Consent In Trials Research Articles

Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients

BACKGROUND The interactive media–based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated. METHODS This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States. Each site was provided with templated materials that had been reviewed and approved by a central institutional review board (cIRB). We collected the dates of milestones, including the study “kickoff call,” start of the social media campaign, dates of online community meetings, date of submission of site report to the cIRB, and cIRB approval date. RESULTS Sixty-two sites were cIRB approved at the time of this analysis. The median time from the kickoff call to the start of the social media campaign was 79 days, with an interquartile range of 33 to 126 days (range, 0–285 days). All social media campaigns ran for the prescribed period of at least 2 months. All sites conducted at least four online community meetings. The median number of days from the kickoff call to cIRB approval was 216 days (interquartile range, 168–281 days; range, 116–459 days). There was no significant difference between sites that had previous experience of EFIC trials. CONCLUSION Using the interactive media–based approach, CC/PD can be completed quickly; however, there are barriers that can incur substantial delays. Greater harmonization of local administrative processes would shorten the time to conduct CC/PD activities and facilitate the timely commencement and execution of EFIC trials. LEVEL OF EVIDENCE Systematic Review without Meta-analysis; Level III.

Researchers experience and views on participants’ comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study

BackgroundInformed consent is the cornerstone of research ethics. One of its goals is that participants enter research with an understanding of what their participation entails. This paper is a study on how researchers understand the informed consent process. Previous studies have looked at this topic from a research participant perspective. However, few studies focus on the perspectives of the researchers. Therefore, this is an important paper that highlights an important issue (informed consent) from the perspective of those who administer it during research.MethodsIn-depth interviews were conducted with 18 researchers from 3 different research centers in Malawi working in clinical trials. The data was analyzed using open code utilizing the thematic approach to qualitative data.ResultsThis study identified that researchers have good awareness of the role of informed consent, how important it is for participants to understand the given information and ways to adjust their practice accordingly when obtaining it in order to enhance participant understanding. According to the research staff, most participants do not really understand all the concepts of the study at the initial visit, they gain more understanding during subsequent visits. It was emphasized that the best method of facilitating informed consent is reading the informed consent to the participant, thus a face-to-face conversation. Long and complex informed consent was identified as one of the barriers to participant understanding of the informed consent. Shortening the informed consent form and having additional conversation with the participants was suggested as one way of improving participant comprehension.ConclusionMost of the participants understand much of the information during subsequent visits as you keep reminding them since informed consent is an ongoing process. Existing relationship or trust between a participant and a researcher, may influence participants’ decision and misguide their understanding on the purpose of the study. Adequate time should be allocated to informed consent discussions. Shortening the informed consent forms and having additional conversations with potential participants may help improve their understanding.

Abstract IA013: Increasing Diversity in Pediatric Cancer Clinical Trials: Challenges and Opportunities

