Fulfilling the Underlying Purpose of Informed Consent to Research

2001 ◽  
Author(s):  
Jessica W. Berg ◽  
Paul S. Appelbaum ◽  
Charles W. Lidz ◽  
Lisa S. Parker
Keyword(s):  
Informed Consent ◽  
Best Interests ◽  
Research Subjects ◽  
Bodily Integrity ◽  
Traditional Concept ◽  
Treatment Situation ◽  
Consent To Treatment ◽  
History Of ◽  
Participation In Research ◽  
Treatment Settings

To a great extent the underlying purposes of informed consent in research settings resemble those in the treatment situation. Informed consent promotes individuals’ autonomy by allowing subjects to make meaningful decisions about participation in research projects. Informed consent is also a means of reducing inequalities of knowledge and power in the researcher-subject relationship and thus increases the cooperation and compliance of subjects. Increased knowledge also enhances patients’ abilities to make decisions that will protect them from unwanted and undesirable intrusions on bodily integrity, perhaps of even greater importance here than in treatment settings, because of the sorry history of abuses inflicted on research subjects. As great as the similarities are between consent to treatment and consent to research, the differences are equally great. In treatment settings, as already noted, clinicians and patients are presumed to share the same goal: promoting patients’ health. They may disagree over the means, but a general coincidence of interests is ordinarily the rule. Charles Fried calls this confluence of interests the principle of personal care. “The traditional concept of the physician’s relation to his patient is one of unqualified fidelity to that patient’s health. He may certainly not do anything that would impair the patient’s health and he must do everything in his ability to further it”. The essence of this principle is that physicians will not allow any other considerations to impinge on their decisions as to what measures are in their patients’ best interests. Since the goal of scientific investigation is the production of generalizable knowledge, not primarily the promotion of individual health, the interests of subjects and researchers are not identical. Clinician-researchers who are providing treatment to subjects in their research studies may feel this clash of interests most acutely as steps taken to protect the generalizability of the data may conflict with the maximization of benefit to individual subjects (2). The need to take this conflict into account in the decisionmaking process is largely responsible for the differences between consent to research and consent to treatment.

Translating Rights into Access: Language Access and the Affordable Care Act

2012 ◽  
Vol 38 (2-3) ◽  
pp. 348-373 ◽  
Author(s):  
Joel Teitelbaum ◽  
Lara Cartwright-Smith ◽  
Sara Rosenbaum
Keyword(s):  
Informed Consent ◽  
Civil Rights ◽  
Healthcare Quality ◽  
The United States ◽  
Language Access ◽  
Consent To Treatment ◽  
Diverse Patient Population ◽  
History Of ◽  
Crucial Information ◽  
Nuremberg Trials

More than twenty-four million people in the United States are considered limited English proficient (LEP), and numerous studies have documented the consequences of communication barriers in healthcare. These consequences include: patients’ inability to become engaged and involved in their care; the absence of crucial information—including cultural information—essential to healthcare quality; risks to patient safety arising from the misunderstanding of physician instructions; and ethical and legal lapses stemming from the absence of informed consent. Addressing healthcare rights necessarily entails coming to grips with how to facilitate communication and the exchange of information between the healthcare system and an increasingly diverse patient population.The history of language access services in healthcare is grounded in two distinct bodies of law: the law of informed consent and civil rights law. Modern notions of informed consent law—which have their roots in the Nuremberg trials of the late 1940s—would recognize a cause of action in tort where a lack of adequate communication creates a barrier to an LEP patient's ability to consent to care. In modern healthcare law, the ability of patients to affirmatively give informed consent to treatment is considered a fundamental element of healthcare quality.

scholarly journals Where Did Informed Consent for Research Come From?

