Integrating Shared Decision Making into Trial Consent: A Nested, Cluster-Randomized Trial
Ellen A. Lipstein, Maggie Breslin, Cassandra M. Dodds, Michael D. Kappelman, Nicholas J. Ollberding, Peter Margolis, Yingying Xu, William B. Brinkman
Patient Education and Counseling, 25 December 2020
Abstract
Objective
Using a nested, cluster-randomized trial, we tested the hypothesis that a shared decision-making intervention, as part of consent, would improve study-related knowledge.
Methods
We developed a shared decision-making intervention then randomized sites in a clinical trial to intervention or control (standard consent). We collected participants’ knowledge (primary outcome) and decisional support data. Other data came from a clinical registry and research coordinator surveys. We compared outcomes between study arms using generalized estimating equation models, accounting for clustering. We used qualitative description to understand variation in intervention use.
Results
265 individuals, from 34 sites, enrolled in the parent trial during our study period. Of those, 241 participants completed our survey. There was no knowledge difference between arms (mean difference = 0.56 (95%CI: -3.8, 4.9)). Both groups had a considerable number of participants with misunderstandings. We also found no difference for decisional support (mean difference = 1.5 (95%CI: -1.8, 4.8)) or enrollment rate between arms. Clinician use of the intervention varied between sites.
Conclusions
We found no differences in outcomes but demonstrated the feasibility and acceptability of incorporating a shared decision-making intervention into consent.
Practice implications
Future work should consider adapting our intervention to other trials and more robust measurement strategies.

Development, Piloting and Evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): A protocol for a mixed methods study
Alina Weise, Julia Lühnen, Stefanie Bühn, Felicia Steffen, Sandro Zacher, Lauberger Julia, Deha Murat Ates, Andreas Böhmer, Henning Rosenau, Anke Steckelberg, Tim Mathes
Research Square, 15 December 2020
Open Access
Abstract
Background
Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconcile these information with legal requirements.
Methods
The development, piloting and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact.
Discussion
The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competences to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased.

Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study
Research Article
John A. Sauceda, Karine Dubé, Brandon Brown, Ashley E. Pérez, Catherine E. Rivas, David Evans, Celia B. Fisher
Journal of Empirical Research on Human Research Ethics, 14 December 2020
Abstract
HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory—a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.

Assessment of the All of Us research program’s informed consent process
Megan Doerr, Sarah Moore, Vanessa Barone, Scott Sutherland, Brian M. Bot, Christine Suver, John Wilbanks
American Journal of Bioethics, 4 December 2020
Open Access
Abstract
Informed consent is the gateway to research participation. We report on the results of the formative evaluation that follows the electronic informed consent process for the All of Us Research Program. Of the nearly 250,000 participants included in this analysis, more than 95% could correctly answer questions distinguishing the program from medical care, the voluntary nature of participation, and the right to withdraw; comparatively, participants were less sure of privacy risk of the program. We also report on a small mixed-methods study of the experience of persons of very low health literacy with All of Us informed consent materials. Of note, many of the words commonly employed in the consent process were unfamiliar to or differently defined by informants. In combination, these analyses may inform participant-centered development and highlight areas for refinement of informed consent materials for the All of Us Research Program and similar studies.

Simulation Training to Improve Informed Consent and Pharmacokinetic/ Pharmacodynamic Sampling in Pediatric Trials
Bjoern B. Burckhardt, Agnes Maria Ciplea, Anna Laven, László Ablonczy, Ingrid Klingmann, Stephanie Läer, Karl Kleine, Michiel Dalinghaus, Milan Ðukic, Johannes M. P. J. Breur, Marijke van der Meulen, Vanessa Swoboda, Holger Schwender, Florian B. Lagler
Frontiers of Pharmacology, December 2020; 11
Open Access
Abstract
Background
Paediatric trials to add missing data for evidence-based pharmacotherapy are still scarce. A tailored training concept appears to be a promising tool to cope with critical and complex situations before enrolling the very first patient and subsequently to ensure high-quality study conduct. The aim was to facilitate study success by optimizing the preparedness of the study staff shift.
Method
An interdisciplinary faculty developed a simulation training focusing on the communication within the informed consent procedure and the conduct of the complex pharmacokinetic/pharmacodynamic (PK/PD) sampling within a simulation facility. Scenarios were video-debriefed by an audio-video system and manikins with artificial blood simulating patients were used. The training was evaluated by participants’ self-assessment before and during trial recruitment.
Results
The simulation training identified different optimization potentials for improved informed consent process and study conduct. It facilitated the reduction of avoidable errors, especially in the early phase of a clinical study. The knowledge gained through the intervention was used to train the study teams, improve the team composition and optimize the on-ward setting for the FP-7 funded “LENA” project (grant agreement no. 602295). Selfperceived ability to communicate core elements of the trial as well as its correct performance of sample preparation increased significantly (mean, 95% CI, p ≤ 0.0001) from 3 (2.5–3.5) to four points (4.0–4.5), and from 2 (1.5–2.5) to five points (4.0–5.0).
Conclusion
An innovative training concept to optimize the informed consent process and study conduct was successfully developed and enabled high-quality conduct of the pediatric trials as of the very first patient visit.

