A historical perspective of informed consent in clinical practice and research

Nelson‐Marten, Paula; Rich, Ben A.

doi:10.1016/s0749-2081(99)80065-5

Cited by 38 publications

(22 citation statements)

References 4 publications

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“…3 Informed consent has developed further in a complex way over the past century. [4][5][6] Full disclosure and shared decision making may not have come naturally to clinicians. 5 7-11 However, there is a clearer understanding of informed consent as being an integral part of risk management and clinical governance.…”

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confidence: 99%

What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the Bath area, UK

El-Wakeel

Taylor²,

Tate³

2006

J Med Ethics

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Background: Medical decision making is based on patient autonomy and informed consent, which is an integral part of medical ethics, risk management and clinical governance. Consent to treatment has been extensively discussed, but the viewpoint of patients is not well represented. A new consent form was introduced by the Department of Health in 2001. Aims: To determine the information most important to patients, to facilitate evidence-based guidelines and to provide a valid and reliable consent-procedure-satisfaction questionnaire. Methods: An anonymous quantitative survey was carried out, asking 100 patients 15 questions regarding procedures they may need to undergo, using a Visual Analogue Scale to test the importance of each question. Results and discussion: In total there were 77 respondents and the mean age was 48.8 (SD 17.63, range 20-82) years. There were 52% women and 48% men. Major complications, such as not undergoing the procedure, future management and long-term effect on work, all scored a median of 95%. Least concerns were related to technical details of the procedure and minor complications (median 64% and 63%, respectively). All other questions were still considered important (median 79-93%). No significant differences were observed between sex, age and professional groups, but a significant difference was observed between the education groups. Qualifications of the doctor did not correlate to any other question. Conclusions: This questionnaire is proposed as a basis for informed consent guidelines to health workers and for measures of satisfaction with the consent procedure.

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mentioning

confidence: 99%

What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the Bath area, UK

El-Wakeel

Taylor²,

Tate³

2006

J Med Ethics

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“…Salgo v Leland Stanford etc. Board of Trustees (1957) is the first case often cited as establishing the legal doctrine of informed consent for medical practice and biomedical research in the United States (for example, Nelson-Marten & Rich, 1999;Faden & Beauchamp, 1986, p. 57). 3 In the case, the plaintiff was awarded damages for not receiving full disclosure of facts relevant to a particular surgical procedure.…”

Section: S: the Foundations Of Informed Consent In Us Law And Pmentioning

confidence: 99%

Recovering the History of Informed Consent for Data Science and Internet Industry Research Ethics

Sedenberg

Hoffmann

2016

SSRN Journal

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Respect for persons is a cornerstone value for any conception of research ethics-though how to best realize respect in practice is an ongoing question. In the late 19th and early 20th centuries, "informed consent" emerged as a particular way to operationalize respect in medical and behavioral research contexts. Today, informed consent has been challenged by increasingly advanced networked information and communication technologies (ICTs) and the massive amounts of data they produce-challenges that have led many researchers and private companies to abandon informed consent as untenable or infeasible online.Against any easy dismissal, we aim to recover insights from the history of informed consent as it developed from the late 19th century to today. With a particular focus on the United States policy context, we show how informed consent is not a fixed or monolithic concept that should be abandoned in view of new data-intensive and technological practices, but rather it is a mechanism that has always been fluid-it has constantly evolved alongside the specific contexts and practices it is intended to regulate. Building on this insight, we articulate some specific challenges and lessons from the history of informed consent that stand to benefit current discussions of informed consent and research ethics in the context of data science and Internet industry research.

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“…Regulatory highlights concerning the protection of human subjects in medical research include the Nuremberg Code in 1947, which served as a standard for building criminal cases against physicians who participated in the Nazi human experiments, and the Belmont Report in 1974, which was developed in reaction to the Tuskegee Syphilis Studies and also led to the establishment of the Institutional Review Board in the United States. [2] Sadly, each of these ethical milestones has come about as reactions to failure in previous systems to elicit voluntary consents from human participants.…”

Section: The Current Situation: Needs Gaps and Challengesmentioning

confidence: 99%

12 Electronic media for engaging patients in the research consent decision process

Schneider¹,

Grando²,

Obeid³

et al. 2015

Information Technology for Patient Empowerment in Healthcare

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Informed consent has long been one of the central ethical tenets in human subjects' research, and it remains a complex challenge for investigators and regulatory authorities today. Those difficulties include meeting the ethical principles outlined in the Belmont Report (respect for persons, beneficence and justice) while simultaneously creating an effective consent process that is informative, non-coercive and comprehensible to every potential research subject. Given rapid technological advances and the omnipresent internet in today's world, the use of electronic mechanisms to obtain informed consent (eConsent) has become a subject of great interest and is rapidly being adopted. While eConsent may provide some new solutions to traditional informed consent issues, it also creates a host of new problems and challenges. This chapter discusses the various issues involved with the utilization of eConsent in human subject research and offers recommendations to improve procedural effectiveness and mitigate ethical challenges. Topics covered include the forms and media through which information is presented to the potential participants in a research study as well as the wide range of factors that may affect their participation including comprehension, voluntariness, literacy and length of the consent document. IntroductionThe topics of electronic consent (eConsent) and the use of multimedia aids in the informed consent process have been under discussion since the late 1990s. The demand for an efficient eConsent process is increasingly significant given the rapid development and ubiquitous availability of electronic devices such as laptop computers, tablets and smartphones combined with widespread internet connectivity. In today's online world, sensitive and private information can be delivered to end users (research subjects) in a secure and efficient manner, although such delivery can often involve new and unique information security challenges. Nonetheless, the continuous evolution and worldwide adoption of such technologies are already having a clear impact on human subject research and informed consent procedures. This impact will require constant review and relevant adaptability by both researchers and regulatory agencies.There are multiple challenges and benefits of using eConsent for both participants and investigators that need to be considered. In addition to the challenges in traditional informed consents including participants' comprehension and literacy,

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A historical perspective of informed consent in clinical practice and research

Cited by 38 publications

References 4 publications

What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the Bath area, UK

What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the Bath area, UK

Recovering the History of Informed Consent for Data Science and Internet Industry Research Ethics

12 Electronic media for engaging patients in the research consent decision process

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