Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses’ experiences
Research
Trails, 11 December 2023; 24(801)
Tove Godskesen, Joar Björk, Niklas Juth
Open Access
Abstract
Background
Clinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.
Methods
A qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis.
Results
The analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians’ recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments.
Conclusions
In conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.

Parental Perceptions of Informed Consent in a Study of Tracheal Intubations in Neonatal Intensive Care
Original Research Article
Susanne Tippmann, Janine Schaefer, Christine Arnold, Julia Winter, Norbert W. Paul, Eva Mildenberger, André Kidszun
Frontiers in Pediatrics, 2023
Abstract
Obtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care. This was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial. We received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant’s participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n=1) approached before birth, 23 parents (82.1%, n=28) approached after birth but before enrolment and 26 (83.9%, n=31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt.

Comparative analysis of multiple models of electronic informed consent in clinical research
Xu Zuo, Yue Li, Yingshuo Huang
Chinese Journal of Medical Science Research Management, 2023; (4) pp 194-199
Objective
To provide decision-making support for electronic informed consent selection and promotion in clinical research, and lay a possible theoretical foundation for better protection of subjects′ rights and interests, as well as promotion of clinical research quality and efficiency.
Methods
This paper summarized the relevant laws and regulations of electronic informed consent, analyzed the advantages and challenges of the application of electronic informed consent in clinical research, sorted out several common electronic informed consent modes in domestic clinical research, explored their operational processes and applications, and discussed their advantages and limitations.
Results
At present, three electronic informed consent modes were mainly used in domestic clinical studies. Each had their own advantages and limitations in terms of convenience of operation, data security, privacy protection of subjects, cost input, popularization degree and so on.
Conclusions
Electronic informed consent needs continuing improvement of relevant laws and regulations and the joint efforts of all stakeholders engaged in clinical research. The sponsor and the researcher should take full consideration of the cost, safety, security, feasibility, and ofters, and make the selection according to the actual needs of the research.

Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members’ and Researchers’ Views
Anita Ho, Soodabeh Joolaee, Michael McDonald, Don Grant, Michel M White, Holly Longstaff, Eirikur Palsson
Ethics of Human Research, November-December 2023
Abstract
Informed consent is a cornerstone of ethical human research. However, as cluster randomized trials (CRTs) are increasingly popular to evaluate health service interventions, especially as health systems aspire toward the learning health system, questions abound how research teams and research ethics boards (REBs) should navigate intertwining consent and data-use considerations. Methodological and ethical questions include who constitute the participants, whose and what types of consent are necessary, and how data from people who have not consented to participation should be managed to optimize the balance of trust in the research enterprise, respect for persons, the promotion of data integrity, and the pursuit of the public good in the research arena. In this paper, we report the findings and lessons learned from a qualitative study examining how researchers and REB members consider the ethical dimensions of when data can be collected and used in CRTs in the evolving research landscape.

Altered stakes: Identifying gaps in the informed consent process for psychedelic-assisted therapy trials
Tahlia R. Harrison
Journal of Psychedelic Studies, 20 November 2023
Abstract
Background and aims
Psychedelic-assisted therapy (P-AT) has been shown to reduce post-traumatic stress disorder (PTSD), depression, and anxiety symptoms, and is likely to be approved in the United States (US) in the coming years. However, concerns about participant safety in these early trials have surfaced, including allegations of sexual misconduct. This paper aims to illuminate how potential risks have been communicated to P-AT participants via informed consent documents and to suggest how existing policy might be modified given the unique risks involved in P-AT trials.
Methods
Publicly available informed consent forms (ICFs) were gathered by searching clinicaltrials.gov. Queries were applied to filter trials involving the use of a classical psychedelic (psilocybin, LSD) or psychedelic-adjacent substance (MDMA, ketamine) in tandem with psychotherapeutic intervention and those with a status of “completed,” “recruiting,” or “active.”
Results
Nineteen ICFs met inclusion criteria and were reviewed to determine what risks, benefits, and safety protocols were communicated to participants in their respective trials. The primary finding from this review of ICFs from P-AT trials revealed that studies were in compliance with federal regulation. However, there were missing elements related to the vulnerability experienced while under the effects of psychedelics that warrant inclusion in future ICFs in P-AT trials.
Conclusion
Although the ICFs for P-AT trials examined in this study covered several important areas related to risk, benefits, safety, and accountability as required by federal regulations in the US, future research should consider ways to expand this content in order to assure that consent is truly informed prior to enrolling subjects.

