Rethinking consent processes for research in emergency departments
Perspective
Joseph Miller, Stephen Guy Costa,  David Alan Taylor, Paul Buntine
Emergency Medicine Australasia, 17 April 2021
Abstract
Emergency medicine researchers face the challenge of prioritising patients’ immediate interests and maintaining hospital flow while attempting to collect clinical data. Even in low‐risk scenarios, excessive consent processes can make it difficult to recruit patients while observing guidelines on efficient triage. We discuss a recent situation in which a six‐page consent form appeared to deter clinicians from recruiting patients to a low‐risk intervention. We then argue that there need be no conflict between the imperatives of patient wellbeing and clinical research. Apparent conflicts between treatment and research could be reduced through creative recruitment techniques: the adoption of an ‘opt‐out’ approach; securing the budget for a dedicated research assistant; early consultation with the institution’s human research ethics committee; and the use of a short, simple participant information and consent form with a QR code linking to a more detailed outline of the study.

Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study
Research
Mohammed I.U. Khan, Lawrence Mbuagbaw, Matthew Holek, Faris Bdair, Zoha H. Durrani, Katie Mellor, Saskia Eddy, Sandra M. Eldridge, Claire L. Chan, Michael J. Campbell, Christine M. Bond, Sally Hopewell, Gillian A. Lancaster, Lehana Thabane
Pilot and Feasibility Studies, 16 April 2021; 7(96)
Open Access
Abstract
Background
Pilot and feasibility studies (PAFS) often have complex objectives aimed at assessing feasibility of conducting a larger study. These may not be clear to participants in pilot studies.
Methods
Here, we aimed to assess the transparency of informed consent in PAFS by investigating whether researchers communicate, through patient information leaflets and consent forms, key features of the studies. We collected this data from original versions of these documents submitted for ethics approval and the final approved documents for PAFS submitted to the Hamilton Integrated Research Ethics Board, Canada.
Results
One hundred eighty-four PAFS, submitted for ethics approval from 2004 to 2020, were included, and we found that of the approved consent documents which were provided to participants, 83.2% (153) stated the terms “pilot” or “feasibility” in their title, 12% (22) stated the definition of a pilot/feasibility study, 42.4% (78) of the studies stated their intent to assess feasibility, 19.6% (36) stated the specific feasibility objectives, 1.6% (3) stated the criteria for success of the pilot study, and 0.5% (1) stated all five of these criteria. After ethics review, a small increase in transparency occurred, ranging from 1.6 to 2.8% depending on the criteria. By extracting data from the protocols of the PAFS, we found that 73.9% (136) stated intent to assess feasibility, 71.2% (131) stated specific feasibility objectives, and 33.7% (62) stated criteria for success of the study to lead to a larger study.
Conclusion
The transparency of informed consent in PAFS is inadequate and needs to be specifically addressed by research ethics guidelines. Research ethics boards and researchers ought to be made aware and mindful of best practices of informed consent in the context of PAFS.

Under consent: participation of people with HIV in an Ebola vaccine trial in Canada
Research Article
Pierre-Marie David, Benjamin Mathiot, Oumy Thiongane & Janice E. Graham
BMC Medical Ethics, 9 April 2021; 22(42)
Open Access
Abstract
Background
Little is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.
Methods
Observation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on “composite characters” based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities.
Results
Ten of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation.
Conclusions
Our findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North.

Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies
Fons-Martínez J, Ferrer-Albero C, Diez-Domingo J
Research Square, 5 April 2021
Abstract
Background
The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.
Methods
An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.
Results
Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertain changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.
Conclusions
The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.

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.