An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – An analysis of consent narratives
Research Article
Unnati Saxena, Debdipta Bose, Mitesh Kumar Maurya, Nithya Jaideep Gogtay, Urmila Mukund Thatte
Clinical Ethics, 20 September 2020
Abstract
Objective
To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019.
Methods
The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s (ICMR) guidelines (2017). We evaluated total number of questions, nature of questions and whether there was an association between education, gender, phase of trials, physician taking consent and number questions being asked.
Results
A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 (40%) of the participants did not ask any question. Among the participants who asked questions, the majority132/171 (77%) participants asked about risks related to investigational products followed by questions related to study procedures 83/171 (49%). Participants/guardians with higher education (relative to those who were educated upto the secondary school and primary school) and those who consented for Phase III studies (relative to Phase I studies) asked significantly more questions (p < 0.0001).
Conclusion
A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked.

Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy
Original Research
Gail Mallett, Kim Hill, Jessica de Voest, Sabine Bousleiman, Donna Allard, Stacy Harris, Ashley Salazar, Kelly Clark, Felecia Ortiz, Anna Bartholomew, Wendy Dalton, Jennifer Craig, Melissa Bickus,
Obstetrics & Gynecology, 10 September 2020
Abstract
Objective
To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
Methods
This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
Results
From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24–1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48–0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34–1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31–2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51–0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44–4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27–4.95) and women without private insurance (aOR 1.68, 95% CI 1.10–2.59).
Conclusion
Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation.

The Informed Consent Process in Health Research with Under-served Populations: A Realist Review Protocol
Eleanor Hoverd, Sophie Staniszewska, Jeremy Dale
Research Square, 9 September 2020
Open Access
Abstract
Background
The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those whom are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research.
Methods
In order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsychInfo), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory.
Discussion
Findings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that trigger both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.

Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis
Original Research
Lydia O’Sullivan, Prasanth Sukumar, Rachel Crowley, Eilish McAuliffe, Peter Doran
Ethics, 3 September 2020
Abstract
Objectives
The first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.
Design
Retrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.
Setting
PILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.
Intervention
Not applicable.
Main outcome measures
PILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.
Results
A total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as ‘Plain English’, 40.3%: ‘Fairly Difficult’, 51.3%: ‘Difficult’ and 1.3%: ‘Very Difficult’. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.
Conclusions
When assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.

Seven-step framework to enhance practitioner explanations and parental understandings of research without prior consent in paediatric emergency and critical care trials
Original Research
Louise Roper, Mark D Lyttle, Carrol Gamble, Amy Humphreys, Shrouk Messahel, Elizabeth D Lee, Joanne Noblet, Helen Hickey, Naomi Rainford, Anand Iyer, Richard Appleton
BMJ Emergency Medicine Journal, 29 August 2020
Abstract
Background
Alternatives to prospective informed consent enable the conduct of paediatric emergency and critical care trials. Research without prior consent (RWPC) involves practitioners approaching parents after an intervention has been given and seeking consent for their child to continue in the trial. As part of an embedded study in the ‘Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children’ (EcLiPSE) trial, we explored how practitioners described the trial and RWPC during recruitment discussions, and how well this information was understood by parents. We aimed to develop a framework to assist trial conversations in future paediatric emergency and critical care trials using RWPC.
Methods
Qualitative methods embedded within the EcLiPSE trial processes, including audiorecorded practitioner–parent trial discussions and telephone interviews with parents. We analysed data using thematic analysis, drawing on the Realpe et al (2016) model for recruitment to trials.
Results
We analysed 76 recorded trial discussions and conducted 30 parent telephone interviews. For 19 parents, we had recorded trial discussion and interview data, which were matched for analysis. Parental understanding of the EcLiPSE trial was enhanced when practitioners: provided a comprehensive description of trial aims; explained the reasons for RWPC; discussed uncertainty about which intervention was best; provided a balanced description of trial intervention; provided a clear explanation about randomisation and provided an opportunity for questions. We present a seven-step framework to assist recruitment practice in trials involving RWPC.
Conclusion
This study provides a framework to enhance recruitment practice and parental understanding in paediatric emergency and critical care trials involving RWPC. Further testing of this framework is required.