Abstract Although childhood cancer is the leading cause of death by disease past infancy in the US, with 17,000 children younger than 21 years being diagnosed annually, survival has improved dramatically, and is now greater than 80% overall. Because of unequal access to services and adverse Social Determinants of Health (SDOH) affecting underserved populations, disparities in survival exist among minoritized youth with cancer. For example, Hispanic children have higher incidence of certain cancers and poorer survival rates than non-Hispanic White children. Minorities are severely under-represented in research. This means that cancer outcomes data are largely based on data from non-Hispanic White participants, and there is incomplete information to adequately assess treatment benefits for minorities. We showed that 53% of Latino parents declined research participation, compared to 20% of non-Hispanic White parents, in our institution. There are several barriers to informed consent for clinical trials. First, there are no mandates to ensure comprehension, and informed consent forms are complex, long, and difficult to understand. This leaves parents of children with cancer with an incomplete understanding of risks, procedures, randomization, alternative treatments, and the voluntary nature of clinical trial participation. Furthermore, pediatric cancer often requires urgent treatment, leaving little time for decision-making. We developed COMPRENDO (ChildhOod Malignancy Peer REsearch NavigatiOn), a peer-navigation intervention to improve research literacy and diversity in pediatric cancer clinical trials. In this intervention, trained peer-navigators, who have the lived experience of having a child diagnosed with cancer, provide in-hospital support. The goals of COMPRENDO are to improve parents’ informed consent experience and comprehension of informed consent for cancer treatment, to explain to parents terms to be discussed by the oncologist during the treatment conference, to introduce to parents concepts of clinical trials and research, and to facilitate and empower shared decision-making. In a pilot study at Rady Children’s Hospital-San Diego, this intervention showed a significant increase in comprehension of therapeutic trials, particularly in Hispanic and Spanish-speaking parents. The demographics of children with cancer enrolled in clinical trials should be comparable to the US population, and approaches to improve enrollment must also be tailored to specific settings. Structural barriers for participation of minorities should be considered during study and informed consent design and planning. Strategies to increase clinical trial enrollment of minority individuals include: Provider-level training on patient-provider communication, development of linguistically appropriate tools, and promotion of culturally aware staff. Key strategies at the patient-level include building trust; education and awareness of clinical trials; implementation of culture, language, and health literacy-concordant interventions; and initiatives to address adverse SDOH. Citation Format: Paula Aristizabal. Increasing Diversity in Pediatric Cancer Clinical Trials: Challenges and Opportunities [abstract]. In: Proceedings of the AACR Special Conference in Cancer Research: Advances in Pediatric Cancer Research; 2024 Sep 5-8; Toronto, Ontario, Canada. Philadelphia (PA): AACR; Cancer Res 2024;84(17 Suppl):Abstract nr IA013.

CLARA-MeD Tool - A System to Help Patients Understand Clinical Trial Announcements and Consent Forms in Spanish.

We present an NLP web-based tool to help users understand consent forms (CFs) and clinical trial announcements (CTAs) in Spanish. For complex word identification, we collected: 1) a lexicon of technical terms and simplified synonyms (14 465 entries); and 2) a glossary (70 547 terms) with explanations from sources such as UMLS, the NCI dictionary, Orphadata or the FDA. For development, we extracted entities from 60 CTAs, 60 CFs and 60 patient information documents (PIDs). To prepare definitions for new terms, we used ChatGPT and experts validated them (28.99% needed to be fixed). We tested the system on 15 new CTAs, 15 CFs, and 15 PIDs, and we achieved an average F1 score of 82.91% (strict match) and of 94.65% (relaxed). The tool is available at: http://claramed.csic.es/demo.

Towards an understanding of the ethics of electronic consent in clinical trials

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

Willingness to participate in an active exception from informed consent trial in the pediatric intensive care unit.

Willingness to participate in an active exception from informed consent trial in the pediatric intensive care unit.

Quality of Informed Consent in Phase III Clinical Trials in Portugal: The Participants' Perspective.

Some studies show that participants do not always fully understand the informed consent form (ICF), which is one of the reasons for dropouts. This study aimed to adapt the Quality of Informed Consent (QuIC) questionnaire into a valid instrument to be applied to the Portuguese population and to measure its reliability and validity in the Portuguese population, by applying it to a sample of participants in controlled trials. The QuIC questionnaire was developed to assess the quality of informed consent in clinical trials and consists of two parts, addressing both the objective (part A) and the subjective (part B) understanding. After being translated and validated into Portuguese, it was implemented in 100 cardiac participants of phase III clinical trials in a University Hospital Center. The QuIC-PT questionnaire showed excellent stability over time and good validity. All patients evaluated their participation and their health positively and recognized the main purpose of the clinical trial. Almost all participants understood their role in helping future patients and the purpose of the trial and realized that, by signing the ICF, they were participating in a clinical trial. However, none of them knew that their experimental treatment was not proven to be the best alternative for their condition. The QuIC-PT questionnaire seems to be a valid and useful instrument to evaluate the participants' understanding of the ICF. In this study, we found that some concepts, like 'study protocol' or 'randomization', were not well understood by participants when signing the ICF, especially by participants with lower education levels. They also believed that the experimental intervention would solve their health condition. Greater awareness about the importance of the informed consent process and ICF is necessary so that participants can fully understand the protocol, especially the risks involved, and their rights as participants.

A Randomized Controlled Trial of Consent for Patients Undergoing Transobturator Slings.

