Informed Consent in Clinical Practice

The 21st century has been revolutionary for the field of clinical genomics, with major advancements and breakthroughs over the years. It is now considered an instrumental tool in clinical and preventive medicine and has been used on a day-to-day basis to complement current clinical practice. However, with advancements in genomics comes greater bioethical concerns, which becomes increasingly complex with more cutting-edge technology. Some of the major ethical concerns include obtaining informed consent, possibility for genetic enhancements and eugenics, genomic equity and potential discrimination and cloning. It is imperative that we appreciate the benefits of genomic medicine in complementing traditional practices, identify and address the ethical concerns with relation to the practice of genomic medicine, and to ensure a common goal of improving human lives. With these in mind, the practice of genomics can have maximum impact in the collective health of the population, with greater benefit to all.

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Informed consent in interventional radiology – are we doing enough?

British Journal of Radiology ◽

10.1259/bjr.20201368 ◽

2021 ◽

pp. 20201368

Author(s):

Akash Prashar ◽

Saqib Butt ◽

Davide Giuseppe Castiglione ◽

Nadeem Shaida

Keyword(s):

Interventional Radiology ◽

Clinical Practice ◽

Informed Consent ◽

Blood Transfusion ◽

Retrospective Analysis ◽

Patient Information ◽

Potential Risk ◽

Current Model ◽

Consent Form ◽

Consent Process

Objectives: Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure. Methods: A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined. Results: 39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this. Conclusion: The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential. Advances in knowledge: The paper highlights the inadequacies of the current model in gaining consent for IR procedures. A more comprehensive consent process making use of all available resources is essential.

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Informed consent in clinical practice

EMERGENCY MEDICINE ◽

10.22141/2224-0586.2.97.2019.161656 ◽

2019 ◽

Vol 0 (2.97) ◽

pp. 143-149

Author(s):

Yu.I. Markov ◽

A.O. Zhezher

Keyword(s):

Clinical Practice ◽

Informed Consent

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The research to practice continuum: Development of an evidence-based visual aid to improve informed consent for procedural sedation

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.303 ◽

2017 ◽

Vol 1 (5) ◽

pp. 316-319 ◽

Cited By ~ 2

Author(s):

M. Fernanda Bellolio ◽

Lucas Oliveira J. e Silva ◽

Henrique Alencastro Puls ◽

Ian G. Hargraves ◽

Daniel Cabrera

Keyword(s):

Emergency Department ◽

Clinical Practice ◽

Informed Consent ◽

Control Process ◽

Reading Level ◽

Communication Process ◽

Research To Practice ◽

Final Version ◽

Visual Aid ◽

Grade Reading Level

IntroductionIn order to fully participate in informed consent, patients must understand what it is that they are agreeing, or not agreeing, to. In most cases, patients look to their clinicians to help develop the appropriate understanding required to give informed consent. Often the quality of the information available as well as the delivery methods are not optimal.MethodsUsing a visual aid as an adjunct to risk communication in a stressful setting as the Emergency Department has a clear potential in facilitating the communication process. To support more accurate and consistent presentation of risk, we formed a team with implementation scientists, patient education specialists, nurses, physicians, and professional designers to transform the information available into a 6th grade reading level visual aid tool. We applied a DMAIC (Define, Measure, Analyze, Improve and Control) process to design the tool. We measured and analyzed its effectiveness through feedback from providers, patients, and caregivers. This cycle happened 3 times until we reached the final version of the visual aid.ResultsWe utilized a DMAIC methodology as well as modified Delphi method to create and refine a visual aid tool. Several rounds of end-user feedback along with DMAIC allowed us to create a tool that was consistently better with each round of development, analysis and feedback. After arriving at the final version of the tool, we surveyed physicians in our Emergency Department. We measured the difficulty to understand the information, whether doctors think the visual aid will help patients to understand the data, and the appropriateness of the tool’s length and the amount of information in it.ConclusionsWe believe that our experience can be replicated by other researchers and clinicians in the endeavor of translating the evidence into clinical practice. An effort should be made to fully translate research findings until the end of the research to practice continuum in order to better translate knowledge into a useful and useable form for informed consent decisions in busy clinical practice.

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Informed Consent: Legal Theory and Clinical Practice.

Annals of Internal Medicine ◽

10.7326/0003-4819-114-9-827_3 ◽

1991 ◽

Vol 114 (9) ◽

pp. 827

Keyword(s):

Clinical Practice ◽

Informed Consent ◽

Legal Theory

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Unethical informed consent caused by overlooking poorly measured nocebo effects

Journal of Medical Ethics ◽

10.1136/medethics-2019-105903 ◽

2020 ◽

pp. medethics-2019-105903

Author(s):

Jeremy Howick

Keyword(s):

Clinical Trials ◽

Clinical Practice ◽

Informed Consent ◽

Natural History ◽

Adverse Events ◽

Placebo Effect ◽

Nocebo Effect ◽

Control Groups ◽

Nocebo Effects ◽

Negative Outcome

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients.

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