From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository
Research Article
Elizabeth Bromley, Alexandra Mendoza-Graf, Sandra Berry, Camille Nebeker, Dmitry Khodyakov
The Journal of Law, Medicine & Ethics, 28 April 2020
Abstract
The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders’ views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant’s ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders’ views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.

Evidence‐Based Communication in Clinical, Mass Media, and Social Media Contexts to Enhance Informed Consent for Participation in Clinical Trials and Precision Medicine Initiatives [BOOK CHAPTER]
Susan E. Morgan, Aurora Occa, Wei Peng, Soroya J. McFarlane
The Handbook of Applied Communication Research
John Wiley & Sons, 17 April 2020; Chapter 49
Summary
This chapter explains that improved clinical trial communication will result in better informed patients who demonstrate greater willingness to participate in a system that is intended to produce significant advances in medical treatment. It centers on the factors where communication scholars and practitioners can best apply their energy and insights. These include clinical communication interventions, including training of physicians, study nurses, and clinical research staff; public communication messages designed to inform a broad audience about scientific concepts that are central to meaningful and informed consent; and the use of social media platforms for participant recruitment and retention. The chapter discusses the implications of these findings for the development of new interventions designed to enroll members of the public in emerging precision medicine (PM) initiatives, particularly among minority populations. It also reviews communication‐based interventions, including interpersonal communication trainings, public communication campaigns, persuasive message design, and targeted message delivery.

Patient perspectives on research use of residual biospecimens and health information: On the necessity of obtaining societal consent by creating a governance structure based on value-sharing
Original Research
Mayumi Yamanaka, Mika Suzuki, Keiko Sato
Research Ethics, April 2020
Open Access
Abstract
Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that uses these items. Few patients felt that obtaining individual consent for each research study was necessary. Most patients expressed the view that researchers should be obligated to inform them about the research use of their items and be subject to self-directed rules (including sanctions). The research community should try to obtain “societal consent regarding an opt-out system” from the public. A salient value-sharing-based governance structure is necessary for obtaining public trust.

Examining consent for interventional research in potential deceased organ donors: a narrative review
Review
Cooper J, Harvey D, Gardiner D
Anaesthesia, 24 Apr 2020
Abstract
In the last decade, research in transplant medicine has focused on developing interventions in the management of the deceased organ donor to improve the quality and quantity of transplantable organs. Despite the promise of interventional donor research, there remain debates about the ethics of this research, specifically regarding gaining research consent. Here, we examine the concerns and ambiguities around consent for interventional donor research, which incorporate questions about who should consent for interventional donor research and what people are being asked to consent for. We highlight the US and UK policy responses to these concerns and argue that, whereas guidance in this area has done much to clarify these ambiguities, there is little consideration of the nature, practicalities and context around consent in this area, particularly regarding organ donors and their families. We review wider studies of consent in critical care research and social science studies of consent in medical research, to gain a broader view of consent in this area as a relational and contextual process. We contend a lack of consideration has been given to: what it might mean to consent to interventional donor research; how families, patients and health professionals might experience providing and seeking this consent; who is best placed to have these discussions; and the socio-institutional contexts affecting these processes. Further, empirical research is required to establish an ethical and sensitive model for consent in interventional donor research, ensuring the principles enshrined in research ethics are met and public trust in organ donation is maintained.

Trust trumps comprehension, visceral factors trump all: A psychological cascade constraining informed consent to clinical trials: A qualitative study with stable patients
Original Research
Michael Rost, Rebecca Nast, Bernice S Elger, David Shaw
Research Ethics, April 2020
Open Access
Abstract
This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early-phase clinical trial participants. Thirty-six semistructured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients’ attitudes towards participating in a fictitious first-in-human trial of a novel intervention. We focused on an in-depth analysis of those statements and explanations that indicated the existence of psychological factors impairing decision-making capacity. Three main themes emerged: insufficient comprehension of the inherent logic of clinical trials (actual comprehension), the recourse to trust over comprehension (prioritization of trust), and visceral factors that override deliberative process (visceral factors). Overall, our results indicate a limited psychological capacity on the part of stable patients to meet the requirements of informed consent as set by Declaration of Helsinki. A redesigned informed consent procedure should take account of these psychological realities.