Optimizing treatment expectations and decision making through informed consent for psychotherapy: A randomized controlled trial
Leonie Gerke, Franz Pauls, Sönke Ladwig, Sarah Liebherz, Klaus Michael Reininger, Levente Kriston, Manuel Trachsel, Martin Härter, Yvonne Nestoriuc
Journal of Consulting and Clinical Psychology, 16 November 2023
Abstract
Objective
The objective of this research was to determine the efficacy and safety of an optimized informed consent (OIC) consultation for psychotherapy.
Method
We performed a randomized controlled superiority online trial involving 2 weeks of treatment and 3 months of follow-up. One hundred twenty-two adults with mental disorders confirmed by structured interview currently neither in out- nor inpatient psychotherapy (mean age: 32, gender identity: 51.6% female, 1.6% diverse), were randomized. Participants received an information brochure about psychotherapy for self-study (treatment as usual [TAU]; n = 61) or TAU plus a one-session OIC utilizing expectation management, contextualization, framing, and shared decision making (n = 61). The primary outcome was treatment expectations at 2-week follow-up.
Results
At 2-week follow-up, participants receiving OIC showed more positive treatment expectations compared to those receiving TAU only (mean difference: 0.70, 95% CI [0.36, 1.04]) with a medium effect size (d = 0.73). Likewise, OIC positively influenced motivation (d = 0.74) and adherence intention (d = 0.46). OIC entailed large effects on reduction of decisional conflict (d = 0.91) and increase of knowledge (d = 0.93). Participants receiving OIC showed higher capacity to consent to treatment (d = 0.63) and higher satisfaction with received information (d = 1.34) compared to TAU. No statistically significant group differences resulted for expected adverse effects of psychotherapy. Results were maintained at 3-month follow-up. Data sets for n = 10 cases (8.2%) were missing (postassessment n = 4, 2-week n = 6, 3-month follow-up n = 8).
Conclusions
Explaining to patients how psychotherapy works via a short consultation was effective in strengthening treatment expectations and decision making in a nonharmful way. Further trials clarifying whether this effectively translates to better treatment outcomes are required. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Informed Consent among Clinical Trial Participants with Different Cancer Diagnoses
Research Article
Connie M. Ulrich, Sarah J. Ratcliffe, Camille J. Hochheimer, Qiuping Zhou, Liming Huang, Thomas Gordon, Kathleen Knafl, Therese Richmond, Marilyn M. Schapira, Victoria Miller, Jun J. Mao, Mary Naylor, Christine Grady
AJOB Empirical Bioethics, 3 November 2023
Abstract
Importance
Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.
Objective
To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.
Design and Setting and Participants
Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334).
Main Outcome Measures
Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.
Results
Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.
Conclusions and Relevance
Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

Effects of same-day consent vs delayed consent on the recruitment and retention of trial participants—an observational SWAT
Methodology
Elfghi, F. Jordan, S. Sultan, W. Tawfick
Trials, 25 October 2023
Open access
Abstract
Background and aim
The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered study. We aimed to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial.
Methods
This SWAT is designed as a prospective cohort design. The host trial was a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification programme in participants with peripheral arterial disease. Researchers screened the participants for inclusion and exclusion criteria. Informed consents were obtained from the participants who were willing to participate in the study on a standardized consent form. Participants were given the option to consent on the same day or to delay their consent. Following the consent, the participants were allocated to two groups (same-day consent vs. delayed consent) based on pre-determined criteria for SWAT. One hundred sixteen participants were consented to take part in the host trial. Seventy-five participants were randomized to the host trial. The primary outcome was the proportion of participants who withdrew consent at the recruitment phase. Secondary outcomes were reasons for consent withdrawal and dropout, attrition rate, and adherence with the host trial intervention.
Results
There was a significantly lower consent-withdrawal rate in same-day consent (17.4%, n = 8/46), compared to the delayed consent group (47.1%, n = 33/70), p = 0.001. There was a significantly lower dropout rate in participants randomized following same-day consent (10.5%, n = 4/38), compared to those randomized after delayed consent (29.7%, n = 11/37), p = 0.038. Transport was the main reason mentioned for consent withdrawal and dropout. In participants randomized to the host trial intervention arm, there was a significant difference in adherence (percentage of the 12-week programme completed) between same-day consent (96.7% ± 4.9) and delayed consent participants (86.4% ± 11.2), p = 0.003, as well as number of weeks completed (mean difference =  − 1.547, 95% confidence intervals (− 2.237 to − 0.85)), p = 0.02.
Conclusion
This SWAT found evidence that participants who gave consent on the same day seemed to have better adherence and fewer-withdrawal and dropout rates.