2018 ◽  
Vol 46 (1) ◽  
pp. 12-29 ◽  
Author(s):  
Alexander Morgan Capron
Keyword(s):  
Human Rights ◽  
Informed Consent ◽  
Research Ethics ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Common Rule ◽  
The Future ◽  
Consent To Treatment

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

Decisional capacity to consent to treatment and anaesthesia in patients over the age of 60 undergoing major orthopaedic surgery

2019 ◽  
Vol 59 (4) ◽  
pp. 247-254 ◽  
Author(s):  
Gabriele Mandarelli ◽  
Giovanna Parmigiani ◽  
Felice Carabellese ◽  
Silvia Codella ◽  
Paolo Roma ◽  
...  
Keyword(s):  
Informed Consent ◽  
Orthopaedic Surgery ◽  
Decisional Capacity ◽  
Capacity To Consent ◽  
Capacity Evaluation ◽  
Decision Making Capacity ◽  
Consent To Treatment ◽  
Major Orthopaedic Surgery ◽  
Pain Symptoms ◽  
State Examination

Despite growing attention to the ability of patients to provide informed consent to treatment in different medical settings, few studies have dealt with the issue of informed consent to major orthopaedic surgery in those over the age of 60. This population is at risk of impaired decision-making capacity (DMC) because older age is often associated with a decline in cognitive function, and they often present with anxiety and depressive symptoms, which could also affect their capacity to consent to treatment. Consent to major orthopaedic surgery requires the patient to understand, retain and reason about complex procedures. This study was undertaken to extend the literature on decisional capacity to consent to surgery and anaesthesia of patients over the age of 60 undergoing major orthopaedic surgery. Recruited patients ( N=83) were evaluated using the Aid to Capacity Evaluation, the Beck Depression Inventory, the State–Trait Anxiety Inventory Y, the Mini-Mental State Examination and a visual analogue scale for measuring pain symptomatology. Impairment of medical DMC was common in the overall sample, with about 50% of the recruited patients showing a doubtful ability, or overt inability, to provide informed consent. Poor cognitive functioning was associated with reduced medical DMC, although no association was found between decisional capacity and depressive, anxiety and pain symptoms. These findings underline the need of an in-depth assessment of capacity in older patients undergoing major orthopaedic surgery.

The contamination of trauma. Traumatized minds, broken families and dysfunctional work groups: Organizational and interpersonal dynamics in complex child welfare court proceedings

2021 ◽  
pp. 053331642110150
Author(s):  
Stuart Stevenson
Keyword(s):  
Decision Making ◽  
Work Groups ◽  
Work Group ◽  
Best Interests ◽  
Organizational Dynamics ◽  
Children And Families ◽  
Vulnerable Children ◽  
History Of ◽  
Adults And Children ◽  
Court Proceedings

Professional work groups engaging with traumatized and dysfunctional families are presented with a disproportionate challenge to an already inevitably painful process that can be an obstacle to balanced decision-making in the children’s best interests. Trauma, abuse and neglect can influence the professional culture that condenses around these families. This occurs more often with the most challenging families with a possible history of professional failure resulting in professional conflict, impulsive and poor decision-making due to the occasions that these destructive dynamics have become unmanageable. Serious case reviews into the deaths of children regularly outline professional failures relating to a breakdown in communication within the professional system and essential and potential lifesaving information having been lost or failing to have been acted upon. The ability to understand complex group and organizational dynamics and the ability to manage relationships with traumatized adults and children, as well as within traumatized work groups is, therefore, an essential skill set for professionals working with the most vulnerable children and families. This article explores trauma and its impact on a work group and why this process was disturbed by uncontained anxiety resulting in professional conflict.

scholarly journals Art. VI.—Notes and Recollections on Tea Cultivation in Kumaon and Garhwál

1877 ◽  
Vol 10 (1) ◽  
pp. 131-156
Author(s):  
J. H. Batten
Keyword(s):  
Early History ◽  
Best Interests ◽  
British India ◽  
The Real ◽  
History Of

The cultivation of Tea in Kumaon has become so important and profitable, that it is interesting to trace the early history of this industry; and the duty of placing on record as true an account as possible of its introduction, rise and progress, is one which ought not to be neglected by those who are acquainted with the real facts; yet, after all, there is not very much to be told, even by those in full possession of all the data, when they show that, in this case—belonging, as it does, in an especial manner, to the best interests of British India—the seed of the sower “fell upon good ground, and yielded fruit, some an hundred-fold, some sixty, some thirty.”

scholarly journals Kepatuhan dan Ketepatan Tenaga Medis dalam Pengisian Assessment Pre Dialisis di Klinik Hemodialisis Nitipuran Health Center

2020 ◽  
Vol 20 (1) ◽  
pp. 268
Author(s):  
Raditya Priambodo ◽  
Elsye Maria Rosa ◽  
Sri Sundari
Keyword(s):  
Quantitative Data ◽  
Descriptive Analysis ◽  
Medical Personnel ◽  
Research Subjects ◽  
Study Approach ◽  
Risk Of Falls ◽  
History Of ◽  
Key Indicators ◽  
Service Standards ◽  
Depth Interviews