Improving patients' recall and understanding of their planned surgery is essential for fully informed consent. The objective of this study was to assess if the addition of an information handout to the standard preoperative consent process for the transobturator midurethral sling procedure improved patient understanding, recall, and satisfaction. This is a randomized controlled trial of adult women undergoing a transobturator midurethral sling procedure for the treatment of stress urinary incontinence. After standard counseling, participants were randomly assigned to either the control or the intervention group, with the latter receiving an extra informational handout detailing surgical information. Before surgery, all participants filled out a questionnaire assessing key points discussed during the surgical consent, which was used to calculate a knowledge score, the primary endpoint. Secondary outcomes included perception of the consent process and patient satisfaction. Of 98 randomized participants (50 control, 48 intervention), knowledge scores were 43% for controls and 57% for the intervention group (P = 0.015). Despite low scores, high self-rated understanding and satisfaction were noted across both groups (78% control, 71% intervention, P = 0.4). Notably, younger individuals, those with some college education, and patients undergoing additional prolapse surgery benefited most from the handout. The informational handout improved knowledge scores, though overall knowledge scores were low in both groups. High satisfaction and perceived understanding of the planned procedure persisted, but the addition of a handout was not associated with a significant difference in knowledge scores.

Coerced consent in clinical research: study protocol for a randomized controlled trial

BackgroundDespite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies.MethodsWe describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women’s College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial.DiscussionThis study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients.Trial registrationThe trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

Obtaining informed consent in veterinary clinical trials mini review.

In September 2023 the United States Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.

Delivery mode after cervical ripening among patients with no prior vaginal births

PurposeTo compare mode of delivery and maternal and neonatal outcomes using cervical ripening balloon (CRB) for induction of labor (IOL) in nulliparous patients vs. those undergoing first trial of labor after cesarean (TOLAC). MethodsRetrospective cohort study including data from two tertiary medical centers. Included were all patients with a singleton pregnancy and a gestational age > 37+0 weeks and no prior vaginal birth undergoing IOL with CRB. Nulliparous patients (nulliparous group) were compared to patients with one prior cesarean delivery (CD) and no prior vaginal delivery (TOLAC group). Patients who withdrew consent for trial of labor at any time in both groups were excluded. The primary outcome was mode of delivery. ResultsOverall, 161 patients were included in the TOLAC group and 1577 in the nulliparous group. The rate of CD was similar in both groups and remained similar after adjusting for confounders (29.8 % vs. 28.9 %, p = 0.86, OR 1.1, 95 %, CI 0.76–1.58). CD due to fetal distress was more common in the TOLAC group (75 % vs. 56 %, p = 0.014). Other maternal outcomes and neonatal outcomes were similar in the two groups. ConclusionComparable vaginal delivery rates may be achieved in patients with or without a previous CD attempting their first trial of labor, with a cervical ripening balloon for labor induction, without increasing adverse maternal or neonatal outcomes.

Influence of family caregivers on clinical trial decisions: Results from a qualitative study.

e23023 Background: Family caregivers are key stakeholders in cancer clinical trial decisions who have been overlooked in previous research. Caregivers play a critical role in supporting patients during clinical trial participation, yet there is little consensus regarding how they should be included in informed consent. Clinical trial staff communicate regularly with patients and caregivers during consent and throughout trial participation, making their perspectives vital to understanding the role caregivers play in these decisions. Methods: This qualitative study identifies the roles caregivers play in cancer trial decision-making, influential factors from the caregiver perspective, and practices of clinical trial staff regarding caregiver inclusion in consent. Patients who were offered a clinical trial at a midwestern comprehensive cancer center were asked to identify a caregiver to participate. Clinical trial staff were recruited via email invitation. We conducted focus groups with caregivers and trial staff, followed by semi-structured interviews with caregivers. Caregivers were asked about attitudes towards research, experiences with trial consent, and their role in decision-making. Trial staff were asked how they included caregivers in consent and attitudes towards their involvement. Transcripts were coded, then analyzed with NVivo using content analysis. Results: Focus groups consisted of 9 caregivers and 10 clinical trial staff, then 15 caregivers completed interviews. Caregiver themes included promoting patient autonomy, influential factors, and burdens of trial participation. Trial staff themes were approaches to caregiver inclusion, navigating challenging situations, and the need for training. Caregivers viewed their role as supporting patient understanding and deferring to the patient as final decision-maker. Hope for therapeutic benefit, oncologist endorsement, and practical barriers (e.g. cost, distance) were influential. Trial staff viewed caregivers as highly influential and encouraged their involvement in consent despite occasional challenges such as family disagreement and undue influence. Conclusions: Early communication with caregivers when offering a trial is vital due to their influential role in decision-making. Clinical trial staff would benefit from training on best practices for inclusion of caregivers, including communication, managing emotions, mediating disagreement, and where to refer caregivers for support. Researchers should consider caregiver burden and potential sources of caregiver support during trial design to minimize barriers to participation.

