Can informed consent apply to information disclosure? Moral and practical implications

2013 ◽  
Vol 9 (1) ◽  
pp. 1-9 ◽  
Author(s):  
Jacques Tamin
Keyword(s):  
Informed Consent ◽  
Information Disclosure ◽  
Practical Implications

scholarly journals Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception from Informed Consent for emergency research

2018 ◽  
Vol 45 (1) ◽  
pp. 18-21
Author(s):  
Victoria Vorholt ◽  
Neal W Dickert
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Services ◽  
Emergency Research ◽  
Emergency Situations ◽  
Risks And Benefits ◽  
Department Of Health ◽  
The Us ◽  
Level Of Understanding ◽  
Practical Implications

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.

scholarly journals Informed consent to clinical research in India: A private law remedy

2020 ◽  
Vol 20 (3) ◽  
pp. 256-283
Author(s):  
Himani Bhakuni
Keyword(s):  
United States ◽  
Informed Consent ◽  
Clinical Research ◽  
Information Disclosure ◽  
Common Law ◽  
Case Law ◽  
The United States ◽  
Private Law ◽  
Patient Relationship ◽  
Treatment Context

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.

Bank Information Disclosure, Financial Transparency and Corporate Governance in Rastin Banking

2019 ◽  
Vol 2 (1) ◽  
pp. 1-13
Author(s):  
Bijan Bidabad ◽  
Mahshid Sherafati
Keyword(s):  
Corporate Governance ◽  
Information Disclosure ◽  
Practical Problem ◽  
Public Trust ◽  
Banking Regulations ◽  
Bank Managers ◽  
Financial Transparency ◽  
Information Circulation ◽  
Practical Implications ◽  
Banking Operations

Purpose: This paper aims to define a set of banking operating regulations for financial transparency, corporate governance, and bank information disclosure. Design: Bank governance, financial transparency, and information disclosure are amongst the most important solutions to attract public trust to financial and banking operations. In order to reach this goal, a new set of regulations should be designed to solve the problem. In this way, Rastin Banking regulations can provide a base to obtain a better information circulation and higher clarity. Findings: A draft of regulations for financial transparency, governance, and bank information disclosure is presented in this paper, which can be employed as a basis for the codification of the respective law. Research limitations: Since such kinds of regulations are novel for banks, they are required to be meticulously scrutinized in the first place, and after adaptation, adjustment, and performing the necessary modifications, the code of law can be codified. Practical implications: Bank managers, through granting various concessions to themselves and their own stakeholders, have violated the rights of shareholders, depositors, and other stakeholders. This issue, through applying the governance methods, is adjustable to a great extent. Social implications: This procedure is a model that can be adopted in other countries, especially those countries that have essential ambiguities in their banking and financial operations. Value: Clearly, the lack of transparency in banking operations can gradually weaken the trust of depositors, stakeholders, and shareholders, and result in probable abuses and damages to all parties in the bank’s contracts. This article fulfills an identified need and solves the practical problem in financial abuses, corruption, and collusion, and can provide positive and essential effects on creating public trust in financial operations.

scholarly journals Exploration of coping strategies among bereaved young adults using six-part story method (6PSM)

2021 ◽  
Vol 2 (1) ◽  
pp. 1
Author(s):  
Merikan Aren ◽  
Venessha Sambasivan
Keyword(s):  
Young Adults ◽  
Content Analysis ◽  
Informed Consent ◽  
Data Collection ◽  
Coping Strategies ◽  
Information Disclosure ◽  
Snowball Sampling ◽  
Social Imagination ◽  
Ethics Of Research ◽  
Counselling Approach

The purpose of this research was to explore the coping strategies among bereaved young adults using Six-Part Story Method (6PSM). More specifically, this study was meant to identify the strengths of coping using 6PSM and the suitability of 6PSM among young adults in counselling approach. Counselling session was adapted as a medium for data collection with the aid of 6PSM as an intervention technique. Purposive sampling and snowball sampling was used to identify the most suitable participants to contribute in this study. The ethics of research and counselling such as anonymity, confidentiality, information disclosure, and the acquisition of informed consent were followed strictly throughout this research. The data collected was then analyzed using content analysis by categorizing the data into themes that present in the BASICPh model introduced by Mooli Lahad (Belief, Affect, Social, Imagination, Cognitive, and Physical)  Other than that, this study had also showed that themes such as belief, affect, and social are highly used among young adults as a way of dealing with bereavement. Not only that, this study had also found that the process of completing 6PSM enables an individual to express themselves in a way that synchronizes with the BASICPh model of coping. Based on the findings, this study would like to implicate that the coping strategies of bereaved young adults falls under the themes of belief, affect, and social. In addition, it also implicated that 6PSM is suitable to be used as an intervention in counselling young adults.

