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.
Month: August 2019
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.”
Informed Consent: an Update
Informed Consent: an Update
Biermann E
Anasthesiol Intensivmed Notfallmed Schmerzther, 25 Jul 2019; 54(7-8) pp 457-473
Abstract
An indication for a medical intervention alone is not sufficient to justify its implementation. In addition, consent has to be obtained from the patient who has been given relevant information by a doctor. If, instead of the patient, other persons are entitled to decide for him (parents for children incapable of consent, authorised representatives, carers), they must be informed. If the patient, who is aware of the significance of his decision, refuses to consent to the measure as a whole or to parts of it, the physician is bound by it – even if the patient’s refusal is based on religious, ideological or other reasons which are not comprehensible to the physician. In urgent cases, and in the case of a patient unable to give consent, the doctor can initiate treatment according to the principle of so-called presumed consent. The physician must inform the patient about all circumstances essential for the consent in a timely and comprehensible manner, i.e. also in the language of the patient in the case of patients who do not understand German. The patient must be informed about alternatives if there are other common treatment methods that are medically equally indicated, but which carry substantially different burdens, risks or chances of recovery. From a medical and forensic point of view, risk education is of the greatest importance, in particular information about the typical risks specific to interventions which are unknown to the patient and which, if they materialise, might have a lasting adverse effect on the patient’s lifestyle. The extent of risk disclosure is influenced by the urgency of the intervention; the scope of risk disclosure is in inverse proportion to its urgency. An enlightened or otherwise adequately informed patient (e.g. in the case of a series of dressing changes under general anaesthesia) does not have to be enlightened every time, provided that the risk spectrum for the patient has not changed. Consent and clarification are also verbally effective, written form is strongly recommended for reasons of preserving evidence. However, the patient’s right to self-determination also means that the patient can expressly dispense with more detailed information. Such a waiver should be carefully documented.
Editor’s note: This is a German language publication.
How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions
How Do We Really Communicate? Challenging the Assumptions behind Informed Consent Interventions
Article
Stephanie Solomon Cargill
Ethics & Human Research, 23 July 2019
Abstract
It is generally accepted that ethical research requires valid informed consent and that current informed consent practice frequently fails to attain it. Interventions concerning the content and methods of communication in informed consent have met with limited success. One explanation is that they reflect an outdated and limited model of how communication functions, the transmission model of communication. This model assumes that communication is linear, is limited in time, and succeeds when the content of a message is passed from one person to another without distortion. Later communication models have challenged the limitations and inaccuracies of this model, emphasizing the continuous, contextual, and relational nature of communication. Looking beyond these assumptions behind current interventions can open multiple paths of research and intervention that have the potential to affect and improve the informed consent process in much greater ways than have been achieved previously.
Bioethical reflexivity and requirements of valid consent: conceptual tools
Bioethical reflexivity and requirements of valid consent: conceptual tools
Debate
John Barugahare
BMC Medical Ethics, 4 July 2019; 20(44)
Open Access
Abstract
Background
Despite existing international, regional and national guidance on how to obtain valid consent to health-related research, valid consent remains both a practical and normative challenge. This challenge persists despite additional evidence-based guidance obtained through conceptual and empirical research in specific localities on the same subject. The purpose of this paper is to provide an account for why, despite this guidance, this challenge still persist and suggest conceptual resources that can help make sense of this problem and eventually mitigate it’.
Main body
This paper argues that despite the existence of detailed official guidance and prior conceptual and empirical research on how to obtain valid consent, the question of ‘how to obtain and ascertain valid consent to participation in health-related research’ cannot always be fully answered by exclusivereference to pre-determined criteria/guidance provided by the guidelines and prior research’. To make intelligible why this is so and how this challenge could be allayed, the paper proposes six concepts. The first five of these are intended to account for the persistent seeming inadequacies of existing guidelines. These are fact-skepticism; guideline insufficiency; generality; context-neutrality and presumptiveness. As an outcome of these five, the paper analyzes and recommends a sixth, called bioethical reflexivity. Bioethical reflexivity is reckoned as a handy tool, skill, and attitude by which, in addition to guidance from context-specific research, the persisting challenges can be further eased.
Conclusions
Existing ethical guidelines on how to obtain valid consent to health-related research are what they ought to be – general, presumptive and context-neutral. This explains their seeming inadequacies whenever they are being applied in concrete situations. Hence, the challenges being encountered while obtaining valid consent can be significantly eased if we appreciate the guidelines’ nature and what this means for their implementation. There is also a need to cultivate reflexive mindsets plus the relevant skills needed to judiciously close the unavoidable gaps between guidelines and their application in concrete cases. This equally applies to the gaps which cannot be filled by reference to additional guidance from prior conceptual and empirical research in specific contexts.
Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition
Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition
Research Article
Jane Paik Kim, Katie Ryan, Laura Weiss Roberts
Journal of Emirical Research on Human Research Ethics, 22 July 2019
Abstract
In this study, participants with a self-reported history of depression, diabetes, or no illness underwent a simulated informed consent process for a hypothetical genetic study related to depression or diabetes. Participants completed a survey assessing their perceived understanding of the research process, perceptions of its risks and benefits, their satisfaction with the informed consent process, and their readiness to make a hypothetical enrollment decision. All participants indicated strong readiness to make an enrollment decision regarding the research characterized in the simulation. Participants reported understanding the consent process relatively well and being generally satisfied with it. Greater concerns were expressed regarding psychosocial risks than biological risks for genetic studies on mental disorders. Our study documented positive attitudes toward volunteering for research that involved the collection of genetic data.
How to Strengthen Patients’ Meaning Response by an Ethical Informed Consent in Psychotherapy
How to Strengthen Patients’ Meaning Response by an Ethical Informed Consent in Psychotherapy
Conceptual Analysis Article
Manuel Trachsel, Martin grosse Holtforth
Frontiers in Psychology, 31 July 2019
Open Access
Abstract
Healthcare professionals including psychotherapists are legally and ethically obliged to ensure informed consent for the provided treatments comprising type and duration or potential benefits and possible risks (e.g., side effects) among others. In the present contribution, we argue that as potential benefit, informed consent can foster the patient’s meaning response. Moerman’s notion of the meaning response as the physiological or psychological effects of meaning in the course and treatment of an illness is a useful concept in explaining the effects of communicating a treatment rationale as part of the informed consent procedure. The more compelling the rational explanation of the targeted treatment effects including an explanatory model and a model of unique and common change mechanisms, the stronger the meaning response is expected to be resulting in increased hope and positive expectations with regard to the treatment.
Center for Informed Consent Integrity 