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At least 73 records · Page 4Linked to original sources
PubMed2005

Elements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials.

The therapeutic misconception arises wherever human subjects misinterpret the primary purpose of a clinical trial as therapeutic. Such misconceptions are particularly prevalent in trials involving severely ill subjects or novel and well-publicized investigational agents. In order to identify possible sources of the therapeutic misconception in gene transfer trials, 286 phase 1 human gene transfer consent documents were analyzed for their description of purpose, alternatives, and their use of the term gene transfer. We report that 20% of trials fail to explain their purpose as safety and dosage, only 41% of oncology trials identify comfort care as an alternative to participation, and that the term gene therapy is used with twice the frequency of the term gene transfer. Trends and coherence in consent form language were analyzed as well. Our results indicate that consent forms used in gene transfer phase 1 trials often contain language that promotes, or does little to deter, therapeutic misconceptions.

Clinical Trials, Phase I as Topic↗
PubMed1995

Impact of an information and consent form on patients having chemotherapy.

Of 100 patients having chemotherapy who were given a written information and consent form, only 34 understood the purpose of the form and only one considered it the major source of information; 75 patients could not name any of their drugs, 26 did not know the goal of therapy and only 15 remembered all of four general side effects. Such forms may not satisfy the requirements of informed consent.

Adult↗
PubMed2004

[Consenting to ambiguities: a documental analysis of informed consent forms used in assisted human reproduction clinics].

With the field of assisted human reproduction as a case study, this article presents the results of a study on informed consent forms, linking the understanding of the use of social languages - especially the language of risk - and its implications on the relationship between health professionals and clients. Informed by a social psychology perspective and aligned with the qualitative tradition in research, the study was oriented by a theoretical approach to discursive practice, whereby the language of risk is understood as a way of speaking of future control of risks. The analysis centered on the text of 27 informed consent forms provided by eight Brazilian clinics. Besides understanding the linguistic specificities, the analysis attempted to answer the question, "What is being consented to?" The results showed the ambiguity of a document which presupposes the use of the metaphor of taking versus not taking risks. That is, the document may be used in a democratic, bureaucratic, or even authoritarian way, while the communication of risks and benefits subsidizes both the decision-making and the dilution of responsibility throughout the relational network.

Decision Making↗
PubMed1987

The consent form as a possible cause of side effects.

In a multicenter trial of aspirin or sulfinpyrazone in the treatment of unstable angina, we examined the possible importance to the outcome of mentioning potential side effects in the consent form. Inclusion, in two of the three centers, of a statement outlining possible gastrointestinal side effects resulted in a sixfold increase (P less than 0.001) in the number of subjects in these centers withdrawing from the study because of subjective, minor gastrointestinal symptoms. Major gastrointestinal complications such as peptic ulcer or bleeding as diagnosed by study physicians were similar in the three centers. Furthermore, no patient discontinued therapy because of subjective, nongastrointestinal side effects. Post hoc analysis suggests that the inclusion of gastrointestinal side effects in the consent form may have increased the likelihood of patients attributing gastrointestinal symptoms to drug therapy, leading to subsequent withdrawal from the study.

Angina Pectoris↗
PubMed1997

Medical disclosure and consent forms: proposal for an international standard.

Disclosure of material risks prior to invasive medical and surgical procedures remains a fiction derived from legal idealism rather than a clinical reality. Where disclosure has been inadequate, legal allocation of individual medical blame fails to address ongoing systems problems in the disclosure process and thereby potentially jeopardizes patient safety. Patient signature of disclosure and consent forms is a standardised international ritual with great potential for ensuring that international ideals and principles of medical ethics (such as those relating to disclosure of risk) become a recognised and consistent part of global medical practice. This article encourages the development of an international standard for disclosure and consent forms.

Ethics↗
PubMed1998

Testing for inherited susceptibility to breast cancer: a survey of informed consent forms for BRCA1 and BRCA2 mutation testing.

The identification of genetic mutations linked to breast cancer has made it possible to test for the genetic predisposition to this disease. However, though this test may provide certain benefits, there are also potential risks involved with the testing process, including social and economic considerations. In light of these potential risks, we sought to determine what information individuals are receiving in the informed decision making process. To learn the minimal amount of information the actual testees receive, we obtained 10 informed consent forms from seven different testing facilities. These testing centers include the major sources of BRCA1 and BRCA2 mutation testing in the United States at this time. We analyzed the content of these forms by developing content categories and scoring them appropriately. We found all ten forms discussed in varying ways and to varying degrees the purpose of genetic testing, limitations of the test, implications of both positive and negative results, and confidentiality procedures; most, but not all, addressed various psychological and insurance risks. Overall, the forms demonstrated substantial variation in content and organization, underlining the need for more discussion and research on the purpose, nature, and effectiveness of informed consent forms for this type of genetic test.

BRCA1 Protein↗
PubMed1981

Consent forms.

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Comprehension↗