Background: The National Hospital Accreditation Standards (SNARS) state that one of the key indicators in patient-focused service standards is patient assessment. The purpose of this study was to analyze the level of compliance and accuracy of medical personnel in pre dialysis assessments at NHC. Subjects and Method: This study uses a mixed method with the Cohort Study approach. Research subjects were medical records for quantitative data and doctors, nurses and head nurses for qualitative data. Quantitative data analysis with descriptive analysis, and qualitative analysis with in-depth interviews. Result: The level of compliance and accuracy of medical personnel in filling the pre dialysis assessment at the Nitipuran Hemodialysis Clinic is not quite good. The implementation of pre dialysis assessment at the NHC includes physical status, medical history, history of drug allergy, assessment of pain, risk of falls, and educational needs. Constraints include time constraints, assessments are filled in immediately without checking in detailly, there are gaps in the hourly monitoring records. Conclusion: compliance and accuracy of medical personnel in filling out assessments must be improved.

scholarly journals Medical Violence, Obstetric Racism, and the Limits of Informed Consent for Black Women

2021 ◽  
pp. 47
Author(s):  
Colleen Campbell
Keyword(s):  
Black Women ◽  
Informed Consent ◽  
Well Being ◽  
Cesarean Sections ◽  
Bodily Integrity ◽  
Early American ◽  
Antebellum Era ◽  
Unnecessary Procedures ◽  
A Site ◽  
Biological Race

This Essay critically examines how medicine actively engages in the reproductive subordination of Black women. In obstetrics, particularly, Black women must contend with both gender and race subordination. Early American gynecology treated Black women as expendable clinical material for its institutional needs. This medical violence was animated by biological racism and the legal and economic exigencies of the antebellum era. Medical racism continues to animate Black women’s navigation of and their dehumanization within obstetrics. Today, the racial disparities in cesarean sections illustrate that Black women are simultaneously overmedicalized and medically neglected—an extension of historical medical practices rooted in the logic of biological race. Though the principle of informed consent traditionally protects the rights of autonomy, bodily integrity, and well-being, medicine nevertheless routinely subjects Black women to medically unnecessary procedures. This Essay adopts the framework of obstetric racism to analyze Black women’s overmedicalization as a site of reproductive subordination. It thus offers a critical interdisciplinary and intersectional lens to broader conversations on race in reproduction and maternal health.

Autism, Autonomy, and Research

2019 ◽  
pp. 53-64 ◽  
Author(s):  
Kenneth A. Richman
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Ethical Concerns ◽  
Autistic People ◽  
Participation In Research

This chapter addresses ethical issues for informed consent when recruiting autistic participants for research. The process of informed consent for participation in research involves some abilities, such as dialogue and understanding the intentions of the researchers, that can be especially challenging when autistic individuals are being asked to participate. This chapter reviews these abilities, and suggests ways to provide meaningful support to promote autonomy and help researchers meet their responsibilities. Beyond these more general challenges, it explores Hans Jonas’s suggestion that true informed consent for research requires that participants identify with the goals of the researchers. Given the plurality of perspectives on how to respond to autism, Jonas’s ideas point to additional ethical concerns that can arise when autistic people are recruited for research on autism.

4. Consent to Treatment

2018 ◽  
Author(s):  
Jonathan Herring
Keyword(s):  
Mental Capacity ◽  
Best Interests ◽  
Living Wills ◽  
Ethical Aspects ◽  
Capacity To Consent ◽  
Delicate Balance ◽  
Mental Capacity Act 2005 ◽  
Consent To Treatment ◽  
Advance Decisions ◽  
Mental Capacity Act

This chapter examines the legal and ethical aspects of treating a patient without consent. It considers the meaning of ‘consent’ and the position of patients who lack the capacity to consent. For children who lack capacity, consent involves a delicate balance between the rights of the children and those of their parents. For adults lacking capacity, the Mental Capacity Act 2005 has emphasized the ‘best interests’ test, but has largely left open the question of how a person’s best interests are to be ascertained. The chapter also considers what weight should be attached to advance decisions (sometimes called living wills).

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