Are the clinical trials in lung cancer an advantage for patients in developing countries?

e20523 Background: Clinical trials are critical to developing new drugs. This study examined the characteristics of patients diagnosed with metastatic non-small cell lung cancer (mNSCLC) and who wanted to participate in clinical trials. This study aims to compare the outcomes of patients who enrolled in clinical trials or not. Methods: The data of the patients who applied to Ankara Yildirim Beyazit University Medical Oncology Department to participate in the first-line treatment-related clinical trials in mNSCLC were retrospectively reviewed. Survival outcomes of patients included in clinical trials (CT) and patients who signed informed consent for clinical trials but could not enroll (standard treatment-ST) were compared. Results: Data from 155 patients who applied to participate in clinical trials were analyzed. Patients who died during the screening process and who lacked systemic treatment information were excluded (n = 14). While 55.3% (n = 78) of the patients participated in the clinical trials, 44.7% (n = 63) could not. Not meeting the inclusion criteria (pathological and clinical) was the most common reason for screen-fail. At a median follow-up of 29 months, median overall survival was 17.1 months (95%CI, 15.1 to 19.1) in the CT group and 9.6 months (95%CI, 7.1 to 12.1) in the ST group (p = 0.015). Median progression-free survival was 11.6 (95% CI, 5.9 - 17.4) and 5.4 (95% CI, 3.7 - 7.2) months, respectively (p = 0.014). Conclusions: Being able to take part in clinical trials is not unfavorable, and it may even improve survival for patients with metastatic non-small cell lung cancer (mNSCLC), particularly in areas of the world where access to novel and effective treatments is limited.

Anxiety in couples undergoing IVF: evidence from E-Freeze randomised controlled trial.

