An international core outcome set for evaluating interventions to improve informed consent to clinical trials: the ELICIT Study
Katie Gillies, Paula R Williamson, Vikki A Entwistle, Heidi Gardner, Shaun Treweek, Marion K Campbell
Journal of Clinical Epidemiology, 26 February 2021
Open Access
Abstract
Objective
To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in RCTs (of healthcare interventions), the ELICIT Study.
Study Design
International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting.
Results
The literature review and stakeholder interviews (n=25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n=79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition.
Conclusion
The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an RCT. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders.

Adding dynamic consent to a longitudinal cohort study: A qualitative study of EXCEED participant perspectives
Research Article
Susan E. Wallace & José Miola
BMC Medical Ethics, 9 February 2021; 22(12)
Open Access
Abstract
Background
Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions of adding a dynamic consent interface to their existing study.
Methods
Adult participants in the Extended Cohort for E-health, Environment and DNA (EXCEED) longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent.
Results
Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED.
Conclusions
Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study.

Patient accrual and understanding of informed consent in a two-stage consent design
Research Article
Andrew J Vickers, Emily A Vertosick, Sigrid V Carlsson, Behfar Ehdaie, Scott Y H Kim
Clinical Trials, 2 February 2021
Abstract
Background
We previously introduced the concept of “two-stage” (or “just-in-time”) informed consent for randomized trials with usual care control. We argued that conducting consent in two stages—splitting information about research procedures from information about the experimental intervention—would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process.
Methods
Patients approached for consent for the biopsy trial were asked to complete the standard “Quality of Informed Consent” questionnaire to assess their knowledge and understanding of the trial.
Results
Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74–76) for the knowledge section and 86 (95% confidence interval = 81–90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87–90).
Conclusion
We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.

Details of risk–benefit communication in informed consent documents for phase I/II trials
Research Article
Hannes Kahrass, Sabine Bossert, Christopher Schürmann, Daniel Strech
Clinical Trials, 24 November 2020
Abstract
Background
Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk–benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.
Method
We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk–benefit communication.
Results
The risk–benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as “common” or “rare,” and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards.
Conclusion
Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk–benefit communication and to clarify ways to specify the likelihood of health benefits.

Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations
Original Article
Caren J. Frost, Erin P. Johnson, Brieanne Witte, Louisa Stark, Jeff Botkin, Erin Rothwell
Journal of Community Genetics, 22 January 2021
Abstract
We developed a video and an app for obtaining consent about allowing newborn blood spots (NBS) to be used as biospecimen resources for biobanking. Newborn screening programs test for treatable diseases and leave residual biospecimens that can be used in future research activities. We conducted focus groups and interviews with three diverse communities to determine (a) how well the consent tools worked and (b) participant familiarity with NBS. Participants preferred the video and noted that they were unaware that NBS could be used for future research. Providing information about how biospecimens could be used was a key issue.

Informed Consent: What Must Be Disclosed and What Must Be Understood?
Joseph Millum, Danielle Bromwich
American Journal of Bioethics, 18 January 2021
Abstract
Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials.

Caregivers’ Understanding of Informed Consent in a Randomized Control Trial
Original Research
Dorothy Helen Boyd, Yinan Zhang, Lee Smith, Lee Adam, L. Foster Page & W. M. Thomson
Journal of Bioethical Inquiry, 15 January 2021
Abstract
There are differences in caregivers’ literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers’ understandings, of the process of informed consent that accompanied their child’s participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants’ perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent.

The reality of informed consent: empirical studies on patient comprehension—systematic review
Review
Tomasz Pietrzykowski, Katarzyna Smilowska
BMC Trials, 14 January 202; 22(57)
Open Access
Abstract
Background
Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients’ comprehension of an informed consent’s basic components shows that their level of understanding is limited.
Methods
Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients’ comprehension of specific informed consent components.
Results
In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.
Conclusions
We found that participants’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process.

Selfie consents, remote rapport, and Zoom debriefings: collecting qualitative data amid a pandemic in four resource-constrained settings
Practice
Mark Donald C Reñosa, Chanda Mwamba, Ankita Meghani, Nora S West, Shreya Hariyani, William Ddaaki, Anjali Sharma, Laura K Beres
BMJ Global Health, 8 January 2021; 6(1)
Open Access
Abstract
In-person interactions have traditionally been the gold standard for qualitative data collection. The COVID-19 pandemic required researchers to consider if remote data collection can meet research objectives, while retaining the same level of data quality and participant protections. We use four case studies from the Philippines, Zambia, India and Uganda to assess the challenges and opportunities of remote data collection during COVID-19. We present lessons learned that may inform practice in similar settings, as well as reflections for the field of qualitative inquiry in the post-COVID-19 era. Key challenges and strategies to overcome them included the need for adapted researcher training in the use of technologies and consent procedures, preparation for abbreviated interviews due to connectivity concerns, and the adoption of regular researcher debriefings. Participant outreach to allay suspicions ranged from communicating study information through multiple channels to highlighting associations with local institutions to boost credibility. Interviews were largely successful, and contained a meaningful level of depth, nuance and conviction that allowed teams to meet study objectives. Rapport still benefitted from conventional interviewer skills, including attentiveness and fluency with interview guides. While differently abled populations may encounter different barriers, the included case studies, which varied in geography and aims, all experienced more rapid recruitment and robust enrollment. Reduced in-person travel lowered interview costs and increased participation among groups who may not have otherwise attended. In our view, remote data collection is not a replacement for in-person endeavours, but a highly beneficial complement. It may increase accessibility and equity in participant contributions and lower costs, while maintaining rich data collection in multiple study target populations and settings.

Informed Consent Procedure in Clinical Trials Promoted by the Hospital: Knowledge and Perceptions of Primary Care Physicians
Gómez-Arbonés J, Salazar-Alarcon E, Solanilla-Puertolas M, Ortega-Bravo M, , Vallez-Valero L, Schoenenberger-Arnaiz JA
Journal of Clinical Trials & Research, 24 April 2020; 3(3) pp 197-202
Open Access
Abstract
Objectives
To evaluate Primary Care Physician’s (PCP) awareness degree concerning their patient’s participation in Clinical Trials (CT) analyze the communication methods used and obtain physicians personal views.
Methods
Authors performed a cross-sectional observational study that included CTs approved by the Institutional Review Board at a Regional University Hospital (n=78). Among these 37 CTs were selected. PCPs involved in these trials received a questionnaire regarding aspects of the CTs in which their patients participated. The communication systems established in the study protocols were analyzed.
Results
Out of 89 PCPs contacted, 82.1% were aware of their patient’s participation in CTs. The information reached them through verbal communication from the participant (56.3%). PCPs also accessed it through electronic medical records (EMR) (34.0%). A majority (97.4%) considered being informed about the participation of their patients in CTs should be compulsory.
Conclusion
Communication of patients’ participation in CTs fundamentally takes place through a verbal interaction between patients and their doctor. PCPs consider that the preferred method of communication would be an alarm system in the patient’s EMR.