Informed Consent and Phase I Trials: Cognitive Failure and Additional Challenges to Informed Decision Making

2019 ◽  
Vol 37 (2) ◽  
pp. 169-169 ◽  
Author(s):  
Jan Schildmann ◽  
Florian Bruns
2004 ◽  
Vol 94 (2) ◽  
pp. 198-205
Author(s):  
Jay M. Baruch

Contrary to popular belief, a patient’s signature on a piece of paper does not constitute informed consent. This article describes the ethical framework of consent in the context of the larger process of informed decision making. The elements of informed consent are examined in practical terms. Common pitfalls are addressed, with strategies to help anticipate and resolve possible dilemmas. These important tools are integral to all levels of medical decision making, including those at the end of life. (J Am Podiatr Med Assoc 94(2): 198-205, 2004)


2015 ◽  
Vol 43 (1) ◽  
pp. 51-58 ◽  
Author(s):  
Aziza Ahmed

Shifting laws and regulations increasingly displace the centrality of women’s needs in the provision of abortion services. Lawmakers and judges contribute to this environment in two ways: by protecting the right of “Crisis Pregnancy Centers” (CPCs) to give false and misleading information about abortion and by supporting legislation mandating that abortion providers give misleading and unnecessary information for the purposes of informed consent. Litigation on informed consent is further complicated through the mobilization of facts — such as the gestational age or sonogram of the fetus — delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose.First Amendment litigation has done little to help prioritize women’s access to appropriate information about abortion that is calibrated to their needs.


2020 ◽  
pp. 152692482097859
Author(s):  
Kara Schick-Makaroff ◽  
Rebecca E. Hays ◽  
Julia Hunt ◽  
Laura A Taylor ◽  
Dianne LaPointe Rudow

Introduction: Although informed consent content elements are prescribed in detailed regulatory guidance, many live kidney donors describe feeling underprepared and under informed. The goal of this pilot study was to explore the educational components needed to support an informed decision-making process for living kidney donors. Methods/Approach: A qualitative description design was conducted with thematic analysis of 5 focus groups with 2 cohorts: living kidney donor candidates (n = 11) and living kidney donors (n = 8). Findings: The educational components needed to engage in an informed decision-making process were: 1) contingent upon, and motivated by, personal circumstances; 2) supported through explanation of risks and benefits; 3) enhanced by understanding the overall donation experience; and 4) personalized by talking to another donor. Discussion: Tailoring education to meet the needs for fully informed decision-making is essential. Current education requirements, as defined by regulatory bodies, remain challenging to transplant teams attempting to ensure fully informed consent of living kidney donor candidates. Information on the emotional, financial, and overall life impact is needed, along with acknowledgement of relational ties driving donor motivations and the hoped-for recipient outcomes. Discussion of care practices, and access to peer mentoring may further strengthen the informed decision-making process


Author(s):  
Kristin L. Long ◽  
Angela M. Ingraham ◽  
Elizabeth M. Wendt ◽  
Megan C. Saucke ◽  
Courtney Balentine ◽  
...  

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