What are the risk factors and impacts of anxiety in women and men in heterosexual couples undergoing IVF as part of a randomised trial, with a delay in embryo transfer in one arm? Duration of infertility, ethnicity, and male partner's anxiety levels were associated with women's anxiety at the start of treatment, while initial anxiety score, partner's anxiety score at embryo transfer, ethnicity, and clinic location were associated with women's anxiety levels at embryo transfer; although women undergoing IVF were more anxious than their partners for slightly different reasons, their self-reported state anxiety was not associated with achieving clinical pregnancy, nor with switching from delayed frozen embryo transfer to fresh embryo transfer in an IVF trial. Use of IVF treatment continues to rise and patients undergoing IVF are anxious. Participating in a randomised controlled trial (RCT) with uncertainty of arm randomisation might increase their anxiety, while a delay in treatment may add further to anxiety. A mixed methods study was conducted using data from the multi-centre E-Freeze RCT cohort conducted across 13 clinics in the UK from 2016 to 2019. A regression analysis on anxiety scores of couples undergoing the IVF trial and a qualitative analysis of participant questionnaires were performed. Six hundred and four couples participating in the E-Freeze trial, who had at least one useable State-Trait Anxiety Inventory (STAI) State Anxiety subscale (STAI-S) standardised self-report questionnaire for at least one of the partners, were included in the study. STAI-S scores were measured at consent for trial (T1) and again at embryo transfer (T2). Linear and log-binomial regression were used to explore the association between characteristics and STAI-S scores, and the associations between STAI-S scores and non-compliance and clinical pregnancy, respectively. Responses to the open text question were qualitatively analysed inductively using content analysis. Women's STAI-S scores at T1 (consent) were associated with their ethnicity, duration of infertility, and their male partner's STAI-S score at T1. Women's STAI-S scores at T2 (embryo transfer) were associated with their ethnicity, location of fertility clinic, their STAI-S score at consent, and their male partner's STAI-S score at embryo transfer. The adjusted coefficient (95% CI) for women's STAI-S scores at T2 was -4.75 (-7.29, -2.20, P < 0.001) for ethnic minority versus White, -2.87 (-4.85, -0.89, P = 0.005) for Scotland versus England, 0.47 (0.37, 0.56, P < 0.001) for each point increase in their own score at T1, and 0.30 (0.21, 0.40, P < 0.001) for each point increase in their male partner's score at T2. On average, women had higher STAI-S scores than men at both time points, and a larger increase of scores between the two time points. However, women's STAI-S scores were not associated with either non-compliance with trial allocation in the 'freeze-all' trial arm, or with chances of pregnancy. Both partners, but particularly women, described feeling anxious about the outcome of IVF, with women carrying the added worry of believing that feeling stressed might itself affect the outcome. Participants highlighted the important role of support from staff in helping them to manage their anxiety. Data were not available on education level or social support, which might influence anxiety scores. Men's baseline characteristics were not collected. Identifying couples at increased risk of emotional distress may be improved by using standardised anxiety measures at the start of the fertility treatment. Women can be reassured that their self-reported state anxiety does not affect their chances of achieving clinical pregnancy through IVF, and this may help to reduce anxiety levels. The psychological wellbeing and experiences of couples undergoing IVF could be supported by patient-centred care: making information about the whole process of treatment and choices available to both partners in accessible formats; ensuring interactions with staff are kind and supportive; and acknowledging and addressing the different concerns of women undergoing IVF and their partners. This study was an NIHR HTA (National Institute for Health and Care Research Health Technology Assessment) funded study. There are no conflicts of interest to declare. ISRCTN registry: ISRCTN61225414.

A reactogenic "placebo" and the ethics of informed consent in Gardasil HPV vaccine clinical trials: A case study from Denmark.

Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits. To examine Merck's scientific rationale for using a reactogenic aluminum-containing "placebo" in Gardasil HPV vaccine pre-licensure clinical trials. We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines. It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study's primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck's proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant "placebo" group. In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as "placebos" in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

Providing informed consent for trials requires providing trial participantswith comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs). A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently,to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third. Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on allknown potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas. Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic.

Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research. The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings. During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public. The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

Informed consent in cancer clinical care: Perspectives of healthcare professionals on information disclosure at a tertiary institution in Uganda.

While there have been several studies examining the understanding and quality of informed consent in clinical trials of cancer therapies, there is limited empirical research on health practitioners' experiences on the informed consent process in cancer care, especially from low resource settings. This study explored health professionals' perspectives on information disclosure during the consenting process in cancer care. A qualitative descriptive approach was used to collect data. Face to face interviews were conducted with 10 purposively selected healthcare professionals who were actively involved in soliciting informed consent at a cancer treatment centre in Uganda. A thematic approach was used to interpret the results. There were five key themes, and these included information disclosure to patients; assessment of patients' cancer awareness, treatment preferences and expectations; informed consent practices; barriers to optimal informed consent and information disclosure; and recommendations for improving the consenting process. All respondents appreciated the value of disclosing accurate information to patients to facilitate informed decision making. However, the informed consent process was deemed sub-optimal. Respondents asserted that patients should be the psychological wellbeing of patients should be protected by mentally preparing them before disclosing potentially distressing information. All healthcare professionals were appreciative of the central role the family plays in the consenting process. Overall, informed consent practices were not ideal because of the several challenges. Inadequate time is devoted to information disclosure and patient education; there is lack of privacy; and informed consent documentation is poor. There is a need for significant improvement in informed consent practices and healthcare professional-patient communication.

Contraception Requirements in Clinical Research Consent Forms: Assessing and Supporting Gender Inclusive Practices.

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

Public perception of participation in low-risk clinical trials in critical care using waived consent: a Canadian national survey.

The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials. We performed a prospective cross-sectional survey of the Canadian public aged 18yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive. We included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively. There is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.