Recruitment and Consent in an observational study
M Goodwin, W Whittaker, T Walsh, R Emsley, M Sutton, M Tickle
Community Dental Health, 30 November 2020; 37(4) pp 287-292
Abstract
Objective
The study sought to explore the consent rate and associated potential bias across a cohort in a large longitudinal population based study.
Research design
Data were taken from a study designed to examine the effects of the reintroduction of community water fluoridation on children’s oral health over a five-year period. Children were recruited from a fluoridated and non-fluoridated area in Cumbria, referred to as Group 1 and Group 2.
Results
Data were available for 3138 individuals. The consent rate was 12.91 percentage points lower in Group 2 than Group 1 (95% CI -16.27 to -9.56, p<0.001). The population in Group 2 was more deprived than Group 1 before consent was taken. Consent was not associated with deprivation in either group.
Conclusion
The cohort appeared to be unaffected by IMD-related non-consent. However there was a difference in consent rate between the two groups. With the population in Group 1 being more deprived than Group 2, it will be important to incorporate these differences into the analysis at the end of this longitudinal study.

Informed consent for neonatal trials: practical points to consider and a check list
Beate Aurich, Eric Vermeulen, Valéry Elie, Mariette H E Driessens, Christine Kubiak, Donato Bonifazi, Evelyne Jacqz-Aigrain
BMJ Pediatrics, 29 November 2020
Open Access
Abstract
Obtaining informed consent from parents of critically ill neonates can be challenging. The parental decision making process is influenced by the severity of the child’s condition, the benefit–risk balance, their emotional state and the quality of the relationship with the clinical team. Independent of local legislation, parents may prefer that consent is sought from both. Misconceptions about the absence of risks or unrealistic expectations about benefits should be openly addressed to avoid misunderstandings which may harm the relationship with the clinical team. Continuous consent can be sought where it is unclear whether the free choice of parental consent has been compromised. Obtaining informed consent is a dynamic process building on trusting relationships. It should include open and honest discussions about benefits and risks. Investigators may benefit from training in effective communication. Finally, involving parents in neonatal research including the development of the informed consent form and the process of obtaining consent should be considered standard practice.

Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?
Adèle Langlois, Stephanie Armstrong, Aloysius Niroshan Siriwardena
Academic Emergency Medicine, 28 November 2020
Open Access
Abstract
In 2010 Largent, Wendler, and Emanuel proposed the “consent substitute model” for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: 1) the research addresses the patients’ urgent medical needs, 2) the risk–benefit ratio is favorable, 3) there are no known conflicts with patients’ values or interests, 4) cumulative net risk is minimal, and 5) consent is given as soon as possible. We review national and international ethics laws, regulations, and guidelines to determine 1) whether they accord with the consent substitute model’s five conditions and 2) the level of congruence across these documents. We find that only one document meets all five conditions and that there is significant disparity among the documents, particularly between national and international ones. These differences may have stymied international collaboration in emergency research. We recommend that the two international documents used most, the International Council for Harmonization’s Guideline for Good Clinical Practice and the World Medical Association’s Declaration of Helsinki, are revised to include more specific provisions on emergency medical research.

Cultural variation in informed consent for clinical research participation [BOOK]
David Resnik, Julia Hecking
Routledge; Handbook of Ethnography in Healthcare Research, 2020
Abstract
Informed consent is one of the cornerstones of ethical research with human subjects. Although most people living in Western countries are familiar with the concept of informed consent, in some parts of the world the idea that an individual has the right to give his or her informed consent for medical care or research participation is a foreign notion. In this chapter, we examine the ethical and legal basis of informed consent and review the published research on cultural variation in informed consent for clinical research participation. Our analysis of this literature identifies four different ways that culture may affect the informed consent process, including: 1) consent of community leaders may be sought prior to obtaining the individual consent of community members; 2) investigators may alter consent documents to better reflect the language and concepts used in the culture; 3) the consent procedure may be modified to reinforce the concept of opt-in participation and give participants more time to discuss their potential enrollment with others; and 4) instead of obtaining informed consent through written documents, researchers may use record consent verbally or through a fingerprint in cultures with an oral history or high rates of illiteracy.

Reflections on dynamic consent in biomedical research: the story so far
Harriet J. A. Teare, Megan Prictor, Jane Kaye
European Journal of Human Genetics, 28 November 2020
Open Access
Abstract
Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to ‘future research’ in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.