The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study
E Villamañán, C Sobrino, M Freire, JN Inmaculada, SR Luis, L Patricia, C Lara, E Fernández De Uzquiano, A Herrero, M Moreno
European Journal of Hospital Pharmacy, 24 March 2020; 27(suppl 1:6ER-023)
Open Access
Abstract
Background and importance
It is the responsibility of institutional review boards (IRBs) and hospital pharmacists, as members of these boards, to review a research proposal and ensure that adequate informed consent procedures are implemented in an ethical way, promoting participant autonomy and protecting them from potential harm. In this context, informed consent forms (ICFs) have become increasingly complex and difficult for patients to understand.
Aim and objectives
To analyse non-approval of clinical research by IRBs, related to deficiencies found in the ICFs. Secondary outcomes were type of objections in terms of readability, length, description of study purpose, design, expected benefits and foreseeable risks. Other ethical and legal aspects, such as voluntary agreement to participate, right to withdraw, biological sample management and access to personal data were also analysed
Material and methods
This was a retrospective observational study of the clinical studies evaluated by the IRB in a tertiary hospital. We evaluated the IRB resolutions of all clinical studies over 4 years, including interventional studies (clinical trials) and non-interventional research assessed by the IRB where a hospital pharmacist was a member of the board. The committee’s decisions on approval were registered in the minutes of the meetings. The pharmacists reviewed the minutes, evaluating the final opinion of the committee (approval/non-approval of the study) in the first review.
Results
A total of 91 sets of minutes, corresponding to the IRB meetings over 4 years, were analysed. In these meetings, 1858 clinical trials were evaluated (1057 clinical trials and 801 non-interventional studies). Of these, 1558 required informed consent for participation (83.9%, 95% CI 82.1–85.5) and 987 were not approved at first review due to deficiencies detected in the ICF (63.3%, 95% CI 60.9–65.7). The main reasons for non-approval were unreadability (11.7%), inadequate information given about access to personal data rights (9.2%), biological sample management (7.8%) and expected benefits (7.6%).
Conclusion and relevance
There was a high proportion of deficiencies in the ICFs for clinical research. They were an important reason for non-approval of protocols evaluated by IRBs. Taken together, there are three fundamental weaknesses in ICFs where IRBs in hospitals play a key role: improving their readability, adapting them to regulations concerning data protection or biological sample management, and avoiding misleading information concerning enrolment.

Ethics (Informed Consent and Conflicts of Interest) [BOOK CHAPTER]
Kara K. Rossfeld, Jordan M. Cloyd, Elizabeth Palmer, Timothy M. Pawlik
Clinical Trials
Springer, 11 March 2020; pp 17-31
Abstract
The aim of clinical trials is to obtain generalizable knowledge that can be used to advance healthcare. The ethical issues in clinical trials arise when human subjects, who may not directly benefit from the research, are faced with the risk of being exploited or harmed. Additional ethical challenges pertain to informed consent of subjects and conflicts of interest of physician-investigators. The current ethical standards for research are based on guidelines and laws which were a necessary response to historical abuses of participants in the name of science. In this chapter, a framework for evaluating clinical research for ethical deficits is discussed, as are challenges in upholding ethical principles, including in obtaining informed consent from research participants as well as in navigating conflicts of interest.

