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
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
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
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]
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.”

The side effects of deemed consent: changing defaults in organ donation
Current Controversy
David M Shaw
Journal of Medical Ethics, 22 June 2019
Abstract
In this Current Controversy article, I describe and analyse the imminent move to a system of deemed consent for deceased organ donation in England and similar planned changes in Scotland, in light of evidence from Wales, where the system changed in 2015. Although the media has tended to focus on the potential benefits and ethical issues relating to the main change from an opt-in default to an opt-out one, other defaults will also change, while some will remain the same. Interaction of these other defaults with the principal one raise several ethical issues that may complicate efforts to use deemed consent to increase donation rates. Most significantly, changing the main default will have the effect of changing the default for patients’ families, who play a vital role in the consent process.

Without Prejudice – Informed consent and the responsibility of healthcare practitioners – medical law
Hickley Hamman
Without Prejudice,  June 2019; 19(5) pp 32 – 34
Abstract 
The Supreme Court of Appeal was recently called upon to adjudicate an appeal relating to a claim based on an alleged failure to obtain informed consent for a medical procedure. In the case of Beukes v Smith (211/2018) [2019] ZASCA 48 the appellant appealed against an order dismissing her claim because she had failed to establish the basis for liability against the respondent. She alleged that the respondent failed to inform her of the full range of treatment options available to her for the treatment of a hernia, that he unilaterally decided to perform a laparoscopic hernia repair, and that this resulted in her sustaining a perforation of her bowel.

Consent, capacity and the law [BOOK CHAPTER]
Jonathan Waite
The ECT Handbook, 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.