Philosophical Basis of Informed Consent, Informed Refusal and Documentation of Medical Information into Medical Record

Philosophical Basis of Informed Consent, Informed Refusal and Documentation of Medical Information into Medical Record
Ismijatie Jenie, Ahdiana Yuni Lestari
Journal Media Hukum, June 2019; 26(1) pp 60-70
Open Access
Abstract
Information delivered by the medical professionals to the patients in their initial communication is crucial in establishing the therapeutic contract (transaction). Based on that information, the patient will decide whether to accept or to refuse the proposed medical treatment. This paper discusses the philosophical basis of the Informed Consent, Informed Refusal and the documentation of medical information into Medical Record. This normative legal research is carried out by library-based study on primary and secondary legal materials. Besides descriptive-analytical approach, the study also employs comparative approach. The comparison is made between continental legal system, common law system, and the Islamic legal system. It is found that philosophical basis of informed consent, informed refusal and documentation of medical information into medical record is basically to protect the patients’ dignity and to maintain their trust and cooperation. Furthermore, from the Islamic perspective the establishment of informed consent is to respect the privacy to blood, property, and family. In addition, the documentation of medical information into the medical record is to give legal protection in the form of strong evidence both for the health providers and health receivers in the event of a medical dispute.

Editor’s note: MEDIA HUKUM (JMH) is journal published by Faculty of Law Universitas Muhammadiyah Yogyakarta. JMH publishes scientific articles that related in law, development and harmonization of Shariah and positive law in Indonesia.

Overvaluing individual consent ignores risks to tribal participants

Overvaluing individual consent ignores risks to tribal participants
Comment
Krystal S. Tsosie, Joseph M. Yracheta, Donna Dickenson
Nature Reviews Genetics, 15 July 2019
Excerpt
Genomic studies often rely on individual-based consent approaches for tribal members residing outside of their communities. This consent model fails to acknowledge the risks to small groups such as tribes, which can implicate the community as a whole.

The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study

The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study
Research Article
Joseph Mumba Zulu, Ingvild Fossgard Sandøy, Karen Marie Moland, Patrick Musonda, Ecloss Munsaka, Astrid Blystad
BMC Medical Ethics, 4 July 2019; 20(45)
Open Access
Abstract
Background
There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters’ participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and informed consent process.
Methods
The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions (4) were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews (11) were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis.
Results
The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot.
Conclusions
Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people’s capability to consent or not consent to a study in an informed manner.

Free, Prior and Informed Consent (FPIC) in Mexico: Elements for its construction and challenges

Free, Prior and Informed Consent (FPIC) in Mexico: Elements for its construction and challenges
Jose Israel Herrera
The Age of Human Rights Journal, June 2019; 12 pp.62-83
Open Access
Abstract
Free, Prior and Informed Consent (FPIC) – Consultation has become one of the most powerful tools indigenous people and minorities have to generate a dialogue and begin a negotiation in the country to face Government decisions, private companies seeking to carry out any work or when legislative measures are about to be implemented on their territories with a possibility of damaging them. In Mexico, this right is based over a group of not articulated among themselves normative foundations. This end up causing confusion and uncertainty on its application. This article presents elements to review the FPIC – Consultation foundations in Mexico for discussion and theoretical deepening in the light of human rights.

Consent for data processing under the General Data Protection Regulation: could ‘dynamic consent’ be a useful tool for researchers?

Consent for data processing under the General Data Protection Regulation: could ‘dynamic consent’ be a useful tool for researchers?
J. Kaye, H. Teare, J. Bell
Journal of Data Protection and Privacy, 19 July 2019
Abstract
The General Data Protection Regulation (GDPR) sets a high bar for consent for the processing of personal data. In the UK, researchers have been directed to rely on legal bases other than consent for processing personal data for research purposes. Informed consent nonetheless, and despite certain shortcomings, holds a central position in ethical research practice, as well as at common law, and in a range of other legislation dealing with research involving humans.