Trust and consent: a prospective study on parents’ perspective during a neonatal trial
Original Research
Sonia Dahan, Camille Jung, Gilles Dassieu, Xavier Durrmeyer, Laurence Caeymaex
Journal of Medical Ethics, 20 February 2020
Abstract
Objective
This study aimed to describe how parents and physicians experienced the informed consent interview and to investigate the aspects of the relationship that influenced parents’ decision during the consent process for a randomised clinical trial in a tertiary neonatal intensive care unit (NICU). The secondary objective was to describe the perspectives of parents and physicians in the specific situation of prenatal informed consent.
Setting
Single centre study in NICU of the Centre Hospitalier Intercommunal de Créteil, France, using a convenience period from February to May 2016.
Design
Ancillary study to a randomised clinical trial: Prettineo. Records of interviews for consent. Population: parents and physicians. Mixed study including qualitative and quantitative interview data about participants’ recall and feelings about the consent process. Interviews were reviewed using thematic discourse analysis.
Results
Parents’ recall and understanding of the study’s main goal and design was good. Parents and physicians had a positive experience, and trust was one of the main reasons for parents to consent. Misunderstanding (bad comprehension) was the main reason for refusal. Before birth, three situations can compromise parents’ consent: the mother already consented to participate in other studies, the absence of the father during the interview and the feeling that the baby’s birth is not an imminent possibility.
Conclusions
Confronting parents and physicians’ perspectives in research can help us reach answers to sensitive issues such as content and timing of information. Each different types of study raises different ethical dilemmas for consent that might be discussed in a more individual way.

Dynamic consent management for clinical trials via private blockchain technology
Original Research
Giuseppe Albanese, Jean-Paul Calbimonte, Michael Schumacher, Davide Calvaresi
Journal of Ambient Intelligence and Humanized Computing, 14 February 2020
Abstract
Clinical trials (CTs) are essential for the advancement of medical research, paving the way for the development and adoption of new treatments, and contributing to the evolution of healthcare. An essential factor for the success of a CT is the appropriate management of its participants and their personal data. According to the current regulations, collecting and using personal data from participants must comply with rigorous standards. Therefore, healthcare institutes need to obtain freely given, specific, informed, and unambiguous consent before being able to collect the data. Some of the major limitations of the current technological solutions are the lack of control over the granularity of consent grants, as well as the difficulty of handling dynamic changes of consent over time. In this paper, we present SCoDES, an approach for trusted and decentralized management of dynamic consent in clinical trials, based on blockchain technology (BCT). The usage of blockchain provides a set of features that allow maintaining consent information with trust guarantees while avoiding the need for a dedicated or centralized third trusted party. We provide a full implementation of SCoDES, made available as a self-contained infrastructure, with the possibility to interact with external services, and using hyperledger as a blockchain framework.

Editor’s note: The SCoDES project is an applied research project on blockchains involving five Hautes Ecoles from French-speaking Switzerland… Its goal is to develop knowledge within the field of blockchain and smart contracts by studying and developing practical cases of use and transferring the acquired knowledge to the regional economic actors.

Research Consent Models Used in Prospective Studies of Neurologically Deceased Organ Donors: A Systematic Review
Research Article
Frederick D’Aragon, Karen E. A. Burns, Amanda Yaworski, Amanda Lucas, Erika Arseneau, Emilie Belley-Cote, Sonny Dhanani, Anne-Julie Frenette, François Lamontagne, François Lauzier, Aemal Akhtar, Simon Oczkowski, Bram Rochwerg, Maureen O. Meade
Journal of Empirical Research on Human Research Ethics, 13 February 2020
Abstract
Research to inform the care of neurologically deceased organ donors is complicated by a lack of standards for research consent. In this systematic review, we aim to describe current practices of soliciting consent for participation in prospective studies of neurologically deceased donors, including the frequency and justification for these various models of consent. Among the 74 studies included, 14 did not report on any regulatory review, and 13 did not report on the study consent procedures. Of the remaining 47 studies, 24 utilized a waiver of research consent. The most common justification for a waiver of research consent related to the fact that neurologically deceased donors are not considered human subjects. In conclusion, among studies of neurologically deceased donors, research consent models vary and are inconsistently reported. Consensus and standardization in the application of research consent models will help to advance this emerging field of research.