Informed Consent

PEDIATRICS ◽  
1967 ◽  
Vol 39 (2) ◽  
pp. 309-309
Author(s):  
H. DAVID MOSIER
Keyword(s):  
Informed Consent ◽  
Clinical Investigation ◽  
Ethical Considerations

It is difficult to imagine a physician investigator who does not also at the same time play the role of "physician-friend" in the sense of Dr. Silverman's proposal (Pediatrics, 38:373, 1966). Any physician responsible for the subjects of clinical investigation must perform his role guided by the same ethical considerations that guide other physicians in the care of their patients. Were it otherwise, the subjects would be placed at some jeopardy as to their welfare and the preservation of their dignity.

scholarly journals A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research

2020 ◽  
Vol 5 (2) ◽  
pp. 73-79
Author(s):  
Rajpal Nandra ◽  
Alan F. Brockie ◽  
Faisal Hussain
Keyword(s):  
Informed Consent ◽  
Emergency Care ◽  
Ethics Committees ◽  
Moral Obligations ◽  
Ethical Considerations ◽  
Vulnerable Patients ◽  
Ethical Approval ◽  
Life Threatening ◽  
Time Critical

A vulnerable participant in research lacks capacity to consent or may be exposed to coercion to participate. Capacity may be temporarily impaired due to loss of consciousness, hypoxia, pain and the consumption of alcohol or elicit substances. To advance emergency care, providing life-threatening measures in life-threatening circumstances, vulnerable patients are recruited into research studies. The urgent need for time-critical treatment conflicts with routine informed consent procedures. This article reviews ethical considerations and moral obligations to safeguard these participants and preserve their autonomy. A particular focus is given to research methodology to waive consent, and the role of ethics committees, research audits, research nurses and community engagement. Research on the acutely unwell patient who lacks capacity is possible with well-designed research trials that are led by investigators who are sufficiently trained, engage the community, gain ethical approval to waive consent and continuously audit practice. Cite this article: EFORT Open Rev 2020;5:73-79. DOI: 10.1302/2058-5241.5.180051

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2017 ◽  
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Conflicts Of Interest ◽  
Institutional Review Boards ◽  
Ethical Considerations ◽  
Governmental Organizations ◽  
Institutional Review ◽  
The Us ◽  
Guidelines And Recommendations ◽  
Study Designs

Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).

Sedation for refractory symptoms

2015 ◽  
pp. 440-448
Author(s):  
Patti Knight ◽  
Laura A. Espinosa ◽  
Bonnie Freeman
Keyword(s):  
Informed Consent ◽  
Case Studies ◽  
Nursing Care ◽  
Hospital Setting ◽  
Palliative Sedation ◽  
Ethical Considerations ◽  
Time To Death ◽  
Refractory Symptoms

This chapter explores the use of palliative sedation in the hospital setting. It presents case studies involving palliative sedation, discusses several definitions of palliative sedation, frequency of palliative sedation, reasons for palliative sedation, medications used, guidelines for nursing care, time-to-death issues, ethical considerations, informed consent, and the role of the nurse-caregiver.

More than consent for ethical open-label placebo research

2020 ◽  
pp. medethics-2019-105893
Author(s):  
Laura Specker Sullivan
Keyword(s):  
Informed Consent ◽  
Clinical Investigation ◽  
Human Subjects ◽  
Not Given ◽  
Placebo Effects ◽  
Ethical Considerations ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
History Of ◽  
Irritable Bowel

Recent studies have explored the effectiveness of open-label placebos (OLPs) for a variety of conditions, including chronic pain, cancer-related fatigue and irritable bowel syndrome. OLPs are thought to sidestep traditional ethical worries about placebos because they do not involve deception: with an OLP, patients or subjects are told outright that they are not given an active substance. As deception is framed as the primary hurdle to ethical placebo use, the door is ostensibly opened to ethical studies of OLPs. In this article, I suggest that even though OLPs seemingly do not involve deception, there are other ethical considerations in their clinical investigation and subsequent use. Research ethics often focusses on informed consent—of which, deception and honesty are a piece—as a means to justify research practices with human subjects. Yet, it is but one of the ethical considerations that should be taken into account. With research into placebo effects in particular, I argue that the history of clinical placebo use grounds special considerations for OLP research that go beyond respect for the autonomy of individual patients through informed consent and encompass structural concerns about the type of patient for whom a placebo has historically been thought appropriate.

Revolutionizing Mental Health with Social Media

2019 ◽  
pp. 259-284
Author(s):  
Munmun De Choudhury
Keyword(s):  
Social Media ◽  
Well Being ◽  
Linguistic Expression ◽  
Ethical Considerations ◽  
Self Disclosure ◽  
Vulnerable Communities ◽  
Tailored Interventions ◽  
Challenges And Opportunities ◽  
Social Media Platforms

Social media platforms have emerged as rich repositories of information relating to people’s activities, emotions, and linguistic expression. This chapter highlights how these data may be harnessed to reason about human mental and psychological well-being. It also discusses the emergent role of social media in providing a platform of self-disclosure and support to distressed and vulnerable communities. It reflects on how this new line of research bears potential for informing the design of timely and tailored interventions, provisions for improved personal and societal well-being assessment, privacy and ethical considerations, and the challenges and opportunities of the increasing ubiquity of social media.

Crisis and Informed Consent: Analysis of a Law-Medicine Malocclusion

1987 ◽  
Vol 12 (1) ◽  
pp. 55-97 ◽  
Author(s):  
Fran Carnerie
Keyword(s):  
Informed Consent ◽  
Medical Treatment ◽  
Clinical Setting ◽  
Patient Relationship ◽  
Physician Patient Relationship ◽  
Catastrophic Illness ◽  
Physician Patient ◽  
Emotional Impairment

AbstractMany individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.

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