Editor’s note: A SWAT is a “study within a trial”.

A Systems Approach to Improving Clinical Trial Informed Consent Forms in Lung Cancer Clinical Trials
Conference Paper
King-Kallimanis, T. Chihuri, A. Ferris, U. BasuRoy
Precision Language In Thoracic Oncology, 11 September 2023
Abstract
Introduction
The informed consent form (ICF) literature is filled with ideas about how to aid potential trial participants in making informed choices. Yet, ICFs continue to grow in length with increased trial complexity and remain dense documents. In our review of lung cancer ICFs presented at WCLC 2022, we reported that these ICFs did not meet the regulatory requirement of being written at an 8th grade reading level. Building on that work we explored, from a systems perspective, the barriers to implementing a patient-centric addendum summarizing key information to the ICF.
Methods
We solicited key stakeholder feedback in three stages to understand barriers and facilitators to creating an addendum. Three stages of work are described. 1. Industry roundtable; Presentation of our earlier work to eight companies followed by a discussion of potential barriers to implementing an addendum. 2. One-on-one research stakeholder interviews; 15 interviews including IRB chairs, legal/compliance advisors, regulators, bioethicists, research nurses and principal investigators. Each interview explored the stakeholder’s role in developing/using ICFs, information selection, and improving the ICF. 3. Patient/Caregiver online survey; open to patients and caregivers living with lung cancer. Participants were asked to read 13 regulatory requirements for ICFs and rank the six most important to them, and provide their preferences regarding the presentation of information.
Results
Industry stakeholders generally supported an addendum to the ICF. However, they raised concerns regarding how “key information” would be selected and not be perceived as “cherry picking”. This concern was raised because of internal efforts of attendees when creating summaries to accompany the ICF for their own trials. In the research stakeholder one-on-one interviews, participants involved in developing ICF language expressed a desire for a standardized form. There was no agreement on the creation of an addendum; some participants argued it is yet another document for review while others supported its creation. One participant succinctly described the addendum as analogous to the patient leaflet for prescribed medications. Surveyed patients and caregivers indicated a strong preference for information to be presented in bullet format (67%). Most participants ranked, as their first preference, the requirement of being told “What will happen during the study” (Figure).
Conclusions
Previous studies identifying methods to help with comprehension of ICFs have gone mostly ignored. By taking a systems approach through leveraging key stakeholder feedback to learn of hidden barriers, we want to ensure patients are making an informed choice to participate in clinical trials.

uConsent: Addressing the gap in measuring understanding of informed consent in clinical research
Richard F. Ittenbach, J. William Gaynor, Jenny M. Dorich, Nancy B. Burnham, Guixia Huang, Madisen T. Harvey, Jeremy J. Corsmo
Clinical and Translational Science, 12 October 2023
Abstract
The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a large, pediatric medical center completed the consenting process of a hypothetical biobanking study. Data were analyzed using a combination of classical and modern theory analytic methods to produce a final set of 19 items referred to as the uConsent scale. A requirement of the scale was that each item mapped directly onto one or more of the Basic Elements of Informed Consent from the 2018 Final Rule. Descriptive statistics were computed for each item as well as the scale as a whole. Partial credit (Rasch) logistic modeling was then used to generate difficulty/endorsability estimates for each item. The final, 19- item uConsent scale was derived using inferential methods to yield a set of items that ranged across difficulty levels (−3.02 to 3.10 logits) with a range of point- measure correlations (0.12 to 0.50), within- range item-  and model- fit statistics, varying item types mapped to both Bloom’s Taxonomy of Learning and required regulatory components of the 2018 Final Rule. Median coverage rate for the uConsent scale was 95% for the 25 randomly selected studies from ClinicalTrials.gov. The uConsent scale may be used as an effective measure of informed consent when measuring and documenting participant understanding in clinical research studies today.