations and by the bylaws of local institutional review boards.
This focus on the consent documents includes the provision of information about potential adverse outcomes or risks, benefits of participating in the study, and the rights of the patient as a research participant. Not surprisingly, investigators view this process of information sharing as a contractual discussion and arrangement with one result being an informed study participant. As such, the consent process probably does not meet all of the needs of the research team and most certainly not the most important need of the eligible participant, which is the assurance that the investigator and study team are committed to the best interests of the potential participant. Rather and sadly so, the process may only convey the impression of a legalistic relationship existing between the two. This becomes a missed opportunity to establish an effective, trusting work relationship between the study team and the participant. Nowhere in this approach do we as investigators tell the participants that we will be responsible for protecting them and their best interests. Nowhere do we say that we are personally committed to the participants' welfare. We do not say, "I am responsible to you." Instead we say, "you have these rights." In this legalistic approach, we seem to convey that because we have informed participants of their rights, they are now fully informed and fully responsible for all outcomes.
A different view, that of the consent process being a personal commitment, represents a philosophical shift, and if we assume this view, we might manage consent differently. Certainly we would still have the expert (study team member) present-but with more attention given to the expert's role in communicating the meaning of the treatment or research, the anticipated impact on the life of the patient and family, and the role of the expert with protecting the best interests of the participant and with monitoring the clinical trial. A witness would also be present but with a role commitment that included following up with the patient and family to ensure their understanding of the consent content and to invite further discussion of concerns, worries, doubts, or feelings that emerged during the process.