This paper evaluates the place of informed consent in research following the GDPR’s implementation, arguing that a fresh approach to consent – specifically the concept known as ‘dynamic consent’ – could provide a way for researchers to meet the new European regulatory requirements for data processing whilst adhering to the highest ethical standards for research conduct. It analysis dynamic consent according to specific GDPR requirements and reflects on practical examples that could inform future implementation of the approach, while remaining aware of the need for further empirical research.

Key Information in the New Common Rule: Can It Save Research Consent?

Key Information in the New Common Rule: Can It Save Research Consent?
Research Article 
Nancy M. P. King
The Journal of Law, Medicine & Ethics, 12 July 2019 
Abstract
Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence

Implementing Regulatory Broad Consent Under the Revised Common Rule: Clarifying Key Points and the Need for Evidence
Research Article 
Holly Fernandez Lynch, Leslie E. Wolf, Mark Barnes
The Journal of Law, Medicine & Ethics, 12 July 2019 
Abstract
The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary’s Advisory Committee on Human Research Protections (SACHRP), and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation.

Blockchain Based Informed Consent with Reputation Support

Blockchain Based Informed Consent with Reputation Support
Advances in Intelligent Systems and Computing book series
Hélder Ribeiro de Sousa, António Pinto
International Congress on Blockchain and Applications, 25 June 2019; pp 54-61
Abstract
Digital economy relies on global data exchange flows. On May 25th 2018 the GDPR came into force, representing a shift in data protection legislation by tightening data protection rules. This paper introduces an innovative solution that aims to diminish the burden resulting from new regulatory demands on all stakeholders. The presented solution allows the data controller to collect the consent, of a European citizen, in accordance to the GDPR and persist proof of said consent on public a blockchain. On the other hand, the data subject will be able to express his consent conveniently through his smartphone and evaluate the data controller’s performance. The regulator’s role was also contemplated, meaning that he can leverage certain system capabilities specifically designed to gauge the status of the relationships between data subjects and data controllers.

Speech as Speech: “Professional Speech” and Missouri’s Informed Consent for Abortion Statute

Speech as Speech: “Professional Speech” and Missouri’s Informed Consent for Abortion Statute
Michael J. Essma
Missouri Law Review, Spring 2019; 84(2)
Open Access
Excerpt
Does life begin at conception? Do women need to see a sonogram to make an informed decision about whether they want an abortion? Some state legislatures believe so.1 Laws mandating politically driven doctor-patient dialogue affect one of the hallmarks of the physician-patient relationship: a patient’s trust in the physician’s expertise. The common law and statutory requirement that a patient provide informed consent for a medical procedure facilitates the development of trust between patient and physician by allowing the patient to understand the procedure and discuss her options with her physician.2 However, provisions of abortion-specific informed consent statutes that require physicians to communicate to the patient messages with which the physician disagrees undermine this trust…

Consent, capacity and the law [BOOK CHAPTER]

Consent, capacity and the law [BOOK CHAPTER]
Jonathan Waite
The ECT Handbook, Cambridge University Press, Online 2018; chapter 22
Summary
All medical procedures, be they therapeutic or investigative, touch on the issue of consent – that is a measure of willingness on the part of the patient to undertake the procedure proposed. In this, ECT is no different to other therapeutic interventions. However, ECT has a particular status both within psychiatry and within the law that makes specific discussion of issues with regard to consent necessary.

Editor’s note: The Cambridge university Press summarizes The ECT Handbook as “present[ing] the latest clinical guidelines on the prescription and practical administration of electroconvulsive therapy (ECT). It clarifies the place of ECT in contemporary practice and reviews the evidence for its efficacy. The ECT Handbook is an essential reference manual for all psychiatrists, for anaesthetists and nurses who work in ECT clinics, for everyone professionally involved in caring for patients for whom ECT may be recommended, and for second-opinion appointed doctors working for the Care Quality Commission.”