scholarly journals The new Italian law 219/2017: an extraordinary clinical tool in internal medicine

2020 ◽  
Author(s):  
Matteo Bolcato ◽  
Giacomo Fassina ◽  
Matteo Sanavio ◽  
Anna Aprile
Keyword(s):  
Internal Medicine ◽  
Informed Consent ◽  
The Other ◽  
Self Determination ◽  
Medical Work ◽  
Clinical Tool ◽  
Medical Activity ◽  
Italian Law ◽  
Practical Implications ◽  
Care Decision

On December 2017, Law 219 named Provisions for informed consent and advance treatment directives was approved in Italy, and on one side this law helped the daily medical activity on the other side it enhanced the patient's self-determination. This contribution analyzes the new legislative disposition and the possible medical-legal and practical implications for patients entrusted in hospitals. In particular, it focuses on the usefulness of an early planning of medical care decision in complex pathological situations in order to enhance the patient's self-determination and his eventual impassable refusal. It also safeguards the medical work from disputes and claims, preserving medical autonomy and competence.

scholarly journals Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Antonia Xu ◽  
Melissa Therese Baysari ◽  
Sophie Lena Stocker ◽  
Liang Joo Leow ◽  
Richard Osborne Day ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Information Disclosure ◽  
Ethics Committees ◽  
Structured Interviews ◽  
Worst Case ◽  
Human Research Ethics ◽  
Written Information ◽  
Human Participants ◽  
The Relationship

Abstract Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.

Protecting privacy on the web

2018 ◽  
Vol 42 (6) ◽  
pp. 734-751 ◽  
Author(s):  
Patrick O’Brien ◽  
Scott W.H. Young ◽  
Kenning Arlitsch ◽  
Karl Benedict
Keyword(s):  
Informed Consent ◽  
Privacy Protection ◽  
Design Methodology ◽  
Academic Library ◽  
Third Party ◽  
Home Pages ◽  
Content Type ◽  
Library Websites ◽  
Practical Implications ◽  
The Web

Purpose The purpose of this paper is to examine the extent to which HTTPS encryption and Google Analytics services have been implemented on academic library websites, and discuss the privacy implications of free services that introduce web tracking of users. Design/methodology/approach The home pages of 279 academic libraries were analyzed for the presence of HTTPS, Google Analytics services and privacy-protection features. Findings Results indicate that HTTPS implementation on library websites is not widespread, and many libraries continue to offer non-secured connections without an automatically enforced redirect to a secure connection. Furthermore, a large majority of library websites included in the study have implemented Google Analytics and/or Google Tag Manager, yet only very few connect securely to Google via HTTPS or have implemented Google Analytics IP anonymization. Practical implications Librarians are encouraged to increase awareness of this issue and take concerted and coherent action across five interrelated areas: implementing secure web protocols (HTTPS), user education, privacy policies, informed consent and risk/benefit analyses. Originality/value Third-party tracking of users is prevalent across the web, and yet few studies demonstrate its extent and consequences for academic library websites.

Informed Patient Decision Making and the Use of Prescription Medications: A Canadian Dermatologic Perspective

1996 ◽  
Vol 1 (1) ◽  
pp. 10-16 ◽  
Author(s):  
Michael I. Singer ◽  
Neil H. Shear
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Information Disclosure ◽  
General Medicine ◽  
Individual Autonomy ◽  
Sufficient Information ◽  
Prescription Medications ◽  
Risk Disclosure ◽  
Legal Concept ◽  
Drug Risk

Background: Informed consent is a potentially beneficial component of medical practice and a basic obligation of physician to patient. Society, in general, and the courts, in particular, have increasingly emphasized the principles of individual autonomy and patient rights, and they have begun to more rigorously require physicians to inform and consult with patients before initiating treatments. Nevertheless, the lack of sufficient information disclosure to patients has become an increasingly common allegation in legal actions against physicians. It has been shown that physicians' understanding of what constitutes informed consent is not always equivalent to the legal definition. While informed consent is generally applied in investigative medical research and before surgical and other invasive procedures, general medicine and dermatology patients do not commonly undergo a process of informed and formal decision making before commencing therapy with sometimes potent medications that often have potentially serious side effects. Objective: The purpose of this article is to explore and clarify the legal concept of informed consent as it applies to the use of prescription medications and to offer dermatologists a strategy to make drug use safer, both medically and legally. Conclusion: In light of recent legal trends including the proclamation of the Ontario Consent to Treatment Act, as well as the application of the “learned intermediary” rule in cases of medical negligence involving lack of drug risk disclosure, Canadian health care practitioners are well advised to become familiar with the concept of informed consent and how it applies to prescription medications.

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